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

Use our guide to learn which trials are right for you!

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
?
mi
from
Berlin, NJ
Click here to add this to my saved trials
Long Beach, California 90806
?
mi
from
Long Beach, CA
Click here to add this to my saved trials