Conditions: Parkinson Disease
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1022
Healthy volunteers: no

Brief summary:
This is a one year, 2-part study to determine the efficacy and safety of preladenant, an adenosine type 2a (A2a) receptor antagonist. The purpose of Part 1 (first 26 weeks) is to determine if preladenant is effective in the treatment of early Parkinson's Disease. The purpose of Part 2 (second 26 weeks) is to determine if preladenant is safe and well tolerated. The primary efficacy hypothesis is that at least the 10 mg twice daily dose of preladenant is superior to placebo as measured by the change from Baseline to Week 26 in the sum of Unified Parkinson's Disease Rating Scale (UPDRS) Parts 2 and 3 scores (UPDRS2+3).

Detailed description:

Arms:
arm 1: Preladenant 2 mg oral tablet and placebo for rasagiline taken in the morning (AM) followed by preladenant 2 mg oral tablet taken in the evening (PM) for 26 weeks (Part 1) and then for another 26 weeks (Part 2). arm 2: Preladenant 5 mg oral tablet and placebo for rasagiline taken in the AM followed by preladenant 5 mg taken in the PM for 26 weeks (Part 1) and then for another 26 weeks (Part 2). arm 3: Preladenant 10 mg oral tablet and placebo for rasagiline taken in the AM followed by preladenant 10 mg taken in the PM for 26 weeks (Part 1) and then for another 26 weeks (Part 2). arm 4: Placebo for preladenant and placebo for rasagiline taken in the AM followed by placebo for preladenant taken in the PM for 26 weeks (Part 1); preladenant 5 mg was taken twice daily for 26 weeks (Part 2). arm 5: Rasagiline 1 mg oral capsule and placebo for preladenant taken in the AM followed by placebo for preladenant taken in the PM for 26 weeks (Part 1) and then for another 26 weeks (Part 2).

Interventions: intervention 1: Preladenant 2 mg tablet intervention 2: Preladenant 5 mg tablet intervention 3: Preladenant 10 mg tablet intervention 4: Rasagiline 1 mg capsule intervention 5: Placebo for Rasagiline 1 mg capsule intervention 6: Placebo for Preladenant
Intervention descriptions: intervention 1: Preladenant 2 mg oral tablet taken twice daily intervention 2: Preladenant 5 mg oral tablet taken twice daily intervention 3: Preladenant 10 mg oral tablet taken twice daily intervention 4: Rasagiline 1 mg oral capsule taken once daily intervention 5: Placebo for rasagiline 1 mg oral capsule taken once daily intervention 6: Placebo for preladenant 2 mg, 5 mg, or 10 mg oral tablet taken twice daily

Protocol document: