Safety of L1-79 in Autism

• Status: Completed
• Trial end date: 2018-02-01
• Target enrollment: 0
• Participant gender: Male

Summary

This is a five-arm designed to assess the safety of L1-79 that incorporates 15 prospectively randomized, placebo controlled patients and 5 open label patients at either 100 tid or 200 tid dosing for 28 days. The open label patients will be assessed for the purpose of understanding PK/PD and to determine if there are any EKG changes associated with the administration of L1-79. Additional safety information will be provided by the 30 patients randomized 2:1 active:placebo.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: F Peter Halas
• Collaborator: Yamo Pharmaceuticals LLC

Criteria

Inclusion Criteria:

1. Males who are not sexually active

2. 13 and 21 years of age

3. Signed informed consent

4. Normal clinical laboratory values

5. DSM-5 compliant diagnosis of autism spectrum disorder, confirmed by the Autistic Diagnosis Interview Review (ADIR), and by the Autism Diagnosis Observation Schedule (ADOS) score consistent with a diagnosis of autism

6. No more than one concomitant medication for the treatment of autism, on a stable for at least 2 weeks prior to enrollment and no planned changes in psychosocial interventions during the trial

7. No medications for any other pathology

Exclusion Criteria:

1. Any co-morbidities, including Fragile-X syndrome, epilepsy, Retts syndrome, ADHD, or other disease or syndrome aside from autism that requires treatment

2. Any other psychiatric disorder, or out of range lab values

3. DSM-5 diagnosis of schizophrenia, schizoaffective disorder, alcohol use disorder

4. Active medical problems: unstable seizures (>2 in past month)

5. Concomitant physical illness