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An Active-Controlled Extension Study to NCT01155466 [P04938] and NCT01227265 [P07037] (P06153)

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ClinicalTrials.gov Identifier: NCT01215227
Recruitment Status : Terminated
First Posted : October 6, 2010
Results First Posted : December 12, 2016
Last Update Posted : November 6, 2018
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Parkinson Disease
Idiopathic Parkinson Disease
Interventions Drug: Preladenant
Drug: Rasagiline
Drug: Placebo to preladenant
Drug: Placebo to rasagiline
Enrollment 839
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Preladenant 2 mg Preladenant 5 mg Preladenant 5 mg (on Placebo in Parent Study) Preladenant 10 mg Rasagiline 1 mg Rasagiline 1 mg (on Placebo in Parent Study)
Hide Arm/Group Description Participants who received preladenant 2 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 2 mg in this extension study. Participants received preladenant 2 mg taken orally twice daily (BID): one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks. Participant who received preladenant 5 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 5 mg in this extension study. Participants received preladenant 5 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks. Participants who received placebo to preladenant tablet in parent study NCT01155466 or NCT01227265 received preladenant 5 mg in this extension study. Participants received preladenant 5 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks. Participants who received preladenant 10 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 10 mg in this extension study. Participants received preladenant 10 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks. Participants who received rasagiline 1 mg in parent study NCT01155466 or NCT01227265 continued to receive rasagiline 1 mg in this extension study. Participants received rasagiline 1 mg capsule once a day: one capsule plus placebo tablet to preladenant in the morning, and one placebo tablet to preladenant in the evening, for 40 weeks. Participants who received placebo to rasagiline capsule in parent study NCT01155466 or NCT01227265 received rasagiline 1 mg in this extension study. Participants received rasagiline 1 mg capsule once a day: one capsule plus placebo tablet to preladenant in the morning, and one placebo tablet to preladenant in the evening, for 40 weeks.
Period Title: Overall Study
Started 218 215 107 97 93 109
Treated 218 215 106 96 93 108
Completed 97 96 50 48 45 51
Not Completed 121 119 57 49 48 58
Reason Not Completed
Adverse Event             11             11             4             8             7             6
Treatment Failure             8             4             1             5             1             1
Lost to Follow-up             1             4             1             1             1             2
Subject Withdrew Consent             16             20             7             10             11             8
Non-Compliance With Protocol             2             6             1             0             0             0
Administrative             83             73             42             24             28             40
Missing Status             0             1             0             0             0             0
Randomized but not treated             0             0             1             1             0             1
Arm/Group Title Preladenant 2 mg Preladenant 5 mg Preladenant 5 mg (on Placebo in Parent Study) Preladenant 10 mg Rasagiline 1 mg Rasagiline 1 mg (on Placebo in Parent Study) Total
Hide Arm/Group Description Participants who received preladenant 2 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 2 mg in this extension study. Participants received preladenant 2 mg taken orally twice daily (BID): one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks. Participant who received preladenant 5 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 5 mg in this extension study. Participants received preladenant 5 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks. Participants who received placebo to preladenant tablet in parent study NCT01155466 or NCT01227265 received preladenant 5 mg in this extension study. Participants received preladenant 5 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks. Participants who received preladenant 10 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 10 mg in this extension study. Participants received preladenant 10 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks. Participants who received rasagiline 1 mg in parent study NCT01155466 or NCT01227265 continued to receive rasagiline 1 mg in this extension study. Participants received rasagiline 1 mg capsule once a day: one capsule plus placebo tablet to preladenant in the morning, and one placebo tablet to preladenant in the evening, for 40 weeks. Participants who received placebo to rasagiline capsule in parent study NCT01155466 or NCT01227265 received rasagiline 1 mg in this extension study. Participants received rasagiline 1 mg capsule once a day: one capsule plus placebo tablet to preladenant in the morning, and one placebo tablet to preladenant in the evening, for 40 weeks. Total of all reporting groups
Overall Number of Baseline Participants 218 215 106 96 93 108 836
Hide Baseline Analysis Population Description
All Participants as Treated: All participants who received at least one dose of study drug in Extension Study P06153. Data were not reported for 3 participants who were randomized but not treated.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 218 participants 215 participants 106 participants 96 participants 93 participants 108 participants 836 participants
62.4  (8.5) 63.0  (8.7) 64.4  (8.7) 63.9  (8.0) 63.8  (9.9) 63.9  (7.8) 63.3  (8.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 218 participants 215 participants 106 participants 96 participants 93 participants 108 participants 836 participants
Female
68
  31.2%
100
  46.5%
55
  51.9%
40
  41.7%
37
  39.8%
41
  38.0%
341
  40.8%
Male
150
  68.8%
115
  53.5%
51
  48.1%
56
  58.3%
56
  60.2%
67
  62.0%
495
  59.2%
1.Primary Outcome
Title Percentage of Participants With Systolic Blood Pressure ≥180 mmHg
Hide Description The percentage of participants with Systolic Blood Pressure ≥180 mm Hg was reported. On Day 1 and Early Termination, blood pressure was measured as follows: Participant lay supine for 5 minutes, then had blood pressure taken; then stood for 3 minutes and had blood pressure taken; then rested for 10 minutes, at which time the process was repeated twice (ie, three rounds total). For all other blood pressure measurements, the procedure needed only to be done once (ie, one round).
