Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT05889273 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

ML-004 Open-Label Extension Study in Adults and Adolescents With Autism Spectrum Disorders (ASD)

StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Trial status changed: Enrolling by Invitation → Active, Not Recruitingv23
  2. Re-verified, no change to tracked fieldsv22
  3. Study sites: 20 to 21v21
  4. Study sites: 17 to 20v20
  5. Study sites: 16 to 17v19
Show 17 earlier versionsHide 17 earlier versions
  1. Study sites: 15 to 16v18
  2. Study sites: 17 to 15v17
  3. Study sites: 16 to 17v16
  4. Primary completion date: May 2026 to Nov 2027
    • Study completion date: Jun 2026 to Dec 2027
    v15
  5. Study sites: 14 to 16v14
  6. Study sites: 15 to 14
    • Eligibility criteria expanded, about 2 words
    v13
  7. Study sites: 14 to 15v12
  8. Study Identification, Study Status, Oversightv11
  9. Study sites: 13 to 14v10
  10. Study sites: 11 to 13v9
  11. Study sites: 7 to 11v8
  12. Study sites: 5 to 7v7
  13. Start date: Jun 15, 2023 to Jun 1, 2023
    • Secondary endpoints: details revised at 4 of 4 entries
    • Study description shortened, about 120 words
    • Eligibility criteria expanded, about 4 words
    v6
  14. Study sites: 4 to 5v5
  15. Study sites: 3 to 4v4
  16. Primary completion date: Aug 2025 to May 2026
    • Study sites: 2 to 3
    • Study completion date: Sep 2025 to Jun 2026
    v3
  17. Trial status: Recruiting to Enrolling by Invitation
    • Study sites: 1 to 2
    • Start date changed from estimate of Jun 2023 to Jun 15, 2023
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
ML-004-003 is a multi-center, open-label extension study that will enroll approximately 120 adolescent and adult subjects with ASD that have completed study ML-004-002. The primary objective of the study will be to evaluate the safety of ML-004 in subjects with ASD.
Trial Details
NCT Number NCT05889273
Lead Sponsor MapLight Therapeutics
Conditions
(from sponsor)		 Autism Spectrum Disorder
Related terms Autism Spectrum Disorder, Autistic Disorder, Communication
Enrollment 120 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov