Trial · NCT01155479
A Placebo- and Active-Controlled Study of Preladenant in Early Parkinson's Disease (PD) (P05664)
NCT01155479, Phase 3, Terminated, Merck Sharp & Dohme LLC; results first posted 2016-07-28
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Placebo- and Active-Controlled Study of Preladenant in Early Parkinson's Disease (PD) (P05664). Trials, record NCT01155479. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01155479
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Placebo- and Active-Controlled Study of Preladenant in Early Parkinson's Disease (PD) (P05664)
- NCT number
- NCT01155479
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 1,022 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Parkinson Disease
- Interventions
- Preladenant 2 mg tablet, Preladenant 5 mg tablet, Preladenant 10 mg tablet, Rasagiline 1 mg capsule, Placebo for Rasagiline 1 mg capsule, Placebo for Preladenant
- First posted
- 2010-07-01
- Last updated
- 2018-11-07
- Other registries' IDs
- eudract:2009-013552-72
- Results first posted
- 2016-07-28
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in the Sum of Unified Parkinson's Disease Rating Scale Parts 2 and 3 Scores (UPDRS2+3) | Baseline and Week 26 | The UPDRS is a clinician based rating scale used to measure motor impairments and disability. The UPDRS assesses six features of PD impairment. These are evaluated using a combination of data collected by interview and examination of the participant. The UPDRS Part 2 is the Activities of Daily Living (ADL) score and can range from 0-52 as determined by the physician. The UPDRS Part 3 is the Motor Examination (Total Motor Score \[TMS\]) and is defined as the total score, ranging from 0-108 as determined by the physician, of the tests given in the motor examination section. The combined scores of Parts 2 and 3 can range from 0-160 with the higher score indicating the worse condition. Change from baseline was analyzed using a constrained longitudinal analysis (cLDA) model with treatment, time, strata and treatment-by-time interaction as fixed effects and participant as a random effect. |
| Primary | Number of Participants With Adverse Events (AEs) in Part 1 | Day 1 to Week 26 | An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product. |
| Primary | Number of Participants Who Discontinued Study Due to an AE in Part 1 | Day 1 to Week 26 | An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product. |
| Primary | Number of Participants With Adverse Events (AEs) in Part 2 | Week 27 to Week 52 | An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product. |
| Primary | Number of Participants Who Discontinued Study Due to an AE in Part 2 | Week 27 to Week 52 | An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product. |
| Secondary | Percentage of Responders (Participants With a ≥20% Improvement in UPDRS2+3) | Baseline and Week 26 | UPDRS is a clinician based rating scale used to measure motor impairments and disability; it assesses 6 features of PD impairment. These are evaluated using a combination of data collected by interview and examination of the participant. UPDRS Part 2 is Activities of Daily Living score and ranges from 0-52. UPDRS Part 3 is Motor Examination and ranges from 0-108. The combined scores of Parts 2 and 3 can range from 0-160 with the higher score indicating the worse condition. A Responder is defined as a participant with at least 20% improvement in UPDRS2+3 from Baseline to Week 26 (End of Part 1 Treatment); a participant with at least a 20% decrease from Baseline score in UPDRS2+3 is defined as a responder. The proportion of Responders was analyzed using a generalized linear mixed model with treatment effect, strata and Baseline UPDRS2+3 as a covariate, and treatment-by-time interaction as fixed effects and subject as random effect. |
| Secondary | Change From Baseline in the UPDRS Part 2 Score (Activities of Daily Living [ADL]) | Baseline and Week 26 | The UPDRS is a clinician based rating scale used to measure motor impairments and disability. The UPDRS assesses six features of PD impairment. These are evaluated using a combination of data collected by interview and examination of the participant. The UPDRS Part 2 is the Activities of Daily Living (ADL) score and can range from 0-52 as determined by the physician with the higher score indicating the worse condition. Change from baseline was analyzed using a cLDA model with treatment, time, strata and treatment-by-time interaction as fixed effects and participant as a random effect. |
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 | Change From Baseline in the Sum of Unified Parkinson's Disease Rating Scale Parts 2 and 3 Scores (UPDRS2+3) | Baseline and Week 26 | Full Analysis Set (FAS): All randomized and treated participants with at least one post-baseline value. | Score on a Scale | MEAN |
| SECONDARY | Percentage of Responders (Participants With a ≥20% Improvement in UPDRS2+3) | Baseline and Week 26 | Full Analysis Set (FAS): All randomized and treated participants with at least one post-baseline value. | Percentage of Responders | NUMBER |
| SECONDARY | Change From Baseline in the UPDRS Part 2 Score (Activities of Daily Living [ADL]) | Baseline and Week 26 | Full Analysis Set (FAS): All randomized and treated participants with at least one post-baseline value. | Score on a Scale | MEAN |