Time Frame Up to 42 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All Participants as Treated (APaT) population, which consisted of all participants who received at least one dose of study drug.
Arm/Group Title Preladenant 2 mg Preladenant 5 mg Preladenant 5 mg (on Placebo in Parent Study) Preladenant 10 mg Rasagiline 1 mg Rasagiline 1 mg (on Placebo in Parent Study)
Hide Arm/Group Description:
Participants who received preladenant 2 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 2 mg in this extension study. Participants received preladenant 2 mg taken orally twice daily (BID): one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
Participant who received preladenant 5 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 5 mg in this extension study. Participants received preladenant 5 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
Participants who received placebo to preladenant tablet in parent study NCT01155466 or NCT01227265 received preladenant 5 mg in this extension study. Participants received preladenant 5 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
Participants who received preladenant 10 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 10 mg in this extension study. Participants received preladenant 10 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
Participants who received rasagiline 1 mg in parent study NCT01155466 or NCT01227265 continued to receive rasagiline 1 mg in this extension study. Participants received rasagiline 1 mg capsule once a day: one capsule plus placebo tablet to preladenant in the morning, and one placebo tablet to preladenant in the evening, for 40 weeks.
Participants who received placebo to rasagiline capsule in parent study NCT01155466 or NCT01227265 received rasagiline 1 mg in this extension study. Participants received rasagiline 1 mg capsule once a day: one capsule plus placebo tablet to preladenant in the morning, and one placebo tablet to preladenant in the evening, for 40 weeks.
Overall Number of Participants Analyzed 218 215 106 96 93 108
Measure Type: Number
Unit of Measure: Percentage of participants
1.4 0.0 0.9 1.0 0.0 0.9
2.Primary Outcome
Title Percentage of Participants With Diastolic Blood Pressure ≥105 mmHg
Hide Description The percentage of participants with Diastolic Blood Pressure ≥105 mmHg was reported. On Day 1 and Early Termination, blood pressure was measured as follows: Participant lay supine for 5 minutes, then had blood pressure taken; then stood for 3 minutes and had blood pressure taken; then rested for 10 minutes, at which time the process was repeated twice (ie, three rounds total). For all other blood pressure measurements, the procedure needed only to be done once (ie, one round).
Time Frame Up to 42 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
APaT population, which consisted of all participants who received at least one dose of study drug.
Arm/Group Title Preladenant 2 mg Preladenant 5 mg Preladenant 5 mg (on Placebo in Parent Study) Preladenant 10 mg Rasagiline 1 mg Rasagiline 1 mg (on Placebo in Parent Study)
Hide Arm/Group Description:
Participants who received preladenant 2 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 2 mg in this extension study. Participants received preladenant 2 mg taken orally twice daily (BID): one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
Participant who received preladenant 5 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 5 mg in this extension study. Participants received preladenant 5 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
Participants who received placebo to preladenant tablet in parent study NCT01155466 or NCT01227265 received preladenant 5 mg in this extension study. Participants received preladenant 5 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
Participants who received preladenant 10 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 10 mg in this extension study. Participants received preladenant 10 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
Participants who received rasagiline 1 mg in parent study NCT01155466 or NCT01227265 continued to receive rasagiline 1 mg in this extension study. Participants received rasagiline 1 mg capsule once a day: one capsule plus placebo tablet to preladenant in the morning, and one placebo tablet to preladenant in the evening, for 40 weeks.
Participants who received placebo to rasagiline capsule in parent study NCT01155466 or NCT01227265 received rasagiline 1 mg in this extension study. Participants received rasagiline 1 mg capsule once a day: one capsule plus placebo tablet to preladenant in the morning, and one placebo tablet to preladenant in the evening, for 40 weeks.
Overall Number of Participants Analyzed 218 215 106 96 93 108
Measure Type: Number
Unit of Measure: Percentage of participants
5.0 4.2 5.7 5.2 7.5 8.3
3.Primary Outcome
Title Percentage of Participants With Alanine Aminotransferase (ALT) ≥3 Times Upper Limit of Normal and ≥10% Increase From Baseline
Hide Description The number of participants with ALT ≥3 times the upper limit of normal and a ≥10% increase was reported. Laboratory safety blood work was collected from participants at Week 4, Week 6, and Week 8 visits.
Time Frame Up to 42 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
APaT population, which consisted of all participants who received at least one dose of study drug.
