A Study to Evaluate SAGE-217 in Participants With Essential Tremor

• Status: Completed
• Trial end date: 2017-12-05
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sage Therapeutics

Criteria

Key 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.

Key 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.