Refractory Partial Onset SeizuresPhase 3NCT00448539
Open-Label Extension Study of Rufinamide Given as Adjunctive Therapy in Patients With Refractory Partial Seizures
A Phase 3 study testing Rufinamide in people with Refractory Partial Onset Seizures, run by Eisai Inc. at 27 sites in United States.
Trial summary
This was an open-label extension study in adolescent and adult (between 12 and 80 years old) participants who had completed their participation in Study E2080-A001-301. The main objective of this study was to evaluate the safety and efficacy of long-term administration of rufinamide for the control of epileptic… Read more about this study
- Who is it for?
- Ages 12 to 80 years
- Conditions the study is for
- Refractory Partial Onset Seizures
- What is being tested?
- Rufinamide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 286 participants
- Where
- 27 sitesUnited States
- Study dates
- 15 Mar 2007to 14 May 2010
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 12 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Completion of Study E2080-A001-301 and full compliance with the inclusion and exclusion criteria for that study (excluding criteria that are related to seizure occurrences).
- Patient willing to participate and written consent signed by patient or legal guardian provided prior to entering this study or undergoing any study procedures. In addition, if the patient is unable to provide written informed consent and it is provided by a legal guardian, assent of the patient (if the patient is able) must also be obtained.
- Female patients of non-childbearing potential by reason of surgery, radiation, or menopause (at least one year post onset); female patients of childbearing potential who are using at least two approved methods of contraception (such as an intrauterine device [IUD], implant, oral contraceptive, or barrier method plus spermicide). Use of a low-dose estrogen oral contraceptive alone will not be permitted. Female patients of childbearing potential must agree to continue to use two approved methods of contraception through the follow-up visit or for 30 days after their final dose of study medication, whichever is longer.
Who cannot join
- Discontinuation from Study E2080-A001-301 for any reason, before the termination of the study.
- Evidence of non-compliance with study drug or ongoing AED dosing during Study E2080-A001-301.
- Evidence of clinically significant disease (cardiac, respiratory, gastrointestinal, hepatic (e.g., ALT > 3x ULN), hematologic, renal, or psychiatric disease, etc.) that in the opinion of the Investigator could affect the patient's safety or trial conduct.
- Progressive central nervous system (CNS) disease, including degenerative CNS diseases and progressive tumors.
- History of alcohol abuse in the past 2 years.
- History of suicide attempt within the previous 10 years.
Show all 12Show fewer
- Multiple drug allergies (dematological, heatological or organ toxicity) or more than one severe drug reaction.
- Concomitant use of felbamate or vigabatrin.
- Pregnancy.
- Clinically significant ECG abnormality.
- All patients with a diagnosis of Congenital Short QT Syndrome. Patients with a family history of Congenital Short QT Syndrome may be excluded on the basis of the Investigator's clinical judgement.
- Presence of major active psychiatric disorder. Patients will be allowed who are taking a stable dose of selective serotonin reuptake inhibitor (SSRI) or mixed serotonin and norepinephrine uptake inhibitor antidepressant.
Trial locations and contacts
27 sites in 1 country.
27 sites in 1 country
United States27 sites
McFarland Clinic PC
Ames, Iowa, 50010-3014
Asheville Neurology Specialists
Asheville, North Carolina, 28806
Child Neurology Associates, PC
Atlanta, Georgia, 30342
John Hopkins Hospital, Dept. of Neurology
Baltimore, Maryland, 21287
Bradenton Research Center
Bradenton, Florida, 34205
Fletcher Allen Healthcare
Burlington, Vermont, 05401
Five Towns Neuroscience Research
Cedarhurst, New York, 11516
Comprehensive Epilepsy Care Center for Children and Adults
Chesterfield, Missouri, 63017
Ohio State University
Columbus, Ohio, 43210
Neurological Clinic of Texas, P.A.
Dallas, Texas, 75230
Texas Tech University Health Sciences Center, Dept. of Neuropsychiatry
El Paso, Texas, 79905
Hattiesburg Clinic
Hattiesburg, Mississippi, 39401
University of Florida, The Neuroscience Institute at Shands
Jacksonville, Florida, 32209
Dartmouth Medical School Neuroscience Center
Lebanon, New Hampshire, 03756-0001
Clinical Trials, Inc.
Little Rock, Arkansas, 72205
Pediatric Neurologists of Palm Beach
Loxahatchee Groves, Florida, 33470
University of Tennessee Health Sciences Center, Dept. of Neurology
Memphis, Tennessee, 38105
University of South Alabama Medical Center
Mobile, Alabama, 36693
Access Clinical Trials, Inc
Nashville, Tennessee, 37203
New York University Medical Centre, Comprehensive Epilepsy Center
New York, New York, 10016
Weill Cornell Medical Center, Comprehensive Epilepsy Center
New York, New York, 10021
Pediatric Neurosciences, PA
Orlando, Florida, 32835
Bay Medical Center
Panama City, Florida, 32405
Hospital of The University of Pennsylvania
Philadelphia, Pennsylvania, 19104-4204
University of Pennsylvania Medical Center-Department of Neurology
Philadelphia, Pennsylvania, 19104-4283
Southern Illinois University Neurology and Pharmacology
Springfield, Illinois, 62794-9643
Medical University of Ohio at Toledo - Dept. of Neurology
Toledo, Ohio
About this study
Official title: An Open-Label Extension Study of Rufinamide Given as Adjunctive Therapy in Patients With Refractory Partial Seizures
This was an open-label extension study in adolescent and adult (between 12 and 80 years old) participants who had completed their participation in Study E2080-A001-301. The main objective of this study was to evaluate the safety and efficacy of long-term administration of rufinamide for the control of epileptic seizures in participants who had refractory partial seizures despite treatment with a maximum of three approved antiepileptic drugs (AEDs).
