None listed
Conditions
Brief summary
The study is an open-label study of PRAX-944 to assess the safety, pharmacokinetics, and efficacy of escalating multiple oral doses in up to 12 adults with generalized epileptic syndromes with absence seizures. Each patient will complete 3 study periods: Screening, Treatment Period (up to 2 dose levels followed by a taper) and Safety Follow-up.
Interventions
PRAX-944 will be taken, in conjunction with the patient’s current antiepileptic medications, at the following doses:
- Dose Level 1: 20 mg once daily for 7 days
- Dose Level 2: 20 mg twice daily for 7 days
- Taper: 20 mg once daily for 2 days and then 20 mg twice daily for 5 days
Patients will only receive enough study drug to complete the dose level or taper at home, e.g. a 5 or 6 day supply. They will complete a home study drug diary, which will indicate the number and time each dose wa
PRAX-944 will be taken, in conjunction with the patient’s current antiepileptic medications, at the following doses: - Dose Level 1: 20 mg once daily for 7 days - Dose Level 2: 20 mg twice daily for 7 days - Taper: 20 mg once daily for 2 days and then 20 mg twice daily for 5 days Patients will only receive enough study drug to complete the dose level or taper at home, e.g. a 5 or 6 day supply. They will complete a home study drug diary, which will indicate the number and time each dose was taken. They will then return to the study site for initiation of the next dose level or taper.
Sponsors
Praxis Precision Medicines, Pty, Ltd.
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
- Male or female between the ages of 18 and 60 years of age (inclusive) - Clinical diagnosis of an epileptic syndrome - Absence seizures persisting despite documented trials with at least two standard anti-epileptic treatments. - Stable dose of all medications or interventions for epilepsy
Exclusion criteria
- Clinically significant unstable medical condition other than epilepsy - History of alcohol or substance abuse - History of focal epilepsy or epileptiform patterns consistent with focal epilepsy - Inadequately treated psychotic or mood disorder - Presence of severe intellectual disability, severe autism spectrum disorder or severe developmental disorder - Significant hepatic or renal disease - History of any suicide attempt or other suicidal behavior within the past year
Outcome results
None listed