Arm/Group Title Preladenant 2 mg Preladenant 5 mg Preladenant 5 mg (on Placebo in Parent Study) Preladenant 10 mg Rasagiline 1 mg Rasagiline 1 mg (on Placebo in Parent Study)
Hide Arm/Group Description:
Participants who received preladenant 2 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 2 mg in this extension study. Participants received preladenant 2 mg taken orally twice daily (BID): one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
Participant who received preladenant 5 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 5 mg in this extension study. Participants received preladenant 5 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
Participants who received placebo to preladenant tablet in parent study NCT01155466 or NCT01227265 received preladenant 5 mg in this extension study. Participants received preladenant 5 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
Participants who received preladenant 10 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 10 mg in this extension study. Participants received preladenant 10 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
Participants who received rasagiline 1 mg in parent study NCT01155466 or NCT01227265 continued to receive rasagiline 1 mg in this extension study. Participants received rasagiline 1 mg capsule once a day: one capsule plus placebo tablet to preladenant in the morning, and one placebo tablet to preladenant in the evening, for 40 weeks.
Participants who received placebo to rasagiline capsule in parent study NCT01155466 or NCT01227265 received rasagiline 1 mg in this extension study. Participants received rasagiline 1 mg capsule once a day: one capsule plus placebo tablet to preladenant in the morning, and one placebo tablet to preladenant in the evening, for 40 weeks.
Overall Number of Participants Analyzed 218 215 106 96 93 108
Measure Type: Number
Unit of Measure: Percentage of participants
1.4 0.5 0.0 1.0 0.0 1.9
4.Primary Outcome
Title Percentage of Participants With Aspartate Aminotransferase (AST) ≥3 Times Upper Limit of Normal and ≥10% Increase From Baseline
Hide Description The number of participants with AST ≥3 times the upper limit of normal and a ≥10% increase was reported. Laboratory safety blood work was collected from participants at Week 4, Week 6, and Week 8 visits.
Time Frame Up to 42 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
APaT population, which consisted of all participants who received at least one dose of study drug.
Arm/Group Title Preladenant 2 mg Preladenant 5 mg Preladenant 5 mg (on Placebo in Parent Study) Preladenant 10 mg Rasagiline 1 mg Rasagiline 1 mg (on Placebo in Parent Study)
Hide Arm/Group Description:
Participants who received preladenant 2 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 2 mg in this extension study. Participants received preladenant 2 mg taken orally twice daily (BID): one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
Participant who received preladenant 5 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 5 mg in this extension study. Participants received preladenant 5 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
Participants who received placebo to preladenant tablet in parent study NCT01155466 or NCT01227265 received preladenant 5 mg in this extension study. Participants received preladenant 5 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
Participants who received preladenant 10 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 10 mg in this extension study. Participants received preladenant 10 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
Participants who received rasagiline 1 mg in parent study NCT01155466 or NCT01227265 continued to receive rasagiline 1 mg in this extension study. Participants received rasagiline 1 mg capsule once a day: one capsule plus placebo tablet to preladenant in the morning, and one placebo tablet to preladenant in the evening, for 40 weeks.
Participants who received placebo to rasagiline capsule in parent study NCT01155466 or NCT01227265 received rasagiline 1 mg in this extension study. Participants received rasagiline 1 mg capsule once a day: one capsule plus placebo tablet to preladenant in the morning, and one placebo tablet to preladenant in the evening, for 40 weeks.
Overall Number of Participants Analyzed 218 215 106 96 93 108
Measure Type: Number
Unit of Measure: Percentage of participants
1.4 0.5 0.0 2.1 1.1 2.8
5.Primary Outcome
Title Percentage of Participants With Suicidality
Hide Description The number 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.
Time Frame Up to 42 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
APaT population, which consisted of all participants who received at least one dose of study drug.
Arm/Group Title Preladenant 2 mg Preladenant 5 mg Preladenant 5 mg (on Placebo in Parent Study) Preladenant 10 mg Rasagiline 1 mg Rasagiline 1 mg (on Placebo in Parent Study)
Hide Arm/Group Description:
Participants who received preladenant 2 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 2 mg in this extension study. Participants received preladenant 2 mg taken orally twice daily (BID): one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
Participant who received preladenant 5 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 5 mg in this extension study. Participants received preladenant 5 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
Participants who received placebo to preladenant tablet in parent study NCT01155466 or NCT01227265 received preladenant 5 mg in this extension study. Participants received preladenant 5 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
Participants who received preladenant 10 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 10 mg in this extension study. Participants received preladenant 10 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
Participants who received rasagiline 1 mg in parent study NCT01155466 or NCT01227265 continued to receive rasagiline 1 mg in this extension study. Participants received rasagiline 1 mg capsule once a day: one capsule plus placebo tablet to preladenant in the morning, and one placebo tablet to preladenant in the evening, for 40 weeks.
Participants who received placebo to rasagiline capsule in parent study NCT01155466 or NCT01227265 received rasagiline 1 mg in this extension study. Participants received rasagiline 1 mg capsule once a day: one capsule plus placebo tablet to preladenant in the morning, and one placebo tablet to preladenant in the evening, for 40 weeks.
