Kinetic II
Posted Date: Jan 23, 2023
- Investigator: Gregory Kuhlman
- Specialties:
- Type of Study: Drug
This is a Phase 2, randomized, double-blind, placebo-controlled, dose-ranging study to evaluate the efficacy, safety, and tolerability of SAGE-324 in participants with Essential Tremor. Participants, site staff, and sponsor personnel will be blinded to treatment allocations. This study includes a Screening Period of up to 28 days, a 90-day double-blind Treatment Period (90 days of dosing), and a 14-day follow-up period. The Screening Period begins with the signing of the informed consent form (ICF). Eligible participants will visit the study center on Day 1 and complete additional eligibility and baseline assessments. Following completion of screening and Day 1 eligibility assessments, participants will be randomized to 1 of 4 treatment groups (placebo or SAGE-324: 15 mg, 30 mg, or 60 mg, oral daily) in a 1:1:1:1 ratio. Starting on Day 1, after randomization, participants will receive a single dose of investigational product (IP) once daily for 90 days on an outpatient basis, to be taken before bed, with a snack if bedtime is not within 2 hours of the evening meal. Guidance on suitable snacks will be provided. During the Treatment Period, participants will return to the study center for efficacy and safety assessments. In addition, safety phone call study visits will be conducted regularly, or more often as deemed appropriate by the investigator, to review the current status of the participant. Participants will be trained on the use of software applications and devices necessary to complete questionnaires or self-rated study assessments. Participants should not engage in potentially hazardous activities requiring mental alertness, such as driving, until any sleepiness and sedative effects of IP have dissipated. Follow-Up Period: Follow-up visits will be conducted on an outpatient basis on Days 97 and 104. Participants will continue to complete questionnaires and will return to the clinic approximately 6 days after the last dose of IP (ie, Day 97) for efficacy and safety monitoring. Participants will return to the study center for an End of Study (EOS) Visit approximately 13 days following the last dose of IP (ie, Day 104). Visit (ETV) visit will be conducted at the time of discontinuation if this occurs any time before Day 104. Participants will be given the opportunity to participate in a SAGE-324 long-term open-label safety study at the conclusion of participation in this study.
Criteria:
Patients Need To Have Been Diagnosed With Essential Tremor For 3+ Years, Be Willing To Come Off Any Other Medication For Treating Essential Tremor For The Duration Of The Study,
Keywords:
Essential Tremor, Drug Study
For More Information:
Kelly Delano
513-558-6275
delanoky@ucmail.uc.edu