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

NCT00595231 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 239

Last updated 2019-02-27

Study results available
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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.

Conditions

  • Generalized Anxiety Disorder

Interventions

DRUG

SYN111

500 mg for 1 week followed by 1000 mg for 7 weeks

DRUG

Placebo

0 mg tablets

Sponsors & Collaborators

  • Syneos Health

    collaborator OTHER

  • Biotie Therapies Inc.

    lead INDUSTRY

Principal Investigators

  • Christpher Kenney, MD · Biotie Therapies Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-03-31
Primary Completion
2008-10-31
Completion
2008-10-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00595231 on ClinicalTrials.gov