Trial Outcomes & Findings for Placebo Controlled Study of Preladenant in Participants With Moderate to Severe Parkinson's Disease (P07037) (NCT NCT01227265)
NCT ID: NCT01227265
Last Updated: 2018-09-24
Results Overview
The "on" state is defined as the period of time during which a patient's symptoms of PD improve or disappear following treatment with L-dopa or dopamine agonists. The "off" state is defined as the period of time characterized by the return of symptoms (i..e. tremor, slowness, and rigidity) following treatment with L-dopa or dopamine agonists. Study participants reported their symptoms at half-hour intervals as "off", "on", or "asleep" on their daily diary for 3 days before randomization (baseline) and for the 3 days immediately before their Week 12 visit. The mean change from baseline in "off" time was based on a constrained longitudinal data analysis (cLDA) with treatment, time, and treatment-by-time interaction as fixed effects and subject as random effect.
COMPLETED
PHASE3
476 participants
Baseline and Week 12
2018-09-24
Participant Flow
Adult participants with a diagnosis of moderate to severe idiopathic Parkinson's disease were selected to participate in this study.
After a Screening Period of up to 5 weeks, participants were randomized into 1 of 3 treatment groups (preladenant 2 or 5 mg twice daily or placebo) for 12 weeks. At the end of treatment, participants could choose to enter into an extension trial or return for a follow-up visit 2 weeks later.
Participant milestones
| Measure |
Preladenant 2 mg
Participants received 2 mg as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extension trial or return for a follow-up visit two (2) weeks later.
|
Preladenant 5 mg
Participants received 5 mg as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extension trial or return for a follow-up visit two (2) weeks later.
|
Placebo
Participants received preladenant-matching placebo as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extention trial or return for a follow-up visit two (2) weeks later.
|
|---|---|---|---|
|
Overall Study
STARTED
|
158
|
159
|
159
|
|
Overall Study
Treated
|
157
|
157
|
159
|
|
Overall Study
COMPLETED
|
139
|
139
|
145
|
|
Overall Study
NOT COMPLETED
|
19
|
20
|
14
|
Reasons for withdrawal
| Measure |
Preladenant 2 mg
Participants received 2 mg as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extension trial or return for a follow-up visit two (2) weeks later.
|
Preladenant 5 mg
Participants received 5 mg as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extension trial or return for a follow-up visit two (2) weeks later.
|
Placebo
Participants received preladenant-matching placebo as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extention trial or return for a follow-up visit two (2) weeks later.
|
|---|---|---|---|
|
Overall Study
Did Not Receive Treatment
|
1
|
2
|
0
|
|
Overall Study
Administrative
|
1
|
0
|
2
|
|
Overall Study
Did Not Meet Protocol Eligibility
|
0
|
0
|
1
|
|
Overall Study
Protocol Violation
|
2
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
7
|
7
|
3
|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
3
|
|
Overall Study
Adverse Event
|
6
|
10
|
5
|
Baseline Characteristics
Placebo Controlled Study of Preladenant in Participants With Moderate to Severe Parkinson's Disease (P07037)
Baseline characteristics by cohort
| Measure |
Preladenant 2 mg
n=157 Participants
Participants received 2 mg as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extension trial or return for a follow-up visit two (2) weeks later.
|
Preladenant 5 mg
n=157 Participants
Participants received 5 mg as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extension trial or return for a follow-up visit two (2) weeks later.
|
Placebo
n=159 Participants
Participants received preladenant-matching placebo as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extention trial or return for a follow-up visit two (2) weeks later.
|
Total
n=473 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
62.9 Years
STANDARD_DEVIATION 9.0 • n=5 Participants
|
64.2 Years
STANDARD_DEVIATION 8.7 • n=7 Participants
|
64.2 Years
STANDARD_DEVIATION 8.9 • n=5 Participants
|
63.8 Years
STANDARD_DEVIATION 8.9 • n=4 Participants
|
|
Sex: Female, Male
Female
|
49 Participants
n=5 Participants
|
71 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
184 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
108 Participants
n=5 Participants
|
86 Participants
n=7 Participants
|
95 Participants
n=5 Participants
|
289 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: Full Analysis Set (FAS): All randomized participants remaining after participants were excluded for failure to receive at least one dose of study treatment, lack of any post-randomization endpoint data subsequent to at least 1 dose of study treatment, or lack of Baseline data for those analyses requiring Baseline data.
