NCT00758277

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
201

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started May 2007

Typical duration for phase_3

Geographic Reach
1 country

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2007

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

September 23, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 25, 2008

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

June 23, 2011

Status Verified

August 1, 2009

Enrollment Period

2.2 years

First QC Date

September 23, 2008

Last Update Submit

June 22, 2011

Conditions

Alcohol DependenceAlcoholic Relapse

Keywords

prevention of alcohol relapse

Outcome Measures

Primary Outcomes (1)

  • Comparison alcohol free "surviving "(heavy alcohol relapse) between experimental therapy (Keppra®) and a group of placebos

    During and after treatment

Secondary Outcomes (8)

  • 1 Time up to first drinking

    During treatment

  • 2 cumulative Time of do not drinking over the study duration

    during treatment

  • 3 Frequency of Lapses

    during treatment

  • Tolerability of the study medication

    during treatment

  • Drop Out rate

    during treatment

  • +3 more secondary outcomes

Study Arms (2)

Levetiracetam

ACTIVE COMPARATOR
Drug: levetiracetam (Keppra)

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

levetiracetam (Keppra)DRUG

levetiracetam daily application 1500-2000 mg

Also known as: KEPPRA
Levetiracetam
PlaceboDRUG

Sugar Pill

Placebo

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Klinikum Nürnberg Nord

Nuremberg, Bavaria, 90419, Germany

Location

Westfälisches Zentrum Bochum, Psychiatrie, Psychotherapie & Psychosomatik, Klinik der Ruhr-Universität

Bochum, North Rhine-Westphalia, 44791, Germany

Location

Klinik und Poliklinik für Psychiatrie und Psychotherapie

Bonn, North Rhine-Westphalia, 53105, Germany

Location

Klinik für Psychiatrie, Psychotherapie und Suchtmedizin Kliniken Essen - Mitte

Essen, North Rhine-Westphalia, 45136, Germany

Location

Klinik für abhängiges Verhalten und Suchtmedizin, Rheinische Kliniken Essen, Kliniken der Universität Duisburg-Essen

Essen, North Rhine-Westphalia, 45147, Germany

Location

Klinik für abhängiges Verhalten und Suchtmedizin, Rheinische Kliniken, Essen, Kliniken der Universität Duisburg - Essen

Essen, North Rhine-Westphalia, 45147, Germany

Location

Klinik für Psychiatrie und Psychotherapie der Martin-Luther-Universität Halle

Halle, Saxony-Anhalt, 06097, Germany

Location

Charité Campus Mitte, Klinik für Psychiatrie und Psychotherapie

Berlin, State of Berlin, 10117, Germany

Location

PUK Charité im SHK

Berlin, State of Berlin, 10559, Germany

Location

Vivantes, Wenckebach-Krankenhaus, Klinik für Psychiatrie und Psychotherapie, Gerontopsychiatrie/Psychosomatik

Berlin, State of Berlin, 12099, Germany

Location

Klinik für Psychiatrie und Psychotherapie, Jüdisches Krankenhaus Berlin

Berlin, State of Berlin, 13347, Germany

Location

Related Publications (2)

  • 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.

    PMID: 16702910BACKGROUND

  • 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.

    PMID: 22722516DERIVED

MeSH Terms

Conditions

Alcoholism

Interventions

Levetiracetam

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

AcetamidesAmidesOrganic ChemicalsAcetatesAcids, AcyclicCarboxylic AcidsPyrrolidinonesPyrrolidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Martin Schaefer, MD

    Department of Psychiarty, Charite Campus Mitte, Berlin, and Department of Psychiatry, Kliniken Essen-Mitte, Essen, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 23, 2008

First Posted

September 25, 2008

Study Start

May 1, 2007

Primary Completion

July 1, 2009

Study Completion

December 1, 2009

Last Updated

June 23, 2011

Record last verified: 2009-08

Locations

DE(11)