Efficacy and safety of levetiracetam in the inpatient treatment of alcohol withdrawal syndrome[Sicherheit und Wirksamkeit von Levetiracetam (Keppra) für die Behandlung des stationären Alkoholentzugsyndroms] - Keppra 1

Charité Campus Mitte, Klinik für Psychiatrie und Psychotherapie0 sites120 target enrollmentJune 15, 2005

Conditionsalcohol withdrawal syndrome (AWS) in inpatients

DrugsKeppra

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: alcohol withdrawal syndrome (AWS) in inpatients
Sponsor: Charité Campus Mitte, Klinik für Psychiatrie und Psychotherapie
Enrollment: 120
Status: Active, not recruiting
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

June 15, 2005

End Date

June 18, 2008

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Charité Campus Mitte, Klinik für Psychiatrie und Psychotherapie

Eligibility Criteria

Inclusion Criteria

•Ages eligible for study: 18\-65 years.
•Meets criteria for alcohol dependence according to DSM\-IV/ICD\-10
•Known withdrawal symptoms in the past in case of discontinuation of alcohol consumption
•Hospital admission for alcohol detoxification
•Able to provide a written informed consent.
•Able to follow verbal and written instructions (incl. a sufficient knowledge of German language).
•Must be medically acceptable for study treatment. No past or present physical disorder that is likely to deteriorate during participation. No ECG abnormality which would likely worsen during participation and no clinical laboratory abnormality that would also suggest deterioration during treatment.
•have a negative urine drug screen for benzodiazepines or heroine or methadone
•Are the trial subjects under 18? no
•Number of subjects for this age range:

Exclusion Criteria

•Current diagnosis of any other substance dependence syndrome other than alcohol dependence (excluding nicotine and caffeine dependence).
•History of idiopathic epilepsy.
•Patient with any current clinically significant psychiatric disorder (acute suiciality) or developmen\-tal disorder (including organic mental disorder), like psychotic disorders.
•Patients with the following complications of alcoholism (lifetime): acute delirium tremens, hallucinatory alcoholic state, Korsakoff\`s syndrome, Wernicke encephalopathy, decompensed liver cirrhosis (Child B, C), suspected cirrhosis with the following clinical symptoms detected at clinical exam: signs of portal hypertension and signs of hepato\-cellular failure, thrombozytopenia.
•Subjects with known sensitivity of previous adverse reaction to levetiracetam
•Contra\-indication (hypersensitivity to levetiracetam or pyrrolidon derivatives) or known non\-response to levetiracetam.
•History of severe GI disease which might render absorption of the medication difficult or produce medical instability of the patient which would include active peptic ulcer disease, ulcerative colitis, regional colitis, or evidence by history or physical exam of GI bleeding.
•Patients with any clinically significant acute or chronic progressive neurological, gastrointestinal, cardiovascular, hepatic, renal, haematological, endocrine, derma\-tological or respiratory disease, such as diabetes, severe infection, acute alcoholic hepatitis, or any other medical condition with significant worsening of the clinical situation of the patient that might interfere with the evaluation of study medica\-tion.
•Female patients pregnant, breast\-feeding or of child bearing age and not protected by effective contraceptive such as implants, injectables, combined oral contracep\-tives, some IUDS, sexual abstinence, sterilization or vasectomised partner.
•actually continous use of pharmacological agents that are known to lower the seizure threshold or augment or decrease the alcohol withdrawal syndrome.