Clinical trial

A Phase 2a, Double-Blind, Placebo-Controlled, Randomized Withdrawal Study Evaluating the Efficacy, Safety, Tolerability, and Pharmacokinetics of SAGE-217 in the Treatment of Subjects With Essential Tremor

Name

217-ETD-201

Description

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.

Trial arms

Trial start

2017-03-24

Estimated PCD

2017-11-22

Trial end

2017-12-05

Status

Completed

Phase

Early phase I

Treatment

SAGE-217

SAGE-217 Oral Solution

Arms:

Part A: SAGE-217 Oral Solution

SAGE-217

SAGE-217 Capsules

Arms:

Part A: SAGE-217 Capsules, Part B: SAGE-217 Capsules, Part C: SAGE-217 Capsules

Placebo

SAGE-217 matching placebo capsules

Arms:

Part B: Placebo

Size

Primary endpoint

Part A: Change From Baseline in Accelerometer-based Kinesia Kinetic Tremor Combined Score at Day 7

Baseline (Day 1) and Day 7 (8 hours postdose)

Part B: Change From Randomization in Accelerometer-based Kinesia Kinetic Tremor Combined Score at Day 14

Randomization (Day 8, predose) and Day 14 (predose)

Part C: Change From Baseline in the Accelerometer-based Kinesia Upper Limb Tremor Combined Score at Day 15

Baseline (Day 1) and Day 15

Eligibility 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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 34, 'type': 'ACTUAL'}}

Updated at

2023-11-28

1 organization

2 products

1 indication

Organization

Product

Indication

Product