|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | Schering-Plough |
|---|---|
| Information provided by (Responsible Party): | Schering-Plough |
| ClinicalTrials.gov Identifier: | NCT01155466 |
Purpose
When a patient with Parkinson disease (PD) is initially treated with L dopa or dopamine agonists, the symptoms of PD improve or disappear. After several years of taking L dopa or dopamine agonists, patients notice that their PD medications wear off sooner than when they first started taking them. This "wearing off" is characterized by the return of symptoms (ie, tremor, slowness, and rigidity) and may occur over the course of a few minutes to an hour. When a patient's PD symptoms have returned, the patient is said to be in the "off" state. When the patient takes another dose of medication, and his/her PD symptoms improve or resolve, the patient is said to be in the "on" state. Antagonism of adenosine Type 2a receptors (A2a) may provide relief of Parkinson's disease (PD) symptoms. This trial will test the hypothesis that A2a receptor antagonism can lead to improvement in the function of PD subjects, as measured by a reduction in "off" time.
| Condition | Intervention | Phase |
|---|---|---|
|
Parkinson Disease |
Drug: Preladenant 2 mg tablet Drug: Preladenant 5 mg tablet Drug: Preladenant 10 mg tablet Drug: Placebo for Preladenant Drug: Rasagiline 1 mg capsule Drug: Placebo for Rasagiline 1 mg capsule |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Phase 3, 12-Week, Double-Blind, Double-Dummy, Placebo- and Active-Controlled Efficacy and Safety Study of Preladenant in Subjects With Moderate to Severe Parkinson's Disease (Phase 3;Protocol No. P04938) |
| Estimated Enrollment: | 750 |
| Study Start Date: | July 2010 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Preladenant 2 mg
2 mg Preladenant Tablet + Placebo for Rasagiline in AM; 2 mg Preladenant in PM
|
Drug: Preladenant 2 mg tablet
one 2 mg tablet orally twice daily
Other Name: SCH 420814
Drug: Placebo for Rasagiline 1 mg capsule
one capsule orally in AM
|
|
Experimental: Preladenant 5 mg
5 mg Preladenant Tablet + Placebo for Rasagiline; 5 mg Preladenant in PM
|
Drug: Preladenant 5 mg tablet
one 5 mg tablet orally twice daily
Other Name: SCH 420814
Drug: Placebo for Rasagiline 1 mg capsule
one capsule orally in AM
|
|
Experimental: Preladenant 10 mg
10 mg Preladenant Tablet + Placebo for Rasagiline; 10 mg Preladenant in PM
|
Drug: Preladenant 10 mg tablet
one 10 mg tablet orally twice daily
Other Name: SCH 420814
Drug: Placebo for Rasagiline 1 mg capsule
one capsule orally in AM
|
|
Placebo Comparator: Placebo
Placebo for preladenant + Placebo Rasagiline in AM; Placebo for preladenant in PM
|
Drug: Placebo for Preladenant
one tablet orally twice daily
Drug: Placebo for Rasagiline 1 mg capsule
one capsule orally in AM
|
|
Active Comparator: Rasagiline
1 mg Rasagiline Capsule + Placebo for preladenant in AM; Placebo for preladenant in PM
|
Drug: Placebo for Preladenant
one tablet orally twice daily
Drug: Rasagiline 1 mg capsule
one 1 mg capsule orally in AM
Other Name: Azilect
|
Eligibility| Ages Eligible for Study: | 30 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Toll Free Number | 1-888-577-8839 | |
| Contact: www.AdvancedParkinsonsStudy.com |
Show 26 Study Locations
More Information
| Responsible Party: | Schering-Plough |
| ClinicalTrials.gov Identifier: | NCT01155466 History of Changes |
| Other Study ID Numbers: | P04938, 2009-015161-31 |
| Study First Received: | June 30, 2010 |
| Last Updated: | April 20, 2012 |
| Health Authority: | United States: Food and Drug Administration |
|
Idiopathic Parkinson Disease Idiopathic Parkinson's Disease |
|
Parkinson Disease Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases Movement Disorders Neurodegenerative Diseases Rasagiline |
Monoamine Oxidase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Neuroprotective Agents Protective Agents Physiological Effects of Drugs Central Nervous System Agents Therapeutic Uses |