E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
detoxified alcohol dependent outpatients |
|
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
investigate in the efficacy and safety of levetiracetam versus placebo to prevent relapse in alcohol dependency |
|
E.2.2 | Secondary objectives of the trial |
craving, drop-out-rate, sleeping quality, frequence of lapses, time to first drinking, life quality, changing in HAM-A, HAM-D, SF12, PSQI, VASC, OCDS, SCL-90. |
|
E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
genetic variations and their association with the alcohol illness, 2006-8-18 , version 1 |
|
E.3 | Principal inclusion criteria |
ages eligible for study 18-70 years meets criteria for alcohol dependence according to DSM-IV/ICD-10 detoxified alcohol dependent patients able to provide a written informed consent able to follow verbal and written instruction (incl. sufficient knowledge of German language)av have a negative urine drug screen for benzodiazepines and opiates |
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E.4 | Principal 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 "tiefenpsychologsiche" single therapy or manual-led group therapies parallel to the clinical study • any further substance dependence except nicotine- and/or coffeinedependence. A Substanzabusus according to the criteria of DSM-IV and/or ICD-10 is not considered as exclusion reason. • Ideopathi 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. polyneuropathia • current co-medication by means of medicines, which can affect significantly withdrawal symptoms or craving or promote the abstinence,e.g. benzodiazepines, antiepileptics, neuroleptics, • Contraindications or heavy side effects in relation to the study medication, or hypersensitivity opposite Pyrrolidonderivate • Pregnancy or quiet time or insufficient contrazeption • Acute severe psychiatric disturbances in need of treatment of the axle I after DSM-IV • Acute suizidality, not convincingly arrangementable • Weight internal illnesses, e.g. pankreatite, pneumonia, cardiac infarct, gastrointerstinale bleedings etc.) • Weight 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) • 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). |
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E.5 End points |
E.5.1 | Primary end point(s) |
With the occurrence one of the exclusion criteria and/or with a heavy relapse, defines for men: at least 5 standard drinks, for women: at least 4 standard drinks over 2 days and/or easy |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Yes |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 11 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
Primary goal is the comparison of the period up to the heavy relapse (time to severe relapse) between experimental therapy (Keppra®) and a group of placebos |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | 27 |