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A Placebo- and Active-Controlled Study of Preladenant in Early Parkinson's Disease (PD) (P05664) (PARADYSE)

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ClinicalTrials.gov Identifier: NCT01155479
Recruitment Status : Terminated (Termininated for business reasons)
First Posted : July 1, 2010
Results First Posted : July 28, 2016
Last Update Posted : November 7, 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
Condition Parkinson Disease
Interventions Drug: Preladenant 2 mg tablet
Drug: Preladenant 5 mg tablet
Drug: Preladenant 10 mg tablet
Drug: Rasagiline 1 mg capsule
Drug: Placebo for Rasagiline 1 mg capsule
Drug: Placebo for Preladenant
Enrollment 1022
Recruitment Details Participants with a diagnosis of idiopathic PD for less than 5 years were selected to participate in this study.
Pre-assignment Details In Part 1, participants were randomized to one of five treatment groups and treated for 26 weeks. In Part 2, which was conducted for an additional 26 weeks, participants continued taking the same study treatment from Part 1, except for placebo participants who were re-assigned to receive preladenant 5 mg twice daily.
Arm/Group Title Preladenant 2 mg Preladenant 5 mg Preladenant 10 mg Placebo Rasagiline
Hide Arm/Group Description Participants received preladenant 2 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 2 mg oral tablet in PM for 26 weeks (Part 1) and then for another 26 weeks (Part 2). Participants received preladenant 5 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 5 mg in the PM for 26 weeks (Part 1) and then for another 26 weeks (Part 2). Participants received preladenant 10 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 10 mg in the PM for 26 weeks (Part 1) and then for another 26 weeks (Part 2). Participants received placebo for preladenant and placebo for rasagiline in the AM followed by placebo for preladenant in the PM for 26 weeks (Part 1); preladenant 5 mg was taken twice daily for 26 weeks (Part 2). Participants received rasagiline 1 mg oral capsule and placebo for preladenant in the AM followed by placebo for preladenant in PM for 26 weeks (Part 1) and then for another 26 weeks (Part 2).
Period Title: Part I
Started 204 204 206 204 204
Treated 200 202 204 198 203
Completed 166 177 167 177 181
Not Completed 38 27 39 27 23
Reason Not Completed
Adverse Event             13             8             18             7             6
Administrative             2             2             2             0             0
Did Not Meet Protocol Eligibility             3             1             2             1             3
Withdrawal by Subject             11             13             8             8             9
Lost to Follow-up             0             0             1             1             0
Treatment Failure             3             0             3             1             2
Did Not Receive Treatment             4             2             2             6             1
Non-Compliance with Protocol             2             1             3             3             2
Period Title: Part II
Started 166 177 167 177 181
Completed 107 116 109 127 126
Not Completed 59 61 58 50 55
Reason Not Completed
Adverse Event             7             6             8             3             4
Administrative             43             49             36             38             46
Withdrawal by Subject             8             4             12             7             3
Lost to Follow-up             1             0             0             0             1
Treatment Failure             0             1             2             0             1
Non-Compliance with Protocol             0             1             0             2             0
Arm/Group Title Preladenant 2 mg Preladenant 5 mg Preladenant 10 mg Placebo Rasagiline Total
Hide Arm/Group Description Participants received preladenant 2 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 2 mg oral tablet in PM for 26 weeks (Part 1) and then for another 26 weeks (Part 2). Participants received preladenant 5 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 5 mg in the PM for 26 weeks (Part 1) and then for another 26 weeks (Part 2). Participants received preladenant 10 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 10 mg in the PM for 26 weeks (Part 1) and then for another 26 weeks (Part 2). Participants received placebo for preladenant and placebo for rasagiline in the AM followed by placebo for preladenant in the PM for 26 weeks (Part 1); preladenant 5 mg was taken twice daily for 26 weeks (Part 2). Participants received rasagiline 1 mg oral capsule and placebo for preladenant in the AM followed by placebo for preladenant in PM for 26 weeks (Part 1) and then for another 26 weeks (Part 2). Total of all reporting groups
Overall Number of Baseline Participants 204 204 206 204 204 1022
Hide Baseline Analysis Population Description
All Participants as Randomized
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 204 participants 204 participants 206 participants 204 participants 204 participants 1022 participants
63.0  (10.5) 62.3  (10.2) 63.8  (11.1) 63.3  (10.0) 62.9  (10.2) 63.1  (10.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 204 participants 204 participants 206 participants 204 participants 204 participants 1022 participants
Female
78
  38.2%
90
  44.1%
90
  43.7%
82
  40.2%
85
  41.7%
425
  41.6%
Male
126
  61.8%
114
  55.9%
116
  56.3%
122
  59.8%
119
  58.3%
597
  58.4%
1.Primary Outcome
Title Change From Baseline in the Sum of Unified Parkinson's Disease Rating Scale Parts 2 and 3 Scores (UPDRS2+3)
Hide Description 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.
Time Frame Baseline and Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): All randomized and treated participants with at least one post-baseline value.
Arm/Group Title Preladenant 2 mg (Part 1) Preladenant 5 mg (Part 1) Preladenant 10 mg (Part 1) Placebo (Part 1) Rasagiline (Part 1)
Hide Arm/Group Description:
Participants received preladenant 2 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 2 mg oral tablet in PM for 26 weeks.
Participants received preladenant 5 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 5 mg in the PM for 26 weeks.
Participants received preladenant 10 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 10 mg in the PM for 26 weeks.
Participants received placebo for preladenant and placebo for rasagiline in the AM followed by placebo for preladenant in the PM for 26 weeks.
Participants received rasagiline 1 mg oral capsule and placebo for preladenant in the AM followed by placebo for preladenant in PM for 26 weeks.
