Expired Study
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Dayton, Ohio 45408


Purpose:

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.


Study summary:

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.


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


NCT ID:

NCT00595231


Primary Contact:

Study Chair
Christpher Kenney, MD
Biotie Therapies Inc.


Backup Contact:

N/A


Location Contact:

Dayton, Ohio 45408
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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