The "on" state is defined as the period of time during which a patient's symptoms of PD improve or disappear following treatment with L-dopa or dopamine agonists. The "off" state is defined as the period of time characterized by the return of symptoms (i..e. tremor, slowness, and rigidity) following treatment with L-dopa or dopamine agonists. Study participants reported their symptoms at half-hour intervals as "off", "on", or "asleep" on their daily diary for 3 days before randomization (baseline) and for the 3 days immediately before their Week 12 visit. The mean change from baseline in "off" time was based on a constrained longitudinal data analysis (cLDA) with treatment, time, and treatment-by-time interaction as fixed effects and subject as random effect.
Outcome measures
| Measure |
Preladenant 2 mg
n=154 Participants
Participants received 2 mg as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extension trial or return for a follow-up visit two (2) weeks later.
|
Preladenant 5 mg
n=153 Participants
Participants received 5 mg as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extension trial or return for a follow-up visit two (2) weeks later.
|
Placebo
n=158 Participants
Participants received preladenant-matching placebo as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extention trial or return for a follow-up visit two (2) weeks later.
|
|---|---|---|---|
|
Change From Baseline in Average "Off" Time (Hours Per Day) at Week 12
|
-1.0 hours per day
Standard Error 0.20
|
-1.1 hours per day
Standard Error 0.20
|
-0.8 hours per day
Standard Error 0.19
|
PRIMARY outcome
Timeframe: Up to Week 14Population: All Participants as Treated (APaT): All participants who received at least one (1) dose of study drug.
The number of participants with Systolic Blood Pressure (SBP) ≥180 mmHg and 20 mmHg increase was reported. Participants lie supine at rest for 5 minutes, then have a single BP measurement taken (ie, 1 reading). Participants then stand for 3 minutes at rest, followed by a single BP measurement (1 reading) in the standing position.
Outcome measures
| Measure |
Preladenant 2 mg
n=157 Participants
Participants received 2 mg as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extension trial or return for a follow-up visit two (2) weeks later.
|
Preladenant 5 mg
n=157 Participants
Participants received 5 mg as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extension trial or return for a follow-up visit two (2) weeks later.
|
Placebo
n=159 Participants
Participants received preladenant-matching placebo as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extention trial or return for a follow-up visit two (2) weeks later.
|
|---|---|---|---|
|
Number of Participants With Systolic Blood Pressure (SBP) ≥180 mmHg and 20 mmHg Increase
Supine
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Systolic Blood Pressure (SBP) ≥180 mmHg and 20 mmHg Increase
Standing
|
1 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to Week 14Population: All Participants as Treated (APaT): All participants who received at least one (1) dose of study drug.
The number of participants with Diastolic Blood Pressure (DBP) ≥105 mmHg and 15 mmHg increase was reported. Participants lie supine at rest for 5 minutes, then have a single BP measurement taken (ie, 1 reading). Participants then stand for 3 minutes at rest, followed by a single BP measurement (1 reading) in the standing position.
Outcome measures
| Measure |
Preladenant 2 mg
n=157 Participants
Participants received 2 mg as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extension trial or return for a follow-up visit two (2) weeks later.
|
Preladenant 5 mg
n=157 Participants
Participants received 5 mg as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extension trial or return for a follow-up visit two (2) weeks later.
|
Placebo
n=159 Participants
Participants received preladenant-matching placebo as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extention trial or return for a follow-up visit two (2) weeks later.
|
|---|---|---|---|
|
Number of Participants With Diastolic Blood Pressure (DBP) ≥105 mmHg and 15 mmHg Increase
Supine
|
1 Participants
|
2 Participants
|
3 Participants
|
|
Number of Participants With Diastolic Blood Pressure (DBP) ≥105 mmHg and 15 mmHg Increase
Standing
|
7 Participants
|
3 Participants
|
6 Participants
|
PRIMARY outcome
Timeframe: Up to Week 12Population: All Participants as Treated (APaT): All participants who received at least one (1) dose of study drug.
The percentage of participants with suicidality using the Columbia - Suicide Severity Rating Scale (C-SSRS) was reported. The C-SSR was used in this study only for the purpose of safety monitoring by measuring the incidence of different types of suicidality categories during treatment. The assessment was done by the nature of the responses, not by a numbered scale. Participants who reported at least one occurrence of suicidal behavior or suicidal ideation were counted as having experienced suicidality. Suicidal behavior included suicide attempt, aborted attempt, interrupted attempt, or preparatory behavior. Suicidal ideation included a wish to die or active suicidal thought with or without method, intent or plan.