Overall Number of Participants Analyzed 218 215 106 96 93 108
Measure Type: Number
Unit of Measure: Percentage of participants
4.1 5.6 0.0 4.2 2.2 2.8
6.Primary Outcome
Title Percentage Change From Baseline in Total Epworth Sleepiness Scale (ESS) Score at Week 40
Hide Description 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 with a higher score indicating greater sleepiness.
Time Frame Baseline and Week 40
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set (FAS) population (all randomized participants who received at least one dose of study drug) that had a baseline value and data at Week 40 for Total ESS Score
Arm/Group Title Preladenant 2 mg Preladenant 5 mg Preladenant 5 mg (on Placebo in Parent Study) Preladenant 10 mg Rasagiline 1 mg Rasagiline 1 mg (on Placebo in Parent Study)
Hide Arm/Group Description:
Participants who received preladenant 2 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 2 mg in this extension study. Participants received preladenant 2 mg taken orally twice daily (BID): one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
Participant who received preladenant 5 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 5 mg in this extension study. Participants received preladenant 5 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
Participants who received placebo to preladenant tablet in parent study NCT01155466 or NCT01227265 received preladenant 5 mg in this extension study. Participants received preladenant 5 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
Participants who received preladenant 10 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 10 mg in this extension study. Participants received preladenant 10 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
Participants who received rasagiline 1 mg in parent study NCT01155466 or NCT01227265 continued to receive rasagiline 1 mg in this extension study. Participants received rasagiline 1 mg capsule once a day: one capsule plus placebo tablet to preladenant in the morning, and one placebo tablet to preladenant in the evening, for 40 weeks.
Participants who received placebo to rasagiline capsule in parent study NCT01155466 or NCT01227265 received rasagiline 1 mg in this extension study. Participants received rasagiline 1 mg capsule once a day: one capsule plus placebo tablet to preladenant in the morning, and one placebo tablet to preladenant in the evening, for 40 weeks.
Overall Number of Participants Analyzed 90 88 47 49 48 49
Mean (95% Confidence Interval)
Unit of Measure: Percentage change
15.5
(-15.0 to 46.2)
24.0
(7.8 to 40.3)
22.5
(-9.5 to 54.5)
13.2
(-5.9 to 32.4)
8.3
(-6.8 to 23.4)
16.3
(-3.3 to 35.9)
Time Frame Up to 42 weeks
Adverse Event Reporting Description APaT population, which consisted of all participants who received at least one dose of study drug.
 
Arm/Group Title Preladenant 2 mg Preladenant 5 mg Preladenant 5 mg (on Placebo in Parent Study) Preladenant 10 mg Rasagiline 1 mg Rasagiline 1 mg (on Placebo in Parent Study)
Hide Arm/Group Description Participants who received preladenant 2 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 2 mg in this extension study. Participants received preladenant 2 mg taken orally twice daily (BID): one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks. Participant who received preladenant 5 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 5 mg in this extension study. Participants received preladenant 5 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks. Participants who received placebo to preladenant tablet in parent study NCT01155466 or NCT01227265 received preladenant 5 mg in this extension study. Participants received preladenant 5 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks. Participants who received preladenant 10 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 10 mg in this extension study. Participants received preladenant 10 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks. Participants who received rasagiline 1 mg in parent study NCT01155466 or NCT01227265 continued to receive rasagiline 1 mg in this extension study. Participants received rasagiline 1 mg capsule once a day: one capsule plus placebo tablet to preladenant in the morning, and one placebo tablet to preladenant in the evening, for 40 weeks. Participants who received placebo to rasagiline capsule in parent study NCT01155466 or NCT01227265 received rasagiline 1 mg in this extension study. Participants received rasagiline 1 mg capsule once a day: one capsule plus placebo tablet to preladenant in the morning, and one placebo tablet to preladenant in the evening, for 40 weeks.
