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Open-Label Extension Study of Rufinamide Given as Adjunctive Therapy in Patients With Refractory Partial Seizures

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00448539
Recruitment Status : Terminated (The study was terminated early by the sponsor due to the discontinuation of clinical development for rufinamide.)
First Posted : March 19, 2007
Results First Posted : December 10, 2012
Last Update Posted : November 22, 2019
Sponsor:
Information provided by (Responsible Party):
Eisai Inc.

Brief 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 seizures in participants who had refractory partial seizures despite treatment with a maximum of three approved antiepileptic drugs (AEDs).

Condition or disease Intervention/treatment Phase
Refractory Partial Onset Seizures Drug: Rufinamide Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 286 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label Extension Study of Rufinamide Given as Adjunctive Therapy in Patients With Refractory Partial Seizures
Actual Study Start Date : March 15, 2007
Actual Primary Completion Date : May 14, 2010
Actual Study Completion Date : May 14, 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Seizures
Drug Information available for: Rufinamide

Arm Intervention/treatment
Experimental: Rufinamide (Rufinamide During Core Study) Drug: Rufinamide
Dose will be maintained within the range of 2400 to 4800 mg/day (i.e., 1200 to 2400 mg twice daily).
Other Name: E2080

Experimental: Rufinamide (Placebo During Core Study) Drug: Rufinamide
Dose will be maintained within the range of 2400 to 4800 mg/day (i.e., 1200 to 2400 mg twice daily).
Other Name: E2080




Primary Outcome Measures :
  1. 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."



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

INCLUSION CRITERIA:

  1. 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).
  2. 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.
  3. 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.

EXCLUSION CRITERIA:

  1. Discontinuation from Study E2080-A001-301 for any reason, before the termination of the study.
  2. Evidence of non-compliance with study drug or ongoing AED dosing during Study E2080-A001-301.
  3. 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.
  4. Progressive central nervous system (CNS) disease, including degenerative CNS diseases and progressive tumors.
  5. History of alcohol abuse in the past 2 years.
  6. History of suicide attempt within the previous 10 years.
  7. Multiple drug allergies (dematological, heatological or organ toxicity) or more than one severe drug reaction.
  8. Concomitant use of felbamate or vigabatrin.
  9. Pregnancy.
  10. Clinically significant ECG abnormality.
  11. 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.
  12. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00448539


Locations
Show Show 27 study locations
Sponsors and Collaborators
Eisai Inc.
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Responsible Party: Eisai Inc.
ClinicalTrials.gov Identifier: NCT00448539    
Other Study ID Numbers: E2080-A001-302
2016-004950-14 ( EudraCT Number )
First Posted: March 19, 2007    Key Record Dates
Results First Posted: December 10, 2012
Last Update Posted: November 22, 2019
Last Verified: November 2019
Keywords provided by Eisai Inc.:
Refractory Partial Onset Seizures, epilepsy
Additional relevant MeSH terms:
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Seizures
Neurologic Manifestations
Nervous System Diseases
Rufinamide
Anticonvulsants
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action