Trial Outcomes & Findings for The SUSTAIN Study Compares the Effects of Sustained and Immediate-release Pramipexole on the noctUrnal Symptoms of paTients With Advanced ParkInsoN's Disease Who Also Take L-Dopa (NCT NCT03521635)
NCT ID: NCT03521635
Last Updated: 2021-02-16
Results Overview
Parkinson's disease Sleep Scale 2nd version (PDSS-2) consists of 15 questions about various sleep and nocturnal disturbances which are to be rated by the patients using one of five categories, from 0 (never) to 4 (very often). Patients were asked to rate the severity of each question based on their experience during the past week (7 days) from 0 (Never) to 4 (Very often, that meant 6 to 7 days a week). PDSS-2 total score ranges from 0 (no disturbance) to 60 (maximum nocturnal disturbance).
COMPLETED
PHASE4
98 participants
Baseline and Week 18
2021-02-16
Participant Flow
This 2-stage open-label, randomised, active controlled parallel group study compared the efficacy and safety of Pramipexole Sustained Release versus Immediate Release administered orally over an 18-week treatment on nocturnal symptoms in patients on Levodopa combined with a Dopa-Decarboxylase-inhibitor with advanced Parkinson's disease.
All subjects were screened for eligibility prior to participation in the trial. Subjects attended a specialist site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria. Subjects were not to be allocated to a treatment group if any of the entry criteria were violated.
Participant milestones
| Measure |
Pramipexole Sustained Release
Tablets of Pramipexole sustained release (SR) with unit strength of 0.375 milligram (mg) and 0.75 mg were administered orally once daily at 7-9 pm before bedtime to achieve daily dose of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg for a treatment period of 18 weeks. The dose of Pramipexole SR was titrated to an optimised level, to achieve a maximum therapeutic effect without intolerable side effects.
|
Pramipexole Immediate Release
Tablets of Pramipexole immediate release (IR) with unit strength of 0.25 milligram (mg) and 1.0 mg were administered in equally divided doses three times per day to achieve a total daily dose of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, the third dose at 7-9 pm before bedtime for a treatment period of 18 weeks.
The dose of Pramipexole IR was titrated to an optimised level, to achieve a maximum therapeutic effect without intolerable side effects.
|
|---|---|---|
|
Overall Study
STARTED
|
49
|
49
|
|
Overall Study
COMPLETED
|
45
|
43
|
|
Overall Study
NOT COMPLETED
|
4
|
6
|
Reasons for withdrawal
| Measure |
Pramipexole Sustained Release
Tablets of Pramipexole sustained release (SR) with unit strength of 0.375 milligram (mg) and 0.75 mg were administered orally once daily at 7-9 pm before bedtime to achieve daily dose of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg for a treatment period of 18 weeks. The dose of Pramipexole SR was titrated to an optimised level, to achieve a maximum therapeutic effect without intolerable side effects.
|
Pramipexole Immediate Release
Tablets of Pramipexole immediate release (IR) with unit strength of 0.25 milligram (mg) and 1.0 mg were administered in equally divided doses three times per day to achieve a total daily dose of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, the third dose at 7-9 pm before bedtime for a treatment period of 18 weeks.
The dose of Pramipexole IR was titrated to an optimised level, to achieve a maximum therapeutic effect without intolerable side effects.
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
1
|
|
Overall Study
Refused to complete study visit
|
1
|
0
|
|
Overall Study
Refused to continue trial medication
|
2
|
2
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Meet exclusion criteria
|
0
|
1
|
|
Overall Study
Patient not taken study medicine
|
0
|
1
|
Baseline Characteristics
The SUSTAIN Study Compares the Effects of Sustained and Immediate-release Pramipexole on the noctUrnal Symptoms of paTients With Advanced ParkInsoN's Disease Who Also Take L-Dopa
Baseline characteristics by cohort
| Measure |
Pramipexole Sustained Release
n=49 Participants
Tablets of Pramipexole sustained release (SR) with unit strength of 0.375 milligram (mg) and 0.75 mg were administered orally once daily at 7-9 pm before bedtime to achieve daily dose of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg for a treatment period of 18 weeks. The dose of Pramipexole SR was titrated to an optimised level, to achieve a maximum therapeutic effect without intolerable side effects.
|
Pramipexole Immediate Release
n=49 Participants
Tablets of Pramipexole immediate release (IR) with unit strength of 0.25 milligram (mg) and 1.0 mg were administered in equally divided doses three times per day to achieve a total daily dose of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, the third dose at 7-9 pm before bedtime for a treatment period of 18 weeks.
The dose of Pramipexole IR was titrated to an optimised level, to achieve a maximum therapeutic effect without intolerable side effects.
|
Total
n=98 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.1 Years
STANDARD_DEVIATION 10.80 • n=5 Participants
|
60.9 Years
STANDARD_DEVIATION 8.83 • n=7 Participants
|
61.0 Years
STANDARD_DEVIATION 9.82 • n=5 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
49 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
98 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
49 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
98 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Parkinson's disease Sleep Scale 2nd version (PDSS-2) total score
|
27.8 Score on scale
STANDARD_DEVIATION 6.45 • n=5 Participants
|
29.2 Score on scale
STANDARD_DEVIATION 8.53 • n=7 Participants
|
28.5 Score on scale
STANDARD_DEVIATION 7.56 • n=5 Participants
|
|
Parkinson's disease Questionnaire (PDQ) -8 score
|
11.3 Score on a scale
STANDARD_DEVIATION 4.83 • n=5 Participants
|
10.5 Score on a scale
STANDARD_DEVIATION 4.99 • n=7 Participants
|
10.9 Score on a scale
STANDARD_DEVIATION 4.90 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 18Population: Full analysis set (FAS) was defined as all patients who were randomised to treatment and received at least one dose of study drug and providing a baseline and at least one PDSS-2 total score measurement in maintenance period.
Parkinson's disease Sleep Scale 2nd version (PDSS-2) consists of 15 questions about various sleep and nocturnal disturbances which are to be rated by the patients using one of five categories, from 0 (never) to 4 (very often). Patients were asked to rate the severity of each question based on their experience during the past week (7 days) from 0 (Never) to 4 (Very often, that meant 6 to 7 days a week). PDSS-2 total score ranges from 0 (no disturbance) to 60 (maximum nocturnal disturbance).
Outcome measures
| Measure |
Pramipexole Sustained Release
n=45 Participants
Tablets of Pramipexole sustained release (SR) with unit strength of 0.375 milligram (mg) and 0.75 mg were administered orally once daily at 7-9 pm before bedtime to achieve daily dose of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg for a treatment period of 18 weeks. The dose of Pramipexole SR was titrated to an optimised level, to achieve a maximum therapeutic effect without intolerable side effects.
|
Pramipexole Immediate Release
n=43 Participants
Tablets of Pramipexole immediate release (IR) with unit strength of 0.25 milligram (mg) and 1.0 mg were administered in equally divided doses three times per day to achieve a total daily dose of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, the third dose at 7-9 pm before bedtime for a treatment period of 18 weeks.
The dose of Pramipexole IR was titrated to an optimised level, to achieve a maximum therapeutic effect without intolerable side effects.
|
|---|---|---|
|
Change From Baseline to Week 18 in Parkinson's Disease Sleep Scale 2nd Version (PDSS-2) Total Score
|
-13.7 Score on a scale
Standard Error 1.16
|
-14.4 Score on a scale
Standard Error 1.20
|
SECONDARY outcome
Timeframe: Baseline and Week 18Population: Full analysis set (FAS) was defined as all patients who were randomised to treatment and received at least one dose of study drug and providing a baseline and at least one PDSS-2 total score measurement in maintenance period.
The Nocturnal Hypokinesia Questionnaire (NHQ) is designed to assess hypokinesia symptoms in night in Parkinson's disease (PD) patients, composed of two sections. Section 1 is assessed by PD patients with 10 one-point items evaluating "turning over in bed", "getting out of bed", "parkinsonian motor symptoms", and "others". Section 2 is assessed by spouses or caregivers who are with the patients during the night with 10 one-point items evaluating the same aspects as Section 1. The score for each section is by summing up points from the items in the respective section. Score of each of the two Sections is from 0 to 10, with a higher score indicating worse symptoms. The score was reported by section: Section 1 by patients, Section 2 by caregivers.
Outcome measures
| Measure |
Pramipexole Sustained Release
n=45 Participants
Tablets of Pramipexole sustained release (SR) with unit strength of 0.375 milligram (mg) and 0.75 mg were administered orally once daily at 7-9 pm before bedtime to achieve daily dose of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg for a treatment period of 18 weeks. The dose of Pramipexole SR was titrated to an optimised level, to achieve a maximum therapeutic effect without intolerable side effects.
|
Pramipexole Immediate Release
n=43 Participants
Tablets of Pramipexole immediate release (IR) with unit strength of 0.25 milligram (mg) and 1.0 mg were administered in equally divided doses three times per day to achieve a total daily dose of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, the third dose at 7-9 pm before bedtime for a treatment period of 18 weeks.
The dose of Pramipexole IR was titrated to an optimised level, to achieve a maximum therapeutic effect without intolerable side effects.
|
|---|---|---|
|
Nocturnal Hypokinesia Questionnaire (NHQ) Score (Change From Baseline)
By patients (Section 1)
|
-1.9 Score on a scale
Standard Error 0.35
|
-1.7 Score on a scale
Standard Error 0.36
|
|
Nocturnal Hypokinesia Questionnaire (NHQ) Score (Change From Baseline)
By caregivers (Section 2)
|
-1.4 Score on a scale
Standard Error 0.61
|
-0.6 Score on a scale
Standard Error 0.67
|
SECONDARY outcome
Timeframe: Baseline and Week 18Population: Full analysis set (FAS) was defined as all patients who were randomised to treatment and received at least one dose of study drug and providing a baseline and at least one PDSS-2 total score measurement in maintenance period.
SCOPA-Sleep score is composed of three parts: a night-time scale (5 item scale with 4 Response Options (0-not at all to 3-very much) addressing night time disturbances. Total night-time scale score runs from 0 to 15, with a higher score indicating more severe problems, a single-item about perceived quality of nocturnal sleep (7-point scale ranging from slept very well to slept very badly.), and a daytime sleepiness scale (6 items with 4 Response options, from 0 (never) to 3 (often), and a maximum total score of 18.).
Outcome measures
| Measure |
Pramipexole Sustained Release
n=45 Participants
Tablets of Pramipexole sustained release (SR) with unit strength of 0.375 milligram (mg) and 0.75 mg were administered orally once daily at 7-9 pm before bedtime to achieve daily dose of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg for a treatment period of 18 weeks. The dose of Pramipexole SR was titrated to an optimised level, to achieve a maximum therapeutic effect without intolerable side effects.
|
Pramipexole Immediate Release
n=43 Participants
Tablets of Pramipexole immediate release (IR) with unit strength of 0.25 milligram (mg) and 1.0 mg were administered in equally divided doses three times per day to achieve a total daily dose of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, the third dose at 7-9 pm before bedtime for a treatment period of 18 weeks.
The dose of Pramipexole IR was titrated to an optimised level, to achieve a maximum therapeutic effect without intolerable side effects.
|
|---|---|---|
|
Scale for Outcomes in Parkinson's Disease (SCOPA)-Sleep Score (Change From Baseline)
Night-time sleep score
|
-3.8 Score on a scale
Standard Error 0.46
|
-3.2 Score on a scale
Standard Error 0.47
|
|
Scale for Outcomes in Parkinson's Disease (SCOPA)-Sleep Score (Change From Baseline)
Overall night sleep score
|
-1.9 Score on a scale
Standard Error 0.20
|
-1.6 Score on a scale
Standard Error 0.21
|
|
Scale for Outcomes in Parkinson's Disease (SCOPA)-Sleep Score (Change From Baseline)
Daytime sleepiness score
|
-1.4 Score on a scale
Standard Error 0.34
|
-0.9 Score on a scale
Standard Error 0.35
|
SECONDARY outcome
Timeframe: Baseline and Week 18Population: Full analysis set (FAS) was defined as all patients who were randomised to treatment and received at least one dose of study drug and providing a baseline and at least one PDSS-2 total score measurement in maintenance period.
The EMO is measured by the question of "do you feel like your bodily movements are poor when you wake up?" Patients answered this question according to the frequency during the previous one week by scoring from 0 ("never") to 4 ("very often" or "6 to 7 days a week").
Outcome measures
| Measure |
Pramipexole Sustained Release
n=45 Participants
Tablets of Pramipexole sustained release (SR) with unit strength of 0.375 milligram (mg) and 0.75 mg were administered orally once daily at 7-9 pm before bedtime to achieve daily dose of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg for a treatment period of 18 weeks. The dose of Pramipexole SR was titrated to an optimised level, to achieve a maximum therapeutic effect without intolerable side effects.
|
Pramipexole Immediate Release
n=43 Participants
Tablets of Pramipexole immediate release (IR) with unit strength of 0.25 milligram (mg) and 1.0 mg were administered in equally divided doses three times per day to achieve a total daily dose of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, the third dose at 7-9 pm before bedtime for a treatment period of 18 weeks.
The dose of Pramipexole IR was titrated to an optimised level, to achieve a maximum therapeutic effect without intolerable side effects.
|
|---|---|---|
|
Early Morning Off (EMO) Score (Change From Baseline)
|
-1.8 Score on a scale
Standard Error 0.18
|
-1.5 Score on a scale
Standard Error 0.18
|
SECONDARY outcome
Timeframe: At Week 18Population: Full analysis set (FAS) was defined as all patients who were randomised to treatment and received at least one dose of study drug and providing a baseline and at least one PDSS-2 total score measurement in maintenance period.
Parkinson's disease Sleep Scale 2nd version (PDSS-2) consists of 15 questions about various sleep and nocturnal disturbances which are to be rated by the patients using one of five categories, from 0 (never) to 4 (very often) based on their experience during the past week. PDSS-2 total score ranges from 0 (no disturbance) to 60 (maximum nocturnal disturbance). The PDSS-2 total score less \< 18 were compared between groups.
Outcome measures
| Measure |
Pramipexole Sustained Release
n=45 Participants
Tablets of Pramipexole sustained release (SR) with unit strength of 0.375 milligram (mg) and 0.75 mg were administered orally once daily at 7-9 pm before bedtime to achieve daily dose of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg for a treatment period of 18 weeks. The dose of Pramipexole SR was titrated to an optimised level, to achieve a maximum therapeutic effect without intolerable side effects.
|
Pramipexole Immediate Release
n=43 Participants
Tablets of Pramipexole immediate release (IR) with unit strength of 0.25 milligram (mg) and 1.0 mg were administered in equally divided doses three times per day to achieve a total daily dose of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, the third dose at 7-9 pm before bedtime for a treatment period of 18 weeks.
The dose of Pramipexole IR was titrated to an optimised level, to achieve a maximum therapeutic effect without intolerable side effects.
|
|---|---|---|
|
Responder Rate for Parkinson's Disease Sleep Scale 2nd Version (PDSS-2) Total Score<18
|
73.3 Percentage of participants
Interval 58.1 to 85.4
|
72.1 Percentage of participants
Interval 56.3 to 84.7
|
SECONDARY outcome
Timeframe: At Week 18Population: Full analysis set (FAS) was defined as all patients who were randomised to treatment and received at least one dose of study drug and providing a baseline and at least one PDSS-2 total score measurement in maintenance period.
The responder of EMO is the patient with an improvement of at least 1 comparing to his/her baseline condition. The EMO is measured by the question of "do you feel like your bodily movements are poor when you wake up?" Patients answered this question according to the frequency during the previous one week by scoring from 0 ("never") to 4 ("very often" or "6 to 7 days a week").
Outcome measures
| Measure |
Pramipexole Sustained Release
n=45 Participants
Tablets of Pramipexole sustained release (SR) with unit strength of 0.375 milligram (mg) and 0.75 mg were administered orally once daily at 7-9 pm before bedtime to achieve daily dose of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg for a treatment period of 18 weeks. The dose of Pramipexole SR was titrated to an optimised level, to achieve a maximum therapeutic effect without intolerable side effects.
|
Pramipexole Immediate Release
n=43 Participants
Tablets of Pramipexole immediate release (IR) with unit strength of 0.25 milligram (mg) and 1.0 mg were administered in equally divided doses three times per day to achieve a total daily dose of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, the third dose at 7-9 pm before bedtime for a treatment period of 18 weeks.
