Efficacy and Safety of Levetiracetam in Prevention of Alcohol Relapse in Recently Detoxified Alcohol Dependent Patients (Keppra-2)

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. Identifier: NCT00758277
Recruitment Status : Completed
First Posted : September 25, 2008
Last Update Posted : June 23, 2011
UCB Pharma
Information provided by:
Charite University, Berlin, Germany

Brief Summary:
Prospective randomized double blind controlled trial in prevention of relapse in recently detoxified alcohol dependent patients with levetiracetam and placebo.

Condition or disease Intervention/treatment Phase
Alcohol Dependence Alcoholic Relapse Drug: levetiracetam (Keppra) Drug: Placebo Phase 3

Detailed Description:

Out-patients with alcohol dependence recently detoxified Primary goal size is the duration of the Abstinenz up to the heavy relapse.

Secondary objective size are:

  • Frequency of Lapses
  • Time up to the first alcohol drinking
  • cumulative times of do not drink
  • Craving
  • Alcohol drinking quantity
  • Sleep quality
  • Tolerability/Bearableness of the study medication
  • Security
  • Drop Out rate
  • Side effects
  • Changes with the neuropsychological testing HAM-A, HAM-D, SF12, PSQI, VASC, OCDS, TLFB, SCL-90.
  • Quality of life

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 201 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Efficacy and Safety of Levetiracetam in Prevention of Alcohol Relapse in Recently Detoxified Alcohol Dependent Patients
Study Start Date : May 2007
Primary Completion Date : July 2009
Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Levetiracetam Drug: levetiracetam (Keppra)
levetiracetam daily application 1500-2000 mg
Other Name: KEPPRA
Placebo Comparator: Placebo Drug: Placebo
Sugar Pill

Primary Outcome Measures :
  1. Comparison alcohol free "surviving "(heavy alcohol relapse) between experimental therapy (Keppra®) and a group of placebos [ Time Frame: During and after treatment ]

Secondary Outcome Measures :
  1. 1 Time up to first drinking [ Time Frame: During treatment ]
  2. 2 cumulative Time of do not drinking over the study duration [ Time Frame: during treatment ]
  3. 3 Frequency of Lapses [ Time Frame: during treatment ]
  4. Tolerability of the study medication [ Time Frame: during treatment ]
  5. Drop Out rate [ Time Frame: during treatment ]
  6. Side effects [ Time Frame: during treatment ]
  7. Changes with the neuropsychological testing, HAM-A, HAM-D, SF12, VASC, OCDS, TLFB, SCL-90 [ Time Frame: during treatment ]
  8. Quality of life [ Time Frame: during treatment ]

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • At least 18 and not older than 70 years
  • Good knowledge of the German language
  • The criteria of an alcohol dependence after DSM IV and ICD 10 fulfill
  • To the recruiting time alkoholabstinently living, i.e. after successful alcohol decontamination, the patients must have understood the meaning and consequence of the study and have delivered before beginning of study your written agreement to the participation.
  • Negative drug screening regarding Benzodiazepines and Opiates.
  • With Females either o at least 1 year Menopause or after Sterilization or contraceptive pill, mini pill, three-monthly syringe, Implanton, Vaginalring, hormone plaster, hormone spiral at least 1 month before study inclusion or use of the double barrier method with Spermiziddiaphragma plus condom use or renouncement of sexual intercourse during the entire study duration and resolution a pregnancy to avoid with negative β-HCG-test

Exclusion Criteria:

