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
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Sponsor:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
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Study Type | Interventional |
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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 |
Participant Flow
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 |
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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 |
Baseline Characteristics
Arm/Group Title | Preladenant 2 mg | Preladenant 5 mg | Preladenant 10 mg | Placebo | Rasagiline | Total | |
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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 | |
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All Participants as Randomized
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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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 |
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Number Analyzed | 204 participants | 204 participants | 206 participants | 204 participants | 204 participants | 1022 participants | |
Female |
78 38.2%
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90 44.1%
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90 43.7%
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82 40.2%
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85 41.7%
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425 41.6%
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Male |
126 61.8%
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114 55.9%
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116 56.3%
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122 59.8%
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119 58.3%
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597 58.4%
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
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
Name/Title: | Senior Vice President, Global Clinical Development |
Organization: | Merck Sharp & Dohme Corp. |
Phone: | 1-800-672-6372 |
EMail: | ClinicalTrialsDisclosure@merck.com |
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 |