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BIS-001ER

Phase 1

Focal Impaired Awareness Seizures | Small molecule | Neurology |Supernus Pharmaceuticals, Inc.|Last Updated: Aug 30, 2022

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment16

FDA Designations

No designations recorded

Clinical trial landscape

BIS-001ER · 1 trial · 1 indication

Phase 1 1
NCT03474770BIS-001-ER for the Treatment of Adult Focal Impaired Awareness SeizuresFocal Impaired Awareness Seizures
ACTIVE NOT_RECRUITING16 Analytics
PHASE1ACTIVE NOT_RECRUITING
BIS-001-ER for the Treatment of Adult Focal Impaired Awareness Seizures
Focal Impaired Awareness Seizures
NCT0347477016
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Study Endpoints

Primary Endpoints

Effect of BIS-001ER on Seizure Count
6 Weeks

Reduction in average daily seizure count between baseline (pre-treatment) and evaluation (on treatment) video EEG monitoring periods.

Secondary Endpoints

Effect of BIS-001ER on Percent Reduction in Daily Seizure Count
6 Weeks
Effect of BIS-001ER on Seizure Count vs Titration Period (Diary)
6 Weeks
Percent of Treatment Responders
6 Weeks
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
BIS-001EREXPERIMENTALDose 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.

Interventions

NameTypeDescription
BIS-001ERDRUGBIS-001 ER is an extended release formulation of the nutritional supplement Huperzine A.
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites2

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. *...

Countries:Australia
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Frequently asked questions about BIS-001ER

What is BIS-001ER used for?

BIS-001ER is an investigational small molecule being developed for the treatment of focal impaired awareness seizures, a type of epilepsy. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.

Who makes BIS-001ER?

BIS-001ER is being developed by Supernus Pharmaceuticals, Inc., a biopharmaceutical company. The company's stock is traded under the ticker symbol SUPN on the NASDAQ exchange.

What phase is BIS-001ER in?

BIS-001ER is currently in Phase 1 clinical development. It is an investigational drug and has not yet received regulatory approval. The drug is being studied in adult patients with focal impaired awareness seizures.

What clinical trials is BIS-001ER in?

BIS-001ER is being studied in a Phase 1 clinical trial with the identifier NCT03474770. This trial is titled 'BIS-001-ER for the Treatment of Adult Focal Impaired Awareness Seizures' and is active but not recruiting participants.

Is BIS-001ER FDA approved?

BIS-001ER is not FDA approved. It is an investigational drug currently in Phase 1 clinical trials. The drug is being studied for the treatment of focal impaired awareness seizures in adults, but it has not yet completed the clinical development process.

Is BIS-001ER the same as BIS-001?

BIS-001ER is a specific formulation of the drug BIS-001, with the 'ER' suffix indicating extended-release properties. The clinical trial NCT03474770 refers to BIS-001-ER, which is being developed by Supernus Pharmaceuticals for focal impaired awareness seizures.