The dose of Pramipexole IR was titrated to an optimised level, to achieve a maximum therapeutic effect without intolerable side effects.
|
|---|---|---|
|
Responder Rate for Early Morning Off (EMO) Score
|
86.7 Percentage of participants
Interval 73.2 to 94.9
|
76.7 Percentage of participants
Interval 61.4 to 88.2
|
SECONDARY outcome
Timeframe: Baseline and Week 18Population: Full analysis set (FAS) was defined as all patients who were randomised to treatment and received at least one dose of study drug and providing a baseline and at least one PDSS-2 total score measurement in maintenance period.
The PDQ-8 is a self-reported questionnaire consisting of 8 questions regarding the subject's disease symptoms. The total score summed up the items together and transformed onto a score from 0 (never have problems/issues) to 100 (always have problems or cannot do at all).
Outcome measures
| Measure |
Pramipexole Sustained Release
n=45 Participants
Tablets of Pramipexole sustained release (SR) with unit strength of 0.375 milligram (mg) and 0.75 mg were administered orally once daily at 7-9 pm before bedtime to achieve daily dose of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg for a treatment period of 18 weeks. The dose of Pramipexole SR was titrated to an optimised level, to achieve a maximum therapeutic effect without intolerable side effects.
|
Pramipexole Immediate Release
n=43 Participants
Tablets of Pramipexole immediate release (IR) with unit strength of 0.25 milligram (mg) and 1.0 mg were administered in equally divided doses three times per day to achieve a total daily dose of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, the third dose at 7-9 pm before bedtime for a treatment period of 18 weeks.
The dose of Pramipexole IR was titrated to an optimised level, to achieve a maximum therapeutic effect without intolerable side effects.
|
|---|---|---|
|
The Parkinson's Disease Questionnaire (PDQ)-8 Score (Change From Baseline)
|
-4.1 Score on a scale
Standard Error 0.60
|
-3.5 Score on a scale
Standard Error 0.62
|
SECONDARY outcome
Timeframe: At Week 18Population: Full analysis set (FAS) was defined as all patients who were randomised to treatment and received at least one dose of study drug and providing a baseline and at least one PDSS-2 total score measurement in maintenance period.
The responder of CGI-I is the patient rated of any improvement (1 = Very much better, 2 = Much better, or 3 = A little better). The CGI-I was rated (from 1: very much improved, to 7: very much worse) by the same evaluator to assess the overall status of Parkinson's disease.
Outcome measures
| Measure |
Pramipexole Sustained Release
n=45 Participants
Tablets of Pramipexole sustained release (SR) with unit strength of 0.375 milligram (mg) and 0.75 mg were administered orally once daily at 7-9 pm before bedtime to achieve daily dose of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg for a treatment period of 18 weeks. The dose of Pramipexole SR was titrated to an optimised level, to achieve a maximum therapeutic effect without intolerable side effects.
|
Pramipexole Immediate Release
n=43 Participants
Tablets of Pramipexole immediate release (IR) with unit strength of 0.25 milligram (mg) and 1.0 mg were administered in equally divided doses three times per day to achieve a total daily dose of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, the third dose at 7-9 pm before bedtime for a treatment period of 18 weeks.
The dose of Pramipexole IR was titrated to an optimised level, to achieve a maximum therapeutic effect without intolerable side effects.
|
|---|---|---|
|
Responder Rate for Clinical Global Impression of Improvement (CGI-I)
|
95.6 Percentage of participants
Interval 84.9 to 99.5
|
86.0 Percentage of participants
Interval 72.1 to 94.7
|
SECONDARY outcome
Timeframe: At Week 18Population: Full analysis set (FAS) was defined as all patients who were randomised to treatment and received at least one dose of study drug and providing a baseline and at least one PDSS-2 total score measurement in maintenance period.
