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Efficacy and Safety of Levetiracetam in Prevention of Alcohol Relapse in Recently Detoxified Alcohol Dependent Patients — Keppra-2  

Alcohol Dependence Clinical Trial

Official title:
Efficacy and Safety of Levetiracetam in Prevention of Alcohol Relapse in Recently Detoxified Alcohol Dependent Patients

Clinical Trial Summary

Prospective randomized double blind controlled trial in prevention of relapse in recently detoxified alcohol dependent patients with levetiracetam and placebo.

Clinical Trial Description

Out-patients with alcohol dependence recently detoxified Primary goal size is the duration of the Abstinenz up to the heavy relapse.

Secondary objective size are:

- Frequency of Lapses

- Time up to the first alcohol drinking

- cumulative times of do not drink

- Craving

- Alcohol drinking quantity

- Sleep quality

- Tolerability/Bearableness of the study medication

- Security

- Drop Out rate

- Side effects

- Changes with the neuropsychological testing HAM-A, HAM-D, SF12, PSQI, VASC, OCDS, TLFB, SCL-90.

- Quality of life ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00758277
Study type Interventional
Source Charite University, Berlin, Germany
Contact
Status Completed
Phase Phase 3
Start date May 2007
Completion date December 2009
View Details
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