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| Sponsor: | Charite University, Berlin, Germany |
|---|---|
| Information provided by: | Charite University, Berlin, Germany |
| ClinicalTrials.gov Identifier: | NCT00146471 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Alcohol Withdrawal Syndrome |
Drug: Levetiracetam Drug: Placebo |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | 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] |
| Enrollment: | 120 |
| Study Start Date: | January 2006 |
| Study Completion Date: | September 2007 |
| Primary Completion Date: | July 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: 2 |
Drug: Levetiracetam
1500-2000 mg daily add-on or Placebo Diazepam as needed
Other Name: KEPPRA
|
| Placebo Comparator: 1: Diazepam plus Placebo |
Drug: Placebo
1500-2000 mg daily add-on or Placebo Diazepam as needed
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Germany | |
| MLU Halle-Wittenberg | |
| Halle, Sachen/Anhalt, Germany, 06097 | |
| Charité - Universitätsmedizin Berlin, Campus Charité Mitte, Klinik für Psychiatrie und Psychotherapie | |
| Berlin, Germany, 10117 | |
| Psychiatrische Klinik der Charité im St.-Hedwig Krankenhaus | |
| Berlin, Germany, 10559 | |
| Klinik für Psychiatrie und Suchtmedizin, Kliniken Essen Mitte | |
| Essen, Germany, 45136 | |
| Zentrum für Seelische Gesundheit | |
| Rhede, Germany, 46414 | |
| Principal Investigator: | Martin Schaefer, MD | Charité Campus Mitte, Klinik für Psychiatrie und Psychotherapie |
More Information
| Responsible Party: | Martin Schaefer, MD, Charite University, Berlin, Germany |
| ClinicalTrials.gov Identifier: | NCT00146471 History of Changes |
| Other Study ID Numbers: | Kep-F10.3.01 |
| Study First Received: | September 6, 2005 |
| Last Updated: | December 29, 2009 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
|
alcohol withdrawal detoxification Inpatients alcohol dependence according to DSM-IV/ICD-10 withdrawal symptoms |
|
Substance Withdrawal Syndrome Substance-Related Disorders Mental Disorders Etiracetam Piracetam Anticonvulsants Central Nervous System Agents |
Therapeutic Uses Pharmacologic Actions Nootropic Agents Neuroprotective Agents Protective Agents Physiological Effects of Drugs |