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CompletedNCT03787758Updated Sep 17, 2025

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

A Phase 1 interventional study of SAGE-718 in Huntington Disease, sponsored by Supernus Pharmaceuticals, Inc.. Completed at 2 sites in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-09-17.

Sponsored by Supernus Pharmaceuticals, Inc. · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Oct 2019, 7 years ago, and no results have been posted to the registry.
Phase
Phase 1
Study type
Interventional
Enrollment
6
Allocation
Not applicable
Ages
18 Years to 70 Years
Sex
All
01

Study 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)

Read the detailed description

This posting addresses Part B

02

Conditions studied

  • Huntington Disease

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03

In context

Huntington Disease

285 studies on the registry are indexed under Huntington Disease; 49 are open to participants now.

This study's enrollment of 6 is below the median of 40 across 203 interventional studies indexed under Huntington Disease.

Browse Huntington Disease studies →

Lead sponsor

Supernus Pharmaceuticals, Inc. is the lead sponsor of 61 studies on the registry; 6 are open to participants now.

Of its 31 completed or terminated interventional studies of FDA-regulated products, 25 (81%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
6 participants (actual)

Study arms

  • Experimental
    SAGE-718

    Drug: SAGE-718

Interventions

  • DrugSAGE-718

    SAGE-718

06

What researchers measure

Primary outcomes

  1. Number of Participants with the Incidence of Adverse Events and Serious Adverse Events.

    Time frame: 21 Days

  2. Percentage of participants with change from baseline in vital signs.

    Time frame: 21 Days

  3. Change from baseline in electrocardiograms (ECGs) including PR interval, QT interval, QTc interval, QTcF, and rhythm abnormalities

    Time frame: 21 Days

  4. Percentage of participants with change from baseline in clinical laboratory parameters.

    Time frame: 21 Days

  5. Change from baseline in Columbia-Suicide Severity Rating Scale (C-SSRS).

    Time frame: 21 Days

Secondary outcomes

  1. PK profile of SAGE-718 following administration of multiple doses of SAGE-718 Oral Solution as assessed by area under the curve [AUC].

    Time frame: 17 Days

  2. PK profile of SAGE-718 following administration of multiple doses of SAGE-718 Oral Solution as assessed by maximum observed concentration [Cmax].

    Time frame: 17 Days

  3. PK profile of SAGE-718 following administration of multiple doses of SAGE-718 Oral Solution as assessed by time of occurrence of Cmax [tmax].

    Time frame: 17 Days

07

Study locations

2 sites
  • Sage Investigational Site
    Long Beach, California 90806, United States
  • Sage Investigational Site
    Marlton, New Jersey 08053, United States
08

References and documents

Publications

  • Koenig A, Lewis M, Wald J, Li S, Varoglu M, Dai J, Sankoh A, Paumier K, Doherty J, Quirk M. Dalzanemdor (SAGE-718), a novel, investigational N-methyl-D-aspartate receptor positive allosteric modulator: Safety, tolerability, and clinical pharmacology in randomized dose-finding studies in healthy participants and an open-label study in participants with Huntington's disease. Clin Transl Sci. 2024 Jul;17(7):e13852. doi: 10.1111/cts.13852. PubMed 38988035 ↗

Individual participant data

Plan to share: No — Data sharing will be consistent with the results submission policy of ClinicalTrials.gov.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 17, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03787758
Lead sponsor
Supernus Pharmaceuticals, Inc.
Responsible party
Sponsor
First posted
Dec 26, 2018
Start date
Feb 28, 2019
Primary completion
Oct 7, 2019
Completion
Oct 7, 2019
Last update
Sep 17, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.

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Discussion

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