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

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ClinicalTrials.gov Identifier: NCT03787758
Recruitment Status : Recruiting
First Posted : December 25, 2018
Last Update Posted : February 1, 2019
Sponsor:
Information provided by (Responsible Party):
Sage Therapeutics

Brief 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) and patients with early manifest Huntington's disease (Part B)

Condition or disease Intervention/treatment Phase
Huntington Disease Drug: SAGE-718 Drug: Placebo Phase 1

Detailed Description:
This posting addresses Part B

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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 and Patients With Early Manifest Huntington's Disease
Estimated Study Start Date : January 2019
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: SAGE-718 Drug: SAGE-718
SAGE-718

Placebo Comparator: Placebo Drug: Placebo
Placebo




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subject has early manifest Huntington's Disease with evidence of genetic mutation.
  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 early manifest 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03787758


Contacts
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Contact: Kevin Moynihan 617-401-8123 Kevin.Moynihan@sagerx.com

Locations
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United States, California
Sage Investigational Site Recruiting
Long Beach, California, United States, 90806
Contact       clinicaltrialsinquiry@sagerx.com   
United States, New Jersey
Sage Investigational Site Recruiting
Berlin, New Jersey, United States, 08009
Contact       clinicaltrialsinquiry@sagerx.com   
Sponsors and Collaborators
Sage Therapeutics

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Responsible Party: Sage Therapeutics
ClinicalTrials.gov Identifier: NCT03787758     History of Changes
Other Study ID Numbers: 718-CLP-102 B
First Posted: December 25, 2018    Key Record Dates
Last Update Posted: February 1, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Huntington Disease
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Dementia
Chorea
Dyskinesias
Movement Disorders
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Cognition Disorders
Neurocognitive Disorders
Mental Disorders