Trial · NCT01097421
Influence of Pramipexole Extended Release on Medication Adherence in Parkinson´s Disease
NCT01097421, Completed, Boehringer Ingelheim; results first posted 2012-11-26
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Influence of Pramipexole Extended Release on Medication Adherence in Parkinson´s Disease. Trials, record NCT01097421. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01097421
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Influence of Pramipexole Extended Release on Medication Adherence in Parkinson´s Disease
- NCT number
- NCT01097421
- Status
- Completed
- Enrollment
- 329 participants, actual
- Lead sponsor
- Boehringer Ingelheim
- Conditions
- Parkinson Disease
- Interventions
- Pramipexole Extended Release
- First posted
- 2010-04-01
- Last updated
- 2014-04-11
- Results first posted
- 2012-11-26
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Patients With a Score of 4 in Morisky Scale After 8-12 Weeks of Treatment | 8-12 weeks | Morisky scale: 4 Yes/No Questions: Do you ever forget to take your medicine? Are you careless at times about taking your medicine? When you feel better do you sometimes stop taking your medicine? Sometimes if you feel worse when you take the medicine, do you stop taking it? Score one point for every NO: 0-1 points = low adherence, 2-3 points = moderate, 4 points = high adherence Confidence interval computed using the Clopper-Pearson (exact) method. |
| Primary | Level of Adherence | 8-12 weeks | Points on Morisky scale |
| Secondary | Patient Preference | 8-12 weeks | Patients were asked about their preference regarding frequency of intake (once daily or three times daily) |
| Secondary | Adverse Events (AE) Considered Related to Observed Medication | 8-12 weeks | Some patients had not related AEs as well as related AEs. |
| Secondary | Pramipexole (PPX) Dose | pre-treatment and after 8-12 weeks | mean Pramipexole (PPX) dose |
| Secondary | Clinical Global Impressions (CGI) | 8-12 weeks | Clinical Global Impression (CGI) scale at final visit |
| Secondary | Patients Global Impressions (PGI) | 8-12 weeks | Assessed by asking the patient at the final visit which alternative described how they had felt during the last 7 days as compared to how they felt at the baseline observation. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Patients With a Score of 4 in Morisky Scale After 8-12 Weeks of Treatment | 8-12 weeks | Full Analysis Set (FAS) defined as all patients who had taken at least one dose of the investigational medicinal product (IMP) and had a post-baseline assessment. | Percent | NUMBER |
| PRIMARY | Level of Adherence | 8-12 weeks | FAS | Participants | NUMBER |
| SECONDARY | Patient Preference | 8-12 weeks | FAS | Participants | NUMBER |
| SECONDARY | Adverse Events (AE) Considered Related to Observed Medication | 8-12 weeks | Safety Analysis Set (SAS) defined as all treated patients with a documented baseline observation. | Patients | NUMBER |
| SECONDARY | Pramipexole (PPX) Dose | pre-treatment and after 8-12 weeks | FAS | mg/24 hr | MEAN |
| SECONDARY | Clinical Global Impressions (CGI) | 8-12 weeks | FAS | Participants | NUMBER |
| SECONDARY | Patients Global Impressions (PGI) | 8-12 weeks | FAS | Participants | NUMBER |
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 |
|---|---|---|---|---|---|
| Patients With a Score of 4 in Morisky Scale After 8-12 Weeks of Treatment | Pramipexole Extended Release | 75.2 | 95% Confidence Interval (70.1, 79.8) | Percent | |
| Level of Adherence | Pramipexole Extended Release | Low Adherence | 4 | Participants | |
| Level of Adherence | Pramipexole Extended Release | Moderate Adherence | 77 | Participants | |
| Level of Adherence | Pramipexole Extended Release | High Adherence | 245 | Participants | |
| Patient Preference | Pramipexole Extended Release | Once daily intake | 284 | Participants | |
| Patient Preference | Pramipexole Extended Release | Three times daily intake | 18 | Participants | |
| Patient Preference | Pramipexole Extended Release | No difference | 24 | Participants | |
| Adverse Events (AE) Considered Related to Observed Medication | Pramipexole Extended Release | related | 20 | Patients | |
| Adverse Events (AE) Considered Related to Observed Medication | Pramipexole Extended Release | not related | 21 | Patients | |
| Adverse Events (AE) Considered Related to Observed Medication | Pramipexole Extended Release | total AE - related and not related | 39 | Patients |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Pramipexole Extended Release | 328 | |
| Overall Study | COMPLETED | Pramipexole Extended Release | 314 | |
| Overall Study | NOT COMPLETED | Pramipexole Extended Release | 14 |
Source ClinicalTrials.gov
Adverse events5
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 |
|---|---|---|---|---|---|---|
| serious | Atrial fibrillation | Cardiac disorders | Pramipexole Extended Release | 1 | 328 | |
| serious | Cardiac failure | Cardiac disorders | Pramipexole Extended Release | 1 | 328 | |
| serious | Sudden death | General disorders | Pramipexole Extended Release | 1 | 328 | |
| serious | Fall | Injury, poisoning and procedural complications | Pramipexole Extended Release | 1 | 328 | |
| serious | Tibia fracture | Injury, poisoning and procedural complications | Pramipexole Extended Release | 1 | 328 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pramipexole Extended Release | ||
| Total, other adverse events | Pramipexole Extended Release | 0 | 328 |
| Total, serious adverse events | Pramipexole Extended Release | 3 | 328 |
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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.
GET https://conductscience.org/api/trials/v1/NCT01097421
GET https://conductscience.org/api/trials/v1/NCT01097421/results?page=2