Efficacy and Safety of Levetiracetam in Prevention of Alcohol Relapse in Recently Detoxified Alcohol Dependent Patients

Alcohol Dependence Clinical Trial

— Keppra-2  

Official title:

Efficacy and Safety of Levetiracetam in Prevention of Alcohol Relapse in Recently Detoxified Alcohol Dependent Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00758277
• Other study ID #: Kep-F10.2.01
• Status: Completed
• Phase: Phase 3
• First received: September 23, 2008
• Last updated: June 22, 2011
• Start date: May 2007
• Est. completion date: December 2009

Study information

• Verified date: August 2009
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 201
• Est. completion date: December 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 ß-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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Alcohol Dependence
• Alcoholic Relapse
• Alcoholism

Intervention

Drug:
• levetiracetam (Keppra)
levetiracetam daily application 1500-2000 mg
• Placebo
Sugar Pill

Locations

Country	Name	City	State
Germany	Charité Campus Mitte, Klinik für Psychiatrie und Psychotherapie	Berlin
Germany	Klinik für Psychiatrie und Psychotherapie, Jüdisches Krankenhaus Berlin	Berlin
Germany	PUK Charité im SHK	Berlin
Germany	Vivantes, Wenckebach-Krankenhaus, Klinik für Psychiatrie und Psychotherapie, Gerontopsychiatrie/Psychosomatik	Berlin
Germany	Westfälisches Zentrum Bochum, Psychiatrie, Psychotherapie & Psychosomatik, Klinik der Ruhr-Universität	Bochum	NRW
Germany	Klinik und Poliklinik für Psychiatrie und Psychotherapie	Bonn	NRW
Germany	Klinik für abhängiges Verhalten und Suchtmedizin, Rheinische Kliniken Essen, Kliniken der Universität Duisburg-Essen	Essen	NRW
Germany	Klinik für abhängiges Verhalten und Suchtmedizin, Rheinische Kliniken, Essen, Kliniken der Universität Duisburg - Essen	Essen	NRW
Germany	Klinik für Psychiatrie, Psychotherapie und Suchtmedizin Kliniken Essen - Mitte	Essen	NRW
Germany	Klinik für Psychiatrie und Psychotherapie der Martin-Luther-Universität Halle	Halle	Sachsen-Anhalt
Germany	Klinikum Nürnberg Nord	Nürnberg	Bayern

Sponsors (2)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany	UCB Pharma

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison alcohol free "surviving "(heavy alcohol relapse) between experimental therapy (Keppra®) and a group of placebos		During and after treatment	No
Secondary	1 Time up to first drinking		During treatment	No
Secondary	2 cumulative Time of do not drinking over the study duration		during treatment	No
Secondary	3 Frequency of Lapses		during treatment	No
Secondary	Tolerability of the study medication		during treatment	Yes
Secondary	Drop Out rate		during treatment	Yes
Secondary	Side effects		during treatment	Yes
Secondary	Changes with the neuropsychological testing, HAM-A, HAM-D, SF12, VASC, OCDS, TLFB, SCL-90		during treatment	No
Secondary	Quality of life		during treatment	No