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

NCT02978781 | Completed Phase 2 Results FDA Drug

• 1 other identifier: 217-ETD-201
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 26

Brief 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.

Conditions

Essential Tremor

Keywords

Tremor

Outcome Measures

Primary Outcomes (3)

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

  The accelerometer-based Kinesia kinetic tremor combined score is the sum of Kinesia kinetic tremor scores across both sides of the body. Tremor is measured using a motion sensor that transmits raw data to a computer where it converts the tremor amplitude to a Kinesia score of 0 to 4 based on validated algorithms; the total score ranges from 0 to 8, higher scores indicate more severe tremor. A negative change from Baseline indicates improvement.

  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

  The accelerometer-based Kinesia kinetic tremor combined score is the sum of Kinesia kinetic tremor scores across both sides of the body. Tremor is measured using a motion sensor that transmits raw data to a computer where it converts the tremor amplitude to a Kinesia score of 0 to 4 based on validated algorithms; the total score ranges from 0 to 8, higher scores indicate more severe tremor. A negative change from Randomization indicates improvement.

  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

  The accelerometer-based Kinesia upper limb total score is the sum of the individual item scores across both sides of the body. The individual items included forward outstretched postural tremor (FOPT), lateral "wing beating" postural tremor (LWBPT), and kinetic tremor (KT) scores from both sides of the body. Each upper limb individual item question score for each side of the body ranges from 0 to 4. The Kinesia upper limb total score ranges from 0 to 24, with higher scores indicating more tremors/greater tremor amplitude. A negative change from Baseline indicates improvement.

  Baseline (Day 1) and Day 15

Secondary Outcomes (23)

• Part A: Change From Baseline in Kinesia Upper Limb Total Score at Day 7

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

• Part A: Change From Baseline in Kinesia Upper Limb Individual Item Score at Day 7

  Baseline (Day 1) and Day 7 (8 hours [hr] postdose [pd])

• Part A: Change From Baseline in the Tremor Research Group (TRG) Essential Tremor Rating Assessment Scale (TETRAS) Upper Limb Total Score at Day 7

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

• Change From Baseline in the TETRAS Upper Limb Individual Items (Performance Subscale Items 4a, 4b, or 4c) Scores at Day 7

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

• Part A: Change From Baseline in TETRAS Performance Subscale Score (Items 6, 7, and 8) at Day 7

  Baseline (Day 1) and Day 7 (predose)

Study Arms (5)

Part A: SAGE-217 Oral Solution

EXPERIMENTAL

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.

Drug: SAGE-217

Part A: SAGE-217 Capsules

EXPERIMENTAL

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.

Drug: SAGE-217

Part B: Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

Part B: SAGE-217 Capsules

EXPERIMENTAL

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.

Drug: SAGE-217

Part C: SAGE-217 Capsules

EXPERIMENTAL

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).

Drug: SAGE-217

Interventions

SAGE-217 DRUG

SAGE-217 Oral Solution

Part A: SAGE-217 Oral Solution

Placebo DRUG

SAGE-217 matching placebo capsules

Part B: Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Biogen: lead

Study Sites (26)

Sage Investigational Site

Anniston, Alabama, 36207, United States

Location

Sage Investigational Site

Little Rock, Arkansas, 72211, United States

Location

Sage Investigational Site

Rogers, Arkansas, 72758, United States

Location

Sage Investigational Site

Cerritos, California, 90703, United States

Location

Sage Investigational Site

Fountain Valley, California, 92708, United States

Location

Sage Investigational Site

Oceanside, California, 92056, United States

Location

Sage Investigational Site

San Diego, California, 92103, United States

Location

Sage Investigational Site

Englewood, Colorado, 80113, United States

Location

Sage Investigational Site

Clearwater, Florida, 33756, United States

Location

Sage Investigational Site

DeLand, Florida, 32720, United States

Location

Sage Investigational Site

Lauderdale Lakes, Florida, 33319, United States

Location

Sage Investigational Site

Orlando, Florida, 32806, United States

Location

Sage Investigational Site

Ormond Beach, Florida, 32174, United States

Location

Sage Investigational Site

St. Petersburg, Florida, 33713, United States

Location

Sage Investigational Site

Tampa, Florida, 33612, United States

Location

Sage Investigational Site

Atlanta, Georgia, 30331, United States

Location

Sage Investigational Site

Decatur, Georgia, 30030, United States

Location

Sage Investigational Site

Chicago, Illinois, 60612, United States

Location

Sage Investigational Site

Urbana, Illinois, 61801, United States

Location

Sage Investigational Site

Springfield, Missouri, 65802, United States

Location

Sage Investigational Site

St Louis, Missouri, 63141, United States

Location

Sage Investigational Site

Raleigh, North Carolina, 27612, United States

Location

Sage Investigational Site

Cincinnati, Ohio, 45212, United States

Location

Sage Investigational Site

Dayton, Ohio, 45417, United States

Location

Sage Investigational Site

Nashville, Tennessee, 37232, United States

Location

Sage Investigational Site

Fort Worth, Texas, 76104, United States

Location

Related Links

• Related Info

MeSH Terms

Conditions

Essential Tremor; Tremor

Interventions

zuranolone

Condition Hierarchy (Ancestors)

Movement Disorders; Central Nervous System Diseases; Nervous System Diseases; Dyskinesias; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Parts A and B were stopped early (in advance of the planned sample size).

Results Point of Contact

• Title: US Biogen Clinical Trial Center
• Organization: Biogen

clinicaltrials@biogen.com

866-633-4636

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2016
• First Posted: December 1, 2016
• Study Start: March 24, 2017
• Primary Completion: November 22, 2017
• Study Completion: December 5, 2017
• Last Updated: November 28, 2023
• Results First Posted: February 17, 2021

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share

Locations

US (26)