At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 42 enrolled
Drug / intervention
L1-79 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating L1-79 and Placebo for Autism. Completed, enrolled 42 participants across 2 sites.
Detailed 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 (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 Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAutism
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
2017201820192020202120222023202420252026
Enrollment StartOct 2016
First PostedOct 2016
Primary CompletionDec 2017
Study CompletionFeb 2018
TodayJul 2026
First PostedOct 27, 2016
Enrollment StartOct 1, 2016
Primary CompletionDec 1, 2017
Study CompletionFeb 1, 2018
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 9.7 years ago
Interventions
L1-79drug
Placebodrug