CompletedPhase 4

A Study of a Drug to be Used in Addition With Another Drug to Treat Adults With Uncontrolled Partial-onset Seizures

United States102 participantsStarted 2017-07-07

Plain-language summary

A study of a drug to be used in addition with another drug to treat adults with Uncontrolled Partial-onset Seizures

Age range18 Years – 99 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Male or female subjects ≥ 18 years of age.
✓. Subject is willing and able to sign informed consent.
✓. Subject has a documented diagnosis of epilepsy with simple POS with a motor component or complex POS with or without secondarily generalized seizures as defined in the Classification of Seizures of the International League Against Epilepsy
✓. Subject has a documented electroencephalogram within 10 years prior to screening.
✓. Subject has had at least 3 POS during previous six months.
✓. Subject has had a sufficient number of seizures at time of enrollment to justify adjunctive therapy, as determined by the Investigator.
✓. Subjects are required to be ESL-naïve AND
✓. Maintained on a stable LEV or LTG regimen for at least 1 month (28 days) prior to screening with no history of adjunctive treatment (for Arm 1, ESL as first add-on).

✕. Subjects with a prior exposure to ESL.
✕. Subjects currently being treated with OXC.
✕. Subject with a history of allergic reaction to OXC or CBZ, or a history of serious allergic reaction (Stevens-Johnson syndrome, Drug Reaction with Eosinophilia and Systemic Symptoms or similar) to any AED, or a history of serious allergic reactions to other medications.
✕. Subjects who have taken warfarin, felbamate, vigabatrin, or perampanel, (unless at stable dose with safety testing for ≥ 1 year) within a 4-week period prior to screening.
✕. Subjects taking ezogabine
✕. Subject has taken any medication prohibited for this protocol within 4 weeks prior to Screening
✕. Subjects using benzodiazepines on more than an occasional basis (defined as more than 2 times per week), except when used chronically as an AED
✕. Seizure disorder characterized primarily by simple POS without motor signs.

The Number of Subjects Completing 24 Weeks Adjunctive Therapy During Maintenance Phase

Timeframe: From the date of the first dose of the study drug until the completion of 24 weeks Maintenance Phase

NCT IDNCT03116828

SponsorSumitomo Pharma America, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-06-06

Results submitted2020-06-01

Who can participate

Age range18 Years – 99 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Male or female subjects ≥ 18 years of age.
✓. Subject is willing and able to sign informed consent.
✓. Subject has a documented diagnosis of epilepsy with simple POS with a motor component or complex POS with or without secondarily generalized seizures as defined in the Classification of Seizures of the International League Against Epilepsy
✓. Subject has a documented electroencephalogram within 10 years prior to screening.
✓. Subject has had at least 3 POS during previous six months.
✓. Subject has had a sufficient number of seizures at time of enrollment to justify adjunctive therapy, as determined by the Investigator.
✓. Subjects are required to be ESL-naïve AND
✓. Maintained on a stable LEV or LTG regimen for at least 1 month (28 days) prior to screening with no history of adjunctive treatment (for Arm 1, ESL as first add-on).

✕. Subjects with a prior exposure to ESL.
✕. Subjects currently being treated with OXC.
✕. Subject with a history of allergic reaction to OXC or CBZ, or a history of serious allergic reaction (Stevens-Johnson syndrome, Drug Reaction with Eosinophilia and Systemic Symptoms or similar) to any AED, or a history of serious allergic reactions to other medications.
✕. Subjects who have taken warfarin, felbamate, vigabatrin, or perampanel, (unless at stable dose with safety testing for ≥ 1 year) within a 4-week period prior to screening.
✕. Subjects taking ezogabine
✕. Subject has taken any medication prohibited for this protocol within 4 weeks prior to Screening
✕. Subjects using benzodiazepines on more than an occasional basis (defined as more than 2 times per week), except when used chronically as an AED
✕. Seizure disorder characterized primarily by simple POS without motor signs.