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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


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

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