Trial Outcomes & Findings for Pivotal Study in Advanced Parkinsons Disease Patients (NCT NCT00466167)
NCT ID: NCT00466167
Last Updated: 2014-07-08
Results Overview
UPDRS II+III total score on Full Analysis Set (FAS)with LOCF (Last observation carried forward), week 18 - baseline, UPDRS II+III ranging from 0 (normal) to 160 (severe). UPDRS part II measures activities of daily living, part III measures motor symptoms
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
517 participants
Primary outcome timeframe
baseline and week 18
Results posted on
2014-07-08
Participant Flow
Participant milestones
| Measure |
Pramipexole ER
Pramipexole Extended Release (ER) (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning
|
Pramipexole IR
Pramipexole Immediate Release (IR) (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day"
|
Placebo
Matching Placebo to Pramipexole IR (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day
Matching Placebo to Pramipexole ER (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning
|
|---|---|---|---|
|
Overall Study
STARTED
|
165
|
175
|
178
|
|
Overall Study
COMPLETED
|
145
|
163
|
157
|
|
Overall Study
NOT COMPLETED
|
20
|
12
|
21
|
Reasons for withdrawal
| Measure |
Pramipexole ER
Pramipexole Extended Release (ER) (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning
|
Pramipexole IR
Pramipexole Immediate Release (IR) (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day"
|
Placebo
Matching Placebo to Pramipexole IR (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day
Matching Placebo to Pramipexole ER (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
8
|
8
|
7
|
|
Overall Study
Lack of Efficacy
|
2
|
0
|
3
|
|
Overall Study
Protocol Violation
|
1
|
1
|
2
|
|
Overall Study
Lost to Follow-up
|
3
|
2
|
2
|
|
Overall Study
Withdrawal by Subject
|
4
|
1
|
6
|
|
Overall Study
patient did not meet inclusion criteria
|
1
|
0
|
1
|
|
Overall Study
Not treated
|
1
|
0
|
0
|
Baseline Characteristics
Pivotal Study in Advanced Parkinsons Disease Patients
Baseline characteristics by cohort
| Measure |
Pramipexole ER
n=164 Participants
Pramipexole Extended Release (ER) (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning
|
Pramipexole IR
n=175 Participants
Pramipexole Immediate Release (IR) (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day"
|
Placebo
n=178 Participants
Matching Placebo to Pramipexole IR (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day
Matching Placebo to Pramipexole ER (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning
|
Total
n=517 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
61.6 years
STANDARD_DEVIATION 9.7 • n=5 Participants
|
62.0 years
STANDARD_DEVIATION 10.3 • n=7 Participants
|
60.9 years
STANDARD_DEVIATION 9.7 • n=5 Participants
|
61.5 years
STANDARD_DEVIATION 9.9 • n=4 Participants
|
|
Sex: Female, Male
Female
|
72 Participants
n=5 Participants
|
77 Participants
n=7 Participants
|
84 Participants
n=5 Participants
|
233 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
92 Participants
n=5 Participants
|
98 Participants
n=7 Participants
|
94 Participants
n=5 Participants
|
284 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: baseline and week 18Population: Full analysis set (FAS 1) population = 507 patients FAS 1 defined as all patients who were dispensed study medication, were documented to have at least one dose of study medication, were treated for 18 weeks (or had prematurely discontinued treatment prior to week 18) and provided baseline and any on-drug post-baseline efficacy assessment
UPDRS II+III total score on Full Analysis Set (FAS)with LOCF (Last observation carried forward), week 18 - baseline, UPDRS II+III ranging from 0 (normal) to 160 (severe). UPDRS part II measures activities of daily living, part III measures motor symptoms
Outcome measures
| Measure |
Pramipexole ER
n=161 Participants
Pramipexole Extended Release (ER) (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning
|
Pramipexole IR
n=172 Participants
Pramipexole Immediate Release (IR) (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day"
|
Placebo
n=174 Participants
Matching Placebo to Pramipexole IR (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day
Matching Placebo to Pramipexole ER (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning
|
|---|---|---|---|
|
Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Parts II+III Score at Week 18
|
-11.0 Percentage of change from baseline
Standard Error 1.0
|
-12.8 Percentage of change from baseline
Standard Error 0.9
|
-6.1 Percentage of change from baseline
Standard Error 0.9
|
SECONDARY outcome
Timeframe: baseline and week 18Population: Full analysis set (FAS 1) population with last observation carried forward (LOCF).
