Status:
COMPLETED
Evaluate SAGE-547 in Participants With Essential Tremor
Lead Sponsor:
Sage Therapeutics
Conditions:
Essential Tremor
Eligibility:
All Genders
35-75 years
Phase:
PHASE2
Brief Summary
Stage 1 is a double-blind, proof-of-concept study designed to evaluate the safety, tolerability, pharmacokinetics (PK), and efficacy of SAGE-547 Injection in male and female participants with essentia...
Eligibility Criteria
Inclusion
- Males and females, 35-75 years old with a diagnosis of essential tremor with symptoms clearly present in at least 1 upper limb; participant 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
- 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
Key Trial Info
Start Date :
September 23 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 14 2015
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT02277106
Start Date
September 23 2014
End Date
August 14 2015
Last Update
June 29 2022
Active Locations (2)
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1
Sage Study Site
Bingham Farms, Michigan, United States
2
Sage Study Site
Raleigh, North Carolina, United States