Clinical trial NCT00537017: Follow Up Safety Study of SCH 420814 in Subjects With Parkinson's Disease (P05175)
Official title: A Phase 2, 36-Week, Open-Label, Uncontrolled Safety Follow-up Study Assessing SCH 420814 (Preladenant) 5 mg BID (P05175)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Parkinson Disease
Neurodegenerative Diseases
Central Nervous System Diseases
Movement Disorders
Brain Diseases
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2007-09-28
Enrollment: 140
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the long term safety of SCH 420814 (preladenant) in participants with moderate to severe Parkinson's Disease who are taking an L-Dopa/dopa decarboxylase inhibitor and/or dopamine agonist. All participants must have participated in the main study (P04501; NCT00406029) entitled "A Phase 2, 12 Week, Double Blind, Dose Finding, Placebo Controlled Study to Assess the Efficacy and Safety of a Range of SCH 420814 Doses in Subjects With Moderate to Severe Parkinson's Disease Experiencing Motor Fluctuations and Dyskinesias."


Eligibility criteria: Inclusion Criteria:

* Participants must have participated in P04501.
* Participants must be \>=30 years of age, with a diagnosis of moderate to severe idiopathic Parkinson's disease.
* Participants must have been on a regimen of L-Dopa and/or a dopamine agonist.

Exclusion Criteria:

* Participants who discontinued from Study P04501 because they experienced a serious adverse event (SAE)
* Participants with any form of drug-induced or atypical parkinsonism, cognitive impairment, or psychosis
* Participants taking tolcapone
* Participants who are participating in any other clinical study

Primary outcomes:
measure: Number of Participants Who Experienced at Least One Adverse Event
timeFrame: Up to 42 weeks
Secondary outcomes:
measure: Time Spent in "Off" State Per Day
timeFrame: Baseline (P04501 BL; P04501 BL_LA), Week 4, Week 8, Week 12, Week 24, Week 36
measure: Awake Time Per Day in the "on" State
timeFrame: Baseline (P04501 BL; P04501 BL_LA), Week 4, Week 8, Week 12, Week 24, Week 36
measure: Time Spent in the "on" State With no Dyskinesias
timeFrame: Baseline (P04501 BL; P04501 BL_LA), Week 4, Week 8, Week 12, Week 24, Week 36
measure: Time Spent in the "on" State With Troublesome Dyskinesias
timeFrame: Baseline (P04501 BL; P04501 BL_LA), Week 4, Week 8, Week 12, Week 24, Week 36
measure: Time Spent in the "on" State Without Troublesome Dyskinesia
timeFrame: Baseline (P04501 BL; P04501 BL_LA), Week 4, Week 8, Week 12, Week 24, Week 36
measure: Absolute Duration of Dyskinesias
timeFrame: Baseline (P04501 BL; P04501 BL_LA), Week 4, Week 8, Week 12, Week 24, Week 36
measure: Total Sleep Time
timeFrame: Baseline (P04501 BL; P04501 BL_LA), Week 4, Week 8, Week 12, Week 24, Week 36
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Factor SA, Wolski K, Togasaki DM, Huyck S, Cantillon M, Ho TW, Hauser RA, Pourcher E. Long-term safety and efficacy of preladenant in subjects with fluctuating Parkinson's disease. Mov Disord. 2013 Jun;28(6):817-20. doi: 10.1002/mds.25395. Epub 2013 Apr 15.