Status:
COMPLETED
MEG Study of Acute STX209 Effects in ASD
Lead Sponsor:
Timothy Roberts
Collaborating Sponsors:
Simons Foundation
Clinical Research Associates, LLC
Conditions:
Autism Disorder
Eligibility:
MALE
14-17 years
Phase:
EARLY_PHASE1
Brief 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 ...
Detailed Description
Recent evidence from magnetoencephalographic (MEG) studies in ASD have pointed to abnormalities (specifically, delays) in auditory evoked neuromagnetic responses (e.g. M100 - see Roberts et al., 2010,...
Eligibility Criteria
Inclusion
- Right- handed males aged 14 to 17.75 years.
- 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.
- Current pharmacological treatment regimen has been stable for at least 4 weeks prior to Screening.
- 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.
- 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
- No known neurological impairment (e.g., head trauma with loss of consciousness for more than 10 minutes, stroke, seizure disorder).
- Claustrophobia
- Metallic implanted prosthetic or stimulation device (including pacemaker)
- Excessive metallic dental work (including braces, non-removable retainers)
- Subjects who are currently receiving treatment with racemic baclofen, vigabatrin, tiagabine, or riluzole.
- Subjects who have taken another investigational drug within the last 30 days.
- Subjects who are not able to take oral medications.
- Subjects who have a history of hypersensitivity to racemic baclofen.
- Parents/guardians or subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.
Key Trial Info
Start Date :
February 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 27 2019
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT02278328
Start Date
February 1 2016
End Date
September 27 2019
Last Update
October 21 2019
Active Locations (1)
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1
Children's Hospital of Phladelphia
Philadelphia, Pennsylvania, United States, 19104