All-Cause Mortality
Preladenant 2 mg Preladenant 5 mg Preladenant 5 mg (on Placebo in Parent Study) Preladenant 10 mg Rasagiline 1 mg Rasagiline 1 mg (on Placebo in Parent Study)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Preladenant 2 mg Preladenant 5 mg Preladenant 5 mg (on Placebo in Parent Study) Preladenant 10 mg Rasagiline 1 mg Rasagiline 1 mg (on Placebo in Parent Study)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   11/218 (5.05%)      15/215 (6.98%)      6/106 (5.66%)      12/96 (12.50%)      5/93 (5.38%)      4/108 (3.70%)    
Blood and lymphatic system disorders             
LEUKOPENIA  1  1/218 (0.46%)  1 0/215 (0.00%)  0 0/106 (0.00%)  0 0/96 (0.00%)  0 0/93 (0.00%)  0 0/108 (0.00%)  0
Cardiac disorders             
ACUTE CORONARY SYNDROME  1  1/218 (0.46%)  1 0/215 (0.00%)  0 0/106 (0.00%)  0 0/96 (0.00%)  0 0/93 (0.00%)  0 0/108 (0.00%)  0
ACUTE MYOCARDIAL INFARCTION  1  1/218 (0.46%)  1 0/215 (0.00%)  0 0/106 (0.00%)  0 0/96 (0.00%)  0 0/93 (0.00%)  0 0/108 (0.00%)  0
ANGINA PECTORIS  1  0/218 (0.00%)  0 1/215 (0.47%)  1 0/106 (0.00%)  0 0/96 (0.00%)  0 0/93 (0.00%)  0 0/108 (0.00%)  0
ANGINA UNSTABLE  1  0/218 (0.00%)  0 1/215 (0.47%)  1 0/106 (0.00%)  0 0/96 (0.00%)  0 0/93 (0.00%)  0 0/108 (0.00%)  0
ATRIAL FIBRILLATION  1  0/218 (0.00%)  0 2/215 (0.93%)  2 0/106 (0.00%)  0 0/96 (0.00%)  0 1/93 (1.08%)  1 0/108 (0.00%)  0
CARDIAC ARREST  1  0/218 (0.00%)  0 1/215 (0.47%)  1 0/106 (0.00%)  0 0/96 (0.00%)  0 0/93 (0.00%)  0 0/108 (0.00%)  0
CARDIAC FAILURE  1  0/218 (0.00%)  0 1/215 (0.47%)  1 0/106 (0.00%)  0 0/96 (0.00%)  0 0/93 (0.00%)  0 0/108 (0.00%)  0
CORONARY ARTERY DISEASE  1  0/218 (0.00%)  0 1/215 (0.47%)  1 0/106 (0.00%)  0 1/96 (1.04%)  1 0/93 (0.00%)  0 0/108 (0.00%)  0
HYPERTENSIVE CARDIOMYOPATHY  1  0/218 (0.00%)  0 0/215 (0.00%)  0 0/106 (0.00%)  0 1/96 (1.04%)  1 0/93 (0.00%)  0 0/108 (0.00%)  0
SICK SINUS SYNDROME  1  1/218 (0.46%)  1 0/215 (0.00%)  0 0/106 (0.00%)  0 0/96 (0.00%)  0 0/93 (0.00%)  0 0/108 (0.00%)  0
Eye disorders             
RETINAL DETACHMENT  1  0/218 (0.00%)  0 1/215 (0.47%)  2 0/106 (0.00%)  0 0/96 (0.00%)  0 0/93 (0.00%)  0 0/108 (0.00%)  0
Gastrointestinal disorders             
CROHN'S DISEASE  1  1/218 (0.46%)  1 0/215 (0.00%)  0 0/106 (0.00%)  0 0/96 (0.00%)  0 0/93 (0.00%)  0 0/108 (0.00%)  0
GASTROINTESTINAL HAEMORRHAGE  1  0/218 (0.00%)  0 0/215 (0.00%)  0 1/106 (0.94%)  1 0/96 (0.00%)  0 0/93 (0.00%)  0 1/108 (0.93%)  1
HIATUS HERNIA  1  0/218 (0.00%)  0 0/215 (0.00%)  0 1/106 (0.94%)  1 0/96 (0.00%)  0 0/93 (0.00%)  0 0/108 (0.00%)  0
ILEUS  1  0/218 (0.00%)  0 0/215 (0.00%)  0 1/106 (0.94%)  1 0/96 (0.00%)  0 0/93 (0.00%)  0 0/108 (0.00%)  0
OBSTRUCTION GASTRIC  1  0/218 (0.00%)  0 0/215 (0.00%)  0 1/106 (0.94%)  1 0/96 (0.00%)  0 0/93 (0.00%)  0 0/108 (0.00%)  0
VOLVULUS  1  0/218 (0.00%)  0 0/215 (0.00%)  0 1/106 (0.94%)  1 0/96 (0.00%)  0 0/93 (0.00%)  0 0/108 (0.00%)  0
General disorders             
ASTHENIA  1  0/218 (0.00%)  0 1/215 (0.47%)  1 0/106 (0.00%)  0 0/96 (0.00%)  0 0/93 (0.00%)  0 0/108 (0.00%)  0
CHEST DISCOMFORT  1  0/218 (0.00%)  0 1/215 (0.47%)  1 0/106 (0.00%)  0 0/96 (0.00%)  0 0/93 (0.00%)  0 0/108 (0.00%)  0