Percentage off-time based on patient diary data, percentage ranging from 0 (best case) to 100 (worst case). Off-time describes a period when the patient experiences increased parkinsonian symptoms (e.g. immobility or inability to move with ease).
Outcome measures
| Measure |
Pramipexole ER
n=160 Participants
Pramipexole Extended Release (ER) (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning
|
Pramipexole IR
n=171 Participants
Pramipexole Immediate Release (IR) (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day"
|
Placebo
n=174 Participants
Matching Placebo to Pramipexole IR (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day
Matching Placebo to Pramipexole ER (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning
|
|---|---|---|---|
|
Change From Baseline in Percentage Off-time at Week 18
|
-13.3 Percentage of off-time
Standard Error 1.4
|
-15.9 Percentage of off-time
Standard Error 1.3
|
-8.8 Percentage of off-time
Standard Error 1.3
|
SECONDARY outcome
Timeframe: baseline and week 18Population: Full analysis set (FAS 1) population with last observation carried forward (LOCF).
Percentage on-time based on patient diary data, percentage ranging from 0 (worst case) to 100 (best case). On-time describes a period when the patient has no symptoms of off-time and is not asleep.
Outcome measures
| Measure |
Pramipexole ER
n=160 Participants
Pramipexole Extended Release (ER) (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning
|
Pramipexole IR
n=171 Participants
Pramipexole Immediate Release (IR) (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day"
|
Placebo
n=174 Participants
Matching Placebo to Pramipexole IR (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day
Matching Placebo to Pramipexole ER (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning
|
|---|---|---|---|
|
Change From Baseline in Percentage On-time Without Dyskinesia at Week 18
|
11.9 Percentage of on-time without dyskinesia
Standard Error 1.7
|
12.6 Percentage of on-time without dyskinesia
Standard Error 1.7
|
8.9 Percentage of on-time without dyskinesia
Standard Error 1.6
|
SECONDARY outcome
Timeframe: baseline and week 18Population: Full analysis set (FAS 1) population with last observation carried forward (LOCF).
Percentage on-time with non-troublesome dyskinesia based on patient diary data, percentage ranging from 0 (worst case) to 100 (best case). On-time describes a period when the patient has no symptoms of off-time and is not asleep.
Outcome measures
| Measure |
Pramipexole ER
n=160 Participants
Pramipexole Extended Release (ER) (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning
|
Pramipexole IR
n=171 Participants
Pramipexole Immediate Release (IR) (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day"
|
Placebo
n=174 Participants
Matching Placebo to Pramipexole IR (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day
Matching Placebo to Pramipexole ER (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning
|
|---|---|---|---|
|
Change From Baseline in Percentage On-time With Non-troublesome Dyskinesia at Week 18
|
1.9 Percentage of on-time
Standard Error 1.2
|
3.9 Percentage of on-time
Standard Error 1.2
|
1.0 Percentage of on-time
Standard Error 1.2
|
SECONDARY outcome
Timeframe: baseline and week 18Population: Full analysis set (FAS 1) population with last observation carried forward (LOCF).
Percentage on-time with troublesome dyskinesia based on patient diary data, percentage ranging from 0 (best case) to 100 (worst case). On-time describes a period when the patient has no symptoms of off-time and is not asleep.
Outcome measures
| Measure |
Pramipexole ER
n=160 Participants
Pramipexole Extended Release (ER) (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning
|
Pramipexole IR
n=171 Participants
Pramipexole Immediate Release (IR) (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day"
|
Placebo
n=174 Participants
Matching Placebo to Pramipexole IR (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day
Matching Placebo to Pramipexole ER (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning
|
|---|---|---|---|
|
Change From Baseline in Percentage On-time With Troublesome Dyskinesia at Week 18
|
-0.8 Percentage of on-time
Standard Error 0.5
|
-0.8 Percentage of on-time
Standard Error 0.5
|
-1.0 Percentage of on-time
Standard Error 0.5
|
SECONDARY outcome
Timeframe: after 18 weeks of treatmentPopulation: Full analysis set (FAS 1) population with last observation carried forward (LOCF).
CGI-I scores ranging from '1' (very much improved) to '7' (very much worse), CGI-I responder have scoring of 1 or 2 (at least much improved)
Outcome measures
| Measure |
Pramipexole ER
n=160 Participants
Pramipexole Extended Release (ER) (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning
|
Pramipexole IR
n=169 Participants
Pramipexole Immediate Release (IR) (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day"
|
Placebo
n=171 Participants
Matching Placebo to Pramipexole IR (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day
Matching Placebo to Pramipexole ER (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning
|
|---|---|---|---|
|
Clinical Global Impression - Global Improvement (CGI-I) Responder
Responder
|
78 Participants
|
88 Participants
|
56 Participants
|
|
Clinical Global Impression - Global Improvement (CGI-I) Responder
Non-Responder
|
82 Participants
|
81 Participants
|
115 Participants
|
SECONDARY outcome
Timeframe: after 18 weeks of treatmentPopulation: Full analysis set (FAS 1) population with last observation carried forward (LOCF).
PGI-I scores ranging from '1' (very much better) to '7' (very much worse), PGI-I responder have scoring 1 or 2 (at least much better)
Outcome measures
| Measure |
Pramipexole ER
n=161 Participants
Pramipexole Extended Release (ER) (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning
|
Pramipexole IR
n=172 Participants
Pramipexole Immediate Release (IR) (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day"
|
Placebo
n=174 Participants
Matching Placebo to Pramipexole IR (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day
Matching Placebo to Pramipexole ER (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning
|
|---|---|---|---|
|
Response in Patient Global Impression (PGI-I)
Responder
|
60 Participants
|
76 Participants
|
47 Participants
|
|
Response in Patient Global Impression (PGI-I)
Non-Responder
|
101 Participants
|
96 Participants
|
127 Participants
|
SECONDARY outcome
Timeframe: baseline and 18 weeksPopulation: Full analysis set (FAS 1) population with last observation carried forward (LOCF).
UPDRS I ranging from 0 (normal) to 16 (severe). UPDRS I measures Mentation, Behavior and Mood
Outcome measures
| Measure |
Pramipexole ER
n=161 Participants
Pramipexole Extended Release (ER) (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning
|
Pramipexole IR
n=172 Participants
Pramipexole Immediate Release (IR) (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day"
|
Placebo
n=174 Participants
Matching Placebo to Pramipexole IR (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day
Matching Placebo to Pramipexole ER (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning
|
|---|---|---|---|
|
Change From Baseline in UPDRS I Score After 18 Weeks
|
0 Units on a scale
Interval -1.0 to 0.0
|
0 Units on a scale
Interval -1.0 to 0.0
|
0 Units on a scale
Interval -1.0 to 0.0
|
SECONDARY outcome
Timeframe: baseline and 18 weeksPopulation: Full analysis set (FAS 1) population with last observation carried forward (LOCF).
UPDRS II ranging from 0 (normal) to 52 (severe). UPDRS Part II is calculated as the average of UPDRS part II at on and UPDRS part II at off-period for each of the 13 activities.
Outcome measures
| Measure |
Pramipexole ER
n=161 Participants
Pramipexole Extended Release (ER) (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning
|
Pramipexole IR
n=172 Participants
Pramipexole Immediate Release (IR) (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day"
|
Placebo
n=174 Participants
Matching Placebo to Pramipexole IR (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day
Matching Placebo to Pramipexole ER (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning
|
|---|---|---|---|
|
Change From Baseline in UPDRS II Score After 18 Weeks, Average at on and Off-period
|
-2.7 Units on a scale
Standard Error 0.3
|
-3.6 Units on a scale
Standard Error 0.3
|
-1.9 Units on a scale
Standard Error 0.3
|
SECONDARY outcome
Timeframe: baseline and 18 weeksPopulation: Full analysis set (FAS 1) population with last observation carried forward (LOCF).
