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

This study has been completed.

First Received: January 7, 2008 Last Updated: December 3, 2009 History of Changes

Sponsor:	Synosia Therapeutics, Inc.
Collaborator:	INC Research Limited
Information provided by:	Synosia Therapeutics, Inc.
ClinicalTrials.gov Identifier:	NCT00595231

Purpose

This is an eight week, randomized, double blind, placebo-controlled, exploratory study. Patients randomized to rufinamide (SYN111) will receive 250 mg BID (total daily dose 500mg) for one week then have their dose increased to 500 mg BID (total daily dose 1000mg) for the remaining 7 weeks of the study. If the 500 mg BID dose is not tolerated, one dose reduction is allowed.

Condition	Intervention	Phase
Generalized Anxiety Disorder	Drug: SYN111	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Anxiety

Drug Information available for: Rufinamide

U.S. FDA Resources

Further study details as provided by Synosia Therapeutics, Inc.:

Primary Outcome Measures:

The study will evaluate the change from baseline in multiple measures including HAMA, HADS, Sheehan Disability Scale, Covi Anxiety Scale, Raskin Depression Scale, Montgomery-Asberg Depressing Rating Scale, Sleep patterns, CGI-S and CGI-I [ Time Frame: Over 8 weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Tolerability in GAD population as assessed by adverse events, change from baseline in physical exam and laboratory measures [ Time Frame: Over 8 weeks of treatment ] [ Designated as safety issue: No ]

Estimated Enrollment:	230
Study Start Date:	March 2008
Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
B: Placebo Comparator Placebo	Drug: SYN111 SYN111 500 mg for 1 week, followed by 1000 mg for 7 weeks

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Outpatient 18-65
Meet DSM IV criteria for GAD
Have moderate to severe anxiety
Sign IRB 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 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,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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00595231

Locations

United States, Georgia
Carmen Research
Atlanta, Georgia, United States, 30080
United States, Ohio
Midwest Clinical Research Center
Dayton, Ohio, United States, 45408

Sponsors and Collaborators

Synosia Therapeutics, Inc.

INC Research Limited

Investigators

Study Chair:	Steve Bandak, MD	Synosia Therapeutics, Inc.
Study Director:	Ann Neale, RN BSN	Synosia Therapeutics, Inc.

More Information

No publications provided

Responsible Party:	Synosia Therapeutics ( Ann Neale )
Study ID Numbers:	SYN111-CL03
Study First Received:	January 7, 2008
Last Updated:	December 3, 2009
ClinicalTrials.gov Identifier:	NCT00595231 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Synosia Therapeutics, Inc.:

GAD

Additional relevant MeSH terms:

Pathologic Processes
Disease
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on February 08, 2010