NCT00595231

Exploratory Study to Evaluate the Effect of SYN111 (Rufinamide) in Patients With Generalized Anxiety Disorder (GAD)

A Multi-Center,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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 239 (actual)
• Sponsor: Biotie Therapies Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Generalized Anxiety Disorder

Interventions

Type	Name	Description
DRUG	SYN111	500 mg for 1 week followed by 1000 mg for 7 weeks
DRUG	Placebo	0 mg tablets

Timeline

• Start date: 2008-03-01
• Primary completion: 2008-10-01
• Completion: 2008-10-01
• First posted: 2008-01-16
• Last updated: 2019-02-27
• Results posted: 2019-01-23

Locations

2 sites across 1 country: United States