UPDRS III ranging from 0 (normal) to 108 (severe). UPDRS part III measures motor symptoms
Outcome measures
| Measure |
Pramipexole ER
n=161 Participants
Pramipexole Extended Release (ER) (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning
|
Pramipexole IR
n=172 Participants
Pramipexole Immediate Release (IR) (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day"
|
Placebo
n=174 Participants
Matching Placebo to Pramipexole IR (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day
Matching Placebo to Pramipexole ER (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning
|
|---|---|---|---|
|
Change From Baseline in UPDRS III Score After 18 Weeks
|
-8.3 Units on a scale
Standard Error 0.7
|
-9.2 Units on a scale
Standard Error 0.7
|
-4.3 Units on a scale
Standard Error 0.7
|
SECONDARY outcome
Timeframe: baseline and 18 weeksPopulation: Full analysis set (FAS 1) population with last observation carried forward (LOCF).
UPDRS IV ranging from 0 (normal) to 23 (severe). UPDRS IV measures complications of therapy
Outcome measures
| Measure |
Pramipexole ER
n=161 Participants
Pramipexole Extended Release (ER) (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning
|
Pramipexole IR
n=172 Participants
Pramipexole Immediate Release (IR) (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day"
|
Placebo
n=174 Participants
Matching Placebo to Pramipexole IR (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day
Matching Placebo to Pramipexole ER (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning
|
|---|---|---|---|
|
Change From Baseline in UPDRS IV Score After 18 Weeks
|
-0.8 Units on a scale
Standard Error 0.2
|
-0.9 Units on a scale
Standard Error 0.2
|
-0.6 Units on a scale
Standard Error 0.2
|
SECONDARY outcome
Timeframe: baseline and 18 weeksPopulation: Full analysis set (FAS 1) population with last observation carried forward (LOCF).
ranging from 0 (best case) to 63 (worst case)
Outcome measures
| Measure |
Pramipexole ER
n=160 Participants
Pramipexole Extended Release (ER) (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning
|
Pramipexole IR
n=169 Participants
Pramipexole Immediate Release (IR) (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day"
|
Placebo
n=171 Participants
Matching Placebo to Pramipexole IR (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day
Matching Placebo to Pramipexole ER (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning
|
|---|---|---|---|
|
Change From Baseline in Beck's Depression Inventory (BDI) After 18 Weeks
|
-3.2 Units on a scale
Standard Error 0.5
|
-4.0 Units on a scale
Standard Error 0.5
|
-2.8 Units on a scale
Standard Error 0.5
|
SECONDARY outcome
Timeframe: baseline and 18 weeksPopulation: Full analysis set (FAS 1) population with last observation carried forward (LOCF).
ranging from 0 (worst case) to 150 (best case)
Outcome measures
| Measure |
Pramipexole ER
n=160 Participants
Pramipexole Extended Release (ER) (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning
|
Pramipexole IR
n=169 Participants
Pramipexole Immediate Release (IR) (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day"
|
Placebo
n=171 Participants
Matching Placebo to Pramipexole IR (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day
Matching Placebo to Pramipexole ER (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning
|
|---|---|---|---|
|
Change From Baseline in Parkinson's Disease Sleep Scale (PDSS) After 18 Weeks
|
8.1 Units on a scale
Standard Error 1.8
|
8.9 Units on a scale
Standard Error 1.7
|
4.9 Units on a scale
Standard Error 1.7
|
SECONDARY outcome
Timeframe: baseline and 18 weeksPopulation: Full analysis set (FAS 1) population with last observation carried forward (LOCF).
Ranging from 0 (best case) to 156 (worst case)
Outcome measures
| Measure |
Pramipexole ER
n=149 Participants
Pramipexole Extended Release (ER) (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning
|
Pramipexole IR
n=165 Participants
Pramipexole Immediate Release (IR) (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day"
|
Placebo
n=164 Participants
Matching Placebo to Pramipexole IR (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day
Matching Placebo to Pramipexole ER (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning
|
|---|---|---|---|
|
Change From Baseline in Parkinson's Disease Quality of Life Questionnaire 39 After 18 Weeks
|
-9.1 Units on a scale
Standard Error 1.9
|
-13.1 Units on a scale
Standard Error 1.8
|
-6.2 Units on a scale
Standard Error 1.8
|
SECONDARY outcome
Timeframe: baseline and 18 weeksPopulation: Full analysis set (FAS 1) population with last observation carried forward (LOCF).
ranging from 0 (worst case) to 100 (best case)
Outcome measures
| Measure |
Pramipexole ER
n=150 Participants
Pramipexole Extended Release (ER) (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning
|
Pramipexole IR
n=165 Participants
Pramipexole Immediate Release (IR) (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day"
|
Placebo
n=164 Participants
Matching Placebo to Pramipexole IR (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day
Matching Placebo to Pramipexole ER (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning
|
|---|---|---|---|
|
Change From Baseline in European Quality of Life (EuroQol) Scale After 18 Weeks
|
5.8 Units on a scale
Standard Error 1.4
|
7.6 Units on a scale
Standard Error 1.3
|
4.3 Units on a scale
Standard Error 1.3
|
SECONDARY outcome
Timeframe: baseline and week 18Population: Full analysis set (FAS 1) population with last observation carried forward (LOCF).
Likert scale is a method used for the measurement of pain. The patients were asked to rate their pain related to PD by ticking the number that best described their pain on the average in the previous week, from zero for "no pain" to ten for "unbearable pain".
Outcome measures
| Measure |
Pramipexole ER
n=160 Participants
Pramipexole Extended Release (ER) (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning
|
Pramipexole IR
n=169 Participants
Pramipexole Immediate Release (IR) (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day"
|
Placebo
n=171 Participants
Matching Placebo to Pramipexole IR (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day
Matching Placebo to Pramipexole ER (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning
|
|---|---|---|---|
|
Change From Baseline in 11-point Likert Scale for Pain Related to PD at Week 18
|
-0.4 units on a scale
Standard Error 0.2
|
-1.0 units on a scale
Standard Error 0.2
|
-0.3 units on a scale
Standard Error 0.2
|
SECONDARY outcome
Timeframe: baseline and week 18Population: Treated set (TS 1) population: defined as all patients who were dispensed study medication, were documented to have at least one dose of study medication and were treated for 18 weeks (or had discontinued treatment prior to week 18). Data limited to visit 8 (or V11 in case of premature discontinuation before visit 8).
Outcome measures
| Measure |
Pramipexole ER
n=150 Participants
Pramipexole Extended Release (ER) (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning
|
Pramipexole IR
n=162 Participants
Pramipexole Immediate Release (IR) (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day"
|
Placebo
n=158 Participants
Matching Placebo to Pramipexole IR (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day
Matching Placebo to Pramipexole ER (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning
|
|---|---|---|---|
|
Clinically Significant Abnormalities: Clinical Laboratory Evaluations (Biochemistry and Haematology)
Haematocrit - decrease
|
2 participants
Interval 26.8 to 43.5
|
3 participants
Interval 32.4 to 48.8
|
1 participants
Interval 13.5 to 26.9
|
|
Clinically Significant Abnormalities: Clinical Laboratory Evaluations (Biochemistry and Haematology)
Haemoglobin - decrease
|
2 participants
|
5 participants
|
3 participants
|
|
Clinically Significant Abnormalities: Clinical Laboratory Evaluations (Biochemistry and Haematology)
Red blood cell ct - decrease
|
1 participants
|
0 participants
|
1 participants
|
|
Clinically Significant Abnormalities: Clinical Laboratory Evaluations (Biochemistry and Haematology)
Eosinophils - Increase
|
3 participants
|
2 participants
|
1 participants
|
|
Clinically Significant Abnormalities: Clinical Laboratory Evaluations (Biochemistry and Haematology)
Neut.,poly. (segs),absol. - decrease
|
0 participants
|
1 participants
|
0 participants
|
|
Clinically Significant Abnormalities: Clinical Laboratory Evaluations (Biochemistry and Haematology)
Sodium - decrease
|
0 participants
|
2 participants
|
0 participants
|
|
Clinically Significant Abnormalities: Clinical Laboratory Evaluations (Biochemistry and Haematology)
GGT - increase
|
1 participants
|
0 participants
|
1 participants
|
|
Clinically Significant Abnormalities: Clinical Laboratory Evaluations (Biochemistry and Haematology)
Glucose - decrease
|
1 participants
|
0 participants
|
1 participants
|
|
Clinically Significant Abnormalities: Clinical Laboratory Evaluations (Biochemistry and Haematology)
Glucose - increase
|
0 participants
|
2 participants
|
1 participants
|
|
Clinically Significant Abnormalities: Clinical Laboratory Evaluations (Biochemistry and Haematology)
Triglyceride - increase
|
2 participants
|
3 participants
|
5 participants
|
|
Clinically Significant Abnormalities: Clinical Laboratory Evaluations (Biochemistry and Haematology)
Weight - decrease
|
0 participants
|
3 participants
|
1 participants
|
|
Clinically Significant Abnormalities: Clinical Laboratory Evaluations (Biochemistry and Haematology)
Blood pressure - increase
|
1 participants
|
2 participants
|
0 participants
|
|
Clinically Significant Abnormalities: Clinical Laboratory Evaluations (Biochemistry and Haematology)
Blood pressure - decrease
|
0 participants
|
0 participants
|
1 participants
|
Adverse Events
Placebo
Serious events: 15 serious events
Other events: 74 other events
Deaths: 0 deaths
Pramipexole ER
Serious events: 8 serious events
Other events: 73 other events
Deaths: 0 deaths
Pramipexole IR
Serious events: 11 serious events
Other events: 90 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=178 participants at risk
Matching Placebo to Pramipexole IR (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day
Matching Placebo to Pramipexole ER (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning
|
Pramipexole ER
n=164 participants at risk
Pramipexole Extended Release (ER) (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning
|
Pramipexole IR
n=175 participants at risk
Pramipexole Immediate Release (IR) (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day"
|
|---|---|---|---|
|
Nervous system disorders
On and off phenomenon
|
0.56%
1/178 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
0.00%
0/164 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
0.00%
0/175 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.56%
1/178 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
0.00%
0/164 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
0.00%
0/175 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
|
Nervous system disorders
Presyncope
|
0.00%
0/178 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
0.61%
1/164 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
0.00%
0/175 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
|
Infections and infestations
Bronchitis
|
0.00%
0/178 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
0.61%
1/164 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
0.00%
0/175 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
|
Infections and infestations
Pneumonia
|
0.56%
1/178 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
0.00%
0/164 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
0.57%
1/175 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
|
Infections and infestations
Post viral fatigue syndrome
|
0.56%
1/178 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
0.00%
0/164 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
0.00%
0/175 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
|
