Conditions: Generalized Anxiety Disorder
Keywords: GAD
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 239
Healthy volunteers: no

Brief summary:
A Multi-Centered Randomized, Double-Blind, Placebo-Controlled, Phase 2, Exploratory Study to Evaluate the Effect of Rufinamide on Anxiety in Patients with Moderate to Severe Generalized Anxiety Disorder.

Detailed description:
This was an exploratory study to evaluate the effect of 500 or 1000 mg per day for 8 weeks of Rufinamide compared to placebo on measures of anxiety in patients with Generalized Anxiety Disorder, and to determine tolerability of Rufinamide in this population.

Arms:
arm 1: 500 mg 1 week, followed by 1000 mg for 7 weeks arm 2: 0 mg tablets

Interventions: intervention 1: SYN111 intervention 2: Placebo
Intervention descriptions: intervention 1: 500 mg for 1 week followed by 1000 mg for 7 weeks intervention 2: 0 mg tablets

Protocol document: