Phase 2
N=239
Exploratory Study to Evaluate the Effect of SYN111 (Rufinamide) in Patients With Generalized Anxiety Disorder (GAD)
Generalized Anxiety Disorder
Bottom Line
View on ClinicalTrials.gov: NCT00595231 ↗Enrolled (actual)
239
Serious AEs
0.9%
Results posted
Jan 2019
Primary outcome: Primary: Change From Baseline in Hamilton Anxiety Scale (HAMA) - Total Score: Summary Statistics - Observed — 25.5; 25.6; 25.5; 25.8 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- SYN111 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Biotie Therapies Inc.
- Primary completion
- Oct 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Hamilton Anxiety Scale (HAMA) - Total Score: Summary Statistics - Observed |
25.5; 25.6; 25.5; 25.8; 21.9; 21.4 | — |
| PRIMARY Change From Baseline in Hospital Anxiety and Depression Scale (HADS). Summary Statistics |
-0.2; -0.1; -0.4; -0.4; -1.0; -0.5 | — |
| PRIMARY Change From Baseline in Montgomery-Asberg Depression Scale (MADRS) Summary Statistics. |
15.7; 16.4 | — |
| PRIMARY Change From Baseline in Clinical Global Impression Scale for Severity of Illness: (CGI-S) |
4.5; 4.4 | — |
| PRIMARY Change From Baseline Raskin Depression Scale. |
5.2; 5.3 | — |
| PRIMARY Change From Baseline in Covi Anxiety Scale (CAS) - Index Total Score: Summary Statistics Observed |
10.7; 10.5; 10.7; 10.6; 8.3; 8.1 | — |
Summary
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00595231). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.