Infections and infestations
Sepsis
|
0.56%
1/178 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
0.00%
0/164 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
0.00%
0/175 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
|
Metabolism and nutrition disorders
Dehydration
|
0.56%
1/178 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
0.00%
0/164 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
0.57%
1/175 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/178 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
0.00%
0/164 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
0.57%
1/175 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
|
Psychiatric disorders
Hallucination, visual
|
0.00%
0/178 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
1.2%
2/164 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
0.00%
0/175 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/178 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
0.00%
0/164 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
1.1%
2/175 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
|
Psychiatric disorders
Agitation
|
0.00%
0/178 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
0.00%
0/164 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
0.57%
1/175 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
|
Psychiatric disorders
Delirium
|
0.00%
0/178 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
0.00%
0/164 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
0.57%
1/175 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
|
Psychiatric disorders
Delusion
|
0.00%
0/178 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
0.61%
1/164 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
0.57%
1/175 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
|
Psychiatric disorders
Depression
|
0.00%
0/178 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
0.00%
0/164 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
0.57%
1/175 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/178 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
0.00%
0/164 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
0.57%
1/175 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
|
Psychiatric disorders
Psychotic disorder
|
0.00%
0/178 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
0.00%
0/164 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
0.57%
1/175 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/178 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
0.00%
0/164 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
0.57%
1/175 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
|
Nervous system disorders
Dementia
|
0.00%
0/178 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
0.00%
0/164 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
0.57%
1/175 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/178 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
0.61%
1/164 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
0.00%
0/175 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/178 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
0.61%
1/164 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
0.00%
0/175 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
|
Nervous system disorders
Radiculpathy
|
0.56%
1/178 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
0.00%
0/164 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
0.00%
0/175 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
|
Nervous system disorders
Syncope
|
0.00%
0/178 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
0.00%
0/164 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
0.57%
1/175 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
|
Cardiac disorders
Arrhythmia
|
0.56%
1/178 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
0.00%
0/164 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
0.00%
0/175 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
|
Cardiac disorders
Atrial fibrillation
|
0.56%
1/178 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
0.00%
0/164 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
0.00%
0/175 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.00%
0/178 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
0.00%
0/164 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
0.57%
1/175 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
|
Vascular disorders
Hypotension
|
0.00%
0/178 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
0.61%
1/164 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
0.00%
0/175 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/178 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
0.00%
0/164 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
0.57%
1/175 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/178 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
0.61%
1/164 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
0.00%
0/175 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/178 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
0.00%
0/164 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
0.57%
1/175 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/178 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
0.61%
1/164 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
0.00%
0/175 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.56%
1/178 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
0.00%
0/164 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
0.00%
0/175 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
|
Gastrointestinal disorders
Diarrhoea
|
0.56%
1/178 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
0.00%
0/164 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
0.00%
0/175 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/178 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
0.00%
0/164 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
0.57%
1/175 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
|
Renal and urinary disorders
Renal failure chronic
|
0.00%
0/178 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
0.00%
0/164 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
0.57%
1/175 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
|
Reproductive system and breast disorders
Uterine prolapse
|
0.56%
1/178 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
0.00%
0/164 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
0.00%
0/175 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