  • Alcohol withdrawal syndrome beginning or existing
  • Simultaneous one ambulatory or stationary curing therapy, not however participation in groups of self-helps
  • Specific ones behavior or deep-psychological single therapy or manual-led group therapies parallel to the clinical study
  • Any further substance dependence except nicotine and/or Caffeine dependence A abuse according to the criteria of DSM-IV and/or ICD-10 is not considered as exclusion reason.
  • Idiopathic epilepsy, not however admitted alcohol withdrawal convulsions
  • Anamnesis of heavy cerebral traumas or other heavy neurological illnesses, not however alcohol-associated neurological disturbances, e.g. Polyneuropathie
  • current CO-medication by means of medicines, which can affect significantly withdrawal symptoms or Craving or promote the Abstinent( Benzodiazepines, Antiepileptics, antipsychotics, Clonidin, antidepressives or Naltrexon (or substances with comparable effect mechanism) or Acamprosat, Disulfiram, or further substances, which can affect glutamaterge, dopaminerge, cholinergic, serotonerge or opiode system the GABAerge,
  • Contraindications or heavy side effects in relation to the study medication, hypersensitivity opposite Pyrrolidonderivate
  • Pregnancy or quiet time or insufficient Contraception
  • Acute severe psychiatric disturbances in need of treatment of the axle I after DSM-IV
  • Acute Suizidalität, not convincingly arrangementable
  • Severe internal illnesses, e.g. Pancreatitis, pneumonia, cardiac infarct, gastrointestinal bleedings etc.)
  • Severe kidney damage (starting from dekompensierter retention - stage 3 after that national Kidney Foundation) or heavy liver damage (starting from Child A after Child Pugh Score with living ore erring trousers) and/or creatinin Clearance of small 30ml/min
  • Simultaneous participation or within the last 4 weeks at another clinical study, however does not exist an exclusion with previous participation in the decontamination study with Keppra ® (Keppra 1).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00758277

Klinikum Nürnberg Nord
Nürnberg, Bayern, Germany, 90419
Westfälisches Zentrum Bochum, Psychiatrie, Psychotherapie & Psychosomatik, Klinik der Ruhr-Universität
Bochum, NRW, Germany, 44791
Klinik und Poliklinik für Psychiatrie und Psychotherapie
Bonn, NRW, Germany, 53105
Klinik für Psychiatrie, Psychotherapie und Suchtmedizin Kliniken Essen - Mitte
Essen, NRW, Germany, 45136
Klinik für abhängiges Verhalten und Suchtmedizin, Rheinische Kliniken Essen, Kliniken der Universität Duisburg-Essen
Essen, NRW, Germany, 45147
Klinik für abhängiges Verhalten und Suchtmedizin, Rheinische Kliniken, Essen, Kliniken der Universität Duisburg - Essen
Essen, NRW, Germany, 45147
Klinik für Psychiatrie und Psychotherapie der Martin-Luther-Universität Halle
Halle, Sachsen-Anhalt, Germany, 06097
Charité Campus Mitte, Klinik für Psychiatrie und Psychotherapie
Berlin, Germany, 10117
PUK Charité im SHK
Berlin, Germany, 10559
Vivantes, Wenckebach-Krankenhaus, Klinik für Psychiatrie und Psychotherapie, Gerontopsychiatrie/Psychosomatik
Berlin, Germany, 12099
Klinik für Psychiatrie und Psychotherapie, Jüdisches Krankenhaus Berlin
Berlin, Germany, 13347
Sponsors and Collaborators
Charite University, Berlin, Germany
UCB Pharma
Principal Investigator: Martin Schaefer, MD Department of Psychiarty, Charite Campus Mitte, Berlin, and Department of Psychiatry, Kliniken Essen-Mitte, Essen, Germany

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Martin Schaefer, MD, Charite University, Berlin, Germany Identifier: NCT00758277     History of Changes
Other Study ID Numbers: Kep-F10.2.01
First Posted: September 25, 2008    Key Record Dates
Last Update Posted: June 23, 2011
Last Verified: August 2009

Keywords provided by Charite University, Berlin, Germany:
prevention of alcohol relapse

Additional relevant MeSH terms:
Disease Attributes
Pathologic Processes
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Nootropic Agents
Neuroprotective Agents
Protective Agents