Overall Number of Participants Analyzed 195 202 200 195 195
Mean (Standard Error)
Unit of Measure: Score on a Scale
0.3  (0.63) -1.0  (0.60) -1.8  (0.61) -2.2  (0.61) -1.9  (0.61)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Preladenant 2 mg (Part 1), Placebo (Part 1)
Comments Preladenant 2 mg (Part 1) vs Placebo (Part 1)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0033
Comments [Not Specified]
Method constrained longitudinal analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Estimated Means
Estimated Value 2.60
Confidence Interval (2-Sided) 95%
0.86 to 4.30
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Preladenant 5 mg (Part 1), Placebo (Part 1)
Comments Preladenant 5 mg (Part 1) vs Placebo (Part 1)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1382
Comments [Not Specified]
Method constrained longitudinal analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Estimated Means
Estimated Value 1.30
Confidence Interval (2-Sided) 95%
-0.41 to 2.94
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Preladenant 10 mg (Part 1), Placebo (Part 1)
Comments Preladenant 10 mg (Part 1) vs Placebo (Part 1)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6378
Comments [Not Specified]
Method constrained longitudinal analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Estimated Means
Estimated Value 0.40
Confidence Interval (2-Sided) 95%
-1.29 to 2.11
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo (Part 1), Rasagiline (Part 1)
Comments Rasagiline (Part 1) vs Placebo (Part 1)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6923
Comments [Not Specified]
Method constrained longitudinal analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Estimated Means
Estimated Value 0.30
Confidence Interval (2-Sided) 95%
-1.35 to 2.03
Estimation Comments [Not Specified]
2.Primary Outcome
Title Number of Participants With Adverse Events (AEs) in Part 1
Hide Description 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.
Time Frame Day 1 to Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
All Participants as Treated: All participants who received at least one dose of study treatment.
Arm/Group Title Preladenant 2 mg (Part 1) Preladenant 5 mg (Part 1) Preladenant 10 mg (Part 1) Placebo (Part 1) Rasagiline (Part 1)
Hide Arm/Group Description:
Participants received preladenant 2 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 2 mg oral tablet in PM for 26 weeks.
Participants received preladenant 5 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 5 mg in the PM for 26 weeks.
Participants received preladenant 10 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 10 mg in the PM for 26 weeks.
Participants received placebo for preladenant and placebo for rasagiline in the AM followed by placebo for preladenant in the PM for 26 weeks.
Participants received rasagiline 1 mg oral capsule and placebo for preladenant in the AM followed by placebo for preladenant in PM for 26 weeks.
Overall Number of Participants Analyzed 200 202 204 198 203
Measure Type: Number
Unit of Measure: Participants
108 110 121 102 105
3.Primary Outcome
Title Number of Participants Who Discontinued Study Due to an AE in Part 1
Hide Description 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.
Time Frame Day 1 to Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
All Participants as Treated: All participants who received at least one dose of study treatment.
Arm/Group Title Preladenant 2 mg (Part 1) Preladenant 5 mg (Part 1) Preladenant 10 mg (Part 1) Placebo (Part 1) Rasagiline (Part 1)
Hide Arm/Group Description:
Participants received preladenant 2 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 2 mg oral tablet in PM for 26 weeks.
Participants received preladenant 5 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 5 mg in the PM for 26 weeks.
Participants received preladenant 10 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 10 mg in the PM for 26 weeks.
Participants received placebo for preladenant and placebo for rasagiline in the AM followed by placebo for preladenant in the PM for 26 weeks.
Participants received rasagiline 1 mg oral capsule and placebo for preladenant in the AM followed by placebo for preladenant in PM for 26 weeks.
Overall Number of Participants Analyzed 200 202 204 198 203
Measure Type: Number
Unit of Measure: Participants
13 8 20 8 6
4.Primary Outcome
Title Number of Participants With Adverse Events (AEs) in Part 2
Hide Description 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.
Time Frame Week 27 to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
All Participants as Treated: All participants who received at least one dose of study treatment.
Arm/Group Title Preladenant 2 mg (Part 2) Preladenant 5 mg (Part 2) Preladenant 10 mg (Part 2) Placebo (Part 2) Rasagiline (Part 2)
Hide Arm/Group Description:
Participants received preladenant 2 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 2 mg oral tablet in PM for 26 weeks.
Participants received preladenant 5 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 5 mg in the PM for 26 weeks.
Participants received preladenant 10 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 10 mg in the PM for 26 weeks.
Participants who had received placebo to preladenant in Part 1 received preladenant 5 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 5 mg in the PM for 26 weeks.
Participants received rasagiline 1 mg oral capsule and placebo for preladenant in the AM followed by placebo for preladenant in PM for 26 weeks.
Overall Number of Participants Analyzed 166 177 167 177 181
Measure Type: Number
Unit of Measure: Participants
116 120 113 120 119
5.Primary Outcome
Title Number of Participants Who Discontinued Study Due to an AE in Part 2
Hide Description 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.
Time Frame Week 27 to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
All Participants as Treated (APaT): All participants who received at least one dose of study treatment.
Arm/Group Title Preladenant 2 mg (Part 2) Preladenant 5 mg (Part 2) Preladenant 10 mg (Part 2) Placebo (Part 2) Rasagiline (Part 2)
Hide Arm/Group Description:
Participants received preladenant 2 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 2 mg oral tablet in PM for 26 weeks.
Participants received preladenant 5 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 5 mg in the PM for 26 weeks.
Participants received preladenant 10 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 10 mg in the PM for 26 weeks.
Participants who had received placebo to preladenant in Part 1 received preladenant 5 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 5 mg in the PM for 26 weeks.
Participants received rasagiline 1 mg oral capsule and placebo for preladenant in the AM followed by placebo for preladenant in PM for 26 weeks.
Overall Number of Participants Analyzed 166 177 167 177 181
Measure Type: Number
Unit of Measure: Participants
7 5 8 3 4
6.Secondary Outcome
Title Percentage of Responders (Participants With a ≥20% Improvement in UPDRS2+3)
Hide Description 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.
Time Frame Baseline and Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): All randomized and treated participants with at least one post-baseline value.
Arm/Group Title Preladenant 2 mg (Part 1) Preladenant 5 mg (Part 1) Preladenant 10 mg (Part 1) Placebo (Part 1) Rasagiline (Part 1)
Hide Arm/Group Description:
Participants received preladenant 2 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 2 mg oral tablet in PM for 26 weeks. The number of participants analyzed (195) represents the number of randomized and treated participants with at least one post-treatment value.
Participants received preladenant 5 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 5 mg in the PM for 26 weeks. The number of participants analyzed (202) represents the number of randomized and treated participants with at least one post-treatment value.
Participants received preladenant 10 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 10 mg in the PM for 26 weeks. The number of participants analyzed (200) represents the number of randomized and treated participants with at least one post-treatment value.
Participants received placebo for preladenant and placebo for rasagiline in the AM followed by placebo for preladenant in the PM for 26 weeks. The number of participants analyzed (195) represents the number of randomized and treated participants with at least one post-treatment value.
Participants received rasagiline 1 mg oral capsule and placebo for preladenant in the AM followed by placebo for preladenant in PM for 26 weeks. The number of participants analyzed (195) represents the number of randomized and treated participants with at least one post-treatment value.
Overall Number of Participants Analyzed 195 202 200 195 195
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Responders
25.90
(18.95 to 34.33)
29.50
(22.50 to 37.72)
31.50
(24.06 to 40.02)
35.20
(27.49 to 43.82)
33.10
(25.60 to 41.51)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Preladenant 2 mg (Part 1), Placebo (Part 1)
Comments Preladenant 2 mg (Part 1) vs Placebo (Part 1)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0785
Comments p-value is for the estimated Odds Ratio based on a generalized linear mixed model with baseline UPDRS2+3 as a covariate and treatment-by-time interaction as fixed effect and participant as random effect.
Method generalized linear mixed model
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference vs Placebo (%)
Estimated Value -9.7
Confidence Interval (2-Sided) 95%
-21.0 to 1.82
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Preladenant 5 mg (Part 1), Placebo (Part 1)
Comments Preladenant 5 mg (Part 1) vs Placebo (Part 1)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2735
Comments p-value is for the estimated Odds Ratio based on a generalized linear mixed model with baseline UPDRS2+3 as a covariate and treatment-by-time interaction as fixed effect and participant as random effect.
Method generalized linear mixed model
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference vs Placebo (%)
Estimated Value -6.3
Confidence Interval (2-Sided) 95%
-17.6 to 5.05
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Preladenant 10 mg (Part 1), Placebo (Part 1)
Comments Preladenant 10 mg (Part 1) vs Placebo (Part 1)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4823
Comments p-value is for the estimated Odds Ratio based on a generalized linear mixed model with baseline UPDRS2+3 as a covariate and treatment-by-time interaction as fixed effect and participant as random effect.
Method generalized linear mixed model
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference vs Placebo (%)
Estimated Value -3.7
Confidence Interval (2-Sided) 95%
-15.2 to 7.99
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo (Part 1), Rasagiline (Part 1)
Comments Rasagiline (Part 1) vs Placebo (Part 1)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6827
Comments p-value is for the estimated Odds Ratio based on a generalized linear mixed model with baseline UPDRS2+3 as a covariate and treatment-by-time interaction as fixed effect and participant as random effect.
Method generalized linear mixed model
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference vs Placebo (%)
Estimated Value -2.3
Confidence Interval (2-Sided) 95%
-13.9 to 9.24
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Change From Baseline in the UPDRS Part 2 Score (Activities of Daily Living [ADL])
Hide Description 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.
Time Frame Baseline and Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): All randomized and treated participants with at least one post-baseline value.
Arm/Group Title Preladenant 2 mg (Part 1) Preladenant 5 mg (Part 1) Preladenant 10 mg (Part 1) Placebo (Part 1) Rasagiline (Part 1)
Hide Arm/Group Description:
Participants received preladenant 2 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 2 mg oral tablet in PM for 26 weeks.
Participants received preladenant 5 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 5 mg in the PM for 26 weeks.
Participants received preladenant 10 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 10 mg in the PM for 26 weeks.
Participants received placebo for preladenant and placebo for rasagiline in the AM followed by placebo for preladenant in the PM for 26 weeks.
Participants received rasagiline 1 mg oral capsule and placebo for preladenant in the AM followed by placebo for preladenant in PM for 26 weeks (Part 1) and then for another 26 weeks (Part 2).
Overall Number of Participants Analyzed 195 202 200 195 195
Mean (Standard Error)
Unit of Measure: Score on a Scale
0.30  (0.22) 0.10  (0.21) -0.20  (0.21) -0.40  (0.21) -0.20  (0.21)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Preladenant 2 mg (Part 1), Placebo (Part 1)
Comments Preladenant 2 mg (Part 1) vs Placebo (Part 1)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0235
Comments [Not Specified]
Method constrained longitudinal analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Estimated Means
Estimated Value 0.70
Confidence Interval (2-Sided) 95%
0.09 to 1.27
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Preladenant 5 mg (Part 1), Placebo (Part 1)
Comments Preladenant 5 mg (Part 1) vs Placebo (Part 1)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1093
Comments [Not Specified]
Method constrained longitudinal analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Estimated Means
Estimated Value 0.50
Confidence Interval (2-Sided) 95%
-0.11 to 1.04
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Preladenant 10 mg (Part 1), Placebo (Part 1)
Comments Preladenant 10 mg (Part 1) vs Placebo (Part 1)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5756
Comments [Not Specified]
Method constrained longitudinal analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Estimated Means
Estimated Value 0.20
Confidence Interval (2-Sided) 95%
-0.42 to 0.75
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo (Part 1), Rasagiline (Part 1)
Comments Rasagiline (Part 1) vs Placebo (Part 1)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6657
Comments [Not Specified]
Method constrained longitudinal analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Estimated Means
Estimated Value 0.10
Confidence Interval (2-Sided) 95%
-0.45 to 0.70
Estimation Comments [Not Specified]
Time Frame Up to 54 weeks (including 2 weeks of follow-up)
Adverse Event Reporting Description All Participants as Treated (APaT) - includes all participants who received at least one (1) dose of study drug.