Outcome measures
| Measure |
Preladenant 2 mg
n=157 Participants
Participants received 2 mg as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extension trial or return for a follow-up visit two (2) weeks later.
|
Preladenant 5 mg
n=157 Participants
Participants received 5 mg as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extension trial or return for a follow-up visit two (2) weeks later.
|
Placebo
n=159 Participants
Participants received preladenant-matching placebo as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extention trial or return for a follow-up visit two (2) weeks later.
|
|---|---|---|---|
|
Percentage of Participants With Suicidality
|
3 Percentage of participants
|
4 Percentage of participants
|
1 Percentage of participants
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: All Participants as Treated (APaT): All participants who received at least one (1) dose of study drug.
The ESS is a self-administered questionnaire providing a measure of a person's general level of daytime sleepiness, or their average sleep propensity in daily life. The scale consists of 8 situations in which the participant rates their tendency to become sleepy on a scale of 0=no chance of dozing to 3=high chance of dozing. The overall score is the sum of the scores for the 8 situations for a minimum of 0 and a maximum of 24 with a higher score indicating greater sleepiness. The mean change from baseline in total EES was based on a cLDA with treatment, time, and treatment-by-time interaction as fixed effects and subject as random effect.
Outcome measures
| Measure |
Preladenant 2 mg
n=157 Participants
Participants received 2 mg as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extension trial or return for a follow-up visit two (2) weeks later.
|
Preladenant 5 mg
n=157 Participants
Participants received 5 mg as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extension trial or return for a follow-up visit two (2) weeks later.
|
Placebo
n=159 Participants
Participants received preladenant-matching placebo as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extention trial or return for a follow-up visit two (2) weeks later.
|
|---|---|---|---|
|
Change From Baseline in Total Epworth Sleepiness Scale (ESS) at Week 12
|
-0.4 Score on a Scale
Standard Error 0.28
|
-0.0 Score on a Scale
Standard Error 0.29
|
-0.2 Score on a Scale
Standard Error 0.28
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Full Analysis Set (FAS): All randomized participants remaining after participants were excluded for failure to receive at least one dose of study treatment, lack of any post-randomization endpoint data subsequent to at least one dose of study treatment, or lack of Baseline data for those analyses requiring Baseline data.
A participant with at least a 30% reduction in mean "off" time from Baseline to End of Treatment (Week 12) is considered as "responder". The "on" state is defined as the period of time during which a patient's symptoms of PD improve or disappear following treatment with L-dopa or dopamine agonists. The "off" state is defined as the period of time characterized by the return of symptoms (i..e. tremor, slowness, and rigidity) following treatment with L-dopa or dopamine agonists. Study participants reported their symptoms at half-hour intervals as "off", "on", or "asleep" on their daily diary for 3 days before randomization and for the 3 days immediately before their Week 12 visit.
Outcome measures
| Measure |
Preladenant 2 mg
n=154 Participants
Participants received 2 mg as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extension trial or return for a follow-up visit two (2) weeks later.
|
Preladenant 5 mg
n=153 Participants
Participants received 5 mg as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extension trial or return for a follow-up visit two (2) weeks later.
|
Placebo
n=158 Participants
Participants received preladenant-matching placebo as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extention trial or return for a follow-up visit two (2) weeks later.
|
|---|---|---|---|
|
Percentage of Participants With >30% Change (Reduction) From Baseline at Week 12 in Mean "Off" Time
|
37.1 Percentage of participants
|
36.9 Percentage of participants
|
30.5 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Full Analysis Set (FAS): All randomized participants remaining after participants were excluded for failure to receive at least one dose of study treatment, lack of any post-randomization endpoint data subsequent to at least 1 dose of study treatment, or lack of Baseline data for those analyses requiring Baseline data.
"On" time is when a PD participant's symptoms are improved. Mean "on" time without troublesome dyskinesias is derived from the available diary data collected for 3 days immediately prior to a clinic visit. "On" time without troublesome dyskinesia is the sum of "on" time without dyskinesia plus "on" time with non-troublesome dyskinesia as recorded in the diary. The mean change from baseline in "on" time was based on a cLDA with treatment, time, and treatment-by-time interaction as fixed effects and subject as random effect.
