Trial · NCT01155466

A Placebo- and Active Controlled Study of Preladenant in Subjects With Moderate to Severe Parkinson's Disease (P04938)

NCT01155466, Phase 3, Completed, Merck Sharp & Dohme LLC; results first posted 2016-02-11

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Placebo- and Active Controlled Study of Preladenant in Subjects With Moderate to Severe Parkinson's Disease (P04938). Trials, record NCT01155466. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01155466

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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 Subjects With Moderate to Severe Parkinson's Disease (P04938)
NCT number: NCT01155466
Status: Completed
Phases: Phase 3
Enrollment: 778 participants, actual
Lead sponsor: Merck Sharp & Dohme LLC
Conditions: Parkinson Disease
Interventions: Preladenant 2 mg tablet, Preladenant 5 mg tablet, Preladenant 10 mg tablet, Placebo to Preladenant Tablet, Rasagiline 1 mg capsule, Placebo to Rasagiline capsule
First posted: 2010-07-01
Last updated: 2018-11-06
Other registries' IDs: eudract:2009-015161-31
Results first posted: 2016-02-11

Source ClinicalTrials.gov

Registered outcomes9

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change From Baseline in Mean "Off" Time	Baseline and Week 12	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 with treatment, time, and treatment-by-time interaction as fixed effects and subject as random effect.
Primary	Numberof Participants With Systolic Blood Pressure >=180 mm Hg	Up to Week 14	The number of participants with Systolic Blood Pressure \>=180 mm Hg was reported.
Primary	Number of Participants With Diastolic Blood Pressure >=105 mm Hg	Up to Week 14	The number of participants with Diastolic Blood Pressure \>=105 mm Hg was reported.
Primary	Number of Participants With Alanine Aminotransferase >=3 Times the Upper Limit of Normal	Up to Week 14	The number of participants with alanine aminotransferase \>=3 times the upper limit of normal and a \>=10% increase was reported.
Primary	Number of Participants With Aspartate Aminotransferase >=3 Times the Upper Limit of Normal	Up to Week 14	The number of participants with aspartate aminotransferase \>=3 times the upper limit of normal and a \>=10% increase was reported.
Primary	Percentage of Participants With Suicidality	Up to Week 12	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.
Primary	Change From Baseline at Week 12 in Epworth Sleepiness Scale (ESS)	Baseline and Week 12	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.
Secondary	Percentage of Participants With >30% Change (Reduction) From Baseline at Week 12 in Mean "Off" Time	Baseline and Week 12	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.
Secondary	Change From Baseline at Week 12 in Mean "On" Time Without Troublesome Dyskinesia	Baseline and Week 12	When a participant is "on" without dyskinesias, parkinsonian symptoms have dissipated and the participant is experiencing no uncontrollable extraneous movements. Study participants reported their parkinsonian symptoms at half-hour intervals as "off", "on without dyskinesia", "on with non-troublesome dyskinesia", "on with troublesome dyskinesia", or "asleep" on their daily diary for 3 days before randomization and for the 3 days immediately before their Week-12 visit. The mean change from baseline in "on without troublesome dyskinesia" time was based on a constrained longitudinal data analysis with treatment, time, and treatment-by-time interaction as fixed effects and subject as random effect.

Source ClinicalTrials.gov

Outcomes9

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 Mean Off Time	Baseline and Week 12	The number of randomized and treated participants with at least one post baseline value.	Hours/day	MEAN
PRIMARY	Numberof Participants With Systolic Blood Pressure >=180 mm Hg	Up to Week 14	The number of participants who received at least one dose of study drug	Participants	NUMBER
PRIMARY	Number of Participants With Diastolic Blood Pressure >=105 mm Hg	Up to Week 14	The number of participants who received at least one dose of study drug	Participants	NUMBER
PRIMARY	Number of Participants With Alanine Aminotransferase >=3 Times the Upper Limit of Normal	Up to Week 14	The number of participants who received at least one dose of study drug	Participants	NUMBER
PRIMARY	Number of Participants With Aspartate Aminotransferase >=3 Times the Upper Limit of Normal	Up to Week 14	The number of participants who received at least one dose of study drug	Participants	NUMBER
PRIMARY	Percentage of Participants With Suicidality	Up to Week 12	The number of participants who received at least one dose of study drug	Percentage of participants	NUMBER
PRIMARY	Change From Baseline at Week 12 in Epworth Sleepiness Scale (ESS)	Baseline and Week 12	The number of participants who received at least one dose of study drug and had baseline and Week 12 data	Scores on a scale	MEAN
SECONDARY	Percentage of Participants With >30% Change (Reduction) From Baseline at Week 12 in Mean Off Time	Baseline and Week 12	The number of randomized and treated participants with a Week 12 value.	Percentage of participants	NUMBER
SECONDARY	Change From Baseline at Week 12 in Mean On Time Without Troublesome Dyskinesia	Baseline and Week 12	The number of randomized and treated participants with at least one post baseline value.	Hours/day	MEAN

