drugset / Trial / NCT05889273
ML-004 Open-Label Extension Study in Adults and Adolescents With Autism Spectrum Disorders (ASD)
NaSingle-groupOpen-labelTreatment
Summary
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.
Timeline
- Start
- 2023-06-01
- Primary completion
- 2027-11
- Completion
- 2027-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ML-004 | Unknown | 12 mg | Oral |
| Subject | ML-004 | Unknown | 24 mg | Oral |
| Subject | ML-004 | Unknown | 48 mg | Oral |
| Subject | ML-004 | Unknown | 72 mg | Oral |