CHEST PAIN  1  0/218 (0.00%)  0 1/215 (0.47%)  1 0/106 (0.00%)  0 0/96 (0.00%)  0 0/93 (0.00%)  0 0/108 (0.00%)  0
MALAISE  1  1/218 (0.46%)  1 0/215 (0.00%)  0 0/106 (0.00%)  0 0/96 (0.00%)  0 0/93 (0.00%)  0 0/108 (0.00%)  0
Infections and infestations             
BRONCHOPNEUMONIA  1  1/218 (0.46%)  1 0/215 (0.00%)  0 0/106 (0.00%)  0 0/96 (0.00%)  0 0/93 (0.00%)  0 0/108 (0.00%)  0
ENCEPHALITIS VIRAL  1  1/218 (0.46%)  1 0/215 (0.00%)  0 0/106 (0.00%)  0 0/96 (0.00%)  0 0/93 (0.00%)  0 0/108 (0.00%)  0
NOSOCOMIAL INFECTION  1  0/218 (0.00%)  0 0/215 (0.00%)  0 0/106 (0.00%)  0 0/96 (0.00%)  0 1/93 (1.08%)  1 0/108 (0.00%)  0
OROPHARYNGEAL CANDIDIASIS  1  0/218 (0.00%)  0 0/215 (0.00%)  0 0/106 (0.00%)  0 1/96 (1.04%)  1 0/93 (0.00%)  0 0/108 (0.00%)  0
PERITONSILLAR ABSCESS  1  0/218 (0.00%)  0 0/215 (0.00%)  0 1/106 (0.94%)  1 0/96 (0.00%)  0 0/93 (0.00%)  0 0/108 (0.00%)  0
PNEUMONIA ESCHERICHIA  1  1/218 (0.46%)  1 0/215 (0.00%)  0 0/106 (0.00%)  0 0/96 (0.00%)  0 0/93 (0.00%)  0 0/108 (0.00%)  0
Injury, poisoning and procedural complications             
CONCUSSION  1  0/218 (0.00%)  0 0/215 (0.00%)  0 0/106 (0.00%)  0 0/96 (0.00%)  0 0/93 (0.00%)  0 1/108 (0.93%)  1
FALL  1  0/218 (0.00%)  0 1/215 (0.47%)  1 1/106 (0.94%)  1 1/96 (1.04%)  1 0/93 (0.00%)  0 0/108 (0.00%)  0
FEMUR FRACTURE  1  0/218 (0.00%)  0 1/215 (0.47%)  1 0/106 (0.00%)  0 0/96 (0.00%)  0 0/93 (0.00%)  0 1/108 (0.93%)  1
FOREARM FRACTURE  1  0/218 (0.00%)  0 0/215 (0.00%)  0 0/106 (0.00%)  0 1/96 (1.04%)  1 0/93 (0.00%)  0 0/108 (0.00%)  0
HAND FRACTURE  1  0/218 (0.00%)  0 1/215 (0.47%)  1 0/106 (0.00%)  0 0/96 (0.00%)  0 0/93 (0.00%)  0 0/108 (0.00%)  0
HUMERUS FRACTURE  1  0/218 (0.00%)  0 0/215 (0.00%)  0 1/106 (0.94%)  1 0/96 (0.00%)  0 0/93 (0.00%)  0 0/108 (0.00%)  0
JOINT DISLOCATION  1  0/218 (0.00%)  0 0/215 (0.00%)  0 1/106 (0.94%)  1 0/96 (0.00%)  0 0/93 (0.00%)  0 0/108 (0.00%)  0
LOWER LIMB FRACTURE  1  0/218 (0.00%)  0 0/215 (0.00%)  0 0/106 (0.00%)  0 0/96 (0.00%)  0 1/93 (1.08%)  1 0/108 (0.00%)  0
NEAR DROWNING  1  0/218 (0.00%)  0 0/215 (0.00%)  0 1/106 (0.94%)  1 0/96 (0.00%)  0 0/93 (0.00%)  0 0/108 (0.00%)  0
RIB FRACTURE  1  0/218 (0.00%)  0 1/215 (0.47%)  1 0/106 (0.00%)  0 0/96 (0.00%)  0 0/93 (0.00%)  0 0/108 (0.00%)  0
SUBDURAL HAEMATOMA  1  0/218 (0.00%)  0 1/215 (0.47%)  1 0/106 (0.00%)  0 0/96 (0.00%)  0 0/93 (0.00%)  0 0/108 (0.00%)  0
Investigations             
BLOOD SODIUM INCREASED  1  0/218 (0.00%)  0 0/215 (0.00%)  0 0/106 (0.00%)  0 1/96 (1.04%)  1 0/93 (0.00%)  0 0/108 (0.00%)  0
Musculoskeletal and connective tissue disorders             
PATELLOFEMORAL PAIN SYNDROME  1  0/218 (0.00%)  0 0/215 (0.00%)  0 0/106 (0.00%)  0 0/96 (0.00%)  0 0/93 (0.00%)  0 1/108 (0.93%)  1
TORTICOLLIS  1  0/218 (0.00%)  0 0/215 (0.00%)  0 0/106 (0.00%)  0 1/96 (1.04%)  2 0/93 (0.00%)  0 0/108 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)             
BASAL CELL CARCINOMA  1  0/218 (0.00%)  0 0/215 (0.00%)  0 0/106 (0.00%)  0 1/96 (1.04%)  1 1/93 (1.08%)  1 0/108 (0.00%)  0
BOWEN'S DISEASE  1  0/218 (0.00%)  0 0/215 (0.00%)  0 0/106 (0.00%)  0 1/96 (1.04%)  1 0/93 (0.00%)  0 0/108 (0.00%)  0
MALIGNANT MELANOMA  1  0/218 (0.00%)  0 0/215 (0.00%)  0 0/106 (0.00%)  0 1/96 (1.04%)  1 0/93 (0.00%)  0 0/108 (0.00%)  0
OVARIAN ADENOMA  1  0/218 (0.00%)  0 0/215 (0.00%)  0 0/106 (0.00%)  0 0/96 (0.00%)  0 1/93 (1.08%)  1 0/108 (0.00%)  0
Nervous system disorders             
CEREBRAL HYPOPERFUSION  1  0/218 (0.00%)  0 0/215 (0.00%)  0 0/106 (0.00%)  0 0/96 (0.00%)  0 0/93 (0.00%)  0 1/108 (0.93%)  1
CEREBROVASCULAR ACCIDENT  1  0/218 (0.00%)  0 0/215 (0.00%)  0 0/106 (0.00%)  0 1/96 (1.04%)  1 0/93 (0.00%)  0 0/108 (0.00%)  0
CONVULSION  1  0/218 (0.00%)  0 0/215 (0.00%)  0 0/106 (0.00%)  0 0/96 (0.00%)  0 0/93 (0.00%)  0 1/108 (0.93%)  1
PARKINSON'S DISEASE  1  1/218 (0.46%)  1 1/215 (0.47%)  1 0/106 (0.00%)  0 1/96 (1.04%)  1 0/93 (0.00%)  0 0/108 (0.00%)  0
THALAMIC INFARCTION  1  0/218 (0.00%)  0 1/215 (0.47%)  1 0/106 (0.00%)  0 0/96 (0.00%)  0 0/93 (0.00%)  0 0/108 (0.00%)  0
Psychiatric disorders             
MENTAL DISORDER  1  0/218 (0.00%)  0 1/215 (0.47%)  1 0/106 (0.00%)  0 0/96 (0.00%)  0 0/93 (0.00%)  0 0/108 (0.00%)  0
PSYCHOTIC DISORDER  1  0/218 (0.00%)  0 0/215 (0.00%)  0 0/106 (0.00%)  0 0/96 (0.00%)  0 1/93 (1.08%)  1 0/108 (0.00%)  0
Renal and urinary disorders             
CYSTITIS GLANDULARIS  1  0/218 (0.00%)  0 0/215 (0.00%)  0 0/106 (0.00%)  0 0/96 (0.00%)  0 1/93 (1.08%)  1 0/108 (0.00%)  0
Respiratory, thoracic and mediastinal disorders             
ACUTE RESPIRATORY FAILURE  1  0/218 (0.00%)  0 0/215 (0.00%)  0 1/106 (0.94%)  1 0/96 (0.00%)  0 0/93 (0.00%)  0 0/108 (0.00%)  0
DYSPNOEA  1  1/218 (0.46%)  1 1/215 (0.47%)  1 0/106 (0.00%)  0 1/96 (1.04%)  1 0/93 (0.00%)  0 0/108 (0.00%)  0
PNEUMONIA ASPIRATION  1  0/218 (0.00%)  0 0/215 (0.00%)  0 0/106 (0.00%)  0 1/96 (1.04%)  1 0/93 (0.00%)  0 0/108 (0.00%)  0
PULMONARY OEDEMA  1  0/218 (0.00%)  0 1/215 (0.47%)  1 0/106 (0.00%)  0 0/96 (0.00%)  0 0/93 (0.00%)  0 0/108 (0.00%)  0
PULMONARY THROMBOSIS  1  1/218 (0.46%)  1 0/215 (0.00%)  0 0/106 (0.00%)  0 0/96 (0.00%)  0 0/93 (0.00%)  0 0/108 (0.00%)  0
RESPIRATORY FAILURE  1  0/218 (0.00%)  0 0/215 (0.00%)  0 0/106 (0.00%)  0 1/96 (1.04%)  1 0/93 (0.00%)  0 0/108 (0.00%)  0
RESPIRATORY PARALYSIS  1  1/218 (0.46%)  1 0/215 (0.00%)  0 0/106 (0.00%)  0 0/96 (0.00%)  0 0/93 (0.00%)  0 0/108 (0.00%)  0
Vascular disorders             
DEEP VEIN THROMBOSIS  1  2/218 (0.92%)  2 0/215 (0.00%)  0 0/106 (0.00%)  0 0/96 (0.00%)  0 0/93 (0.00%)  0 0/108 (0.00%)  0
HYPERTENSION  1  1/218 (0.46%)  1 0/215 (0.00%)  0 0/106 (0.00%)  0 0/96 (0.00%)  0 0/93 (0.00%)  0 0/108 (0.00%)  0
LYMPHOSTASIS  1  0/218 (0.00%)  0 1/215 (0.47%)  1 0/106 (0.00%)  0 0/96 (0.00%)  0 0/93 (0.00%)  0 0/108 (0.00%)  0
ORTHOSTATIC HYPOTENSION  1  0/218 (0.00%)  0 1/215 (0.47%)  1 0/106 (0.00%)  0 0/96 (0.00%)  0 0/93 (0.00%)  0 0/108 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Preladenant 2 mg Preladenant 5 mg Preladenant 5 mg (on Placebo in Parent Study) Preladenant 10 mg Rasagiline 1 mg Rasagiline 1 mg (on Placebo in Parent Study)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   64/218 (29.36%)      71/215 (33.02%)      30/106 (28.30%)      35/96 (36.46%)      25/93 (26.88%)      38/108 (35.19%)    