| PRIMARY | Number of Participants With Adverse Events (AEs) in Part 1 | Day 1 to Week 26 | All Participants as Treated: All participants who received at least one dose of study treatment. | Participants | NUMBER |
| PRIMARY | Number of Participants Who Discontinued Study Due to an AE in Part 1 | Day 1 to Week 26 | All Participants as Treated: All participants who received at least one dose of study treatment. | Participants | NUMBER |
| PRIMARY | Number of Participants With Adverse Events (AEs) in Part 2 | Week 27 to Week 52 | All Participants as Treated: All participants who received at least one dose of study treatment. | Participants | NUMBER |
| PRIMARY | Number of Participants Who Discontinued Study Due to an AE in Part 2 | Week 27 to Week 52 | All Participants as Treated (APaT): All participants who received at least one dose of study treatment. | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group35
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in the Sum of Unified Parkinson's Disease Rating Scale Parts 2 and 3 Scores (UPDRS2+3) | Preladenant 2 mg (Part 1) | 0.3 | Standard Error 0.63 | Score on a Scale | |
| Change From Baseline in the Sum of Unified Parkinson's Disease Rating Scale Parts 2 and 3 Scores (UPDRS2+3) | Preladenant 5 mg (Part 1) | -1.0 | Standard Error 0.60 | Score on a Scale | |
| Change From Baseline in the Sum of Unified Parkinson's Disease Rating Scale Parts 2 and 3 Scores (UPDRS2+3) | Preladenant 10 mg (Part 1) | -1.8 | Standard Error 0.61 | Score on a Scale | |
| Change From Baseline in the Sum of Unified Parkinson's Disease Rating Scale Parts 2 and 3 Scores (UPDRS2+3) | Placebo (Part 1) | -2.2 | Standard Error 0.61 | Score on a Scale | |
| Change From Baseline in the Sum of Unified Parkinson's Disease Rating Scale Parts 2 and 3 Scores (UPDRS2+3) | Rasagiline (Part 1) | -1.9 | Standard Error 0.61 | Score on a Scale | |
| Percentage of Responders (Participants With a ≥20% Improvement in UPDRS2+3) | Preladenant 2 mg (Part 1) | 25.90 | 95% Confidence Interval 18.95 to 34.33 | Percentage of Responders | |
| Percentage of Responders (Participants With a ≥20% Improvement in UPDRS2+3) | Preladenant 5 mg (Part 1) | 29.50 | 95% Confidence Interval 22.50 to 37.72 | Percentage of Responders | |
| Percentage of Responders (Participants With a ≥20% Improvement in UPDRS2+3) | Preladenant 10 mg (Part 1) | 31.50 | 95% Confidence Interval 24.06 to 40.02 | Percentage of Responders | |
| Percentage of Responders (Participants With a ≥20% Improvement in UPDRS2+3) | Placebo (Part 1) | 35.20 | 95% Confidence Interval 27.49 to 43.82 | Percentage of Responders | |
| Percentage of Responders (Participants With a ≥20% Improvement in UPDRS2+3) | Rasagiline (Part 1) | 33.10 | 95% Confidence Interval 25.60 to 41.51 | Percentage of Responders |
1 to 10 of 35Source ClinicalTrials.gov
See all 35 results by groupParticipant flow35
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Part I | STARTED | Preladenant 2 mg | 204 | |
| Part I | STARTED | Preladenant 5 mg | 204 | |
| Part I | STARTED | Preladenant 10 mg | 206 | |
| Part I | STARTED | Placebo | 204 | |
| Part I | STARTED | Rasagiline | 204 | |
| Part I | Treated | Preladenant 2 mg | 200 | |
| Part I | Treated | Preladenant 5 mg | 202 | |
| Part I | Treated | Preladenant 10 mg | 204 | |
| Part I | Treated | Placebo | 198 | |
| Part I | Treated | Rasagiline | 203 |
1 to 10 of 35Source ClinicalTrials.gov
See all 35 participant flowAdverse events680
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 | Constipation | Gastrointestinal disorders | Preladenant 2 mg - Part 1 | 5 | 200 | 6 |
| other | Constipation | Gastrointestinal disorders | Preladenant 5 mg - Part 1 | 9 | 202 | 10 |
| other | Constipation | Gastrointestinal disorders | Preladenant 10 mg - Part 1 | 11 | 204 | 11 |
| other | Constipation | Gastrointestinal disorders | Placebo - Part 1 | 5 | 198 | 5 |
| other | Constipation | Gastrointestinal disorders | Rasagiline - Part 1 | 3 | 203 | 3 |
| other | Constipation | Gastrointestinal disorders | Preladenant 2 mg - Part 2 | 1 | 166 | 1 |
| other | Constipation | Gastrointestinal disorders | Preladenant 5 mg - Part 2 | 1 | 177 | 1 |
| other | Constipation | Gastrointestinal disorders | Preladenant 10 mg - Part 2 | 4 | 167 | 4 |
| other | Constipation | Gastrointestinal disorders | Placebo/Preladenant 5 Mg-Part 2 | 4 | 177 | 5 |
| other | Constipation | Gastrointestinal disorders | Rasagiline - Part 2 | 2 | 181 | 2 |
1 to 10 of 680Source ClinicalTrials.gov
See all 680 adverse eventsAdverse event totals30
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Preladenant 2 mg - Part 1 | ||
| Total, all-cause mortality | Preladenant 5 mg - Part 1 | ||
| Total, all-cause mortality | Preladenant 10 mg - Part 1 | ||
| Total, all-cause mortality | Placebo - Part 1 | ||
| Total, all-cause mortality | Rasagiline - Part 1 | ||
| Total, all-cause mortality | Preladenant 2 mg - Part 2 | ||
| Total, all-cause mortality | Preladenant 5 mg - Part 2 | ||
| Total, all-cause mortality | Preladenant 10 mg - Part 2 | ||
| Total, all-cause mortality | Placebo/Preladenant 5 Mg-Part 2 | ||
| Total, all-cause mortality | Rasagiline - Part 2 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 28490648 | RESULT |
Source PubMed
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/NCT01155479
GET https://conductscience.org/api/trials/v1/NCT01155479/results?page=2