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

Biotie Therapies

Status and phase: Completed; Phase 2

Conditions: Generalized Anxiety Disorder

Treatments: Drug: SYN111; Drug: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00595231

SYN111-CL03

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 239 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

239 participants in 2 patient groups, including a placebo group

SYN111

Experimental group

Description:

500 mg 1 week, followed by 1000 mg for 7 weeks

Treatment:

Drug: SYN111

Placebo

Placebo Comparator group

Description:

0 mg tablets

Treatment:

Drug: Placebo