TopiramateNCT00241995
Antiglutamate Anticonvulsants in the Treatment of Alcohol Withdrawal Syndrome
A study testing Anticonvulsants in people with Topiramate and Lamotrigine, run by St. Petersburg State Pavlov Medical University.
Trial summary
The study is aimed to evaluate the efficacy of antiglutamate anticonvulsants (topiramate, lamotrigine, and memantine) in the treatment of alcohol withdrawal syndrome Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Topiramate, Lamotrigine, Memnatine
- What is being tested?
- Anticonvulsants
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Interventional
- 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 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Alcohol dependence Alcohol withdrawal syndrome
Who cannot join
- Drug dependence Major psychiatric diagnoses Severe somatic illness
About this study
The study is aimed to evaluate the efficacy of antiglutamate anticonvulsants (topiramate, lamotrigine, and memantine) in the treatment of alcohol withdrawal syndrome
- Conditions
- Topiramate, Lamotrigine, Memnatine, Diazepam, Placebo
- Being tested
- Anticonvulsants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AnticonvulsantsDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2005 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TopiramateStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Sponsor and investigators
- Lead sponsor
- St. Petersburg State Pavlov Medical University
- Sponsor type
- University, hospital or other
- Investigators
- Evgeny M Krupitsky, MD, PhD, Principal investigator, St. Petersburg State Pavlov Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00241995
- Sponsor's protocol ID
- RCT-RCT_LOND_GAT_AWS_2003
- Status last verified
- Oct 2005
- First submitted
- 17 Oct 2005
- Last updated
- 18 Oct 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antiglutamate Anticonvulsants in the Treatment of Alcohol Withdrawal Syndrome
- ClinicalTrials.gov ID
- NCT00241995
- Acronym / sponsor ID
- RCT-RCT_LOND_GAT_AWS_2003
- Conditions
- Topiramate, Lamotrigine, Memnatine, Diazepam, Placebo
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- St. Petersburg State Pavlov Medical UniversityUniversity, hospital or other
- First posted
- 19 Oct 2005 (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.
The study is aimed to evaluate the efficacy of antiglutamate anticonvulsants (topiramate, lamotrigine, and memantine) in the treatment of alcohol withdrawal syndrome
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Alcohol dependence Alcohol withdrawal syndrome
Key exclusion criteria (1 listed)
- Drug dependence Major psychiatric diagnoses Severe somatic illness
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 |
|---|---|---|
| Anticonvulsants | Drug | – |
Primary outcome
Not reported in the source record.
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 18 Oct 2006.
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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.
Evgeny M Krupitsky, MD, PhD principal investigator
St. Petersburg State Pavlov Medical University
Questions about this trial
What is this clinical trial studying?
A study testing Anticonvulsants in people with Topiramate and Lamotrigine, run by St. Petersburg State Pavlov Medical University.
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 1 inclusion and 1 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 18 Oct 2006. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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.
Where can I read the original study information?
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 18 Oct 2006.