 
Arm/Group Title Preladenant 2 mg - Part 1 Preladenant 5 mg - Part 1 Preladenant 10 mg - Part 1 Placebo - Part 1 Rasagiline - Part 1 Preladenant 2 mg - Part 2 Preladenant 5 mg - Part 2 Preladenant 10 mg - Part 2 Placebo/Preladenant 5 Mg-Part 2 Rasagiline - Part 2
Hide Arm/Group Description Participants received preladenant 2 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 2 mg oral tablet in PM for 26 weeks (Part 1). Participants received preladenant 5 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 5 mg in the PM for 26 weeks (Part 1). Participants received preladenant 10 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 10 mg in the PM for 26 weeks (Part 1). Participants received placebo for preladenant and placebo for rasagiline in the AM followed by placebo for preladenant in the PM for 26 weeks (Part 1). Participants received rasagiline 1 mg oral capsule and placebo for preladenant in the AM followed by placebo for preladenant in PM for 26 weeks (Part 1). Participants received preladenant 2 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 2 mg oral tablet in PM for 26 weeks (Part 2). Participants received preladenant 5 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 5 mg in the PM for 26 weeks (Part 2). Participants received preladenant 10 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 10 mg in the PM for 26 weeks (Part 2). Participants received preladenant 5 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 5 mg oral tablet in the PM for 26 weeks (Part 2). Participants received rasagiline 1 mg oral capsule and placebo for preladenant in the AM followed by placebo for preladenant in PM for 26 weeks (Part 2).
All-Cause Mortality
Preladenant 2 mg - Part 1 Preladenant 5 mg - Part 1 Preladenant 10 mg - Part 1 Placebo - Part 1 Rasagiline - Part 1 Preladenant 2 mg - Part 2 Preladenant 5 mg - Part 2 Preladenant 10 mg - Part 2 Placebo/Preladenant 5 Mg-Part 2 Rasagiline - Part 2
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--      --/--      --/--      --/--      --/--      --/--    
Hide Serious Adverse Events
Preladenant 2 mg - Part 1 Preladenant 5 mg - Part 1 Preladenant 10 mg - Part 1 Placebo - Part 1 Rasagiline - Part 1 Preladenant 2 mg - Part 2 Preladenant 5 mg - Part 2 Preladenant 10 mg - Part 2 Placebo/Preladenant 5 Mg-Part 2 Rasagiline - Part 2
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events 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   4/200 (2.00%)      5/202 (2.48%)      8/204 (3.92%)      3/198 (1.52%)      9/203 (4.43%)      7/166 (4.22%)      1/177 (0.56%)      8/167 (4.79%)      4/177 (2.26%)      8/181 (4.42%)    
Cardiac disorders                     
Atrial Fibrillation † 1  0/200 (0.00%)  0 0/202 (0.00%)  0 1/204 (0.49%)  1 0/198 (0.00%)  0 0/203 (0.00%)  0 1/166 (0.60%)  1 0/177 (0.00%)  0 0/167 (0.00%)  0 0/177 (0.00%)  0 0/181 (0.00%)  0
Acute Coronary Syndrome † 1  0/200 (0.00%)  0 1/202 (0.50%)  1 0/204 (0.00%)  0 0/198 (0.00%)  0 0/203 (0.00%)  0 0/166 (0.00%)  0 0/177 (0.00%)  0 0/167 (0.00%)  0 0/177 (0.00%)  0 0/181 (0.00%)  0
Acute Myocardial Infarction † 1  0/200 (0.00%)  0 0/202 (0.00%)  0 0/204 (0.00%)  0 0/198 (0.00%)  0 0/203 (0.00%)  0 0/166 (0.00%)  0 0/177 (0.00%)  0 1/167 (0.60%)  1 0/177 (0.00%)  0 0/181 (0.00%)  0
Angina Pectoris † 1  0/200 (0.00%)  0 0/202 (0.00%)  0 0/204 (0.00%)  0 0/198 (0.00%)  0 0/203 (0.00%)  0 0/166 (0.00%)  0 0/177 (0.00%)  0 0/167 (0.00%)  0 0/177 (0.00%)  0 1/181 (0.55%)  1
Angina Unstable † 1  0/200 (0.00%)  0 0/202 (0.00%)  0 0/204 (0.00%)  0 0/198 (0.00%)  0 1/203 (0.49%)  1 0/166 (0.00%)  0 0/177 (0.00%)  0 0/167 (0.00%)  0 0/177 (0.00%)  0 1/181 (0.55%)  1
Cardiac Failure † 1  0/200 (0.00%)  0 0/202 (0.00%)  0 1/204 (0.49%)  1 0/198 (0.00%)  0 0/203 (0.00%)  0 0/166 (0.00%)  0 0/177 (0.00%)  0 0/167 (0.00%)  0 1/177 (0.56%)  1 0/181 (0.00%)  0
Coronary Artery Disease † 1  0/200 (0.00%)  0 0/202 (0.00%)  0 0/204 (0.00%)  0 0/198 (0.00%)  0 1/203 (0.49%)  1 0/166 (0.00%)  0 0/177 (0.00%)  0 0/167 (0.00%)  0 0/177 (0.00%)  0 0/181 (0.00%)  0
Left Ventricular Failure † 1  0/200 (0.00%)  0 0/202 (0.00%)  0 0/204 (0.00%)  0 0/198 (0.00%)  0 0/203 (0.00%)  0 0/166 (0.00%)  0 0/177 (0.00%)  0 0/167 (0.00%)  0 1/177 (0.56%)  1 0/181 (0.00%)  0
Myocardial Infarction † 1  0/200 (0.00%)  0 0/202 (0.00%)  0 0/204 (0.00%)  0 0/198 (0.00%)  0 1/203 (0.49%)  1 0/166 (0.00%)  0 0/177 (0.00%)  0 0/167 (0.00%)  0 0/177 (0.00%)  0 0/181 (0.00%)  0
Gastrointestinal disorders                     
Constipation † 1  0/200 (0.00%)  0 0/202 (0.00%)  0 0/204 (0.00%)  0 0/198 (0.00%)  0 0/203 (0.00%)  0 0/166 (0.00%)  0 0/177 (0.00%)  0 1/167 (0.60%)  1 0/177 (0.00%)  0 0/181 (0.00%)  0
Pancreatitis † 1  0/200 (0.00%)  0 0/202 (0.00%)  0 0/204 (0.00%)  0 1/198 (0.51%)  1 0/203 (0.00%)  0 0/166 (0.00%)  0 0/177 (0.00%)  0 0/167 (0.00%)  0 0/177 (0.00%)  0 0/181 (0.00%)  0
Pancreatitis Acute † 1  0/200 (0.00%)  0 0/202 (0.00%)  0 0/204 (0.00%)  0 0/198 (0.00%)  0 1/203 (0.49%)  1 0/166 (0.00%)  0 0/177 (0.00%)  0 0/167 (0.00%)  0 0/177 (0.00%)  0 0/181 (0.00%)  0
General disorders                     
Chest Pain † 1  0/200 (0.00%)  0 0/202 (0.00%)  0 0/204 (0.00%)  0 0/198 (0.00%)  0 1/203 (0.49%)  1 0/166 (0.00%)  0 0/177 (0.00%)  0 0/167 (0.00%)  0 0/177 (0.00%)  0 0/181 (0.00%)  0
Local Swelling † 1  0/200 (0.00%)  0 0/202 (0.00%)  0 0/204 (0.00%)  0 0/198 (0.00%)  0 0/203 (0.00%)  0 0/166 (0.00%)  0 0/177 (0.00%)  0 0/167 (0.00%)  0 0/177 (0.00%)  0 1/181 (0.55%)  1
Sudden Cardiac Death † 1  0/200 (0.00%)  0 0/202 (0.00%)  0 0/204 (0.00%)  0 0/198 (0.00%)  0 0/203 (0.00%)  0 0/166 (0.00%)  0 0/177 (0.00%)  0 1/167 (0.60%)  1 0/177 (0.00%)  0 0/181 (0.00%)  0
Hepatobiliary disorders                     
Cholecystitis † 1  0/200 (0.00%)  0 0/202 (0.00%)  0 0/204 (0.00%)  0 1/198 (0.51%)  1 0/203 (0.00%)  0 0/166 (0.00%)  0 1/177 (0.56%)  1 0/167 (0.00%)  0 0/177 (0.00%)  0 0/181 (0.00%)  0
Cholecystitis Acute † 1  0/200 (0.00%)  0 0/202 (0.00%)  0 0/204 (0.00%)  0 1/198 (0.51%)  1 0/203 (0.00%)  0 0/166 (0.00%)  0 0/177 (0.00%)  0 0/167 (0.00%)  0 0/177 (0.00%)  0 0/181 (0.00%)  0
Jaundice Cholestatic † 1  0/200 (0.00%)  0 0/202 (0.00%)  0 0/204 (0.00%)  0 1/198 (0.51%)  1 0/203 (0.00%)  0 0/166 (0.00%)  0 0/177 (0.00%)  0 0/167 (0.00%)  0 0/177 (0.00%)  0 0/181 (0.00%)  0
Infections and infestations                     
Appendicitis † 1  0/200 (0.00%)  0 0/202 (0.00%)  0 1/204 (0.49%)  1 0/198 (0.00%)  0 0/203 (0.00%)  0 1/166 (0.60%)  1 0/177 (0.00%)  0 0/167 (0.00%)  0 0/177 (0.00%)  0 0/181 (0.00%)  0
Erysipelas † 1  0/200 (0.00%)  0 0/202 (0.00%)  0 0/204 (0.00%)  0 0/198 (0.00%)  0 0/203 (0.00%)  0 0/166 (0.00%)  0 0/177 (0.00%)  0 1/167 (0.60%)  1 0/177 (0.00%)  0 0/181 (0.00%)  0
Gastroenteritis † 1  0/200 (0.00%)  0 0/202 (0.00%)  0 1/204 (0.49%)  1 0/198 (0.00%)  0 0/203 (0.00%)  0 0/166 (0.00%)  0 0/177 (0.00%)  0 0/167 (0.00%)  0 0/177 (0.00%)  0 0/181 (0.00%)  0
Lower Respiratory Tract Infection † 1  0/200 (0.00%)  0 0/202 (0.00%)  0 0/204 (0.00%)  0 0/198 (0.00%)  0 0/203 (0.00%)  0 0/166 (0.00%)  0 0/177 (0.00%)  0 0/167 (0.00%)  0 1/177 (0.56%)  1 0/181 (0.00%)  0
Pneumonia † 1  0/200 (0.00%)  0 0/202 (0.00%)  0 0/204 (0.00%)  0 0/198 (0.00%)  0 0/203 (0.00%)  0 1/166 (0.60%)  1 0/177 (0.00%)  0 0/167 (0.00%)  0 0/177 (0.00%)  0 0/181 (0.00%)  0
Pneumonia Bacterial † 1  0/200 (0.00%)  0 0/202 (0.00%)  0 0/204 (0.00%)  0 0/198 (0.00%)  0 1/203 (0.49%)  1 0/166 (0.00%)  0 0/177 (0.00%)  0 0/167 (0.00%)  0 0/177 (0.00%)  0 0/181 (0.00%)  0
Sepsis † 1  0/200 (0.00%)  0 0/202 (0.00%)  0 0/204 (0.00%)  0 0/198 (0.00%)  0 1/203 (0.49%)  1 0/166 (0.00%)  0 0/177 (0.00%)  0 0/167 (0.00%)  0 1/177 (0.56%)  1 0/181 (0.00%)  0
Upper Respiratory Tract Infection † 1  0/200 (0.00%)  0 0/202 (0.00%)  0 1/204 (0.49%)  1 0/198 (0.00%)  0 0/203 (0.00%)  0 0/166 (0.00%)  0 0/177 (0.00%)  0 0/167 (0.00%)  0 0/177 (0.00%)  0 0/181 (0.00%)  0
Urinary Tract Infection † 1  1/200 (0.50%)  1 0/202 (0.00%)  0 0/204 (0.00%)  0 0/198 (0.00%)  0 0/203 (0.00%)  0 0/166 (0.00%)  0 0/177 (0.00%)  0 0/167 (0.00%)  0 0/177 (0.00%)  0 0/181 (0.00%)  0
Injury, poisoning and procedural complications                     
Brain Contusion † 1  0/200 (0.00%)  0 0/202 (0.00%)  0 1/204 (0.49%)  1 0/198 (0.00%)  0 0/203 (0.00%)  0 0/166 (0.00%)  0 0/177 (0.00%)  0 0/167 (0.00%)  0 0/177 (0.00%)  0 0/181 (0.00%)  0
Femur Fracture † 1  0/200 (0.00%)  0 0/202 (0.00%)  0 0/204 (0.00%)  0 0/198 (0.00%)  0 0/203 (0.00%)  0 1/166 (0.60%)  1 0/177 (0.00%)  0 0/167 (0.00%)  0 0/177 (0.00%)  0 0/181 (0.00%)  0
Fibula Fracture † 1  0/200 (0.00%)  0 0/202 (0.00%)  0 0/204 (0.00%)  0 0/198 (0.00%)  0 0/203 (0.00%)  0 0/166 (0.00%)  0 0/177 (0.00%)  0 0/167 (0.00%)  0 1/177 (0.56%)  1 0/181 (0.00%)  0
Hip Fracture † 1  0/200 (0.00%)  0 0/202 (0.00%)  0 0/204 (0.00%)  0 0/198 (0.00%)  0 0/203 (0.00%)  0 0/166 (0.00%)  0 0/177 (0.00%)  0 0/167 (0.00%)  0 0/177 (0.00%)  0 1/181 (0.55%)  1
Pelvic Fracture † 1  0/200 (0.00%)  0 0/202 (0.00%)  0 0/204 (0.00%)  0 0/198 (0.00%)  0 0/203 (0.00%)  0 0/166 (0.00%)  0 0/177 (0.00%)  0 0/167 (0.00%)  0 0/177 (0.00%)  0 1/181 (0.55%)  1
Tendon Rupture † 1  0/200 (0.00%)  0 0/202 (0.00%)  0 0/204 (0.00%)  0 0/198 (0.00%)  0 1/203 (0.49%)  1 0/166 (0.00%)  0 0/177 (0.00%)  0 0/167 (0.00%)  0 0/177 (0.00%)  0 0/181 (0.00%)  0
Tibia Fracture † 1  0/200 (0.00%)  0 0/202 (0.00%)  0 0/204 (0.00%)  0 0/198 (0.00%)  0 0/203 (0.00%)  0 0/166 (0.00%)  0 0/177 (0.00%)  0 0/167 (0.00%)  0 1/177 (0.56%)  1 0/181 (0.00%)  0
Investigations                     
Alanine Aminotransferase Increased † 1  0/200 (0.00%)  0 1/202 (0.50%)  2 0/204 (0.00%)  0 0/198 (0.00%)  0 0/203 (0.00%)  0 0/166 (0.00%)  0 0/177 (0.00%)  0 0/167 (0.00%)  0 0/177 (0.00%)  0 0/181 (0.00%)  0
Antinuclear Antibody Increased † 1  0/200 (0.00%)  0 0/202 (0.00%)  0 1/204 (0.49%)  1 0/198 (0.00%)  0 0/203 (0.00%)  0 0/166 (0.00%)  0 0/177 (0.00%)  0 0/167 (0.00%)  0 0/177 (0.00%)  0 0/181 (0.00%)  0
Aspartate Aminotransferase Increased † 1  0/200 (0.00%)  0 1/202 (0.50%)  1 0/204 (0.00%)  0 0/198 (0.00%)  0 0/203 (0.00%)  0 0/166 (0.00%)  0 0/177 (0.00%)  0 0/167 (0.00%)  0 0/177 (0.00%)  0 0/181 (0.00%)  0
Hepatic Enzyme Increased † 1  0/200 (0.00%)  0 1/202 (0.50%)  1 0/204 (0.00%)  0 0/198 (0.00%)  0 0/203 (0.00%)  0 0/166 (0.00%)  0 0/177 (0.00%)  0 0/167 (0.00%)  0 0/177 (0.00%)  0 0/181 (0.00%)  0
Metabolism and nutrition disorders                     
Hyponatraemia † 1  0/200 (0.00%)  0 0/202 (0.00%)  0 1/204 (0.49%)  1 0/198 (0.00%)  0 0/203 (0.00%)  0 0/166 (0.00%)  0 0/177 (0.00%)  0 0/167 (0.00%)  0 0/177 (0.00%)  0 0/181 (0.00%)  0
Vitamin B12 Deficiency † 1  0/200 (0.00%)  0 0/202 (0.00%)  0 1/204 (0.49%)  1 0/198 (0.00%)  0 0/203 (0.00%)  0 0/166 (0.00%)  0 0/177 (0.00%)  0 0/167 (0.00%)  0 0/177 (0.00%)  0 0/181 (0.00%)  0
Musculoskeletal and connective tissue disorders                     
Back Pain † 1  0/200 (0.00%)  0 1/202 (0.50%)  1 0/204 (0.00%)  0 0/198 (0.00%)  0 0/203 (0.00%)  0 0/166 (0.00%)  0 0/177 (0.00%)  0 0/167 (0.00%)  0 0/177 (0.00%)  0 0/181 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)                     
Colon Cancer † 1  0/200 (0.00%)  0 0/202 (0.00%)  0 1/204 (0.49%)  1 0/198 (0.00%)  0 0/203 (0.00%)  0 0/166 (0.00%)  0 0/177 (0.00%)  0 0/167 (0.00%)  0 0/177 (0.00%)  0 0/181 (0.00%)  0
