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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00595231
Recruitment Status : Completed
First Posted : January 16, 2008
Last Update Posted : January 5, 2018
INC Research
Information provided by (Responsible Party):
Biotie Therapies Inc.

Brief Summary:
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 or disease Intervention/treatment Phase
Generalized Anxiety Disorder Drug: SYN111 - Placebo Drug: SYN111 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 239 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, 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
Study Start Date : March 2008
Actual Primary Completion Date : October 2008
Actual Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety
Drug Information available for: Rufinamide
U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: B
Drug: SYN111 - Placebo
SYN111 - Placebo
Active Comparator: SYN111
500 mg 1 week, followed by 1000 mg for 7 weeks
Drug: SYN111
500 mg for 1 week followed by 1000 mg for 7 weeks
Other Name: Rufinamide

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00595231

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
Study Chair: Steve Bandak, MD Biotie Therapies Inc.

Responsible Party: Biotie Therapies Inc. Identifier: NCT00595231     History of Changes
Other Study ID Numbers: SYN111-CL03
First Posted: January 16, 2008    Key Record Dates
Last Update Posted: January 5, 2018
Last Verified: February 2014

Keywords provided by Biotie Therapies Inc.:

Additional relevant MeSH terms:
Anxiety Disorders
Pathologic Processes
Mental Disorders