Source ClinicalTrials.gov

Results by group45

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Change From Baseline in Mean Off Time	Preladenant 2 mg	-0.9	Standard Error 0.21	Hours/day
Change From Baseline in Mean Off Time	Preladenant 5 mg	-0.9	Standard Error 0.21	Hours/day
Change From Baseline in Mean Off Time	Preladenant 10 mg	-0.8	Standard Error 0.21	Hours/day
Change From Baseline in Mean Off Time	Placebo	-0.8	Standard Error 0.21	Hours/day
Change From Baseline in Mean Off Time	Rasagiline 1 mg	-1.1	Standard Error 0.21	Hours/day
Numberof Participants With Systolic Blood Pressure >=180 mm Hg	Preladenant 2 mg	1	0.21	Participants
Numberof Participants With Systolic Blood Pressure >=180 mm Hg	Preladenant 5 mg	1	0.21	Participants
Numberof Participants With Systolic Blood Pressure >=180 mm Hg	Preladenant 10 mg	3	0.21	Participants
Numberof Participants With Systolic Blood Pressure >=180 mm Hg	Placebo	1	0.21	Participants
Numberof Participants With Systolic Blood Pressure >=180 mm Hg	Rasagiline 1 mg	0	0.21	Participants

1 to 10 of 45Source ClinicalTrials.gov

See all 45 results by group

Participant flow20

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Preladenant 2 mg	156
Overall Study	STARTED	Preladenant 5 mg	155
Overall Study	STARTED	Preladenant 10 mg	156
Overall Study	STARTED	Placebo	155
Overall Study	STARTED	Rasagiline 1 mg	156
Overall Study	Treated	Preladenant 2 mg	154
Overall Study	Treated	Preladenant 5 mg	153
Overall Study	Treated	Preladenant 10 mg	153
Overall Study	Treated	Placebo	155
Overall Study	Treated	Rasagiline 1 mg	154

1 to 10 of 20Source ClinicalTrials.gov

See all 20 participant flow

Adverse events230

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	5	154	5
other	Constipation	Gastrointestinal disorders	Preladenant 5 mg	5	153	5
other	Constipation	Gastrointestinal disorders	Preladenant 10 mg	16	153	17
other	Constipation	Gastrointestinal disorders	Placebo	1	155	1
other	Constipation	Gastrointestinal disorders	Rasagiline 1 mg	2	154	2
other	Back pain	Musculoskeletal and connective tissue disorders	Preladenant 2 mg	4	154	4
other	Back pain	Musculoskeletal and connective tissue disorders	Preladenant 5 mg	2	153	2
other	Back pain	Musculoskeletal and connective tissue disorders	Preladenant 10 mg	2	153	2
other	Back pain	Musculoskeletal and connective tissue disorders	Placebo	8	155	8
other	Back pain	Musculoskeletal and connective tissue disorders	Rasagiline 1 mg	1	154	1

1 to 10 of 230Source ClinicalTrials.gov

See all 230 adverse events

Adverse event totals15

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Preladenant 2 mg
Total, all-cause mortality	Preladenant 5 mg
Total, all-cause mortality	Preladenant 10 mg
Total, all-cause mortality	Placebo
Total, all-cause mortality	Rasagiline 1 mg
Total, other adverse events	Preladenant 2 mg	18	154
Total, other adverse events	Preladenant 5 mg	20	153
Total, other adverse events	Preladenant 10 mg	29	153
Total, other adverse events	Placebo	34	155
Total, other adverse events	Rasagiline 1 mg	25	154

1 to 10 of 15Source ClinicalTrials.gov

See all 15 adverse event totals

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
26523919	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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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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