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Huntington Disease

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

Sponsored by Sage Therapeutics

About this trial

Last updated 3 years ago

Study ID

718-CLP-102 B

Status

Completed

Type

Interventional

Phase

Phase 1

Placebo

No

Accepting

18-75 Years
18 to 70 Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 6 years ago

What is this trial about?

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)

What are the participation requirements?

Yes

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.

No

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

Location

Status

For more information, view the full study details:

NCT03787758