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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03474770




Registration number
NCT03474770
Ethics application status
Date submitted
12/03/2018
Date registered
23/03/2018
Date last updated
30/08/2022

Titles & IDs
Public title
BIS-001-ER for the Treatment of Adult Focal Impaired Awareness Seizures
Scientific title
Evaluation of Safety and Efficacy of BIS-001-ER for the Treatment of Adult Focal Impaired Awareness Seizures
Secondary ID [1] 0 0
BNI-02-1b
Universal Trial Number (UTN)
Trial acronym
FIAS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Focal Impaired Awareness Seizures 0 0
Condition category
Condition code
Neurological 0 0 0 0
Epilepsy
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - BIS-001ER

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.


Treatment: Drugs: BIS-001ER
BIS-001 ER is an extended release formulation of the nutritional supplement Huperzine A.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Effect of BIS-001ER on Seizure Count
Timepoint [1] 0 0
6 Weeks
Secondary outcome [1] 0 0
Effect of BIS-001ER on Percent Reduction in Daily Seizure Count
Timepoint [1] 0 0
6 Weeks
Secondary outcome [2] 0 0
Effect of BIS-001ER on Seizure Count vs Titration Period (Diary)
Timepoint [2] 0 0
6 Weeks
Secondary outcome [3] 0 0
Percent of Treatment Responders
Timepoint [3] 0 0
6 Weeks
Secondary outcome [4] 0 0
Effect of BIS-001ER on Seizure Count During Extension Phase
Timepoint [4] 0 0
12 Months
Secondary outcome [5] 0 0
Complete Seizure Protection
Timepoint [5] 0 0
6 Weeks
Secondary outcome [6] 0 0
Need for Rescue Medication
Timepoint [6] 0 0
6 Weeks

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
NA
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
10/04/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/12/2026
Actual
Sample size
Target
16
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [2] 0 0
The Royal Melbourne Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3050 - Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Supernus Pharmaceuticals, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Azmi Nasser, PhD
Address 0 0
Supernus Pharmaceuticals, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT03474770