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CompletedNCT00612859Updated Nov 26, 2013

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

A Phase 2 interventional study of levetiracetam in Anxiety Disorders, sponsored by UCB Pharma. Completed. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2013-11-26.

Sponsored by UCB Pharma · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
217
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Anxiety Disorders

Keywords

  • Levetiracetam
  • Keppra
03

In context

Anxiety Disorders

4,868 studies on the registry are indexed under Anxiety Disorders; 1,390 are open to participants now.

This study's enrollment of 217 is above the median of 80 across 4,174 interventional studies indexed under Anxiety Disorders.

Browse Anxiety Disorders studies →

Lead sponsor

UCB Pharma is the lead sponsor of 238 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
217 participants (actual)

Interventions

  • Druglevetiracetam
06

What researchers measure

Primary outcomes

  1. 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

  2. Safety: monitoring of AEs, clinical laboratory tests, physical examination and vital signs.

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 26, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00612859
Lead sponsor
UCB Pharma
First posted
Feb 12, 2008
Start date
Sep 2003
Primary completion
Jun 2004
Completion
Jun 2004
Last update
Nov 26, 2013

Study contacts

UCB Clinical Trial Call Center
study director · +1 877 822 9493 (UCB)

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2009. You cannot join it, but the record below documents what was studied.

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