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

This study has been completed.
Sponsor:
Information provided by:
Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT00146471
First received: September 6, 2005
Last updated: December 29, 2009
Last verified: September 2008
  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 3

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]

Resource links provided by NLM:


Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • 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 [ Time Frame: during trial ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Secondary come-out parameters are - safety criteria (AE) - reduction of alcohol withdrawal score over the days [ Time Frame: during trial ] [ Designated as safety issue: Yes ]

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
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00146471

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
Sponsors and Collaborators
Charite University, Berlin, Germany
Investigators
Principal Investigator: Martin Schaefer, MD Charité Campus Mitte, Klinik für Psychiatrie und Psychotherapie
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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

Keywords provided by Charite University, Berlin, Germany:
alcohol withdrawal
detoxification
Inpatients
alcohol dependence according to DSM-IV/ICD-10
withdrawal symptoms

Additional relevant MeSH terms:
Syndrome
Substance Withdrawal Syndrome
Disease
Pathologic Processes
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Etiracetam
Piracetam
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Nootropic Agents
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 16, 2014