A Study to Evaluate SAGE-217 in Participants With Essential Tremor
Purpose
This study is a three-part, multicenter, Phase 2a study to evaluate the efficacy, safety, tolerability, and pharmacokinetics of SAGE-217 in adult participants with essential tremor.
Condition
- Essential Tremor
Eligibility
- Eligible Ages
- Between 18 Years and 80 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Participant must have a diagnosis of Essential Tremor (ET), defined as bilateral postural tremor and kinetic tremor, involving hands and forearms, that is visible and persistent and the duration is >5 years prior to screening.
Exclusion Criteria
- Participant has presence of abnormal neurological signs other than tremor or Froment's sign. - Participant has presence of known causes of enhanced physiological tremor. - Participant has concurrent or recent exposure (14 days prior to admission visit) to tremorogenic drugs. - Participant has had direct or indirect trauma to the nervous system within 3 months before the onset of tremor. - Participant has historical or clinical evidence of tremor with psychogenic origin. - Participant has convincing evidence of sudden tremor onset or evidence of stepwise deterioration of tremor.
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Part A: SAGE-217 Oral Solution |
Participants received SAGE-217 10 mg oral solution on Day 1, 20 mg on Day 2 and 30 mg on Days 3 to 7 with food in the morning. |
|
|
Experimental Part A: SAGE-217 Capsules |
Participants received SAGE-217 10 mg capsules on Day 1, 20 mg on Day 2 and 30 mg on Days 3 to 7, orally, with food in the morning. |
|
|
Placebo Comparator Part B: Placebo |
Participants who received maximum tolerated dose of SAGE-217 in Part A and achieved response on Day 8 were randomized to receive to SAGE-217 matching placebo for 7 days beginning on Day 8 with food in the morning. |
|
|
Experimental Part B: SAGE-217 Capsules |
Participants who received maximum tolerated dose of SAGE-217 in Part A and achieved response on Day 8 were randomized to receive to SAGE-217 for 7 days beginning on Day 8 with food in the morning. |
|
|
Experimental Part C: SAGE-217 Capsules |
Participants received SAGE-217 10 mg capsules on Day 1, 20 mg on Day 2, 30 mg on Day 3, orally, with food in the evening. Beginning on Day 4 through Day 14, participants received a 40-mg total daily dose (administered as 10 mg with food in the morning and 30 mg with food in the evening). |
|
More Details
- Status
- Completed
- Sponsor
- Biogen
Study Contact
Detailed Description
Part A of the study was an open-label design with morning dosing of SAGE-217 for 7 days and included 16 participants, 8 of whom qualified for, and entered, Part B. Part B had a double-blind, placebo-controlled, randomized withdrawal design with morning dosing for 7 days. Part C was an open-label design with morning and evening dosing for 14 days and included a different set of 18 participants. Parts A and B were stopped early (in advance of the planned sample size). This study was previously posted by Sage Therapeutics. In November 2023, sponsorship of the trial was transferred to Biogen.