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

June 22, 2011 updated by: Charite University, Berlin, Germany
Prospective randomized double blind controlled trial in prevention of relapse in recently detoxified alcohol dependent patients with levetiracetam and placebo.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

201

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 10117
        • Charité Campus Mitte, Klinik für Psychiatrie und Psychotherapie
      • Berlin, Germany, 10559
        • PUK Charité im SHK
      • Berlin, Germany, 12099
        • Vivantes, Wenckebach-Krankenhaus, Klinik für Psychiatrie und Psychotherapie, Gerontopsychiatrie/Psychosomatik
      • Berlin, Germany, 13347
        • Klinik für Psychiatrie und Psychotherapie, Jüdisches Krankenhaus Berlin
    • Bayern
      • Nürnberg, Bayern, Germany, 90419
        • Klinikum Nürnberg Nord
    • NRW
      • Bochum, NRW, Germany, 44791
        • Westfälisches Zentrum Bochum, Psychiatrie, Psychotherapie & Psychosomatik, Klinik der Ruhr-Universität
      • Bonn, NRW, Germany, 53105
        • Klinik und Poliklinik für Psychiatrie und Psychotherapie
      • Essen, NRW, Germany, 45136
        • Klinik für Psychiatrie, Psychotherapie und Suchtmedizin Kliniken Essen - Mitte
      • Essen, NRW, Germany, 45147
        • 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
    • Sachsen-Anhalt
      • Halle, Sachsen-Anhalt, Germany, 06097
        • Klinik für Psychiatrie und Psychotherapie der Martin-Luther-Universität Halle

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Sugar Pill
Active Comparator: Levetiracetam
Drug: levetiracetam (Keppra)
levetiracetam daily application 1500-2000 mg
Other Names:
  • KEPPRA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Comparison alcohol free "surviving "(heavy alcohol relapse) between experimental therapy (Keppra®) and a group of placebos
Time Frame: During and after treatment
During and after treatment

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charite University, Berlin, Germany

Collaborators

UCB Pharma

Investigators

  • Principal Investigator: Martin Schaefer, MD, Department of Psychiarty, Charite Campus Mitte, Berlin, and Department of Psychiatry, Kliniken Essen-Mitte, Essen, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2007

Primary Completion (Actual)

July 1, 2009

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

September 23, 2008

First Submitted That Met QC Criteria

September 23, 2008

First Posted (Estimate)

September 25, 2008

Study Record Updates

Last Update Posted (Estimate)

June 23, 2011

Last Update Submitted That Met QC Criteria

June 22, 2011

Last Verified

August 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Kep-F10.2.01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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