Clinical trial NCT03474770: BIS-001-ER for the Treatment of Adult Focal Impaired Awareness Seizures
Official title: Evaluation of Safety and Efficacy of BIS-001-ER for the Treatment of Adult Focal Impaired Awareness Seizures
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Focal Impaired Awareness Seizures
Lead sponsor: Supernus Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2018-03-23
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to examine safety signals and demonstrate seizure reduction in adults with FIAS treated with BIS-001ER as an add-on therapy in an in-patient and out-patient study design.


Eligibility criteria: Inclusion Criteria:

* Speak English with sufficient proficiency to read and comprehend the Informed Consent document, and to communicate with study staff.
* Be able to consent to participate by signing the Informed Consent document after a full explanation of the nature and purpose of this study.
* Have signed the Informed Consent before any study-specific procedures are performed.
* Be males or females between 18 - 65 years of age.
* Have a diagnosis of FIAS type epilepsy with or without additional focal aware or non-aware seizures with generalization.
* Have a current minimum average of 5 countable seizures / week to enroll in study.
* Have at least 5 focal impaired awareness seizures during the 96-hour baseline VEM period.
* Be receiving stable doses (for at least 4 weeks) of one to four currently marketed anti-epileptic drugs (AEDs), with or without vagus nerve stimulation (in which case the patient should be on the same stimulation parameters for at least 4 weeks).
* Have a negative urinary pregnancy test upon admission to the site on Day 1.
* Be in good general health in the judgment of the Principal Investigator based upon medical history, physical examination, standard 12-lead ECG, and clinical laboratory evaluations obtained within the two weeks prior to enrollment.
* Be able to comply with all study-specified procedures.
* Weight between 40 and 120 kg.

Exclusion Criteria:

* Has taken Huperzine A within the past year.
* Is planning to become pregnant or impregnate spouse, not using an acceptable method of birth control (defined as use of double-barrier birth control methods, use of oral contraceptives, or surgical sterilization), pregnant or nursing.
* Have non-epileptic events that could be confused by the patient and/or study staff as epileptic seizures.
* Has seizures that are difficult to count; for example, seizure clusters defined as multiple seizures with at least one seizure within 30 minutes of the previous seizure.
* Have less than the 5 minimum accepted seizures required during baseline evaluation period screen.
* Have a history of only seizure clusters, for example, seizure clusters defined as multiple seizures with at least one seizure within 30 minutes of the previous seizure.
* Has attempted suicide within the past 2 years.
* Has a history of status epilepticus in the 6 months previous to enrollment.
* Has a pre-existing medical condition (including an existing progressive or degenerative neurological disorder including brain tumor, active encephalitis, active meningitis or abscess) or takes medications that, in the Principal Investigator's opinion, could interfere with the participant's suitability for participation in the study.
* Has a history or evidence of significant psychiatric disturbance or illness, including alcohol or drug abuse within the past 2 years, or symptoms of psychosis (hallucinations, delusions) in the last 5 years.
* Has had any clinical laboratory abnormalities within the past two months, prior to screening, considered of clinical significance by the Principal Investigator.
* Is on concomitant therapy with non-AEDs that are cholinergic.
* Has participated in any clinical investigational drug or device study within four weeks prior to study entry.
* Inability to complete seizure diary.
* Is currently taking or has taken Epigallocatechin gallate (EGCG) within the past 14 days, or consume foods or drinks containing EGCG; including green, white, oolong teas and certain black teas, or food containing \>100grams of carob powder within the past 14 days.

Primary outcomes:
measure: Effect of BIS-001ER on Seizure Count
timeFrame: 6 Weeks
Secondary outcomes:
measure: Effect of BIS-001ER on Percent Reduction in Daily Seizure Count
timeFrame: 6 Weeks
measure: Effect of BIS-001ER on Seizure Count vs Titration Period (Diary)
timeFrame: 6 Weeks
measure: Percent of Treatment Responders
timeFrame: 6 Weeks
measure: Effect of BIS-001ER on Seizure Count During Extension Phase
timeFrame: 12 Months
measure: Complete Seizure Protection
timeFrame: 6 Weeks
measure: Need for Rescue Medication
timeFrame: 6 Weeks
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: The Alfred Hospital
state: Victoria
city: Melbourne
country: Australia
facility: The Royal Melbourne Hospital
state: Victoria
Study officials:
affiliation: Supernus Pharmaceuticals, Inc.
name: Azmi Nasser, PhD
role: STUDY_CHAIR
References: