Efficacy of YKP3089 in Patients With Photosensitive Epilepsy

NCT00616148 | Completed Phase 2 DMC

• 1 other identifier: AA40616
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 4

Brief Summary

The aim of this study is to evaluate the ability of a single oral dose of YKP3089 to abolish or clearly reduce the IPS-induced photo-paroxysmal EEG response in photosensitive epilepsy patients, and to measure the onset and duration of the effect. Several cohorts will be used, to sequentially investigate different doses.

Conditions

Epilepsy

Keywords

Epilepsy; Seizures

Outcome Measures

Primary Outcomes (1)

• Determine if YKP3089 will reduce or abolish the photosensitivity response as compared to placebo.

  At the completion of each cohort

Secondary Outcomes (1)

• Assessment of serum concentrations of concomitant AEDs during administration of YKP3089 as compared to the placebo day. Assessment of safety/tolerability at multiple dose levels.

  At the completion of each cohort

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

YKP3089

EXPERIMENTAL

Drug: YKP3089

Interventions

YKP3089 DRUG

Oral dosage form

YKP3089

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 16 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Male or female age 18-60 years.
• A diagnosis and history of epilepsy for which patients are on 0-2 concomitant antiepileptic drugs.
• If the patient is taking two concomitant medications, the second drug must be levetiracetam, gabapentin or pregabalin.
• A reproducible IPS-induced photo-paroxysmal response (PPR) on EEG of at least 3 points on a frequency assessment scale (See Section 6.16) in at least one eye condition and no change of more than 3 frequencies in 2 repeated measurements recorded over the 2 months prior to study entry in at least one eye condition.
• Patients in otherwise good health (with the exception of epilepsy), as determined by the PI via the medical history, a physical examination and screening laboratory investigations.
• A body mass index (BMI) between 18 and 35.
• Able and willing to provide written informed consent to participate in the study in accordance with the ICH, GCP guidelines.

You may not qualify if:

• A history of non epileptic seizures (e.g. metabolic, structural or pseudo-seizures).
• Women who are pregnant or lactating.
• Women of reproductive potential who do not agree to use effective birth-control methods.
• Patients taking medications that are known substrates of CYP2B6 and CYP2C19 including but not limited to phenytoin, Phenobarbital, omeprazole, fluvoxamine and efavirenz.
• Any clinically significant laboratory abnormality which, in the opinion of the investigator, will exclude the patient from the study.
• An active CNS infection, demyelinating disease, degenerative neurological disease or any CNS disease deemed to be progressive during the course of the study that may confound the interpretation of the study results.
• Any clinically significant psychiatric illness, psychological or behavioral problems which, in the opinion of the investigator, would interfere with the patient's ability to participate in the study.
• Patients who are suffering from clinically significant active liver disease, porphyria or with a family history of severe hepatic dysfunction indicated by abnormal liver function tests greater than 3 times the upper limit of normal (AST and ALT).
• A history of alcoholism, drug abuse, or drug addiction (within the past 12 months).
• Patients who would normally be contraindicated for YKP3089 administration.
• Patients who have participated in any other trials involving an investigational product or device within 30 days of screening or longer as required by local regulations.

Sponsors & Collaborators

• SK Life Science, Inc.: lead
• The Epilepsy Study Consortium: collaborator

Study Sites (4)

Johns Hopkins Medical Center

Baltimore, Maryland, 21287, United States

Location

Cornell Medical Center

New York, New York, 10021, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

University of Pennsylvania Epilepsy Center

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

• Kasteleijn-Nolst Trenite DGA, DiVentura BD, Pollard JR, Krauss GL, Mizne S, French JA. Suppression of the photoparoxysmal response in photosensitive epilepsy with cenobamate (YKP3089). Neurology. 2019 Aug 6;93(6):e559-e567. doi: 10.1212/WNL.0000000000007894. Epub 2019 Jul 10.

  PMID: 31292226 DERIVED

MeSH Terms

Conditions

Epilepsy; Seizures

Interventions

Cenobamate

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jacqueline French, M.D.

  NYU MEDICAL CENTER

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2008
• First Posted: February 15, 2008
• Study Start: August 1, 2007
• Primary Completion: January 1, 2009
• Study Completion: January 1, 2010
• Last Updated: January 31, 2014

Record last verified: 2013-12

Locations

US (4)