Trial · NCT03521635
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
NCT03521635, Phase 4, Completed, Boehringer Ingelheim; results first posted 2021-02-16
3 sourcestrials-2026-11-12-0.4.0
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ConductScience Library. 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. Trials, record NCT03521635. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03521635
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- 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 number
- NCT03521635
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 98 participants, actual
- Lead sponsor
- Boehringer Ingelheim
- Conditions
- Parkinson Disease
- Interventions
- Pramipexole SR, Pramipexole IR
- First posted
- 2018-05-11
- Last updated
- 2021-02-16
- Results first posted
- 2021-02-16
- Limitations and caveats
- According to the study results, the decision was made to stop transitioning to Stage II. Therefore, only results of Stage I were reported.
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline to Week 18 in Parkinson's Disease Sleep Scale 2nd Version (PDSS-2) Total Score | Baseline and Week 18 | 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). |
| Secondary | Nocturnal Hypokinesia Questionnaire (NHQ) Score (Change From Baseline) | Baseline and Week 18 | 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. |
| Secondary | Scale for Outcomes in Parkinson's Disease (SCOPA)-Sleep Score (Change From Baseline) | Baseline and Week 18 | 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.). |
| Secondary | Early Morning Off (EMO) Score (Change From Baseline) | Baseline and Week 18 | 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"). |
| Secondary | Responder Rate for Parkinson's Disease Sleep Scale 2nd Version (PDSS-2) Total Score<18 | At Week 18 | 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. |
| Secondary | Responder Rate for Early Morning Off (EMO) Score | At Week 18 | 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"). |
| Secondary | The Parkinson's Disease Questionnaire (PDQ)-8 Score (Change From Baseline) | Baseline and Week 18 | 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). |
| Secondary | Responder Rate for Clinical Global Impression of Improvement (CGI-I) | At Week 18 | 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. |
| Secondary | Responder Rate for Patient Global Impression of Improvement (PGI-I) | At Week 18 | 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. |
| Secondary | Epworth Sleepiness Scale (ESS) Score (Change From Baseline) | Baseline and Week 18 | 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. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline to Week 18 in Parkinson's Disease Sleep Scale 2nd Version (PDSS-2) Total Score | Baseline and Week 18 | 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. | Score on a scale | MEAN |
| SECONDARY | Nocturnal Hypokinesia Questionnaire (NHQ) Score (Change From Baseline) | Baseline and Week 18 | 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. | Score on a scale | MEAN |
| SECONDARY | Scale for Outcomes in Parkinson's Disease (SCOPA)-Sleep Score (Change From Baseline) | Baseline and Week 18 | 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. | Score on a scale | MEAN |
| SECONDARY | Early Morning Off (EMO) Score (Change From Baseline) | Baseline and Week 18 | 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. | Score on a scale | MEAN |
| SECONDARY | Responder Rate for Parkinson's Disease Sleep Scale 2nd Version (PDSS-2) Total Score<18 | At Week 18 | 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. | Percentage of participants | NUMBER |
| SECONDARY | Responder Rate for Early Morning Off (EMO) Score | At Week 18 | 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. | Percentage of participants | NUMBER |
| SECONDARY | The Parkinson's Disease Questionnaire (PDQ)-8 Score (Change From Baseline) | Baseline and Week 18 | 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. | Score on a scale | MEAN |
| SECONDARY | Responder Rate for Clinical Global Impression of Improvement (CGI-I) | At Week 18 | 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. | Percentage of participants | NUMBER |
| SECONDARY | Responder Rate for Patient Global Impression of Improvement (PGI-I) | At Week 18 | 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. | Percentage of participants | NUMBER |
