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ML-004 in Adolescents and Adults With Autism Spectrum Disorders (ASD)

Primary Purpose

Autism Spectrum Disorder

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
ML-004 (IR)/(ER) tablet
ML-004 Placebo
Sponsored by
MapLight Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism Spectrum Disorder focused on measuring ASD, Autism, Autism Spectrum Disorder, social communication deficit

Eligibility Criteria

12 Years - 45 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age 12 to 45 at screening
  • Has a designated care/study partner who can reliably report on symptoms
  • Has a diagnosis of Autism Spectrum Disorder (ASD)
  • Full scale IQ (or equivalent) ≥70 score
  • Psychoactive medications and adjunctive therapies are stable for 4 weeks prior to screening
  • Must be able to swallow study medication

Exclusion Criteria:

  • Has Rett syndrome or Child Disintegrative Disorder
  • Has participated in any other study and received any other investigational medication (other than COVID-19 vaccination) or device within 60 days prior to screening
  • History of epilepsy without current adequate control, or any seizure in the 6 months preceding screening
  • History of suicidal ideation or behavior in the past 12 months, or a positive response to C-SSRS questions 4 and/or 5
  • Systolic blood pressure ≥160 mmHg, or diastolic blood pressure ≥100, or a clinical history of uncontrolled or severe hypertension
  • If female, is pregnant or lactating

Sites / Locations

  • Harmonex Neuroscience ResearchRecruiting
  • Southwest Autism Research & Resource Center, Clinical ResearchRecruiting
  • University of California, San FranciscoRecruiting
  • Yale Child Study CenterRecruiting
  • Children's National Health System - The Children's Research Institute (CRI)Recruiting
  • APG Research, LLCRecruiting
  • University of South Florida Psychiatry and Behavioral NeurosciencesRecruiting
  • AMR-Baber Research IncRecruiting
  • Massachusetts General Hospital's Lurie Center for AutismRecruiting
  • Neurobehavioral Medicine GroupRecruiting
  • University of Missouri, Thompson Center for Autism & Neurodevelopmental DisordersRecruiting
  • Hassman Research InstituteRecruiting
  • Jersey Shore University Medical CenterRecruiting
  • Nathan Kline Institute for Psychiatric ResearchRecruiting
  • Richmond Behavioral AssociatesRecruiting
  • Center for Autism and the Developing Brain, New York State Psychiatric InstituteRecruiting
  • Ohio State University Nisonger CenterRecruiting
  • Suburban Research AssociatesRecruiting
  • Children's Hospital of PhiladelphiaRecruiting
  • Red Oak Psychiatry Associates, PARecruiting
  • Road Runner Research, Ltd.Recruiting
  • Cedar Clinical ResearchRecruiting
  • Seattle Children's HospitalRecruiting
  • Brain and Mind CentreRecruiting
  • Children's Health Queensland Hospital and Health ServiceRecruiting
  • Mater ResearchRecruiting
  • Flinders Medical CentreRecruiting
  • The Royal Children's Hospital, Murdoch Children's Research InstituteRecruiting
  • OCT Research ULC (dba Okanagan Clinical Trials)Recruiting
  • Lawson Health Research Institute/ London Health Sciences CentreRecruiting
  • Holland Bloorview Kids Rehabilitation HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

ML-004 (IR)/(ER) tablet

ML-004 Placebo

Arm Description

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).

Matched placebo oral tablets will consist of same excipients as the investigational drug but without any ML-004. Placebo taken orally once daily to match tablet number of ML-004 dose levels for 12 mg (1 tablet), 24 mg (1 tablet), 48 mg (2 tablets), and 72 mg (3 tablets).

Outcomes

Primary Outcome Measures

Change from Baseline in Autism Behavior Inventory (ABI)-Social Communication Domain Score
Change from baseline in the ABI-Social Communication Domain Score will be reported. The ABI is a 62-item questionnaire for reporting the behaviors of subjects (ages: 3 years-adulthood) diagnosed with ASD. The tool is suitable for completion by parents or care/study partners of people with ASD. Each item assesses either quality (from not at all to without help) or frequency (never to very often) of a particular behavior. The Social Communication domain score is the sum of the scores in the social communication domain divided by the number of items in the domain.

