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



Status:Recruiting
Conditions:Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:18 - 65
Updated:2/3/2019
Start Date:January 2019
End Date:June 2019
Contact:Kevin Moynihan
Email:Kevin.Moynihan@sagerx.com
Phone:617-401-8123

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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

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)

This posting addresses Part B

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.
We found this trial at
2
sites
Berlin, New Jersey 08009
2388
mi
from 91732
Berlin, NJ
Click here to add this to my saved trials
Long Beach, California 90806
23
mi
from 91732
Long Beach, CA
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