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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00146471
First Posted: September 7, 2005
Last Update Posted: December 30, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Charite University, Berlin, Germany
September 6, 2005
September 7, 2005
December 30, 2009
January 2006
July 2007   (Final data collection date for primary outcome measure)
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 ]
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
Complete list of historical versions of study NCT00146471 on ClinicalTrials.gov Archive Site
Secondary come-out parameters are - safety criteria (AE) - reduction of alcohol withdrawal score over the days [ Time Frame: during trial ]
Secondary come-out parameters are - safety criteria (AE) - reduction of alcohol withdrawal score over the days
Not Provided
Not Provided
 
Efficacy and Safety of Levetiracetam in the Inpatient Treatment of Alcohol Withdrawal Syndrome
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]
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Alcohol Withdrawal Syndrome
  • Drug: Levetiracetam
    1500-2000 mg daily add-on or Placebo Diazepam as needed
    Other Name: KEPPRA
  • Drug: Placebo
    1500-2000 mg daily add-on or Placebo Diazepam as needed
  • Active Comparator: 2
    Intervention: Drug: Levetiracetam
  • Placebo Comparator: 1: Diazepam plus Placebo
    Intervention: Drug: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
September 2007
July 2007   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT00146471
Kep-F10.3.01
Yes
Not Provided
Not Provided
Martin Schaefer, MD, Charite University, Berlin, Germany
Charite University, Berlin, Germany
Not Provided
Principal Investigator: Martin Schaefer, MD Charité Campus Mitte, Klinik für Psychiatrie und Psychotherapie
Charite University, Berlin, Germany
September 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP