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

Alcohol Withdrawal Syndrome Clinical Trial

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]

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00146471
• Other study ID #: Kep-F10.3.01
• Status: Completed
• Phase: Phase 3
• First received: September 6, 2005
• Last updated: December 29, 2009
• Start date: January 2006
• Est. completion date: September 2007

Study information

• Verified date: September 2008
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: September 2007
• Est. primary completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Alcohol Withdrawal Syndrome
• Substance Withdrawal Syndrome
• Syndrome

Intervention

Drug:
• Levetiracetam
1500-2000 mg daily add-on or Placebo Diazepam as needed
• Placebo
1500-2000 mg daily add-on or Placebo Diazepam as needed

Locations

Country	Name	City	State
Germany	Charité - Universitätsmedizin Berlin, Campus Charité Mitte, Klinik für Psychiatrie und Psychotherapie	Berlin
Germany	Psychiatrische Klinik der Charité im St.-Hedwig Krankenhaus	Berlin
Germany	Klinik für Psychiatrie und Suchtmedizin, Kliniken Essen Mitte	Essen
Germany	MLU Halle-Wittenberg	Halle	Sachen/Anhalt
Germany	Zentrum für Seelische Gesundheit	Rhede

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Secondary come-out parameters are - safety criteria (AE) - reduction of alcohol withdrawal score over the days		during trial	Yes