Gastrointestinal disorders             
CONSTIPATION  1  9/218 (4.13%)  10 12/215 (5.58%)  14 7/106 (6.60%)  7 5/96 (5.21%)  5 1/93 (1.08%)  1 3/108 (2.78%)  5
NAUSEA  1  6/218 (2.75%)  6 8/215 (3.72%)  11 3/106 (2.83%)  3 1/96 (1.04%)  1 2/93 (2.15%)  2 7/108 (6.48%)  8
General disorders             
FATIGUE  1  7/218 (3.21%)  7 6/215 (2.79%)  6 3/106 (2.83%)  3 5/96 (5.21%)  5 0/93 (0.00%)  0 2/108 (1.85%)  2
Infections and infestations             
NASOPHARYNGITIS  1  12/218 (5.50%)  14 7/215 (3.26%)  7 3/106 (2.83%)  3 2/96 (2.08%)  2 4/93 (4.30%)  4 7/108 (6.48%)  7
URINARY TRACT INFECTION  1  10/218 (4.59%)  10 10/215 (4.65%)  12 6/106 (5.66%)  7 5/96 (5.21%)  9 2/93 (2.15%)  2 6/108 (5.56%)  6
Injury, poisoning and procedural complications             
FALL  1  7/218 (3.21%)  8 16/215 (7.44%)  21 5/106 (4.72%)  5 3/96 (3.13%)  3 3/93 (3.23%)  3 4/108 (3.70%)  5
Investigations             
BLOOD CREATINE PHOSPHOKINASE INCREASED  1  7/218 (3.21%)  7 4/215 (1.86%)  5 1/106 (0.94%)  1 5/96 (5.21%)  5 3/93 (3.23%)  3 1/108 (0.93%)  1
WEIGHT DECREASED  1  1/218 (0.46%)  1 2/215 (0.93%)  2 0/106 (0.00%)  0 1/96 (1.04%)  1 5/93 (5.38%)  5 2/108 (1.85%)  2
Musculoskeletal and connective tissue disorders             
ARTHRALGIA  1  3/218 (1.38%)  3 2/215 (0.93%)  3 0/106 (0.00%)  0 5/96 (5.21%)  7 2/93 (2.15%)  2 9/108 (8.33%)  10
BACK PAIN  1  5/218 (2.29%)  5 7/215 (3.26%)  7 7/106 (6.60%)  7 1/96 (1.04%)  1 3/93 (3.23%)  3 5/108 (4.63%)  6
Nervous system disorders             
DYSKINESIA  1  10/218 (4.59%)  11 19/215 (8.84%)  22 5/106 (4.72%)  6 8/96 (8.33%)  12 8/93 (8.60%)  8 9/108 (8.33%)  11
PARKINSON'S DISEASE  1  10/218 (4.59%)  12 12/215 (5.58%)  13 4/106 (3.77%)  5 4/96 (4.17%)  6 3/93 (3.23%)  3 0/108 (0.00%)  0
TREMOR  1  5/218 (2.29%)  5 2/215 (0.93%)  2 1/106 (0.94%)  1 5/96 (5.21%)  5 0/93 (0.00%)  0 1/108 (0.93%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.0
This study was terminated early due to the lack of efficacy of preladenant in the parent studies NCT1155466 and NCT01227265.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The investigator agrees to provide to the Sponsor 45 days prior to submission for publication or presentation, review copies of abstracts or manuscripts for publication (including, without limitation, slides and texts of oral or other public presentations and texts of any transmission through any electronic media, eg, any computer access system such as the Internet, World Wide Web, etc) that report any results of the trial.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck, Sharp & Dohme Corp.
Phone: 1-800-672-6372
EMail: ClinicalTrialsDisclosure@merck.com
Layout table for additonal information
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01215227     History of Changes
Other Study ID Numbers: P06153
2009-015162-57 ( EudraCT Number )
First Submitted: October 4, 2010
First Posted: October 6, 2010
Results First Submitted: October 18, 2016
Results First Posted: December 12, 2016
Last Update Posted: November 6, 2018