- Conditions
- Refractory Partial Onset Seizures
- Being tested
- Rufinamide
- Keywords
- Refractory Partial Onset Seizures, epilepsy
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RufinamideDrug
Also called E2080
Dose will be maintained within the range of 2400 to 4800 mg/day (i.e., 1200 to 2400 mg twice daily).
| Study group | Role | What they receive |
|---|---|---|
| Rufinamide (Rufinamide During Core Study) | Experimental | Not described Receives: Drug: Rufinamide |
| Rufinamide (Placebo During Core Study) | Experimental | Not described Receives: Drug: Rufinamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage Change in Total Partial Seizure Frequency Per 28 Days Relative to the Baseline Phase
Seizure data was collected via patient diaries. "OL" refers to "open-label."
Measured: Baseline, Titration Phase (Days 1 to 18), Maintenance Phase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2007 (estimated)
- Study start15 Mar 2007
- Primary completion14 May 2010
- Study completion14 May 2010
Why it stopped: The study was terminated early by the sponsor due to the discontinuation of clinical development for rufinamide.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Refractory Partial Onset SeizuresStudies of the same condition, open and under way.
- More trials run by Eisai Inc.The 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 286 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00448539
- Sponsor's protocol ID
- E2080-A001-302
- Other IDs
- 2016-004950-14, 2016
- Status last verified
- Nov 2019
- First submitted
- 15 Mar 2007
- Last updated
- 22 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Extension Study of Rufinamide Given as Adjunctive Therapy in Patients With Refractory Partial Seizures
- ClinicalTrials.gov ID
- NCT00448539
- Acronym / sponsor ID
- E2080-A001-302
- Conditions
- Refractory Partial Onset Seizures
- Keywords
- Refractory Partial Onset Seizures, epilepsy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated early by the sponsor due to the discontinuation of clinical development for rufinamide.
- Enrolment
- 286 participants (actual)
- Lead sponsor
- Eisai Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Mar 2007 (actual)
- Primary completion
- 14 May 2010 (actual)
- Study completion
- 14 May 2010 (actual)
- First posted
- 19 Mar 2007 (estimated)
- Results
- Posted 10 Dec 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This was an open-label extension study in adolescent and adult (between 12 and 80 years old) participants who had completed their participation in Study E2080-A001-301. The main objective of this study was to evaluate the safety and efficacy of long-term administration of rufinamide for the control of epileptic seizures in participants who had refractory partial seizures despite treatment with a maximum of three approved antiepileptic drugs (AEDs).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rufinamide (Rufinamide During Core Study) | Experimental | Drug: Rufinamide |
| Rufinamide (Placebo During Core Study) | Experimental | Drug: Rufinamide |
Who may qualify
- Ages
- 12 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Completion of Study E2080-A001-301 and full compliance with the inclusion and exclusion criteria for that study (excluding criteria that are related to seizure occurrences).
- Patient willing to participate and written consent signed by patient or legal guardian provided prior to entering this study or undergoing any study procedures. In addition, if the patient is unable to provide written informed consent and it is provided by a legal guardian, assent of the patient (if the patient is able) must also be obtained.
- Female patients of non-childbearing potential by reason of surgery, radiation, or menopause (at least one year post onset); female patients of childbearing potential who are using at least two approved methods of contraception (such as an intrauterine device [IUD], implant, oral contraceptive, or barrier method plus spermicide). Use of a low-dose estrogen oral contraceptive alone will not be permitted. Female patients of childbearing potential must agree to continue to use two approved methods of contraception through the follow-up visit or for 30 days after their final dose of study medication, whichever is longer.
Key exclusion criteria (12 listed)
- Discontinuation from Study E2080-A001-301 for any reason, before the termination of the study.
- Evidence of non-compliance with study drug or ongoing AED dosing during Study E2080-A001-301.
- Evidence of clinically significant disease (cardiac, respiratory, gastrointestinal, hepatic (e.g., ALT > 3x ULN), hematologic, renal, or psychiatric disease, etc.) that in the opinion of the Investigator could affect the patient's safety or trial conduct.
- Progressive central nervous system (CNS) disease, including degenerative CNS diseases and progressive tumors.
- History of alcohol abuse in the past 2 years.
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 |
|---|---|---|
| RufinamideAlso: E2080Dose will be maintained within the range of 2400 to 4800 mg/day (i.e., 1200 to 2400 mg twice daily). | Drug | Rufinamide (Placebo During Core Study), Rufinamide (Rufinamide During Core Study) |
Primary outcome
Percentage Change in Total Partial Seizure Frequency Per 28 Days Relative to the Baseline Phase
Time frame: Baseline, Titration Phase (Days 1 to 18), Maintenance Phase
Seizure data was collected via patient diaries. "OL" refers to "open-label."
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
27 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 Rufinamide in people with Refractory Partial Onset Seizures, run by Eisai Inc. at 27 sites 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 3 inclusion and 12 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: stopped early, as of the sponsor's last update on 22 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites 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 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?
Yes. Results are posted in the registry (first posted 10 Dec 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage Change in Total Partial Seizure Frequency Per 28 Days Relative to the Baseline Phase (time frame: Baseline, Titration Phase (Days 1 to 18), Maintenance Phase). 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 22 Nov 2019.