Study to Assess the Efficacy and Safety of Levetiracetam for the Treatment of Social Anxiety Disorder (Generalized Type)

Anxiety Disorders Clinical Trial

Official title:

A Multicenter, Randomized, Double-Blind, PBO-Controlled, Parallel Group Study to Assess the Efficacy and Safety of Levetiracetam Versus PBO for the Treatment of Social Anxiety Disorder (Generalized Type)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00612859
• Other study ID #: N01086
• Status: Completed
• Phase: Phase 2
• First received: January 14, 2008
• Last updated: November 25, 2013
• Start date: September 2003
• Est. completion date: June 2004

Study information

• Verified date: September 2009
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Preclinical and clinical findings indicate that LEV has some anxiolytic potential. There is reason to believe that compounds with anxiolytic activity may have broad clinical utility across the anxiety spectrum. This trial was intended to explore LEV's utility in adults with social anxiety disorder.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 217
• Est. completion date: June 2004
• Est. primary completion date: June 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Male or female outpatients between 18 and 70 years old inclusive;

• symptoms of social anxiety disorders (generalized type) present for at least 1 year prior to Selection Visit;

• had a score of >=60 on the LSAS at the Selection Visit and at the Randomization Visit. Additionally, the clinician's gloal impression of change score must have been >= 2 at the Randomization Visit;

• had a telephone where they could be directly contacted.

Exclusion Criteria:

• History of autism or Asperger's Disease;

• had another primary axis I disorder or fulfilled diagnostic and statistical manual of mental disorders-4th edition (DSM-IV) criteria in the 6 months prior to Screening;

• major depression as measured by a Hamilton Depression Rating Scale (HAM-D-17 items) total score of > 17 and/or a suicide subscale score on the HAM-D-17 items of > 2 at the Selection or Randomization Visit;

• history of electroconvulsive therapy within the prior 3 months;

• history of psychotherapy which was not stable and ongoing for at least 6 months prior to Visit 1;

• clinical history of significantly impaired renal function with an estimated creatinine clearance below 80 mL/min;

• clinically significant medical condition;

• history of any clinically significant allergic condition or allergy to LEV or pyrrolidone derivatives;

• neutrophil count of less than 1800/µL.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anxiety Disorders
• Phobic Disorders

Intervention

Drug:
• levetiracetam

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
UCB Pharma

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in Liebowitz Social Anxiety Scale (LSAS) score from Visit 2 to the last Evaluation period visit attended using last observation carried forward (LOCF) methods
Primary	Safety: monitoring of AEs, clinical laboratory tests, physical examination and vital signs.

External Links

•   Clinical Study Summary on UCB.com