BIS-001-ER for the Treatment of Adult Focal Impaired Awareness Seizures (FIAS)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03474770|
Recruitment Status : Recruiting
First Posted : March 23, 2018
Last Update Posted : March 23, 2018
|Condition or disease||Intervention/treatment||Phase|
|Focal Impaired Awareness Seizures||Drug: BIS-001ER||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||16 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of Safety and Efficacy of BIS-001-ER for the Treatment of Adult Focal Impaired Awareness Seizures|
|Estimated Study Start Date :||April 2, 2018|
|Estimated Primary Completion Date :||November 30, 2018|
|Estimated Study Completion Date :||November 30, 2018|
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 Name: Huperzine A ER
- 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.
- 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).
- 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.
- Percent of Treatment Responders [ Time Frame: 6 Weeks ]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.
- Effect of BIS-001ER on Seizure Count During Extension Phase [ Time Frame: 12 Months ]Percent reduction of average number of seizures vs. baseline/retrospective diary at 1, 3, 6, 12 months during the extension period.
- Complete Seizure Protection [ Time Frame: 6 Weeks ]Proportion of subjects with 100% seizure reduction.
- Need for Rescue Medication [ Time Frame: 6 Weeks ]Proportion of subjects requiring rescue medication at different dosages.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03474770
|Contact: Joshua T Johnstone, PhDfirstname.lastname@example.org|
|Contact: Peter Goldstein, MSemail@example.com|
|The Alfred Hospital||Recruiting|
|Melbourne, Victoria, Australia, 3050|
|Contact: Jack Germaine +61 03 9076 2029 firstname.lastname@example.org|
|Principal Investigator: Terence O'Brien, MD|
|The Royal Melbourne Hospital||Recruiting|
|Melbourne, Victoria, Australia, 3050|
|Contact: Darren Germaine, RN +61 03 9342 7879 email@example.com|
|Principal Investigator: Patrick Kwan, PhD, MB Bchir|
|Study Chair:||Stephen D Collins, MD, PhD||Biscayne Neurotherapeutics, Inc.|