Efficacy and Safety of Levetiracetam in the Inpatient Treatment of Alcohol Withdrawal Syndrome
Information source: Charite University, Berlin, Germany
Information obtained from ClinicalTrials.gov on August 08, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Alcohol Dependence According to DSM-IV/ICD-10; Withdrawal Symptoms; Inpatient
Intervention: Levetiracetam (Drug)
Phase: Phase 3
Status: Not yet recruiting
Sponsored by: Charite University, Berlin, Germany Official(s) and/or principal investigator(s):
Martin Schaefer, MD, Principal Investigator, Affiliation: Charité Campus Mitte, Klinik für Psychiatrie und Psychotherapie
Summary
To evaluate the efficacy and safety of levetiracetam for treating alcohol withdrawal syndrome
(AWS) in inpatients (vs. placebo) The primary come-out parameter is the reduction of the
total needed amount of diazepam for add-on treatment of acute alcohol withdrawal symptoms
secondary come-out parameter are - safety criteria (AE) - reduction of alcohol withdrawal
score over the days.
Clinical Details
Official title: 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]
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: To evaluate the efficacy and safety of levetiracetam for treating alcohol withdrawal syndrome in inpatients. The primary come-out parameter is the reduction of the amount of diazepam for add-on treatment of acute alcohol withdrawal
Secondary outcome: Secondary come-out parameters are - safety criteria (AE) - reduction of alcohol withdrawal score over the days
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
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
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 developmental 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,
decomposed 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, thrombocytopenia.
- Subjects with known sensitivity of previous adverse reaction to levetiracetam
- Contra-indication (hypersensitivity to levetiracetam or pyrrolidone 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,
dermatological 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
medication.
- Female patients pregnant, breast-feeding or of child bearing age and not protected by
effective contraceptive such as implants, injectables, combined oral contraceptives,
some IUDS, sexual abstinence, sterilization or vasectomized partner.
- Actually continuous use of pharmacological agents that are known to lower the seizure
threshold or augment or decrease the alcohol withdrawal syndrome.
- Subjects with known sensitivity of previous adverse reaction to diazepam or clonidine
- Contra-indication or known non-response to diazepam or clonidine
Locations and Contacts
Charité - Universitätsmedizin Berlin, Campus Charité Mitte, Klinik für Psychiatrie und Psychotherapie, Berlin 10117, Germany; Not yet recruiting
Martin Schaefer, MD, Phone: 030-2311-2896, Email: martin.schaefer@charite.de
Christoph Richter, MD, Phone: 030-2311-2896/2940, Email: ch.richter@charite.de
Christoph Richter, MD, Sub-Investigator
Axel Hinzpeter, MD, Sub-Investigator
Martin Schaefer, MD, Principal Investigator
Psychiatrische Klinik der Charité im St.-Hedwig Krankenhaus, Berlin 10559, Germany; Not yet recruiting
Christoph Richter, MD, Phone: 030-2311-2896, Email: ch.richter@charite.de
Christoph Richter, MD, Sub-Investigator
Johanna Odebrecht Stiftung, Greifswald, Mecklenburg-Vorpommern 17489, Germany; Not yet recruiting
Ulrich Preuss, MD, Phone: (03834) 543450, Email: Ulrich_preuss@hotmail.com
Ulrich Preuss, MD, Sub-Investigator
St. Vinzenz-Hospital Rhede, Rhede, Nordrhein-Westfalen 46414, Germany; Not yet recruiting
Thomas Plenge, MD, Phone: (02872) 802 – 201, Email: info@st-vinzenz.rhede.de
Thomas Plenge, MD, Sub-Investigator
Additional Information
Starting date: December 2005
Last updated: November 21, 2005
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