| SECONDARY | Epworth Sleepiness Scale (ESS) Score (Change From Baseline) | Baseline and Week 18 | 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. | Score on a scale | MEAN |
Source ClinicalTrials.gov
Results by group26
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline to Week 18 in Parkinson's Disease Sleep Scale 2nd Version (PDSS-2) Total Score | Pramipexole Sustained Release | -13.7 | Standard Error 1.16 | Score on a scale | |
| Change From Baseline to Week 18 in Parkinson's Disease Sleep Scale 2nd Version (PDSS-2) Total Score | Pramipexole Immediate Release | -14.4 | Standard Error 1.20 | Score on a scale | |
| Nocturnal Hypokinesia Questionnaire (NHQ) Score (Change From Baseline) | Pramipexole Sustained Release | By patients (Section 1) | -1.9 | Standard Error 0.35 | Score on a scale |
| Nocturnal Hypokinesia Questionnaire (NHQ) Score (Change From Baseline) | Pramipexole Immediate Release | By patients (Section 1) | -1.7 | Standard Error 0.36 | Score on a scale |
| Nocturnal Hypokinesia Questionnaire (NHQ) Score (Change From Baseline) | Pramipexole Sustained Release | By caregivers (Section 2) | -1.4 | Standard Error 0.61 | Score on a scale |
| Nocturnal Hypokinesia Questionnaire (NHQ) Score (Change From Baseline) | Pramipexole Immediate Release | By caregivers (Section 2) | -0.6 | Standard Error 0.67 | Score on a scale |
| Scale for Outcomes in Parkinson's Disease (SCOPA)-Sleep Score (Change From Baseline) | Pramipexole Sustained Release | Night-time sleep score | -3.8 | Standard Error 0.46 | Score on a scale |
| Scale for Outcomes in Parkinson's Disease (SCOPA)-Sleep Score (Change From Baseline) | Pramipexole Immediate Release | Night-time sleep score | -3.2 | Standard Error 0.47 | Score on a scale |
| Scale for Outcomes in Parkinson's Disease (SCOPA)-Sleep Score (Change From Baseline) | Pramipexole Sustained Release | Overall night sleep score | -1.9 | Standard Error 0.20 | Score on a scale |
| Scale for Outcomes in Parkinson's Disease (SCOPA)-Sleep Score (Change From Baseline) | Pramipexole Immediate Release | Overall night sleep score | -1.6 | Standard Error 0.21 | Score on a scale |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Pramipexole Sustained Release | 49 | |
| Overall Study | STARTED | Pramipexole Immediate Release | 49 | |
| Overall Study | COMPLETED | Pramipexole Sustained Release | 45 | |
| Overall Study | COMPLETED | Pramipexole Immediate Release | 43 | |
| Overall Study | NOT COMPLETED | Pramipexole Sustained Release | 4 | |
| Overall Study | NOT COMPLETED | Pramipexole Immediate Release | 6 |
Source ClinicalTrials.gov
Adverse events14
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Dizziness | Nervous system disorders | Pramipexole Sustained Release | 3 | 49 | |
| other | Dizziness | Nervous system disorders | Pramipexole Immediate Release | 3 | 49 | |
| other | Dyskinesia | Nervous system disorders | Pramipexole Sustained Release | 1 | 49 | |
| other | Dyskinesia | Nervous system disorders | Pramipexole Immediate Release | 3 | 49 | |
| other | Somnolence | Nervous system disorders | Pramipexole Sustained Release | 1 | 49 | |
| other | Somnolence | Nervous system disorders | Pramipexole Immediate Release | 3 | 49 | |
| serious | Mechanical ileus | Gastrointestinal disorders | Pramipexole Sustained Release | 0 | 49 | |
| serious | Mechanical ileus | Gastrointestinal disorders | Pramipexole Immediate Release | 1 | 49 | |
| serious | Cholecystitis | Hepatobiliary disorders | Pramipexole Sustained Release | 0 | 49 | |
| serious | Cholecystitis | Hepatobiliary disorders | Pramipexole Immediate Release | 1 | 49 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pramipexole Sustained Release | 0 | 49 |
| Total, all-cause mortality | Pramipexole Immediate Release | 0 | 49 |
| Total, other adverse events | Pramipexole Sustained Release | 4 | 49 |
| Total, other adverse events | Pramipexole Immediate Release | 7 | 49 |
| Total, serious adverse events | Pramipexole Sustained Release | 0 | 49 |
| Total, serious adverse events | Pramipexole Immediate Release | 1 | 49 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Pramipexole Sustained Release vs Pramipexole Immediate Release: deaths from any cause | Trial comparisons |
| Pramipexole Sustained Release vs Pramipexole Immediate Release: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
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