Conditions: Parkinson Disease
Keywords: Idiopathic Parkinson Disease Idiopathic Parkinson's Disease
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 778
Healthy volunteers: no

Brief summary:
When a patient with Parkinson's 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 (i.e., 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 PD symptoms. This trial will test the hypothesis that A2a receptor antagonism can lead to improvement in the function of PD participants taking a stable dose of L-dopa, as measured by a reduction in "off" time.

Detailed description:

Arms:
arm 1: Preladenant 2 mg tablet + placebo to rasagiline capsule in AM and preladenant 2 mg tablet in PM for 12 weeks arm 2: Preladenant 5 mg tablet + placebo to rasagiline capsule in AM and preladenant 5 mg tablet in PM for 12 weeks arm 3: Preladenant 10 mg tablet + placebo to rasagiline capsule in AM and preladenant 10 mg tablet in PM for 12 weeks arm 4: Placebo to preladenant tablet + placebo to rasagiline capsule in AM and placebo to preladenant tablet in PM for 12 weeks arm 5: Rasagiline 1 mg capsule + placebo to preladenant tablet in AM and placebo to preladenant tablet in PM for 12 weeks

Interventions: intervention 1: Preladenant 2 mg tablet intervention 2: Preladenant 5 mg tablet intervention 3: Preladenant 10 mg tablet intervention 4: Placebo to Preladenant Tablet intervention 5: Rasagiline 1 mg capsule intervention 6: Placebo to Rasagiline capsule
Intervention descriptions: intervention 1: one 2 mg tablet orally twice daily intervention 2: one 5 mg tablet orally twice daily intervention 3: one 10 mg tablet orally twice daily intervention 4: one tablet orally twice daily intervention 5: one 1 mg capsule orally in AM intervention 6: one capsule orally in AM

Protocol document: