Safety of L1-79 in Adolescent and Adult Males With Autism
Public ClinicalTrials.gov record NCT02947048. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized, Placebo-controlled Phase 2 Study With Open-Label and Double-Blind Portions to Evaluate the Safety of L1-79 in Adolescent and Young Adult Males With Autism
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT02947048
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 42 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 12 Years to 21 Years
- Sex
- Male
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 30, 2016
- Primary completion
- Nov 30, 2017
- Completion
- Jan 31, 2018
- Last update posted
- Aug 20, 2024
2016 – 2018
United States locations
- U.S. sites
- 2
- U.S. states
- 1
- U.S. cities
- 2
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Eric Bartky MD, Bartky Health Care Center | Livingston | New Jersey | 07039 | — |
| F. Peter Halas MD, Sea Girt Pediatrics | Sea Girt | New Jersey | 07850 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02947048, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 20, 2024 · Synced Sep 9, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02947048 live on ClinicalTrials.gov.