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

This study has been completed.
Sponsor:
Collaborator:
INC Research Limited
Information provided by:
Biotie Therapies Inc.
ClinicalTrials.gov Identifier:
NCT00595231
First received: January 7, 2008
Last updated: December 3, 2009
Last verified: December 2009
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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:


Further study details as provided by Biotie Therapies 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
Placebo Comparator: B
Placebo
Drug: SYN111
SYN111 500 mg for 1 week, followed by 1000 mg for 7 weeks
Other Name: rufinamide

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Biotie Therapies Inc.
INC Research Limited
Investigators
Study Chair: Steve Bandak, MD Biotie Therapies Inc.
Study Director: Ann Neale, RN BSN Biotie Therapies Inc.
  More Information

No publications provided

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

Keywords provided by Biotie Therapies Inc.:
GAD

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 25, 2014