|
General disorders
Chest pain
|
0.00%
0/178 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
0.61%
1/164 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
0.00%
0/175 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/178 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
0.00%
0/164 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
1.1%
2/175 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.56%
1/178 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
0.00%
0/164 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
0.57%
1/175 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/178 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
0.00%
0/164 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
0.57%
1/175 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.00%
0/178 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
0.00%
0/164 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
0.57%
1/175 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
|
Injury, poisoning and procedural complications
Forearm fracture
|
0.00%
0/178 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
0.61%
1/164 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
0.00%
0/175 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.56%
1/178 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
0.00%
0/164 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
0.00%
0/175 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
|
Injury, poisoning and procedural complications
Ligament injury
|
0.56%
1/178 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
0.00%
0/164 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
0.00%
0/175 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/178 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
0.00%
0/164 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
0.57%
1/175 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.00%
0/178 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
0.00%
0/164 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
0.57%
1/175 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
|
Injury, poisoning and procedural complications
Peripheral nerve injury
|
0.56%
1/178 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
0.00%
0/164 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
0.00%
0/175 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
|
Injury, poisoning and procedural complications
Tendon injury
|
0.56%
1/178 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
0.00%
0/164 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
0.00%
0/175 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.00%
0/178 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
0.00%
0/164 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
0.57%
1/175 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
|
Surgical and medical procedures
Medical device change
|
0.56%
1/178 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
0.00%
0/164 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
0.00%
0/175 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
Other adverse events
| Measure |
Placebo
n=178 participants at risk
Matching Placebo to Pramipexole IR (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day
Matching Placebo to Pramipexole ER (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning
|
Pramipexole ER
n=164 participants at risk
Pramipexole Extended Release (ER) (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning
|
Pramipexole IR
n=175 participants at risk
Pramipexole Immediate Release (IR) (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day"
|
|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
6.7%
12/178 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
1.8%
3/164 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
4.0%
7/175 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
|
Metabolism and nutrition disorders
Anorexia
|
2.2%
4/178 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
5.5%
9/164 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
1.1%
2/175 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
|
Psychiatric disorders
Hallucination
|
1.1%
2/178 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
5.5%
9/164 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
5.7%
10/175 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
|
Psychiatric disorders
Insomnia
|
2.2%
4/178 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
5.5%
9/164 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
3.4%
6/175 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
|
Nervous system disorders
Dyskinesia
|
9.0%
16/178 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
17.1%
28/164 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
19.4%
34/175 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
|
Nervous system disorders
Somnolence
|
16.3%
29/178 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
14.6%
24/164 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
17.1%
30/175 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
|
Nervous system disorders
Dizziness
|
5.1%
9/178 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
5.5%
9/164 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
10.9%
19/175 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
|
Nervous system disorders
Headache
|
2.8%
5/178 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
8.5%
14/164 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
5.1%
9/175 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
|
Gastrointestinal disorders
Nausea
|
10.7%
19/178 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
11.0%
18/164 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
11.4%
20/175 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
|
Gastrointestinal disorders
Constipation
|
5.1%
9/178 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
6.7%
11/164 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
5.7%
10/175 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
|
Gastrointestinal disorders
Vomiting
|
2.8%
5/178 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
1.2%
2/164 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
5.7%
10/175 • From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)
After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).
|
Additional Information
Boehringer Ingelheim Call Center
Boehringer Ingelheim Pharmaceuticals
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.
- Publication restrictions are in place
Restriction type: OTHER