EpilepsyPhase 2NCT00034814
Multicenter Trial for Adults With Partial Seizures
A Phase 2 study testing Talampanel in people with Epilepsy, run by Teva Branded Pharmaceutical Products R&D, Inc..
Trial summary
To compare seizure frequency in patients with refactory partial seizures (with or without generalization) who are taking Talampanel versus placebo as an add-on therapy to other licensed concomitant antiepileptic drugs (AEDs) and to determine the safety of Talampanel in this group of patients. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Epilepsy
- What is being tested?
- Talampanel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 190 participants
- Where
- No sites listed yet
- Study dates
- Jan 2002to Jan 2006
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- must weigh greater than or equal to 40kg
- Patients must have diagnosis of partial seizures
- At least 3 observable partial seizures a month
- Are currently being treated with 1 and no more than 2 marketed Anti-epileptic Drugs.
Who cannot join
- Patients on Valproic acid, and Felbamate
About this study
Official title: Efficacy and Safety of Talampanel as Adjunctive Therapy in Patients With Partial Seizures: A Phase II Clinical Trial.
To compare seizure frequency in patients with refactory partial seizures (with or without generalization) who are taking Talampanel versus placebo as an add-on therapy to other licensed concomitant antiepileptic drugs (AEDs) and to determine the safety of Talampanel in this group of patients.
Read the detailed description
A randomized, double-blind, placebo controlled, multicenter, efficacy and safety study of talampanel (TLP) in 190 patients (18-65 years old) with refractory partial seizures.
- Conditions
- Epilepsy
- Being tested
- Talampanel, Placebo
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TalampanelDrug
Non-enzyme-inducing TLP 35mg TID
PlaceboDrug
Enzyme-inducing placebo TID
TalampanelDrug
Enzyme-inducing Talampanel 35 mg TID
TalampanelDrug
Enzyme-inducing TLP 50mg TID
PlaceboDrug
Non-enzyme-inducing placebo TID
TalampanelDrug
Non-enzyme-inducing TLP 25mg TID
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Enzyme-inducing placebo TID Receives: Drug: Placebo |
| 2 | Experimental | Enzyme-inducing Talampanel 35 mg TID Receives: Drug: Talampanel |
| 3 | Experimental | Enzyme-inducing TLP 50mg TID Receives: Drug: Talampanel |
| 4 | Placebo comparator | Non-enzyme-inducing placebo TID Receives: Drug: Placebo |
| 5 | Experimental | Non-enzyme-inducing TLP 25mg TID Receives: Drug: Talampanel |
| 6 | Experimental | Non-enzyme-inducing TLP 35mg TID Receives: Drug: Talampanel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in frequency of partial seizures
Change in frequency of recognizable seizures as measured by entries in a seizure diary
Measured: 12 weeks
Secondary outcomes (1)
The number of seizure-free days and percent responders
A responder was defined as a patient with greater than or equal to 50% reduction in seizure frequency compared to baseline
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2002 (estimated)
- Study startJan 2002
- Primary completionJan 2006
- Study completionJan 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 2
- Primary purpose
- Treatment
- Enrolment
- 190 participants (actual)
Sponsor and investigators
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00034814
- Sponsor's protocol ID
- IXL-201-14-189
- Status last verified
- Mar 2011
- First submitted
- 2 May 2002
- Last updated
- 17 Mar 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Talampanel as Adjunctive Therapy in Patients With Partial Seizures: A Phase II Clinical Trial.
- ClinicalTrials.gov ID
- NCT00034814
- Acronym / sponsor ID
- IXL-201-14-189
- Conditions
- Epilepsy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 190 participants (actual)
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2002
- Primary completion
- Jan 2006 (actual)
- Study completion
- Jan 2006 (actual)
- First posted
- 3 May 2002 (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.
To compare seizure frequency in patients with refactory partial seizures (with or without generalization) who are taking Talampanel versus placebo as an add-on therapy to other licensed concomitant antiepileptic drugs (AEDs) and to determine the safety of Talampanel in this group of patients.
Detailed description
A randomized, double-blind, placebo controlled, multicenter, efficacy and safety study of talampanel (TLP) in 190 patients (18-65 years old) with refractory partial seizures.
Study design
- Primary purpose
- Treatment
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Drug: PlaceboEnzyme-inducing placebo TID |
| 2 | Experimental | Drug: TalampanelEnzyme-inducing Talampanel 35 mg TID |
| 3 | Experimental | Drug: TalampanelEnzyme-inducing TLP 50mg TID |
| 4 | Placebo comparator | Drug: PlaceboNon-enzyme-inducing placebo TID |
| 5 | Experimental | Drug: TalampanelNon-enzyme-inducing TLP 25mg TID |
| 6 | Experimental | Drug: TalampanelNon-enzyme-inducing TLP 35mg TID |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- must weigh greater than or equal to 40kg
- Patients must have diagnosis of partial seizures
- At least 3 observable partial seizures a month
- Are currently being treated with 1 and no more than 2 marketed Anti-epileptic Drugs.
Key exclusion criteria (1 listed)
- Patients on Valproic acid, and Felbamate
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 |
|---|---|---|
| TalampanelNon-enzyme-inducing TLP 35mg TID | Drug | 6 |
| PlaceboEnzyme-inducing placebo TID | Drug | 1 |
| TalampanelEnzyme-inducing Talampanel 35 mg TID | Drug | 2 |
| TalampanelEnzyme-inducing TLP 50mg TID | Drug | 3 |
| PlaceboNon-enzyme-inducing placebo TID | Drug | 4 |
| TalampanelNon-enzyme-inducing TLP 25mg TID | Drug | 5 |
Primary outcome
Reduction in frequency of partial seizures
Time frame: 12 weeks
Change in frequency of recognizable seizures as measured by entries in a seizure diary
1 secondary outcome
The number of seizure-free days and percent responders
Time frame: 12 weeks
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 17 Mar 2011.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Talampanel in people with Epilepsy, run by Teva Branded Pharmaceutical Products R&D, Inc..
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 4 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 17 Mar 2011. 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. 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 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 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?
Reduction in frequency of partial seizures (time frame: 12 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 17 Mar 2011.