Efficacy and Safety of Levetiracetam in Prevention of Alcohol Relapse in Recently Detoxified Alcohol Dependent Patients (Keppra-2)
Primary Purpose
Alcohol Dependence, Alcoholic Relapse
Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
levetiracetam (Keppra)
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Alcohol Dependence focused on measuring prevention of alcohol relapse
Eligibility 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).
Sites / Locations
- Klinikum Nürnberg Nord
- Westfälisches Zentrum Bochum, Psychiatrie, Psychotherapie & Psychosomatik, Klinik der Ruhr-Universität
- Klinik und Poliklinik für Psychiatrie und Psychotherapie
- Klinik für Psychiatrie, Psychotherapie und Suchtmedizin Kliniken Essen - Mitte
- Klinik für abhängiges Verhalten und Suchtmedizin, Rheinische Kliniken Essen, Kliniken der Universität Duisburg-Essen
- Klinik für abhängiges Verhalten und Suchtmedizin, Rheinische Kliniken, Essen, Kliniken der Universität Duisburg - Essen
- Klinik für Psychiatrie und Psychotherapie der Martin-Luther-Universität Halle
- Charité Campus Mitte, Klinik für Psychiatrie und Psychotherapie
- PUK Charité im SHK
- Vivantes, Wenckebach-Krankenhaus, Klinik für Psychiatrie und Psychotherapie, Gerontopsychiatrie/Psychosomatik
- Klinik für Psychiatrie und Psychotherapie, Jüdisches Krankenhaus Berlin
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Levetiracetam
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Comparison alcohol free "surviving "(heavy alcohol relapse) between experimental therapy (Keppra®) and a group of placebos
Secondary Outcome Measures
1 Time up to first drinking
2 cumulative Time of do not drinking over the study duration
3 Frequency of Lapses
Tolerability of the study medication
Drop Out rate
Side effects
Changes with the neuropsychological testing, HAM-A, HAM-D, SF12, VASC, OCDS, TLFB, SCL-90
Quality of life
Full Information
NCT ID
NCT00758277
First Posted
September 23, 2008
Last Updated
June 22, 2011
Sponsor
Charite University, Berlin, Germany
Collaborators
UCB Pharma
1. Study Identification
Unique Protocol Identification Number
NCT00758277
Brief Title
Efficacy and Safety of Levetiracetam in Prevention of Alcohol Relapse in Recently Detoxified Alcohol Dependent Patients
Acronym
Keppra-2
Official Title
Efficacy and Safety of Levetiracetam in Prevention of Alcohol Relapse in Recently Detoxified Alcohol Dependent Patients
Study Type
Interventional
2. Study Status
Record Verification Date
August 2009
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
December 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Charite University, Berlin, Germany
Collaborators
UCB Pharma
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Prospective randomized double blind controlled trial in prevention of relapse in recently detoxified alcohol dependent patients with levetiracetam and placebo.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Dependence, Alcoholic Relapse
Keywords
prevention of alcohol relapse
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
201 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Levetiracetam
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
levetiracetam (Keppra)
Other Intervention Name(s)
KEPPRA
Intervention Description
levetiracetam daily application 1500-2000 mg
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Sugar Pill
Primary Outcome Measure Information:
Title
Comparison alcohol free "surviving "(heavy alcohol relapse) between experimental therapy (Keppra®) and a group of placebos
Time Frame
During and after treatment
Secondary Outcome Measure Information:
Title
1 Time up to first drinking
Time Frame
During treatment
Title
2 cumulative Time of do not drinking over the study duration
Time Frame
during treatment
Title
3 Frequency of Lapses
Time Frame
during treatment
Title
Tolerability of the study medication
Time Frame
during treatment
Title
Drop Out rate
Time Frame
during treatment
Title
Side effects
Time Frame
during treatment
Title
Changes with the neuropsychological testing, HAM-A, HAM-D, SF12, VASC, OCDS, TLFB, SCL-90
Time Frame
during treatment
Title
Quality of life
Time Frame
during treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Schaefer, MD
Organizational Affiliation
Department of Psychiarty, Charite Campus Mitte, Berlin, and Department of Psychiatry, Kliniken Essen-Mitte, Essen, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Klinikum Nürnberg Nord
City
Nürnberg
State/Province
Bayern
ZIP/Postal Code
90419
Country
Germany
Facility Name
Westfälisches Zentrum Bochum, Psychiatrie, Psychotherapie & Psychosomatik, Klinik der Ruhr-Universität
City
Bochum
State/Province
NRW
ZIP/Postal Code
44791
Country
Germany
Facility Name
Klinik und Poliklinik für Psychiatrie und Psychotherapie
City
Bonn
State/Province
NRW
ZIP/Postal Code
53105
Country
Germany
Facility Name
Klinik für Psychiatrie, Psychotherapie und Suchtmedizin Kliniken Essen - Mitte
City
Essen
State/Province
NRW
ZIP/Postal Code
45136
Country
Germany
Facility Name
Klinik für abhängiges Verhalten und Suchtmedizin, Rheinische Kliniken Essen, Kliniken der Universität Duisburg-Essen
City
Essen
State/Province
NRW
ZIP/Postal Code
45147
Country
Germany
Facility Name
Klinik für abhängiges Verhalten und Suchtmedizin, Rheinische Kliniken, Essen, Kliniken der Universität Duisburg - Essen
City
Essen
State/Province
NRW
ZIP/Postal Code
45147
Country
Germany
Facility Name
Klinik für Psychiatrie und Psychotherapie der Martin-Luther-Universität Halle
City
Halle
State/Province
Sachsen-Anhalt
ZIP/Postal Code
06097
Country
Germany
Facility Name
Charité Campus Mitte, Klinik für Psychiatrie und Psychotherapie
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
PUK Charité im SHK
City
Berlin
ZIP/Postal Code
10559
Country
Germany
Facility Name
Vivantes, Wenckebach-Krankenhaus, Klinik für Psychiatrie und Psychotherapie, Gerontopsychiatrie/Psychosomatik
City
Berlin
ZIP/Postal Code
12099
Country
Germany
Facility Name
Klinik für Psychiatrie und Psychotherapie, Jüdisches Krankenhaus Berlin
City
Berlin
ZIP/Postal Code
13347
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
16702910
Citation
Krebs M, Leopold K, Richter C, Kienast T, Hinzpeter A, Heinz A, Schaefer M. Levetiracetam for the treatment of alcohol withdrawal syndrome: an open-label pilot trial. J Clin Psychopharmacol. 2006 Jun;26(3):347-9. doi: 10.1097/01.jcp.0000219926.49799.89. No abstract available.
Results Reference
background
PubMed Identifier
22722516
Citation
Richter C, Effenberger S, Bschor T, Bonnet U, Haasen C, Preuss UW, Heinz A, Forg A, Volkmar K, Glauner T, Schaefer M. Efficacy and safety of levetiracetam for the prevention of alcohol relapse in recently detoxified alcohol-dependent patients: a randomized trial. J Clin Psychopharmacol. 2012 Aug;32(4):558-62. doi: 10.1097/JCP.0b013e31825e213e.
Results Reference
derived
Learn more about this trial
Efficacy and Safety of Levetiracetam in Prevention of Alcohol Relapse in Recently Detoxified Alcohol Dependent Patients
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