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

NCT ID: NCT00595231

Last Updated: 2019-02-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 239 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-03-31
• Study Completion Date: 2008-10-31

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.

Conditions

Generalized Anxiety Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

SYN111

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

Group Type: EXPERIMENTAL

SYN111

Intervention Type: DRUG

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

Placebo

0 mg tablets

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

0 mg tablets

Interventions

SYN111

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

Intervention Type: DRUG

Placebo

0 mg tablets

Intervention Type: DRUG

Other Intervention Names

Rufinamide

Eligibility Criteria

Inclusion Criteria

• Outpatient 18-65
• Meet Diagnostic and Statistical Manual,(DSM) IV criteria for GAD
• Have moderate to severe anxiety
• Sign IRB (Institutional Review Board) approved consent and can comply with visits and procedures
• Women of childbearing potential must use acceptable method of contraception

Exclusion Criteria

• Have diagnosis of adjustment disorder or anxiety disorder Not otherwise specified (NOS)
• Have diagnosis of specific phobia
• Have diagnosis of antisocial personality disorder or other Axis II Disorder
• Have diagnosis of substance abuse disorder within 3 months of study entry
• Have diagnosis of major depressive disorder or panic disorder within 6 months of study entry
• Have diagnosis of PTSD, eating disorder substance dependence disorder within 12 months of study entry
• Have diagnosis anytime during lifetime of schizophrenia or other psychotic disorder, bipolar mood disorder, Obsessive-Compulsive Disorder (OCD), psychosurgery
• Require medication to treat GAD other than study medication
• Failed to show improvement with past treatment for GAD
• Excessively consume caffeine
• Are receiving treatment with prohibited medications
• Uncontrolled thyroid condition
• Positive urine drug screen
• Obese
• Clinically significant ECG finding
• Participating in other clinical trial
• Clinically significant out of range lab value
• Past exposure to rufinamide
• Pregnant or nursing females

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Syneos Health

OTHER

Sponsor Role: collaborator

Biotie Therapies Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christpher Kenney, MD

Role: STUDY_CHAIR

Biotie Therapies Inc.

Locations

Carmen Research

Atlanta, Georgia, United States

Midwest Clinical Research Center

Dayton, Ohio, United States

Countries

United States

Other Identifiers

SYN111-CL03

Identifier Type: -

Identifier Source: org_study_id