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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT00595231
• Date of registration: 07/01/2008
• Prospective Registration: Yes
• Primary sponsor: Biotie Therapies Inc.
• Public title: Exploratory Study to Evaluate the Effect of SYN111 (Rufinamide) in Patients With Generalized Anxiety Disorder (GAD)
• Scientific 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
• Date of first enrolment: March 2008
• Target sample size: 239
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00595231
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: Christpher Kenney, MD
• Affiliation: Biotie Therapies Inc.

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Generalized Anxiety Disorder

Intervention(s)

Drug: SYN111

Drug: Placebo

Primary Outcome(s)

Change From Baseline in Covi Anxiety Scale (CAS) - Index Total Score: Summary Statistics Observed [Time Frame: 8 weeks]

Change From Baseline in Clinical Global Impression Scale for Severity of Illness: (CGI-S) [Time Frame: 8 weeks]

Change From Baseline in Hamilton Anxiety Scale (HAMA) - Total Score: Summary Statistics - Observed [Time Frame: 8 Weeks]

Change From Baseline Raskin Depression Scale. [Time Frame: 8 weeks]

Change From Baseline in Montgomery-Asberg Depression Scale (MADRS) Summary Statistics. [Time Frame: 8 Weeks]

Change From Baseline in Hospital Anxiety and Depression Scale (HADS). Summary Statistics [Time Frame: 8 Weeks]

Secondary ID(s)

SYN111-CL03

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Syneos Health

Results

• Results available: Yes
• Date Posted: 23/01/2019
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00595231