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

NCT00146471 | Completed Phase 3 DMC

• 1 other identifier: Kep-F10.3.01
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 5

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.

Conditions

Alcohol Withdrawal Syndrome

Keywords

alcohol withdrawal; detoxification; Inpatients; alcohol dependence according to DSM-IV/ICD-10; withdrawal symptoms

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Secondary come-out parameters are - safety criteria (AE) - reduction of alcohol withdrawal score over the days

  during trial

Study Arms (2)

2

ACTIVE COMPARATOR

Drug: Levetiracetam

1: Diazepam plus Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Levetiracetam DRUG

1500-2000 mg daily add-on or Placebo Diazepam as needed

Also known as: KEPPRA

2

Placebo DRUG

1500-2000 mg daily add-on or Placebo Diazepam as needed

1: Diazepam plus Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (5)

MLU Halle-Wittenberg

Halle, Sachen/Anhalt, 06097, Germany

Location

Charité - Universitätsmedizin Berlin, Campus Charité Mitte, Klinik für Psychiatrie und Psychotherapie

Berlin, State of Berlin, 10117, Germany

Location

Psychiatrische Klinik der Charité im St.-Hedwig Krankenhaus

Berlin, State of Berlin, 10559, Germany

Location

Klinik für Psychiatrie und Suchtmedizin, Kliniken Essen Mitte

Essen, 45136, Germany

Location

Zentrum für Seelische Gesundheit

Rhede, 46414, Germany

Location

Related Publications (2)

• 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.

  PMID: 16702910 BACKGROUND

• 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.

  PMID: 21105289 DERIVED

MeSH Terms

Conditions

Substance Withdrawal Syndrome

Interventions

Levetiracetam

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Acetamides; Amides; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids; Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Martin Schaefer, MD

  Charité Campus Mitte, Klinik für Psychiatrie und Psychotherapie

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 6, 2005
• First Posted: September 7, 2005
• Study Start: January 1, 2006
• Primary Completion: July 1, 2007
• Study Completion: September 1, 2007
• Last Updated: December 30, 2009

Record last verified: 2008-09

Locations

DE (5)