Secondary Outcome Measures

Change from Baseline in Clinician Global Impression of Improvement (CGI-I)
The CGI-I score is a single-item instrument based on a 7-point scale routinely used in clinical trials to capture the Investigator's global impression of response. The Investigator or designee rates the improvement observed from 1 (very much improved) to 7 (very much worse).
Change from Baseline in Autism Behavior Inventory-Clinician (ABI-C) Score
The ABI-Clinician (ABI-C) captures the clinician rating of behaviors of a person with ASD that occurred over the week prior to assessment. It contains 14 items reflecting the core and associated autism behavior domains: Social Communication, Restrictive Behaviors, Mood and Anxiety, Self Regulation, and Challenging Behavior. Each item is rated on a 7-point scale from 1 (none; no symptoms present) to 7 (very severe; persistent interference with function or adaptation).
Change from Baseline in Aberrant Behavior Checklist 2-Irritability (ABC-I) Subscale Score
The ABC is a parent- or care/study partner-reported behavior rating assessment with five domains and 58 items, each rated on a 0 (not a problem) to 3 (the problem is severe in degree) scale. The irritability domain consists of 15 items.
Change from baseline in the Clinician Global Impression of Severity (CGI-S) Score
The CGI-S is a global assessment of the clinician-rater's impression of the severity of the participant's illness. It is rated on a scale of 1 (normal, not at all ill) to 7 (among the most extremely ill).
Change from baseline in the ABI Repetitive/Restrictive Behavior Domain Score
Each item on the ABI-Repetitive/Restrictive Behavior Domain is rated by frequency (0=never to 3=very often). The domain score is the sum of all domain items scores divided by the number of items in the domain.
Change from baseline in the ABI Mood and Anxiety Domain Score
Each item on the ABI- Mood and Anxiety Domain is rated by frequency (0=never to 3=very often). The domain score is the sum of all domain items scores divided by the number of items in the domain.
Change from baseline in the ABI Challenging Behavior Domain Score
Each item on the ABI- Challenging Behavior Domain is rated by frequency (0=never to 3=very often). The domain score is the sum of all domain items scores divided by the number of items in the domain.
Change from baseline in the ABI Self-regulation Domain Score
Each item on the ABI- Self-regulation Domain is rated by frequency (0=never to 3=very often). The domain score is the sum of all domain items scores divided by the number of items in the domain.
Change from baseline in the ABI-Short Form (ABI-S) Score
The ABI-S is a 24-item short version of the ABI, containing items from each of the five domains. The domain score for each domain is calculated as the sum of scores all domain items divided by the number of items in the domain.
Change from baseline in the ABC-Social Withdrawal (ABC-SW) Subscale Score
The ABC-SW subscale consists of 16 items of the ABC-2 rated from 0 (not a problem) to 3 (the problem is severe in degree).
Change from baseline in the Social Responsiveness Scale 2 (SRS-2) Score
The SRS-2 consists of 65 items across 5 subscales. Responses range from 1 (not true) to 4 (almost always true).
Change from baseline in the Vineland-3 (Domain Level Version) Score: total of Communication, Socialization, and Maladaptive behavior domains
The Vineland-3 Domain Level Version contains 5 domains. Responses on each item are rated from 0 (never) to 2 (usually).

Full Information

First Posted
October 5, 2021
Last Updated
September 26, 2023
Sponsor
MapLight Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT05081245
Brief Title
ML-004 in Adolescents and Adults With Autism Spectrum Disorders (ASD)
Official Title
A Randomized, Double-blind, Parallel Group, Placebo-controlled Study to Investigate the Efficacy, Safety, and Tolerability of ML-004 in Adolescents and Adults With Autism Spectrum Disorders (ASD).
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 11, 2022 (Actual)
Primary Completion Date
March 31, 2025 (Anticipated)
Study Completion Date
April 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MapLight Therapeutics

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
ML-004-002 is a multi-center, randomized, double-blind, placebo-controlled study that will enroll approximately 150 adolescent and adult subjects with ASD
Detailed Description
ML-004-002 is a Phase 2, multi-center, randomized, double-blind, placebo- controlled study that will enroll approximately 150 adolescent and adult subjects with ASD. The primary objective of the study will be to evaluate the efficacy of ML-004 compared with placebo for the treatment of care/study partner-reported social communication deficits in patients with ASD. Subjects will be randomized to study treatment in a 1:1 ratio of ML-004: placebo. Treatment will begin with 2 weeks of once daily dosing of ML-004 or placebo followed by a 9-12 day dose-titration phase until the maximum allowable tolerated dose (based on subject weight) is reached. The maximum dose tolerated during dose titration will become the maintenance dose (MD) for that subject, and the subject will remain on this dose for 12 weeks, followed by a down titration. An independent DSMC will monitor trial progress and ensure that the safety of trial subjects is not compromised.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder
Keywords
ASD, Autism, Autism Spectrum Disorder, social communication deficit

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Multi-center, randomized, double-blind, placebo-controlled study
Masking
ParticipantCare ProviderInvestigator
Masking Description
Double-blind
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ML-004 (IR)/(ER) tablet
Arm Type
Experimental
Arm Description
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).
Arm Title
ML-004 Placebo
Arm Type
Placebo Comparator
Arm Description
Matched placebo oral tablets will consist of same excipients as the investigational drug but without any ML-004. Placebo taken orally once daily to match tablet number of ML-004 dose levels for 12 mg (1 tablet), 24 mg (1 tablet), 48 mg (2 tablets), and 72 mg (3 tablets).
Intervention Type
Drug
Intervention Name(s)
ML-004 (IR)/(ER) tablet
Intervention Description
Participants will receive ML-004 once daily for up to 16 weeks.
Intervention Type
Drug
Intervention Name(s)
ML-004 Placebo
Intervention Description
Participants will receive matching placebo once daily for up to 16 weeks
Primary Outcome Measure Information:
Title
Change from Baseline in Autism Behavior Inventory (ABI)-Social Communication Domain Score
Description
Change from baseline in the ABI-Social Communication Domain Score will be reported. The ABI is a 62-item questionnaire for reporting the behaviors of subjects (ages: 3 years-adulthood) diagnosed with ASD. The tool is suitable for completion by parents or care/study partners of people with ASD. Each item assesses either quality (from not at all to without help) or frequency (never to very often) of a particular behavior. The Social Communication domain score is the sum of the scores in the social communication domain divided by the number of items in the domain.
Time Frame
Baseline up to Day 110
Secondary Outcome Measure Information:
Title
Change from Baseline in Clinician Global Impression of Improvement (CGI-I)
Description
The CGI-I score is a single-item instrument based on a 7-point scale routinely used in clinical trials to capture the Investigator's global impression of response. The Investigator or designee rates the improvement observed from 1 (very much improved) to 7 (very much worse).
Time Frame
Day 110
Title
Change from Baseline in Autism Behavior Inventory-Clinician (ABI-C) Score
Description
