NCT00146471

Efficacy and Safety of Levetiracetam in the Inpatient Treatment of Alcohol Withdrawal Syndrome

Efficacy and Safety of Levetiracetam in the Inpatient Treatment of Alcohol Withdrawal Syndrome [Sicherheit Und Wirksamkeit Von Levetiracetam (Keppra) für Die Behandlung Des stationären Alkoholentzugsyndroms]

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Charite University, Berlin, Germany · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy and safety of levetiracetam for treating alcohol withdrawal syndrome (AWS) in inpatients (vs. placebo). The primary come-out parameter is the reduction of the total needed amount of diazepam for add-on treatment of acute alcohol withdrawal symptoms. The secondary come-out parameter are - safety criteria (AE) - reduction of alcohol withdrawal score over the days.

Conditions

• Alcohol Withdrawal Syndrome

Interventions

Type	Name	Description
DRUG	Levetiracetam	1500-2000 mg daily add-on or Placebo Diazepam as needed
DRUG	Placebo	1500-2000 mg daily add-on or Placebo Diazepam as needed

Timeline

• Start date: 2006-01-01
• Primary completion: 2007-07-01
• Completion: 2007-09-01
• First posted: 2005-09-07
• Last updated: 2009-12-30

Locations

5 sites across 1 country: Germany