Osteoma † 1  0/200 (0.00%)  0 0/202 (0.00%)  0 0/204 (0.00%)  0 0/198 (0.00%)  0 0/203 (0.00%)  0 0/166 (0.00%)  0 0/177 (0.00%)  0 1/167 (0.60%)  1 0/177 (0.00%)  0 0/181 (0.00%)  0
Sinonasal Papilloma † 1  0/200 (0.00%)  0 0/202 (0.00%)  0 0/204 (0.00%)  0 0/198 (0.00%)  0 0/203 (0.00%)  0 0/166 (0.00%)  0 0/177 (0.00%)  0 0/167 (0.00%)  0 0/177 (0.00%)  0 1/181 (0.55%)  1
Uterine Leiomyoma † 1  0/200 (0.00%)  0 0/202 (0.00%)  0 0/204 (0.00%)  0 0/198 (0.00%)  0 0/203 (0.00%)  0 1/166 (0.60%)  1 0/177 (0.00%)  0 0/167 (0.00%)  0 0/177 (0.00%)  0 0/181 (0.00%)  0
Nervous system disorders                     
Cerebrovascular Accident † 1  0/200 (0.00%)  0 0/202 (0.00%)  0 0/204 (0.00%)  0 0/198 (0.00%)  0 0/203 (0.00%)  0 0/166 (0.00%)  0 0/177 (0.00%)  0 1/167 (0.60%)  1 0/177 (0.00%)  0 0/181 (0.00%)  0
Haemorrhagic Stroke † 1  0/200 (0.00%)  0 0/202 (0.00%)  0 1/204 (0.49%)  1 0/198 (0.00%)  0 0/203 (0.00%)  0 0/166 (0.00%)  0 0/177 (0.00%)  0 0/167 (0.00%)  0 0/177 (0.00%)  0 0/181 (0.00%)  0
Parkinson's Disease † 1  0/200 (0.00%)  0 0/202 (0.00%)  0 0/204 (0.00%)  0 0/198 (0.00%)  0 0/203 (0.00%)  0 0/166 (0.00%)  0 0/177 (0.00%)  0 1/167 (0.60%)  1 0/177 (0.00%)  0 1/181 (0.55%)  1
Sciatica † 1  0/200 (0.00%)  0 0/202 (0.00%)  0 0/204 (0.00%)  0 1/198 (0.51%)  1 0/203 (0.00%)  0 0/166 (0.00%)  0 0/177 (0.00%)  0 0/167 (0.00%)  0 0/177 (0.00%)  0 0/181 (0.00%)  0
Vertebrobasilar Insufficiency † 1  0/200 (0.00%)  0 0/202 (0.00%)  0 0/204 (0.00%)  0 0/198 (0.00%)  0 0/203 (0.00%)  0 0/166 (0.00%)  0 0/177 (0.00%)  0 0/167 (0.00%)  0 1/177 (0.56%)  1 0/181 (0.00%)  0
Psychiatric disorders                     
Depression Suicidal † 1  0/200 (0.00%)  0 0/202 (0.00%)  0 0/204 (0.00%)  0 0/198 (0.00%)  0 1/203 (0.49%)  1 0/166 (0.00%)  0 0/177 (0.00%)  0 0/167 (0.00%)  0 0/177 (0.00%)  0 0/181 (0.00%)  0
Suicidal Ideation † 1  1/200 (0.50%)  1 0/202 (0.00%)  0 0/204 (0.00%)  0 0/198 (0.00%)  0 0/203 (0.00%)  0 0/166 (0.00%)  0 0/177 (0.00%)  0 0/167 (0.00%)  0 0/177 (0.00%)  0 0/181 (0.00%)  0
Suicide Attempt † 1  0/200 (0.00%)  0 0/202 (0.00%)  0 0/204 (0.00%)  0 0/198 (0.00%)  0 0/203 (0.00%)  0 1/166 (0.60%)  1 0/177 (0.00%)  0 0/167 (0.00%)  0 0/177 (0.00%)  0 0/181 (0.00%)  0
Renal and urinary disorders                     
Cystitis Haemorrhagic † 1  0/200 (0.00%)  0 0/202 (0.00%)  0 0/204 (0.00%)  0 0/198 (0.00%)  0 0/203 (0.00%)  0 1/166 (0.60%)  1 0/177 (0.00%)  0 0/167 (0.00%)  0 0/177 (0.00%)  0 0/181 (0.00%)  0
Nephrolithiasis † 1  0/200 (0.00%)  0 0/202 (0.00%)  0 1/204 (0.49%)  1 0/198 (0.00%)  0 0/203 (0.00%)  0 0/166 (0.00%)  0 0/177 (0.00%)  0 0/167 (0.00%)  0 0/177 (0.00%)  0 0/181 (0.00%)  0
Renal Failure Acute † 1  1/200 (0.50%)  1 0/202 (0.00%)  0 0/204 (0.00%)  0 0/198 (0.00%)  0 0/203 (0.00%)  0 0/166 (0.00%)  0 0/177 (0.00%)  0 0/167 (0.00%)  0 0/177 (0.00%)  0 0/181 (0.00%)  0
Renal Failure Chronic † 1  0/200 (0.00%)  0 1/202 (0.50%)  1 0/204 (0.00%)  0 0/198 (0.00%)  0 0/203 (0.00%)  0 0/166 (0.00%)  0 0/177 (0.00%)  0 0/167 (0.00%)  0 0/177 (0.00%)  0 0/181 (0.00%)  0
Reproductive system and breast disorders                     
Benign Prostatic Hyperplasia † 1  1/200 (0.50%)  1 0/202 (0.00%)  0 0/204 (0.00%)  0 0/198 (0.00%)  0 0/203 (0.00%)  0 0/166 (0.00%)  0 0/177 (0.00%)  0 1/167 (0.60%)  1 0/177 (0.00%)  0 0/181 (0.00%)  0
Respiratory, thoracic and mediastinal disorders                     
Pulmonary Embolism † 1  0/200 (0.00%)  0 0/202 (0.00%)  0 0/204 (0.00%)  0 0/198 (0.00%)  0 0/203 (0.00%)  0 1/166 (0.60%)  1 0/177 (0.00%)  0 0/167 (0.00%)  0 0/177 (0.00%)  0 1/181 (0.55%)  1
Pulmonary Fibrosis † 1  0/200 (0.00%)  0 0/202 (0.00%)  0 0/204 (0.00%)  0 0/198 (0.00%)  0 0/203 (0.00%)  0 0/166 (0.00%)  0 0/177 (0.00%)  0 0/167 (0.00%)  0 1/177 (0.56%)  1 0/181 (0.00%)  0
Social circumstances                     
Pregnancy of Partner † 1  0/200 (0.00%)  0 0/202 (0.00%)  0 0/204 (0.00%)  0 0/198 (0.00%)  0 1/203 (0.49%)  1 0/166 (0.00%)  0 0/177 (0.00%)  0 0/167 (0.00%)  0 0/177 (0.00%)  0 0/181 (0.00%)  0
Vascular disorders                     
Phlebitis † 1  0/200 (0.00%)  0 0/202 (0.00%)  0 0/204 (0.00%)  0 0/198 (0.00%)  0 0/203 (0.00%)  0 1/166 (0.60%)  1 0/177 (0.00%)  0 0/167 (0.00%)  0 0/177 (0.00%)  0 0/181 (0.00%)  0
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Preladenant 2 mg - Part 1 Preladenant 5 mg - Part 1 Preladenant 10 mg - Part 1 Placebo - Part 1 Rasagiline - Part 1 Preladenant 2 mg - Part 2 Preladenant 5 mg - Part 2 Preladenant 10 mg - Part 2 Placebo/Preladenant 5 Mg-Part 2 Rasagiline - Part 2
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events 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   33/200 (16.50%)      39/202 (19.31%)      40/204 (19.61%)      36/198 (18.18%)      34/203 (16.75%)      18/166 (10.84%)      22/177 (12.43%)      17/167 (10.18%)      16/177 (9.04%)      19/181 (10.50%)    
Gastrointestinal disorders                     
Constipation † 1  5/200 (2.50%)  6 9/202 (4.46%)  10 11/204 (5.39%)  11 5/198 (2.53%)  5 3/203 (1.48%)  3 1/166 (0.60%)  1 1/177 (0.56%)  1 4/167 (2.40%)  4 4/177 (2.26%)  5 2/181 (1.10%)  2
Musculoskeletal and connective tissue disorders                     
Back Pain † 1  6/200 (3.00%)  6 10/202 (4.95%)  11 8/204 (3.92%)  8 6/198 (3.03%)  6 6/203 (2.96%)  6 3/166 (1.81%)  3 9/177 (5.08%)  9 3/167 (1.80%)  3 7/177 (3.95%)  8 7/181 (3.87%)  7
Nervous system disorders                     
Dizziness † 1  7/200 (3.50%)  7 11/202 (5.45%)  12 5/204 (2.45%)  6 9/198 (4.55%)  9 10/203 (4.93%)  11 4/166 (2.41%)  4 1/177 (0.56%)  1 4/167 (2.40%)  4 1/177 (0.56%)  2 6/181 (3.31%)  7
Headache † 1  13/200 (6.50%)  19 10/202 (4.95%)  13 15/204 (7.35%)  20 5/198 (2.53%)  7 10/203 (4.93%)  10 11/166 (6.63%)  16 4/177 (2.26%)  6 9/167 (5.39%)  11 5/177 (2.82%)  5 7/181 (3.87%)  8
Tremor † 1  8/200 (4.00%)  15 7/202 (3.47%)  11 3/204 (1.47%)  3 11/198 (5.56%)  13 6/203 (2.96%)  8 7/166 (4.22%)  8 11/177 (6.21%)  12 5/167 (2.99%)  5 8/177 (4.52%)  10 6/181 (3.31%)  7
Vascular disorders                     
Hypertension † 1  4/200 (2.00%)  4 11/202 (5.45%)  13 11/204 (5.39%)  12 11/198 (5.56%)  12 11/203 (5.42%)  11 1/166 (0.60%)  1 5/177 (2.82%)  6 6/167 (3.59%)  7 4/177 (2.26%)  4 5/181 (2.76%)  5
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.0
[Not Specified]
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 not to publish or publicly present any interim results of the trial without the prior written consent of the sponsor. The Investigator further agrees to provide the sponsor 45 days prior to submission for publication or presentation, review copies of abstracts or manuscripts for publication that report any results of the trial. The sponsor shall have the right to review and comment.
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
Publications of Results:
Stocchi F, Rascol O, Hauser RA, Huyck S, Tzontcheva A, Capece R, Ho TW, Sklar P, Lines C, Michelson D, Hewitt DJ; Preladenant Early Parkinson Disease Study Group. Randomized trial of preladenant, given as monotherapy, in patients with early Parkinson disease. Neurology. 2017 Jun 6;88(23):2198-2206. doi: 10.1212/WNL.0000000000004003. Epub 2017 May 10.
Layout table for additonal information
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01155479    
Other Study ID Numbers: P05664
2009-013552-72 ( EudraCT Number )
MK-3814-024 ( Other Identifier: Merck Study Number )
First Submitted: June 30, 2010
First Posted: July 1, 2010
Results First Submitted: June 15, 2016
Results First Posted: July 28, 2016
Last Update Posted: November 7, 2018