Seizure, Alcohol RelatedPhase 2NCT00627133
Efficacy of Keppra in Acute Alcohol Related Seizure Control--A Pilot Study
A Phase 2 study testing levetiracetam in people with Seizure, Alcohol Related, run by Medical University of South Carolina at 1 site in United States.
Trial summary
Pilot study to evaluate efficacy of Keppra (levetiracetam) for seizure control in patients with alcohol related seizures. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Seizure, Alcohol Related
- What is being tested?
- levetiracetam
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2008to Feb 2008
- Phase
- Phase 2
- 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 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- No trauma
- Not pregnant
- No other cause for seizure (hypoglycemia, CNS causes, trauma)
- Good family support
- Working telephone contact
Who cannot join
- Pregnancy
- Renal failure (creatine > 2mg/dl
- Fever or illness
- Hypotension
- Any trauma
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
Official title: A Pilot Study Examining the Efficacy of Keppra in Acute Alcohol Related Seizure Control in the Emergency Department Setting
Pilot study to evaluate efficacy of Keppra (levetiracetam) for seizure control in patients with alcohol related seizures.
- Conditions
- Seizure, Alcohol Related
- Being tested
- levetiracetam
- Keywords
- Alcohol seizure
- Medical subject headings
- Alcohol Withdrawal Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
levetiracetamDrug
2 gram iv load, 500mg bid
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: levetiracetam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decreased seizures
Measured: 1, 2, 4, 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2008 (estimated)
- Study startFeb 2008
- Primary completionFeb 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Seizure, Alcohol RelatedStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- UCB Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00627133
- Sponsor's protocol ID
- K17644
- Status last verified
- Feb 2008
- First submitted
- 20 Feb 2008
- Last updated
- 7 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study Examining the Efficacy of Keppra in Acute Alcohol Related Seizure Control in the Emergency Department Setting
- ClinicalTrials.gov ID
- NCT00627133
- Acronym / sponsor ID
- K17644
- Conditions
- Seizure, Alcohol Related
- Keywords
- Alcohol seizure
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- UCB Pharma
- Study start
- Feb 2008
- Primary completion
- Feb 2008 (actual)
- First posted
- 29 Feb 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.
Pilot study to evaluate efficacy of Keppra (levetiracetam) for seizure control in patients with alcohol related seizures.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: levetiracetam |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- No trauma
- Not pregnant
- No other cause for seizure (hypoglycemia, CNS causes, trauma)
- Good family support
- Working telephone contact
Key exclusion criteria (5 listed)
- Pregnancy
- Renal failure (creatine > 2mg/dl
- Fever or illness
- Hypotension
- Any trauma
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 |
|---|---|---|
| levetiracetam2 gram iv load, 500mg bid | Drug | 1 |
Primary outcome
Decreased seizures
Time frame: 1, 2, 4, 8 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2018.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing levetiracetam in people with Seizure, Alcohol Related, run by Medical University of South Carolina at 1 site in United States.
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 5 inclusion and 5 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: withdrawn, as of the sponsor's last update on 7 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was withdrawn before enrolling participants, so there are no results.
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?
Decreased seizures (time frame: 1, 2, 4, 8 weeks). It is what the study was designed to measure, not a finding.
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 7 Jun 2018.