Safety of L1-79 in Adolescent and Adult Males With Autism
Completed · Phase 2 · Has a placebo group
Conditions studied: Autism
In brief
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 (three times daily) 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.
Key facts
- Study ID
- NCT02947048
- Run by
- Yamo Pharmaceuticals LLC
- People needed
- 42
- Starts
- 2016-10-01
- Expected to finish
- 2018-02-01
- Last updated by the study team
- 2024-08-21
Who can join
Age: 12 and older, up to 21. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- Males who are not sexually active
- 12 and 21 years of age
- Signed informed consent
- Normal clinical laboratory values
- 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
- 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
- No medications for any other pathology
You may not qualify if…
- Any co-morbidities, including Fragile-X syndrome, epilepsy, Retts syndrome, ADHD, or other disease or syndrome aside from autism that requires treatment
- Any other psychiatric disorder, or out of range lab values
- DSM-5 diagnosis of schizophrenia, schizoaffective disorder, alcohol use disorder
- Active medical problems: unstable seizures (>2 in past month)
- Concomitant physical illness
Where it is running
- Eric Bartky MD, Bartky Health Care Center — Livingston, New Jersey, United States
- F. Peter Halas MD, Sea Girt Pediatrics — Sea Girt, New Jersey, United States
Full record on ClinicalTrials.gov
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