The responder of PGI-I is the patient rated of any improvement (1 = Very much better, 2 = Much better, or 3 = A little better). The PGI-I scale is a patient-rated instrument (from 1: very much better, to 7: very much worse) which was used to measure the improvement of the patient's Parkinson disease symptoms throughout the study.
Outcome measures
| Measure |
Pramipexole Sustained Release
n=45 Participants
Tablets of Pramipexole sustained release (SR) with unit strength of 0.375 milligram (mg) and 0.75 mg were administered orally once daily at 7-9 pm before bedtime to achieve daily dose of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg for a treatment period of 18 weeks. The dose of Pramipexole SR was titrated to an optimised level, to achieve a maximum therapeutic effect without intolerable side effects.
|
Pramipexole Immediate Release
n=43 Participants
Tablets of Pramipexole immediate release (IR) with unit strength of 0.25 milligram (mg) and 1.0 mg were administered in equally divided doses three times per day to achieve a total daily dose of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, the third dose at 7-9 pm before bedtime for a treatment period of 18 weeks.
The dose of Pramipexole IR was titrated to an optimised level, to achieve a maximum therapeutic effect without intolerable side effects.
|
|---|---|---|
|
Responder Rate for Patient Global Impression of Improvement (PGI-I)
|
95.6 Percentage of participants
Interval 84.9 to 99.5
|
86.0 Percentage of participants
Interval 72.1 to 94.7
|
SECONDARY outcome
Timeframe: Baseline and Week 18Population: Full analysis set (FAS) was defined as all patients who were randomised to treatment and received at least one dose of study drug and providing a baseline and at least one PDSS-2 total score measurement in maintenance period.
The ESS is a patient-rated scale about how likely one is to fall asleep during situations of passive and inconsequential to active. The total score ranges from 0-24 where higher values indicate greater daytime sleepiness.
Outcome measures
| Measure |
Pramipexole Sustained Release
n=45 Participants
Tablets of Pramipexole sustained release (SR) with unit strength of 0.375 milligram (mg) and 0.75 mg were administered orally once daily at 7-9 pm before bedtime to achieve daily dose of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg for a treatment period of 18 weeks. The dose of Pramipexole SR was titrated to an optimised level, to achieve a maximum therapeutic effect without intolerable side effects.
|
Pramipexole Immediate Release
n=43 Participants
Tablets of Pramipexole immediate release (IR) with unit strength of 0.25 milligram (mg) and 1.0 mg were administered in equally divided doses three times per day to achieve a total daily dose of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, the third dose at 7-9 pm before bedtime for a treatment period of 18 weeks.
The dose of Pramipexole IR was titrated to an optimised level, to achieve a maximum therapeutic effect without intolerable side effects.
|
|---|---|---|
|
Epworth Sleepiness Scale (ESS) Score (Change From Baseline)
|
-2.4 Score on a scale
Standard Error 0.54
|
-2.6 Score on a scale
Standard Error 0.56
|
Adverse Events
Pramipexole Sustained Release
Pramipexole Immediate Release
Serious adverse events
| Measure |
Pramipexole Sustained Release
n=49 participants at risk
Tablets of Pramipexole sustained release (SR) with unit strength of 0.375 milligram (mg) and 0.75 mg were administered orally once daily at 7-9 pm before bedtime to achieve daily dose of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg for a treatment period of 18 weeks. The dose of Pramipexole SR was titrated to an optimised level, to achieve a maximum therapeutic effect without intolerable side effects.
|
Pramipexole Immediate Release
n=49 participants at risk
Tablets of Pramipexole immediate release (IR) with unit strength of 0.25 milligram (mg) and 1.0 mg were administered in equally divided doses three times per day to achieve a total daily dose of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, the third dose at 7-9 pm before bedtime for a treatment period of 18 weeks.
The dose of Pramipexole IR was titrated to an optimised level, to achieve a maximum therapeutic effect without intolerable side effects.
|
|---|---|---|
|
Gastrointestinal disorders
Mechanical ileus
|
0.00%
0/49 • From randomisation through end of treatment until end of follow up visit, up to 18 weeks + 2 days.
