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

This study has been completed.
Sponsor:
Collaborator:
UCB, Inc.
Information provided by:
Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT00758277
First received: September 23, 2008
Last updated: June 22, 2011
Last verified: August 2009
  Purpose

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


Condition Intervention Phase
Alcohol Dependence
Alcoholic Relapse
Drug: levetiracetam (Keppra)
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: Efficacy and Safety of Levetiracetam in Prevention of Alcohol Relapse in Recently Detoxified Alcohol Dependent Patients

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Comparison alcohol free "surviving "(heavy alcohol relapse) between experimental therapy (Keppra®) and a group of placebos [ Time Frame: During and after treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 1 Time up to first drinking [ Time Frame: During treatment ] [ Designated as safety issue: No ]
  • 2 cumulative Time of do not drinking over the study duration [ Time Frame: during treatment ] [ Designated as safety issue: No ]
  • 3 Frequency of Lapses [ Time Frame: during treatment ] [ Designated as safety issue: No ]
  • Tolerability of the study medication [ Time Frame: during treatment ] [ Designated as safety issue: Yes ]
  • Drop Out rate [ Time Frame: during treatment ] [ Designated as safety issue: Yes ]
  • Side effects [ Time Frame: during treatment ] [ Designated as safety issue: Yes ]
  • Changes with the neuropsychological testing, HAM-A, HAM-D, SF12, VASC, OCDS, TLFB, SCL-90 [ Time Frame: during treatment ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: during treatment ] [ Designated as safety issue: No ]

Enrollment: 201
Study Start Date: May 2007
Study Completion Date: December 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Levetiracetam Drug: levetiracetam (Keppra)
levetiracetam daily application 1500-2000 mg
Other Name: KEPPRA
Placebo Comparator: Placebo Drug: Placebo
Sugar Pill

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
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00758277

Locations
Germany
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
Klinik für Psychiatrie und Psychotherapie, Jüdisches Krankenhaus Berlin
Berlin, Germany, 13347
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
Sponsors and Collaborators
Charite University, Berlin, Germany
UCB, Inc.
Investigators
Principal Investigator: Martin Schaefer, MD Department of Psychiarty, Charite Campus Mitte, Berlin, and Department of Psychiatry, Kliniken Essen-Mitte, Essen, Germany
  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: NCT00758277     History of Changes
Other Study ID Numbers: Kep-F10.2.01
Study First Received: September 23, 2008
Last Updated: June 22, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

Additional relevant MeSH terms:
Alcoholism
Recurrence
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Disease Attributes
Pathologic Processes
Ethanol
Etiracetam
Piracetam
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Central Nervous System Depressants
Physiological Effects of Drugs
Central Nervous System Agents
Anticonvulsants
Nootropic Agents
Neuroprotective Agents
Protective Agents

ClinicalTrials.gov processed this record on August 28, 2014