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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2 | Active Comparator |
| |
| 1: Diazepam plus Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levetiracetam | Drug | 1500-2000 mg daily add-on or Placebo Diazepam as needed |
|
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the efficacy and safety of levetiracetam for treating alcohol withdrawal syndrome in inpatients. The primary come-out parameter is the reduction of the amount of diazepam for add-on treatment of acute alcohol withdrawal | during trial |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary come-out parameters are - safety criteria (AE) - reduction of alcohol withdrawal score over the days | during trial |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Martin Schaefer, MD | Charité Campus Mitte, Klinik für Psychiatrie und Psychotherapie | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MLU Halle-Wittenberg | Halle | Sachen/Anhalt | 06097 | Germany | ||
| Charité - Universitätsmedizin Berlin, Campus Charité Mitte, Klinik für Psychiatrie und Psychotherapie |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16702910 | Background | Krebs M, Leopold K, Richter C, Kienast T, Hinzpeter A, Heinz A, Schaefer M. Levetiracetam for the treatment of alcohol withdrawal syndrome: an open-label pilot trial. J Clin Psychopharmacol. 2006 Jun;26(3):347-9. doi: 10.1097/01.jcp.0000219926.49799.89. No abstract available. | |
| 21105289 | Derived | Richter C, Hinzpeter A, Schmidt F, Kienast T, Preuss UW, Plenge T, Heinz A, Schaefer M. Levetiracetam for the treatment of alcohol withdrawal syndrome: a multicenter, prospective, randomized, placebo-controlled trial. J Clin Psychopharmacol. 2010 Dec;30(6):720-5. doi: 10.1097/jcp.0b013e3181faf53e. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 19, 2024 | |
| Reset | Aug 15, 2024 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 19, 2024 | Aug 15, 2024 |
| ID | Term |
|---|---|
| D013375 | Substance Withdrawal Syndrome |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000077287 | Levetiracetam |
| ID | Term |
|---|---|
| D000081 | Acetamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000085 | Acetates |
| D000144 |
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| Placebo | Drug | 1500-2000 mg daily add-on or Placebo Diazepam as needed |
|
| Berlin |
| State of Berlin |
| 10117 |
| Germany |
| Psychiatrische Klinik der Charité im St.-Hedwig Krankenhaus | Berlin | State of Berlin | 10559 | Germany |
| Klinik für Psychiatrie und Suchtmedizin, Kliniken Essen Mitte | Essen | 45136 | Germany |
| Zentrum für Seelische Gesundheit | Rhede | 46414 | Germany |
| Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D011760 | Pyrrolidinones |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |