Alcohol DependencePhase 3Keppra-2NCT00758277
Efficacy and Safety of Levetiracetam in Prevention of Alcohol Relapse in Recently Detoxified Alcohol Dependent Patients
A Phase 3 study testing levetiracetam (Keppra) in people with Alcohol Dependence and Alcoholic Relapse, run by Charite University, Berlin, Germany at 11 sites in Germany.
Trial summary
Prospective randomized double blind controlled trial in prevention of relapse in recently detoxified alcohol dependent patients with levetiracetam and placebo. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Alcohol Dependence, Alcoholic Relapse
- What is being tested?
- levetiracetam (Keppra)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 201 participants
- Where
- 11 sitesGermany
- Study dates
- May 2007to Dec 2009
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 β-HCG-test
Who cannot join
- 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
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- 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).
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
Germany11 sites
Charité Campus Mitte, Klinik für Psychiatrie und Psychotherapie
Berlin, State of Berlin, 10117
PUK Charité im SHK
Berlin, State of Berlin, 10559
Vivantes, Wenckebach-Krankenhaus, Klinik für Psychiatrie und Psychotherapie, Gerontopsychiatrie/Psychosomatik
Berlin, State of Berlin, 12099
Klinik für Psychiatrie und Psychotherapie, Jüdisches Krankenhaus Berlin
Berlin, State of Berlin, 13347
Westfälisches Zentrum Bochum, Psychiatrie, Psychotherapie & Psychosomatik, Klinik der Ruhr-Universität
Bochum, North Rhine-Westphalia, 44791
Klinik und Poliklinik für Psychiatrie und Psychotherapie
Bonn, North Rhine-Westphalia, 53105
Klinik für Psychiatrie, Psychotherapie und Suchtmedizin Kliniken Essen - Mitte
Essen, North Rhine-Westphalia, 45136
Klinik für abhängiges Verhalten und Suchtmedizin, Rheinische Kliniken Essen, Kliniken der Universität Duisburg-Essen
Essen, North Rhine-Westphalia, 45147
Klinik für abhängiges Verhalten und Suchtmedizin, Rheinische Kliniken, Essen, Kliniken der Universität Duisburg - Essen
Essen, North Rhine-Westphalia, 45147
Klinik für Psychiatrie und Psychotherapie der Martin-Luther-Universität Halle
Halle, Saxony-Anhalt, 06097
Klinikum Nürnberg Nord
Nuremberg, Bavaria, 90419
About this study
Prospective randomized double blind controlled trial in prevention of relapse in recently detoxified alcohol dependent patients with levetiracetam and placebo.
Read the detailed 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
- Conditions
- Alcohol Dependence, Alcoholic Relapse
- Being tested
- levetiracetam (Keppra), Placebo
- Keywords
- prevention of alcohol relapse
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
levetiracetam (Keppra)Drug
Also called KEPPRA
levetiracetam daily application 1500-2000 mg
PlaceboDrug
Sugar Pill
| Study group | Role | What they receive |
|---|---|---|
| Levetiracetam | Active comparator | Not described Receives: Drug: levetiracetam (Keppra) |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison alcohol free "surviving "(heavy alcohol relapse) between experimental therapy (Keppra®) and a group of placebos
Measured: During and after treatment
Secondary outcomes (8)
1 Time up to first drinking
Measured: During treatment
2 cumulative Time of do not drinking over the study duration
Measured: during treatment
3 Frequency of Lapses
Measured: during treatment
Tolerability of the study medication
Measured: during treatment
Drop Out rate
Measured: during treatment
Side effects
Measured: during treatment
Changes with the neuropsychological testing, HAM-A, HAM-D, SF12, VASC, OCDS, TLFB, SCL-90
Measured: during treatment
Quality of life
Measured: during treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2008 (estimated)
- Study startMay 2007
- Primary completionJul 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Alcohol DependenceStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 201 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- UCB Pharma
- Investigators
- Martin Schaefer, MD, Principal investigator, Department of Psychiarty, Charite Campus Mitte, Berlin, and Department of Psychiatry, Kliniken Essen-Mitte, Essen, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00758277
- Sponsor's protocol ID
- Kep-F10.2.01
- Acronym
- Keppra-2
- Status last verified
- Aug 2009
- First submitted
- 23 Sep 2008
- Last updated
- 23 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 16702910Richter 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.
PubMed 22722516
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Levetiracetam in Prevention of Alcohol Relapse in Recently Detoxified Alcohol Dependent Patients
- ClinicalTrials.gov ID
- NCT00758277
- Acronym / sponsor ID
- Keppra-2 / Kep-F10.2.01
- Conditions
- Alcohol Dependence, Alcoholic Relapse
- Keywords
- prevention of alcohol relapse
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 201 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- UCB Pharma
- Study start
- May 2007
- Primary completion
- Jul 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 25 Sep 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prospective randomized double blind controlled trial in prevention of relapse in recently detoxified alcohol dependent patients with levetiracetam and placebo.
Detailed 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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Levetiracetam | Active comparator | Drug: levetiracetam (Keppra) |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| levetiracetam (Keppra)Also: KEPPRAlevetiracetam daily application 1500-2000 mg | Drug | Levetiracetam |
| PlaceboSugar Pill | Drug | Placebo |
Primary outcome
Comparison alcohol free "surviving "(heavy alcohol relapse) between experimental therapy (Keppra®) and a group of placebos
Time frame: During and after treatment
8 secondary outcomes
1 Time up to first drinking
Time frame: During treatment
2 cumulative Time of do not drinking over the study duration
Time frame: during treatment
3 Frequency of Lapses
Time frame: during treatment
Tolerability of the study medication
Time frame: during treatment
Drop Out rate
Time frame: during treatment
Side effects
Time frame: during treatment
Changes with the neuropsychological testing, HAM-A, HAM-D, SF12, VASC, OCDS, TLFB, SCL-90
Time frame: during treatment
Quality of life
Time frame: during treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2011.
- Background: PubMed 16702910Krebs 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.
- Derived from this study: PubMed 22722516Richter 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin Schaefer, MD principal investigator
Department of Psychiarty, Charite Campus Mitte, Berlin, and Department of Psychiatry, Kliniken Essen-Mitte, Essen, Germany
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing levetiracetam (Keppra) in people with Alcohol Dependence and Alcoholic Relapse, run by Charite University, Berlin, Germany at 11 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison alcohol free "surviving "(heavy alcohol relapse) between experimental therapy (Keppra®) and a group of placebos (time frame: During and after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00758277, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2011.