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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT06401538




Registration number
NCT06401538
Ethics application status
Date submitted
2/05/2024
Date registered
6/05/2024
Date last updated
6/05/2024

Titles & IDs
Public title
BMB-101 in Epilepsy With Eyelid Myoclonia (EEM)
Scientific title
An Open-Label Phase 2 Study to Evaluate the Efficacy, Safety and Tolerability of BMB-101 in Adolescents and Adults With Epilepsy With Eyelid Myoclonia (EEM; Jeavons Syndrome) Including Those With Prominent Photic Induction (Sunflower Syndrome)
Secondary ID [1] 0 0
BMB-101-102
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Jeavons Syndrome 0 0
Condition category
Condition code
Neurological 0 0 0 0
Epilepsy
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - BMB-101

Experimental: BMB-101 - BMB-101 10 mg/ml liquid


Treatment: Drugs: BMB-101
BMB-101 liquid administered orally twice a day for 3 months
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change from baseline in seizure frequency
Timepoint [1] 0 0
10 weeks
Secondary outcome [1] 0 0
Change from baseline in quality of life
Timepoint [1] 0 0
10 weeks

Eligibility
Key inclusion criteria
1. Subject is male or non-pregnant, non-lactating female, age 12 to 65 years, inclusive
as of the day of the screening visit.

2. Subjects must have a diagnosis of Epilepsy with Eyelid Myoclonia (EEM, "Jeavons
Syndrome") with or without absence including those with prominent photic induction
("Sunflower Syndrome").

3. Subjects must experience sufficient episodes of eyelid myoclonia (EM) or handwaving
episodes (HWE) during the 1 month baseline period.

1. For those with eyelid myoclonia, episodes should occur on at least 8 days out of
the month.

2. For those with prominent photic stimulation, handwaving episodes (HWE) which
involve seeking out a light source, staring at the light source, and waving one
hand in front of their eye(s) should occur on average of at least 5 times per
day.

4. Subject must have tried at least one anti-seizure medication at a recommended dose and
duration and must be on a stable dose on their current anti-seizure medications for at
least 4 weeks prior to screening and remain stable throughout the study.

5. Subject's parent/caregiver is willing and able to be compliant with diary completion,
visit schedule, and study drug accountability.

6. Female subjects of childbearing potential must have a negative urine pregnancy test at
screening. Subjects of childbearing or child-fathering potential must be willing to
use medically acceptable forms of birth control, which includes abstinence, while in
this study and for 90 days after the last dose of study drug.
Minimum age
12 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Any condition that is thought to be a degenerative neurological disease.

2. Subject has a history of drug or alcohol abuse.

3. Subject has pulmonary arterial hypertension.

4. Subject has current or past history of cardiovascular or cerebrovascular disease, such
as cardiac valvulopathy, myocardial infarction or stroke, or clinically significant
structural cardiac abnormality.

5. Subject is receiving concomitant therapy with: fenfluramine, lorcaserin,
monoamine-oxidase inhibitors, SSRIs, SNRIs, tricyclic antidepressants or other
serotonergic agonists or antagonists (antipsychotics).

6. Subject is institutionalized in a general nursing home (i.e., in a facility that does
not provide skilled epilepsy care). Subject does not have a reliable caregiver who can
provide seizure diary information throughout the study.

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
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 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
15/07/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
15/10/2025
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Alfred Health - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Bright Minds Biosciences Pty Ltd
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The study is a pilot, open-label, study to test whether BMB-101 is safe and effective in
reducing the frequency of seizures in subjects with Epilepsy with Eyelid Myoclonia (also
called Jeavons Syndrome). The study will last up to 6 months. There will be a 1 month
screening period, then 3 months on open-label BMB-101 including titration and
tapering/washout periods, and then a 1 month follow-up period. There will be 7 clinic visits.
Trial website
https://clinicaltrials.gov/ct2/show/NCT06401538
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Terence O'Brien, MD
Address 0 0
The Alfred
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Suzy Cake
Address 0 0
Country 0 0
Phone 0 0
+61 408 771 971
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT06401538