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

Part of paid clinical trials in Dothan, Alabama.

Sponsor
MapLight Therapeutics
Study ID
NCT05889273
Phase
PHASE2
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

Sex
ALL
Age
12 Years - 46 Years
Healthy Volunteers
Not accepted

Interventions

  • ML-004 (IR)/(ER) tablet — DRUG
    Participants will receive ML-004 once daily.

Study Details

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.

Key Dates

Start date
Jun 1, 2023
Status verified
Mar 2026
Primary completion
Nov 30, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
120 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: ML-004 (IR)/(ER) tablet
    ML-004 is a bilayer immediate-release (IR)/extended-release (ER, gastroretentive) oral tablet formulation. ML-004 is taken orally once daily and provided as a tablet in two dose strengths of 12 mg (3 mg IR/9 mg ER) and 24 mg tablet (6 mg IR/18 mg ER). Dose levels for this study are 12 mg (provided as one 12 mg tablet), 24 mg (one 24 mg tablet), 48 mg (two 24 mg tablets), and 72 mg (three 24 mg tablets).

Primary Outcome Measure

Frequency of occurrence of treatment-emergent adverse events (TEAEs). [ Time Frame: Baseline up to Day 362 ]

Locations (18)

FacilityCityStateZIPSite coordinators
Harmonex Neuroscience ResearchDothanAlabama36303-
Southwest Autism Research and Resource CenterPhoenixArizona85006-
Cortica HealthcareGlendaleCalifornia91203-
NRC Research InstituteOrangeCalifornia92868-
CorticaSan RafaelCalifornia94903-
Yale Child Study CenterNew HavenConnecticut06519-
The Children's Research InstituteWashington D.C.District of Columbia20010-
Abba Medical GroupMiamiFlorida33176-
APG Research, LLCOrlandoFlorida32803-
University of South Florida Psychiatry and Behavioral NeurosciencesTampaFlorida33613-
Neurobehavioral Medicine GroupBloomfield HillsMichigan48302-
University of Missouri, Thompson Center for Autism & NeurodevelopmentColumbiaMissouri65211-
Nathan Kline Institute for Psychiatric ResearchOrangeburgNew York10962-
Richmond Behavioral AssociatesStaten IslandNew York10314-
Suburban Research AssociatesMediaPennsylvania19063-
BioBehavioral Research of AustinAustinTexas78759-
Road Runner Research, Ltd.San AntonioTexas78249-
Family Psychiatry of The WoodlandsThe WoodlandsTexas77381-

Find similar trials in Dothan, AL

By condition
Autism spectrum disorder
By specialty
Pediatrics
By research site
Harmonex Neuroscience Research· Dothan, ALSouthwest Autism Research and Resource Center· Phoenix, AZCortica Healthcare· Glendale, CANRC Research Institute· Orange, CACortica· San Rafael, CAYale Child Study Center· New Haven, CT

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