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

NCT ID: NCT02978781

Last Updated: 2023-11-28

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-24

Study Completion Date

2017-12-05

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Essential Tremor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

SAGE-217

Intervention Type DRUG

SAGE-217 Oral Solution

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.

Group Type EXPERIMENTAL

SAGE-217

Intervention Type DRUG

SAGE-217 Capsules

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

SAGE-217 matching placebo capsules

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.

Group Type EXPERIMENTAL

SAGE-217

Intervention Type DRUG

SAGE-217 Capsules

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).

Group Type EXPERIMENTAL

SAGE-217

Intervention Type DRUG

SAGE-217 Capsules

Interventions

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SAGE-217

SAGE-217 Oral Solution

Intervention Type DRUG

SAGE-217

SAGE-217 Capsules

Intervention Type DRUG

Placebo

SAGE-217 matching placebo capsules

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Biogen

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Sage Investigational Site

Anniston, Alabama, United States

Site Status

Sage Investigational Site

Little Rock, Arkansas, United States

Site Status

Sage Investigational Site

Rogers, Arkansas, United States

Site Status

Sage Investigational Site

Cerritos, California, United States

Site Status

Sage Investigational Site

Fountain Valley, California, United States

Site Status

Sage Investigational Site

Oceanside, California, United States

Site Status

Sage Investigational Site

San Diego, California, United States

Site Status

Sage Investigational Site

Englewood, Colorado, United States

Site Status

Sage Investigational Site

Clearwater, Florida, United States

Site Status

Sage Investigational Site

DeLand, Florida, United States

Site Status

Sage Investigational Site

Lauderdale Lakes, Florida, United States

Site Status

Sage Investigational Site

Orlando, Florida, United States

Site Status

Sage Investigational Site

Ormond Beach, Florida, United States

Site Status

Sage Investigational Site

St. Petersburg, Florida, United States

Site Status

Sage Investigational Site

Tampa, Florida, United States

Site Status

Sage Investigational Site

Atlanta, Georgia, United States

Site Status

Sage Investigational Site

Decatur, Georgia, United States

Site Status

Sage Investigational Site

Chicago, Illinois, United States

Site Status

Sage Investigational Site

Urbana, Illinois, United States

Site Status

Sage Investigational Site

Springfield, Missouri, United States

Site Status

Sage Investigational Site

St Louis, Missouri, United States

Site Status

Sage Investigational Site

Raleigh, North Carolina, United States

Site Status

Sage Investigational Site

Cincinnati, Ohio, United States

Site Status

Sage Investigational Site

Dayton, Ohio, United States

Site Status

Sage Investigational Site

Nashville, Tennessee, United States

Site Status

Sage Investigational Site

Fort Worth, Texas, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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http://www.sagerx.com

Related Info

Other Identifiers

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217-ETD-201

Identifier Type: -

Identifier Source: org_study_id