The ABI-Clinician (ABI-C) captures the clinician rating of behaviors of a person with ASD that occurred over the week prior to assessment. It contains 14 items reflecting the core and associated autism behavior domains: Social Communication, Restrictive Behaviors, Mood and Anxiety, Self Regulation, and Challenging Behavior. Each item is rated on a 7-point scale from 1 (none; no symptoms present) to 7 (very severe; persistent interference with function or adaptation).
Time Frame
Baseline up to Day 110
Title
Change from Baseline in Aberrant Behavior Checklist 2-Irritability (ABC-I) Subscale Score
Description
The ABC is a parent- or care/study partner-reported behavior rating assessment with five domains and 58 items, each rated on a 0 (not a problem) to 3 (the problem is severe in degree) scale. The irritability domain consists of 15 items.
Time Frame
Baseline up to Day 110
Title
Change from baseline in the Clinician Global Impression of Severity (CGI-S) Score
Description
The CGI-S is a global assessment of the clinician-rater's impression of the severity of the participant's illness. It is rated on a scale of 1 (normal, not at all ill) to 7 (among the most extremely ill).
Time Frame
Baseline up to Day 110
Title
Change from baseline in the ABI Repetitive/Restrictive Behavior Domain Score
Description
Each item on the ABI-Repetitive/Restrictive Behavior Domain is rated by frequency (0=never to 3=very often). The domain score is the sum of all domain items scores divided by the number of items in the domain.
Time Frame
Baseline up to Day 110
Title
Change from baseline in the ABI Mood and Anxiety Domain Score
Description
Each item on the ABI- Mood and Anxiety Domain is rated by frequency (0=never to 3=very often). The domain score is the sum of all domain items scores divided by the number of items in the domain.
Time Frame
Baseline up to Day 110
Title
Change from baseline in the ABI Challenging Behavior Domain Score
Description
Each item on the ABI- Challenging Behavior Domain is rated by frequency (0=never to 3=very often). The domain score is the sum of all domain items scores divided by the number of items in the domain.
Time Frame
Baseline up to Day 110
Title
Change from baseline in the ABI Self-regulation Domain Score
Description
Each item on the ABI- Self-regulation Domain is rated by frequency (0=never to 3=very often). The domain score is the sum of all domain items scores divided by the number of items in the domain.
Time Frame
Baseline up to Day 110
Title
Change from baseline in the ABI-Short Form (ABI-S) Score
Description
The ABI-S is a 24-item short version of the ABI, containing items from each of the five domains. The domain score for each domain is calculated as the sum of scores all domain items divided by the number of items in the domain.
Time Frame
Baseline up to Day 110
Title
Change from baseline in the ABC-Social Withdrawal (ABC-SW) Subscale Score
Description
The ABC-SW subscale consists of 16 items of the ABC-2 rated from 0 (not a problem) to 3 (the problem is severe in degree).
Time Frame
Baseline up to Day 110
Title
Change from baseline in the Social Responsiveness Scale 2 (SRS-2) Score
Description
The SRS-2 consists of 65 items across 5 subscales. Responses range from 1 (not true) to 4 (almost always true).
Time Frame
Baseline up to Day 110
Title
Change from baseline in the Vineland-3 (Domain Level Version) Score: total of Communication, Socialization, and Maladaptive behavior domains
Description
The Vineland-3 Domain Level Version contains 5 domains. Responses on each item are rated from 0 (never) to 2 (usually).
Time Frame
Baseline up to Day 110