Outcome measures
| Measure |
Preladenant 2 mg
n=154 Participants
Participants received 2 mg as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extension trial or return for a follow-up visit two (2) weeks later.
|
Preladenant 5 mg
n=153 Participants
Participants received 5 mg as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extension trial or return for a follow-up visit two (2) weeks later.
|
Placebo
n=158 Participants
Participants received preladenant-matching placebo as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extention trial or return for a follow-up visit two (2) weeks later.
|
|---|---|---|---|
|
Change From Baseline in Average "On" Time (Hours Per Day) Without Troublesome Dyskinesia at Week 12
|
0.6 hours per day
Standard Error 0.21
|
0.7 hours per day
Standard Error 0.21
|
0.5 hours per day
Standard Error 0.20
|
Adverse Events
Preladenant 2 mg
Preladenant 5 mg
Placebo
Serious adverse events
| Measure |
Preladenant 2 mg
n=157 participants at risk
Participants received 2 mg as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extension trial or return for a follow-up visit two (2) weeks later.
|
Preladenant 5 mg
n=157 participants at risk
Participants received 5 mg as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extension trial or return for a follow-up visit two (2) weeks later.
|
Placebo
n=159 participants at risk
Participants received preladenant-matching placebo as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extention trial or return for a follow-up visit two (2) weeks later.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.64%
1/157 • Number of events 1 • Up to 14 weeks (including 14 days of follow-up)
All Participants as Treated
|
0.00%
0/157 • Up to 14 weeks (including 14 days of follow-up)
All Participants as Treated
|
0.00%
0/159 • Up to 14 weeks (including 14 days of follow-up)
All Participants as Treated
|
|
Gastrointestinal disorders
Diverticulum
|
0.64%
1/157 • Number of events 1 • Up to 14 weeks (including 14 days of follow-up)
All Participants as Treated
|
0.00%
0/157 • Up to 14 weeks (including 14 days of follow-up)
All Participants as Treated
|
0.00%
0/159 • Up to 14 weeks (including 14 days of follow-up)
All Participants as Treated
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/157 • Up to 14 weeks (including 14 days of follow-up)
All Participants as Treated
|
0.64%
1/157 • Number of events 1 • Up to 14 weeks (including 14 days of follow-up)
All Participants as Treated
|
0.00%
0/159 • Up to 14 weeks (including 14 days of follow-up)
All Participants as Treated
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.64%
1/157 • Number of events 1 • Up to 14 weeks (including 14 days of follow-up)
All Participants as Treated
|
0.00%
0/157 • Up to 14 weeks (including 14 days of follow-up)
All Participants as Treated
|
0.00%
0/159 • Up to 14 weeks (including 14 days of follow-up)
All Participants as Treated
|
|
Gastrointestinal disorders
Lower Gastrointestinal Haemorrhage
|
0.64%
1/157 • Number of events 1 • Up to 14 weeks (including 14 days of follow-up)
All Participants as Treated
|
0.00%
0/157 • Up to 14 weeks (including 14 days of follow-up)
All Participants as Treated
|
0.00%
0/159 • Up to 14 weeks (including 14 days of follow-up)
All Participants as Treated
|
|
General disorders
Chest Pain
|
0.64%
1/157 • Number of events 1 • Up to 14 weeks (including 14 days of follow-up)
All Participants as Treated
|
0.00%
0/157 • Up to 14 weeks (including 14 days of follow-up)
All Participants as Treated
|
0.00%
0/159 • Up to 14 weeks (including 14 days of follow-up)
All Participants as Treated
|
|
Infections and infestations
Lymphangitis
|
0.64%
1/157 • Number of events 1 • Up to 14 weeks (including 14 days of follow-up)
All Participants as Treated
|
0.00%
0/157 • Up to 14 weeks (including 14 days of follow-up)
All Participants as Treated
|
0.00%
0/159 • Up to 14 weeks (including 14 days of follow-up)
All Participants as Treated
|
|
Infections and infestations
Pneumonia
|
0.00%
0/157 • Up to 14 weeks (including 14 days of follow-up)
All Participants as Treated
|
0.00%
0/157 • Up to 14 weeks (including 14 days of follow-up)
All Participants as Treated
|
0.63%
1/159 • Number of events 1 • Up to 14 weeks (including 14 days of follow-up)
All Participants as Treated
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/157 • Up to 14 weeks (including 14 days of follow-up)
All Participants as Treated
|
0.64%
1/157 • Number of events 1 • Up to 14 weeks (including 14 days of follow-up)
All Participants as Treated
