- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03474770
BIS-001-ER for the Treatment of Adult Focal Impaired Awareness Seizures (FIAS)
August 29, 2022 updated by: Supernus Pharmaceuticals, Inc.
Evaluation of Safety and Efficacy of BIS-001-ER for the Treatment of Adult Focal Impaired Awareness Seizures
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
16
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Victoria
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Melbourne, Victoria, Australia, 3050
- The Royal Melbourne Hospital
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Melbourne, Victoria, Australia, 3050
- The Alfred Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: BIS-001ER
Dose administration for each participant will begin at 0.25mg b.i.d.
escalating sequentially every 4 days to a maximum tolerated dose or target dose of 1.75mg b.i.d.
Upon reaching the target dose or maximum tolerated dose, participants will maintain that dose for the balance of the 1 month out-patient titration period, after which they will begin a 96-hour in-patient video EEG monitoring treatment period.
|
BIS-001 ER is an extended release formulation of the nutritional supplement Huperzine A.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Effect of BIS-001ER on Seizure Count
Time Frame: 6 Weeks
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Reduction in average daily seizure count between baseline (pre-treatment) and evaluation (on treatment) video EEG monitoring periods.
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6 Weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Effect of BIS-001ER on Percent Reduction in Daily Seizure Count
Time Frame: 6 Weeks
|
Percent reduction in average daily seizure count from the baseline VEM period compared to the evaluation video EEG monitoring period (on treatment).
|
6 Weeks
|
Effect of BIS-001ER on Seizure Count vs Titration Period (Diary)
Time Frame: 6 Weeks
|
Percent reduction in average number of seizures from the baseline period.
(screening/retrospective diary) compared to the last week of the titration treatment period.
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6 Weeks
|
Percent of Treatment Responders
Time Frame: 6 Weeks
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Percent of participants considered treatment responders defined as those with a ≥25%, ≥50%, ≥75% reduction in seizures from the baseline VEM period compared to the VEM treatment evaluation period.
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6 Weeks
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Effect of BIS-001ER on Seizure Count During Extension Phase
Time Frame: 12 Months
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Percent reduction of average number of seizures vs. baseline/retrospective diary at 1, 3, 6, 12 months during the extension period.
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12 Months
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Complete Seizure Protection
Time Frame: 6 Weeks
|
Proportion of subjects with 100% seizure reduction.
|
6 Weeks
|
Need for Rescue Medication
Time Frame: 6 Weeks
|
Proportion of subjects requiring rescue medication at different dosages.
|
6 Weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Azmi Nasser, PhD, Supernus Pharmaceuticals, Inc.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 10, 2018
Primary Completion (Anticipated)
December 30, 2026
Study Completion (Anticipated)
December 30, 2026
Study Registration Dates
First Submitted
March 12, 2018
First Submitted That Met QC Criteria
March 21, 2018
First Posted (Actual)
March 23, 2018
Study Record Updates
Last Update Posted (Actual)
August 30, 2022
Last Update Submitted That Met QC Criteria
August 29, 2022
Last Verified
August 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BNI-02-1b
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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