Focal Impaired Awareness SeizuresPhase 1/2FIASNCT03474770
BIS-001-ER for the Treatment of Adult Focal Impaired Awareness Seizures
A Phase 1/2 study testing BIS-001ER in people with Focal Impaired Awareness Seizures, run by Supernus Pharmaceuticals, Inc. at 2 sites in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Focal Impaired Awareness Seizures
- What is being tested?
- BIS-001ER
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 2 sitesAustralia
- Study dates
- 10 Apr 2018to 30 Dec 2026
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 1 country.
Australia2 sites
The Alfred Hospital
Melbourne, Victoria, 3050
The Royal Melbourne Hospital
Melbourne, Victoria, 3050
About this study
Official title: 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.
- Conditions
- Focal Impaired Awareness Seizures
- Being tested
- BIS-001ER
- Medical subject headings
- Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIS-001ERDrug
Also called Huperzine A ER
BIS-001 ER is an extended release formulation of the nutritional supplement Huperzine A.
| Study group | Role | What they receive |
|---|---|---|
| BIS-001ER | Experimental | 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. Receives: Drug: BIS-001ER |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of BIS-001ER on Seizure Count
Reduction in average daily seizure count between baseline (pre-treatment) and evaluation (on treatment) video EEG monitoring periods.
Measured: 6 Weeks
Secondary outcomes (6)
Effect of BIS-001ER on Percent Reduction in Daily Seizure Count
Percent reduction in average daily seizure count from the baseline VEM period compared to the evaluation video EEG monitoring period (on treatment).
Measured: 6 Weeks
Effect of BIS-001ER on Seizure Count vs Titration Period (Diary)
Percent reduction in average number of seizures from the baseline period. (screening/retrospective diary) compared to the last week of the titration treatment period.
Measured: 6 Weeks
Percent of Treatment Responders
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.
Measured: 6 Weeks
Effect of BIS-001ER on Seizure Count During Extension Phase
Percent reduction of average number of seizures vs. baseline/retrospective diary at 1, 3, 6, 12 months during the extension period.
Measured: 12 Months
Complete Seizure Protection
Proportion of subjects with 100% seizure reduction.
Measured: 6 Weeks
Need for Rescue Medication
Proportion of subjects requiring rescue medication at different dosages.
Measured: 6 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2018
- Study start10 Apr 2018
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Focal Impaired Awareness SeizuresStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Supernus Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Azmi Nasser, PhD, Study chair, Supernus Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03474770
- Sponsor's protocol ID
- BNI-02-1b
- Acronym
- FIAS
- Status last verified
- Aug 2022
- First submitted
- 12 Mar 2018
- Last updated
- 30 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Safety and Efficacy of BIS-001-ER for the Treatment of Adult Focal Impaired Awareness Seizures
- ClinicalTrials.gov ID
- NCT03474770
- Acronym / sponsor ID
- FIAS / BNI-02-1b
- Conditions
- Focal Impaired Awareness Seizures
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Supernus Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 10 Apr 2018 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 23 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BIS-001ER | Experimental | Drug: BIS-001ERDose 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BIS-001ERAlso: Huperzine A ERBIS-001 ER is an extended release formulation of the nutritional supplement Huperzine A. | Drug | BIS-001ER |
Primary outcome
Effect of BIS-001ER on Seizure Count
Time frame: 6 Weeks
Reduction in average daily seizure count between baseline (pre-treatment) and evaluation (on treatment) video EEG monitoring periods.
6 secondary outcomes
Effect of BIS-001ER on Percent Reduction in Daily Seizure Count
Time frame: 6 Weeks
Effect of BIS-001ER on Seizure Count vs Titration Period (Diary)
Time frame: 6 Weeks
Percent of Treatment Responders
Time frame: 6 Weeks
Effect of BIS-001ER on Seizure Count During Extension Phase
Time frame: 12 Months
Complete Seizure Protection
Time frame: 6 Weeks
Need for Rescue Medication
Time frame: 6 Weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2022.
Related trials for Focal Impaired Awareness Seizures
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RecruitingPhase 2
Prophylactic Anti-Seizure Medication vs No Anti-Seizure Medication for Patients With Primary Motor Cortex Brain Metastases
Seizures, Primary Motor Cortex
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Azmi Nasser, PhD study chair
Supernus Pharmaceuticals, Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing BIS-001ER in people with Focal Impaired Awareness Seizures, run by Supernus Pharmaceuticals, Inc. at 2 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 30 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of BIS-001ER on Seizure Count (time frame: 6 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2022.