Evaluate SAGE-547 in Patients With Essential Tremor

• Status: Completed
• Trial end date: 2015-08-01
• Target enrollment: 0
• Participant gender: All

Summary

Stage 1 is a double-blind, proof-of-concept study designed to evaluate the safety, tolerability, PK, and efficacy of SAGE-547 Injection in male and female patients with essential tremor in the upper limb.

Stage 2 is an open-label arm designed to evaluate the safety, tolerability, PK, and effeciveness of SAGE-547 Injection at a higher dose than in Stage 1. Subjects who completed Stage 1 will be invited to participate in Stage 2.

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

Details

• Lead Sponsor: Sage Therapeutics
• Treatments: Brexanolone

Criteria

Inclusion Criteria:

• Males and females, 35-75 years old with a diagnosis of essential tremor with symptoms clearly present in at least 1 upper limb; patient has had tremor present for at least 2 years prior to Screening

• Off medication, or on a stable dose of medication for their tremor for at least 28 days prior to Screening

Exclusion Criteria:

• Recent history or active clinically significant manifestations of metabolic, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, musculoskeletal, dermatological, urogenital, eyes, ears, nose, or throat, psychiatric, or neurological (other than essential tremor) disorders

• Medical history of seizures