|
0.00%
0/159 • Up to 14 weeks (including 14 days of follow-up)
All Participants as Treated
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/157 • Up to 14 weeks (including 14 days of follow-up)
All Participants as Treated
|
0.64%
1/157 • Number of events 1 • Up to 14 weeks (including 14 days of follow-up)
All Participants as Treated
|
0.00%
0/159 • Up to 14 weeks (including 14 days of follow-up)
All Participants as Treated
|
|
Injury, poisoning and procedural complications
Kidney Rupture
|
0.00%
0/157 • Up to 14 weeks (including 14 days of follow-up)
All Participants as Treated
|
0.00%
0/157 • Up to 14 weeks (including 14 days of follow-up)
All Participants as Treated
|
0.63%
1/159 • Number of events 1 • Up to 14 weeks (including 14 days of follow-up)
All Participants as Treated
|
|
Injury, poisoning and procedural complications
Subdural Haematoma
|
0.00%
0/157 • Up to 14 weeks (including 14 days of follow-up)
All Participants as Treated
|
0.64%
1/157 • Number of events 1 • Up to 14 weeks (including 14 days of follow-up)
All Participants as Treated
|
0.00%
0/159 • Up to 14 weeks (including 14 days of follow-up)
All Participants as Treated
|
|
Injury, poisoning and procedural complications
Upper Limb Fracture
|
0.64%
1/157 • Number of events 1 • Up to 14 weeks (including 14 days of follow-up)
All Participants as Treated
|
0.00%
0/157 • Up to 14 weeks (including 14 days of follow-up)
All Participants as Treated
|
0.00%
0/159 • Up to 14 weeks (including 14 days of follow-up)
All Participants as Treated
|
|
Injury, poisoning and procedural complications
Wrist Fracture
|
0.64%
1/157 • Number of events 1 • Up to 14 weeks (including 14 days of follow-up)
All Participants as Treated
|
0.00%
0/157 • Up to 14 weeks (including 14 days of follow-up)
All Participants as Treated
|
0.00%
0/159 • Up to 14 weeks (including 14 days of follow-up)
All Participants as Treated
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.64%
1/157 • Number of events 1 • Up to 14 weeks (including 14 days of follow-up)
All Participants as Treated
|
0.00%
0/157 • Up to 14 weeks (including 14 days of follow-up)
All Participants as Treated
|
0.00%
0/159 • Up to 14 weeks (including 14 days of follow-up)
All Participants as Treated
|
|
Nervous system disorders
Cerebral Haematoma
|
0.00%
0/157 • Up to 14 weeks (including 14 days of follow-up)
All Participants as Treated
|
0.64%
1/157 • Number of events 1 • Up to 14 weeks (including 14 days of follow-up)
All Participants as Treated
|
0.00%
0/159 • Up to 14 weeks (including 14 days of follow-up)
All Participants as Treated
|
|
Psychiatric disorders
Completed Suicide
|
0.64%
1/157 • Number of events 1 • Up to 14 weeks (including 14 days of follow-up)
All Participants as Treated
|
0.00%
0/157 • Up to 14 weeks (including 14 days of follow-up)
All Participants as Treated
|
0.00%
0/159 • Up to 14 weeks (including 14 days of follow-up)
All Participants as Treated
|
|
Psychiatric disorders
Confusional State
|
0.00%
0/157 • Up to 14 weeks (including 14 days of follow-up)
All Participants as Treated
|
0.00%
0/157 • Up to 14 weeks (including 14 days of follow-up)
All Participants as Treated
|
0.63%
1/159 • Number of events 1 • Up to 14 weeks (including 14 days of follow-up)
All Participants as Treated
|
|
Psychiatric disorders
Depression
|
0.64%
1/157 • Number of events 1 • Up to 14 weeks (including 14 days of follow-up)
All Participants as Treated
|
0.00%
0/157 • Up to 14 weeks (including 14 days of follow-up)
All Participants as Treated
|
0.00%
0/159 • Up to 14 weeks (including 14 days of follow-up)
All Participants as Treated
|
|
Renal and urinary disorders
Stress Urinary Incontinence
|
0.00%
0/157 • Up to 14 weeks (including 14 days of follow-up)
All Participants as Treated
|
0.00%
0/157 • Up to 14 weeks (including 14 days of follow-up)
All Participants as Treated
|
0.63%
1/159 • Number of events 1 • Up to 14 weeks (including 14 days of follow-up)
All Participants as Treated
|
|
Skin and subcutaneous tissue disorders
Decubitus Ulcer
|
0.64%
1/157 • Number of events 1 • Up to 14 weeks (including 14 days of follow-up)
All Participants as Treated
|
0.00%
0/157 • Up to 14 weeks (including 14 days of follow-up)
All Participants as Treated
|
0.00%
0/159 • Up to 14 weeks (including 14 days of follow-up)
All Participants as Treated
|
Other adverse events
| Measure |
Preladenant 2 mg
n=157 participants at risk
Participants received 2 mg as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extension trial or return for a follow-up visit two (2) weeks later.
