MEG Study of Acute STX209 Effects in ASD

• Status: Completed
• Trial end date: 2019-09-27
• Target enrollment: 0
• Participant gender: Male

Summary

This is a single-site, randomized, acute dose-response study to determine whether STX209 produces a dose-dependent significant change in MEG target parameters compared to baseline as well as compared to placebo treatment.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Children's Hospital of Philadelphia; Timothy Roberts
• Collaborators: Clinical Research Associates, LLC; Simons Foundation

Criteria

Inclusion Criteria:

1. Right- handed males aged 14 to 17.75 years.

2. Diagnosis of ASD with the last 12 months according to the DSM-IV criteria, including Autistic Disorder, Pervasive Developmental Disorder - Not Otherwise Specified (PDD-NOS), and Asperger's Syndrome but excluding Childhood Dis-integrative Disorder and Rett Syndrome.

3. Current pharmacological treatment regimen has been stable for at least 4 weeks prior to Screening.

4. If the subject is already receiving stable non-pharmacological educational, behavioral, and/or dietary interventions, participation in these programs must have been continuous during the 2 months prior to Screening and subjects or their parent/caregiver may not electively initiate new or modify ongoing interventions for the duration of the study. Typical school vacations are not considered modifications of stable programming.

5. Prior to the conduct of any study-specific procedures, the subject must provide verbal assent to participate in the study (if developmentally appropriate), and the parent/caregiver must provide written informed consent. If the caregiver attending the clinic visits is not the parent, written consent must be obtained from the parent for the caregiver's participation in the study.

Exclusion Criteria:

1. No known neurological impairment (e.g., head trauma with loss of consciousness for more than 10 minutes, stroke, seizure disorder).

2. Claustrophobia

3. Metallic implanted prosthetic or stimulation device (including pacemaker)

4. Excessive metallic dental work (including braces, non-removable retainers)

5. Subjects who are currently receiving treatment with racemic baclofen, vigabatrin, tiagabine, or riluzole.

6. Subjects who have taken another investigational drug within the last 30 days.

7. Subjects who are not able to take oral medications.

8. Subjects who have a history of hypersensitivity to racemic baclofen.

9. Parents/guardians or subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.