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

Phase 3

Completed

• Conditions: Alcohol Withdrawal Syndrome
• Interventions: Drug: Placebo; Drug: Levetiracetam

• Registration Number: NCT00146471
• Lead Sponsor: Charite University, Berlin, Germany

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2005-09-06
• Study First Submitted QC: 2005-09-06
• Study First Posted: 2005-09-07
• Study Start: 2006-01
• Primary Completion: 2007-07
• Study Completion: 2007-09
• Status Verified: 2008-09
• Last Update Submitted: 2009-12-29
• Last Update Posted: 2009-12-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Ages eligible for study: 18-65 years.
• Meets criteria for alcohol dependence according to DSM-IV/ICD-10
• Known withdrawal symptoms in the past in case of discontinuation of alcohol consumption
• Hospital admission for alcohol detoxification
• Able to provide a written informed consent.
• Able to follow verbal and written instructions (incl. a sufficient knowledge of German language).
• Must be medically acceptable for study treatment. No past or present physical disorder that is likely to deteriorate during participation. No ECG abnormality which would likely worsen during participation and no clinical laboratory abnormality that would also suggest deterioration during treatment.
• Have a negative urine drug screen for benzodiazepines or heroine or methadone

Exclusion Criteria

• Current diagnosis of any other substance dependence syndrome other than alcohol dependence (excluding nicotine and caffeine dependence).
• History of idiopathic epilepsy.
• Patient with any current clinically significant psychiatric disorder (acute suiciality) or developmental disorder (including organic mental disorder), like psychotic disorders.
• Patients with the following complications of alcoholism (lifetime): acute delirium tremens, hallucinatory alcoholic state, Korsakoff's syndrome, Wernicke encephalopathy, decomposed liver cirrhosis (Child B, C), suspected cirrhosis with the following clinical symptoms detected at clinical exam: signs of portal hypertension and signs of hepato-cellular failure, thrombocytopenia.
• Subjects with known sensitivity of previous adverse reaction to levetiracetam
• Contra-indication (hypersensitivity to levetiracetam or pyrrolidone derivatives) or known non-response to levetiracetam.
• History of severe GI disease which might render absorption of the medication difficult or produce medical instability of the patient which would include active peptic ulcer disease, ulcerative colitis, regional colitis, or evidence by history or physical exam of GI bleeding.
• Patients with any clinically significant acute or chronic progressive neurological, gastrointestinal, cardiovascular, hepatic, renal, haematological, endocrine, dermatological or respiratory disease, such as diabetes, severe infection, acute alcoholic hepatitis, or any other medical condition with significant worsening of the clinical situation of the patient that might interfere with the evaluation of study medication.
• Female patients pregnant, breast-feeding or of child bearing age and not protected by effective contraceptive such as implants, injectables, combined oral contraceptives, some IUDS, sexual abstinence, sterilization or vasectomized partner.
• Actually continuous use of pharmacological agents that are known to lower the seizure threshold or augment or decrease the alcohol withdrawal syndrome.
• Subjects with known sensitivity of previous adverse reaction to diazepam or clonidine
• Contra-indication or known non-response to diazepam or clonidine

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1: Diazepam plus Placebo	Placebo	-
2	Levetiracetam	-

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Secondary come-out parameters are - safety criteria (AE) - reduction of alcohol withdrawal score over the days	during trial

Trial Locations

Locations (5)

Klinik für Psychiatrie und Suchtmedizin, Kliniken Essen Mitte; 🇩🇪 Essen, Germany

Charité - Universitätsmedizin Berlin, Campus Charité Mitte, Klinik für Psychiatrie und Psychotherapie; 🇩🇪 Berlin, Germany

Zentrum für Seelische Gesundheit; 🇩🇪 Rhede, Germany

Psychiatrische Klinik der Charité im St.-Hedwig Krankenhaus; 🇩🇪 Berlin, Germany

MLU Halle-Wittenberg; 🇩🇪 Halle, Sachen/Anhalt, Germany