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COMPLETEDPHASE1

A Study to Evaluate Safety, Tolerability, and Pharmacokinetics of SAGE-718 Oral Solution in Patients With Huntington's Disease - Part B

A Phase 1, Double-blind, Placebo-controlled, Multiple Ascending Dose Study to Determine the Safety, Tolerability, and Pharmacokinetics of SAGE-718 Oral Solution in Healthy Adults With an Open-label Cohort of Patients With Huntington's Disease

NCT03787758•Supernus Pharmaceuticals, Inc.

View on ClinicalTrials.gov

Summary

This study is a phase 1, double-blind, placebo-controlled, multiple ascending dose study to determine the safety, tolerability, and pharmacokinetics of SAGE-718 oral solution in healthy adults (Part A) with an open-label cohort of patients with Huntington's disease (Part B)

Detailed Description

This posting addresses Part B

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Subject is positive for mutant HTT (documented CAG repeats ≥ 40 units).
•2. Subject has a body weight ≥50 kg and body mass index ≥18.0 and ≤30.0 kg/m2 at screening.

Exclusion Criteria

•1. Subject has any clinically significant abnormal finding on the physical exam at screening or admission.
•2. Subject has a history or presence of a neurologic disease or condition (other than Huntington's disease), including but not limited to severe chorea, epilepsy, closed head trauma with clinically significant sequelae, or a prior seizure.
•3. Subject has a family history of epilepsy.
•4. Subject has a positive screening test for alcohol or drugs of abuse (including marijuana) at screening or admission.

Locations (2)

Sage Investigational Site

Long Beach, California, United States

Sage Investigational Site

Marlton, New Jersey, United States

Key Dates

Start Date

February 28, 2019

Primary Completion Date

October 7, 2019

Completion Date

October 7, 2019

Last Updated

September 17, 2025

Enrollment

ACTUAL participants

Conditions

Huntington Disease

Interventions

SAGE-718

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 17, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study to Evaluate Safety, Tolerability, and Pharmacokinetics of SAGE-718 Oral Solution in Patients With Huntington's Disease - Part B

Inclusion Criteria

Exclusion Criteria

Study of BDNF Pathway Biomarkers in the Cerebrospinal Fluid in Patients With Huntington's Disease

Study to Evaluate Music Therapy on Irritability and Impulsivity in Patients With Huntington's Disease (MUSIC-HD)

A Safety and Pharmacokinetics Trial of VO659 in SCA1, SCA3 and HD

IMarkHD: in Vivo Longitudinal Imaging of HD Pathology

Gene Therapy Development and Validation for Huntington's Disease Fibro TG-HD

GENERATION HD2. A Study to Evaluate the Safety, Biomarkers, and Efficacy of Tominersen Compared With Placebo in Participants With Prodromal and Early Manifest Huntington's Disease