|
Preladenant 5 mg
n=157 participants at risk
Participants received 5 mg as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extension trial or return for a follow-up visit two (2) weeks later.
|
Placebo
n=159 participants at risk
Participants received preladenant-matching placebo as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extention trial or return for a follow-up visit two (2) weeks later.
|
|---|---|---|---|
|
Gastrointestinal disorders
Constipation
|
7.0%
11/157 • Number of events 11 • Up to 14 weeks (including 14 days of follow-up)
All Participants as Treated
|
9.6%
15/157 • Number of events 18 • Up to 14 weeks (including 14 days of follow-up)
All Participants as Treated
|
2.5%
4/159 • Number of events 4 • Up to 14 weeks (including 14 days of follow-up)
All Participants as Treated
|
|
Gastrointestinal disorders
Nausea
|
3.2%
5/157 • Number of events 6 • Up to 14 weeks (including 14 days of follow-up)
All Participants as Treated
|
5.7%
9/157 • Number of events 10 • Up to 14 weeks (including 14 days of follow-up)
All Participants as Treated
|
1.3%
2/159 • Number of events 2 • Up to 14 weeks (including 14 days of follow-up)
All Participants as Treated
|
|
Injury, poisoning and procedural complications
Fall
|
4.5%
7/157 • Number of events 9 • Up to 14 weeks (including 14 days of follow-up)
All Participants as Treated
|
5.7%
9/157 • Number of events 12 • Up to 14 weeks (including 14 days of follow-up)
All Participants as Treated
|
6.3%
10/159 • Number of events 14 • Up to 14 weeks (including 14 days of follow-up)
All Participants as Treated
|
|
Nervous system disorders
Dizziness
|
6.4%
10/157 • Number of events 11 • Up to 14 weeks (including 14 days of follow-up)
All Participants as Treated
|
3.8%
6/157 • Number of events 6 • Up to 14 weeks (including 14 days of follow-up)
All Participants as Treated
|
1.9%
3/159 • Number of events 3 • Up to 14 weeks (including 14 days of follow-up)
All Participants as Treated
|
|
Nervous system disorders
Dyskinesia
|
1.9%
3/157 • Number of events 3 • Up to 14 weeks (including 14 days of follow-up)
All Participants as Treated
|
7.0%
11/157 • Number of events 13 • Up to 14 weeks (including 14 days of follow-up)
All Participants as Treated
|
3.1%
5/159 • Number of events 5 • Up to 14 weeks (including 14 days of follow-up)
All Participants as Treated
|
|
Nervous system disorders
Headache
|
7.6%
12/157 • Number of events 13 • Up to 14 weeks (including 14 days of follow-up)
All Participants as Treated
|
6.4%
10/157 • Number of events 11 • Up to 14 weeks (including 14 days of follow-up)
All Participants as Treated
|
3.1%
5/159 • Number of events 5 • Up to 14 weeks (including 14 days of follow-up)
All Participants as Treated
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Results disclosure agreements
- Principal investigator is a sponsor employee The investigator agrees not to publish or publicly present any interim results of the trial without the prior written consent of the sponsor. The investigator further agrees to provide to the sponsor 45 days prior to submission for publication or presentation, review copies of abstracts or manuscripts for publication that report any results of the trial.
- Publication restrictions are in place
Restriction type: OTHER