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 12 to 45 at screening Has a designated care/study partner who can reliably report on symptoms Has a diagnosis of Autism Spectrum Disorder (ASD) Full scale IQ (or equivalent) ≥70 score Psychoactive medications and adjunctive therapies are stable for 4 weeks prior to screening Must be able to swallow study medication Exclusion Criteria: Has Rett syndrome or Child Disintegrative Disorder Has participated in any other study and received any other investigational medication (other than COVID-19 vaccination) or device within 60 days prior to screening History of epilepsy without current adequate control, or any seizure in the 6 months preceding screening History of suicidal ideation or behavior in the past 12 months, or a positive response to C-SSRS questions 4 and/or 5 Systolic blood pressure ≥160 mmHg, or diastolic blood pressure ≥100, or a clinical history of uncontrolled or severe hypertension If female, is pregnant or lactating
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kelly Amaguin
Phone
+1 650-839-4388
Email
kamaguin@maplightrx.com
Facility Information:
Facility Name
Harmonex Neuroscience Research
City
Dothan
State/Province
Alabama
ZIP/Postal Code
36303
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nelson Handal-Thome, MD
Phone
334-836-2000
Facility Name
Southwest Autism Research & Resource Center, Clinical Research
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christopher Smith, PhD
Phone
480-443-0050
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert Hendren, DO
Phone
415-476-7803
Facility Name
Yale Child Study Center
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Roger Jou, MD, PhD
Phone
203-737-4378
Facility Name
Children's National Health System - The Children's Research Institute (CRI)
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adelaide Robb, MD
Phone
202-476-3042
Facility Name
APG Research, LLC
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Morteza Nadjafi, MD
Phone
407-423-7149
Facility Name
University of South Florida Psychiatry and Behavioral Neurosciences
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Fallon, MD
Phone
813-974-4657
Facility Name
AMR-Baber Research Inc
City
Naperville
State/Province
Illinois
ZIP/Postal Code
60563
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Riaz Baber, MD
Phone
630-272-4844
Facility Name
Massachusetts General Hospital's Lurie Center for Autism
City
Lexington
State/Province
Massachusetts
ZIP/Postal Code
02421
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christopher Keary, MD
Phone
781-860-1729
Facility Name
Neurobehavioral Medicine Group
City
Bloomfield Hills
State/Province
Michigan
ZIP/Postal Code
48302
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Richard Jackson, MD
Phone
248-290-5400
Facility Name
University of Missouri, Thompson Center for Autism & Neurodevelopmental Disorders
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65211
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Benjamin Black, MD
Phone
573-884-6052
Facility Name
Hassman Research Institute
City
Berlin
State/Province
New Jersey
ZIP/Postal Code
08009
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Steve Glass, MD
Phone
856-753-7335
Ext
350
Facility Name
Jersey Shore University Medical Center
City
Neptune
State/Province
New Jersey
ZIP/Postal Code
07753
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stacy Doumas, MD
Phone
732-776-4930
Facility Name
Nathan Kline Institute for Psychiatric Research
City
Orangeburg
State/Province
New York
ZIP/Postal Code
10962
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Russell Tobe, MD
Phone
845-398-5525
Facility Name
Richmond Behavioral Associates
City
Staten Island
State/Province
New York
ZIP/Postal Code
10314
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mark DiBuono, MD
Phone
718-317-5522
Ext
1301
Facility Name
Center for Autism and the Developing Brain, New York State Psychiatric Institute
City
White Plains
State/Province
New York
ZIP/Postal Code
10605
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeremy Veenstra-VanderWeele, MD
Phone
646-774-5251
Facility Name
Ohio State University Nisonger Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eugene Arnold, MD
Phone
614-685-6701
Facility Name
Suburban Research Associates
City
Media
State/Province
Pennsylvania
ZIP/Postal Code
19063
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shivkumar Hatti, MD
Phone
610-891-7200
Facility Name
Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amanda Bennett, MD
Phone
267-366-8371
Facility Name
Red Oak Psychiatry Associates, PA
City
Houston
State/Province
Texas
ZIP/Postal Code
77090
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lawrence Ginsberg, MD
Phone
281-893-4111
Facility Name
Road Runner Research, Ltd.
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78249
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jerry Tomasovic, MD
Phone
210-949-0505
Facility Name
Cedar Clinical Research
City
Draper
State/Province
Utah
ZIP/Postal Code
84020
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Reid Robison, MD
Phone
801-704-9722
Facility Name
Seattle Children's Hospital
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gary Stobbe, MD
Phone
206-987-8080
Facility Name
Brain and Mind Centre
City
Camperdown
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adam Gaustella, Prof
Phone
+61 2 9351 0539
Facility Name
Children's Health Queensland Hospital and Health Service
City
South Brisbane
State/Province
Queensland
ZIP/Postal Code
4101
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Helen Heussler, MBBS
Phone
617 3068 3815
Facility Name
Mater Research
City
South Brisbane
State/Province
Queensland
ZIP/Postal Code
4101
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Catherine Franklin, MBBS
Phone
07 3163 2412
Facility Name
Flinders Medical Centre
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5042
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dylan Mordaunt, MBBS
Phone
618 8240 4623
Facility Name
The Royal Children's Hospital, Murdoch Children's Research Institute
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3052
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Amor, MBBS
Phone
613 9936 6404
Facility Name
OCT Research ULC (dba Okanagan Clinical Trials)
City
Kelowna
State/Province
British Columbia
ZIP/Postal Code
V1Y 1Z9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Euguene Okorie, MD
Phone
250-862-8141
Facility Name
Lawson Health Research Institute/ London Health Sciences Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5W9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rob Nicolson, MD, FRCP (C)
Phone
519-685-8427
Facility Name
Holland Bloorview Kids Rehabilitation Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4G 1R8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Danielle Baribeau, MD
Phone
416-753-6005

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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ML-004 in Adolescents and Adults With Autism Spectrum Disorders (ASD)

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