EpilepsyPhase 3NCT00175864
Open Label Study (Everyone Who Participates Receives Drug) to Further Determine How Safe and Effective Oral Treatment of Seletracetam is in Patients With Refractory Epilepsy.
A Phase 3 study testing Seletracetam (ucb 44212) in people with Epilepsy, run by UCB Pharma.
Trial summary
This is a safety and efficacy study of add on therapy with seletracetam in patients experiencing refractory epilepsy. Read more about this study
- Who is it for?
- Ages 16 to 65 years
- Conditions the study is for
- Epilepsy
- What is being tested?
- Seletracetam (ucb 44212)
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Feb 2006to not given
- 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 16 to 65 years
- All sexes
- Child, Adult, Older adult
Who may be able to join
- An IRB/IEC approved written informed consent form signed and dated Male/Female patients age 18 (or 16 years where permitted by law) to 65.
- Minimum body weight of 40 kg.
- Patients with a confirmed diagnosis of refractory epilepsy of ≥ 6 months.
- Patients must be receiving 1 - 3 concomitant AEDs.
- Female patients without childbearing potentials (2 years post-menopausal or surgical sterilization) are eligible. Female patients with childbearing potential are eligible if they use a medically accepted non-hormonal contraceptive method.
Who cannot join
- Seizures occurring in clusters (seizures occurring either too frequently or indistinctly separated to be reliably counted).
- Status epilepticus within 3 months of Visit 1.
- History of non-epileptic seizures.
- Patients on vigabatrin.
- Patients on felbamate, unless treatment has been continuous for ≥ 18 months.
- Use of benzodiazepines (for any indication) taken at a higher frequency than an average of once a week, unless counted as one of the concomitant AEDs.
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- Ongoing psychiatric disease other than mild controlled disorders.
- Patients with a clinically significant organ dysfunction.
- Known allergic reaction or intolerance to pyrrolidine derivatives and/or excipients.
- Pregnant or lactating women. Any woman with childbearing potential who is not using a medically accepted, non-hormonal method of birth control.
About this study
Official title: Open Label, Multicenter Study of the Safety and Efficacy of Oral Treatment With Immediate Release Seletracetam (Ucb 44212) at Individualized Doses up to a Maximum of 160mg/Day in Refractory Epileptic Patients.
This is a safety and efficacy study of add on therapy with seletracetam in patients experiencing refractory epilepsy.
- Conditions
- Epilepsy
- Being tested
- Seletracetam (ucb 44212)
- Keywords
- Partial Onset, Primary Generalized Seizures, Seletracetam
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Seletracetam (ucb 44212)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety profile of seletracetam
Secondary outcomes (1)
Reduction in seizure frequency
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startFeb 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- UCB Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Barbara Bennett, PhD, Study director, UCB Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00175864
- Sponsor's protocol ID
- N01212
- Other IDs
- Not yet available
- Status last verified
- Mar 2012
- First submitted
- 9 Sep 2005
- Last updated
- 20 Mar 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label, Multicenter Study of the Safety and Efficacy of Oral Treatment With Immediate Release Seletracetam (Ucb 44212) at Individualized Doses up to a Maximum of 160mg/Day in Refractory Epileptic Patients.
- ClinicalTrials.gov ID
- NCT00175864
- Acronym / sponsor ID
- N01212
- Conditions
- Epilepsy
- Keywords
- Partial Onset, Primary Generalized Seizures, Seletracetam
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- UCB PharmaIndustry (pharma, biotech, devices)
- Study start
- Feb 2006
- First posted
- 15 Sep 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.
This is a safety and efficacy study of add on therapy with seletracetam in patients experiencing refractory epilepsy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- An IRB/IEC approved written informed consent form signed and dated Male/Female patients age 18 (or 16 years where permitted by law) to 65.
- Minimum body weight of 40 kg.
- Patients with a confirmed diagnosis of refractory epilepsy of ≥ 6 months.
- Patients must be receiving 1 - 3 concomitant AEDs.
- Female patients without childbearing potentials (2 years post-menopausal or surgical sterilization) are eligible. Female patients with childbearing potential are eligible if they use a medically accepted non-hormonal contraceptive method.
Key exclusion criteria (10 listed)
- Seizures occurring in clusters (seizures occurring either too frequently or indistinctly separated to be reliably counted).
- Status epilepticus within 3 months of Visit 1.
- History of non-epileptic seizures.
- Patients on vigabatrin.
- Patients on felbamate, unless treatment has been continuous for ≥ 18 months.
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 |
|---|---|---|
| Seletracetam (ucb 44212) | Drug | – |
Primary outcome
Safety profile of seletracetam
1 secondary outcome
Reduction in seizure frequency
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 20 Mar 2012.
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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.
Barbara Bennett, PhD study director
UCB Pharma
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Seletracetam (ucb 44212) in people with Epilepsy, run by UCB Pharma.
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 10 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 20 Mar 2012. 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.
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 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?
Safety profile of seletracetam. 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 20 Mar 2012.