Treated set (TS) was defined as all patients who were dispensed study medication and were documented to have at least one dose of investigational treatment.
|
2.0%
1/49 • From randomisation through end of treatment until end of follow up visit, up to 18 weeks + 2 days.
Treated set (TS) was defined as all patients who were dispensed study medication and were documented to have at least one dose of investigational treatment.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/49 • From randomisation through end of treatment until end of follow up visit, up to 18 weeks + 2 days.
Treated set (TS) was defined as all patients who were dispensed study medication and were documented to have at least one dose of investigational treatment.
|
2.0%
1/49 • From randomisation through end of treatment until end of follow up visit, up to 18 weeks + 2 days.
Treated set (TS) was defined as all patients who were dispensed study medication and were documented to have at least one dose of investigational treatment.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/49 • From randomisation through end of treatment until end of follow up visit, up to 18 weeks + 2 days.
Treated set (TS) was defined as all patients who were dispensed study medication and were documented to have at least one dose of investigational treatment.
|
2.0%
1/49 • From randomisation through end of treatment until end of follow up visit, up to 18 weeks + 2 days.
Treated set (TS) was defined as all patients who were dispensed study medication and were documented to have at least one dose of investigational treatment.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/49 • From randomisation through end of treatment until end of follow up visit, up to 18 weeks + 2 days.
Treated set (TS) was defined as all patients who were dispensed study medication and were documented to have at least one dose of investigational treatment.
|
2.0%
1/49 • From randomisation through end of treatment until end of follow up visit, up to 18 weeks + 2 days.
Treated set (TS) was defined as all patients who were dispensed study medication and were documented to have at least one dose of investigational treatment.
|
Other adverse events
| Measure |
Pramipexole Sustained Release
n=49 participants at risk
Tablets of Pramipexole sustained release (SR) with unit strength of 0.375 milligram (mg) and 0.75 mg were administered orally once daily at 7-9 pm before bedtime to achieve daily dose of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg for a treatment period of 18 weeks. The dose of Pramipexole SR was titrated to an optimised level, to achieve a maximum therapeutic effect without intolerable side effects.
|
Pramipexole Immediate Release
n=49 participants at risk
Tablets of Pramipexole immediate release (IR) with unit strength of 0.25 milligram (mg) and 1.0 mg were administered in equally divided doses three times per day to achieve a total daily dose of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, the third dose at 7-9 pm before bedtime for a treatment period of 18 weeks.
The dose of Pramipexole IR was titrated to an optimised level, to achieve a maximum therapeutic effect without intolerable side effects.
|
|---|---|---|
|
Nervous system disorders
Dizziness
|
6.1%
3/49 • From randomisation through end of treatment until end of follow up visit, up to 18 weeks + 2 days.
Treated set (TS) was defined as all patients who were dispensed study medication and were documented to have at least one dose of investigational treatment.
|
6.1%
3/49 • From randomisation through end of treatment until end of follow up visit, up to 18 weeks + 2 days.
Treated set (TS) was defined as all patients who were dispensed study medication and were documented to have at least one dose of investigational treatment.
|
|
Nervous system disorders
Dyskinesia
|
2.0%
1/49 • From randomisation through end of treatment until end of follow up visit, up to 18 weeks + 2 days.
Treated set (TS) was defined as all patients who were dispensed study medication and were documented to have at least one dose of investigational treatment.
|
6.1%
3/49 • From randomisation through end of treatment until end of follow up visit, up to 18 weeks + 2 days.
Treated set (TS) was defined as all patients who were dispensed study medication and were documented to have at least one dose of investigational treatment.
|
|
Nervous system disorders
Somnolence
|
2.0%
1/49 • From randomisation through end of treatment until end of follow up visit, up to 18 weeks + 2 days.
Treated set (TS) was defined as all patients who were dispensed study medication and were documented to have at least one dose of investigational treatment.
|
6.1%
3/49 • From randomisation through end of treatment until end of follow up visit, up to 18 weeks + 2 days.
Treated set (TS) was defined as all patients who were dispensed study medication and were documented to have at least one dose of investigational treatment.
|
Additional Information
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Results disclosure agreements
- Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER