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Dopamine Precursor

L-DOPA + Social Skills Training for Autism Spectrum Disorder (ACEP4 Trial)

Phase 2
Waitlist Available
Led By James T McCracken, MD
Research Sponsored by University of California, Los Angeles
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Meets diagnostic criteria for ASD by clinical evaluation and ADOS
Ages 13 - 30 years inclusive
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 8 (midpoint), week 16 (4 month/end of study)
Awards & highlights

ACEP4 Trial Summary

This trial will use L-DOPA or placebo to study social reward processes in adolescents and young adults with ASD, and how dopamine affects these processes. It will enroll 56 participants with ASD and 18 healthy controls.

Eligible Conditions
  • Autism Spectrum Disorder

ACEP4 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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You have been diagnosed with autism by a doctor and have completed an evaluation called ADOS.
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People between 13 and 30 years old can participate.
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Your estimated IQ score is higher than 70.

ACEP4 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 8 (midpoint), week 16 (4 month/end of study)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 8 (midpoint), week 16 (4 month/end of study) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in fMRI: Social Reward Task from Baseline to week 16 (4 months)
Secondary outcome measures
Change on Adult Behavior Checklist (ABCL)
Change on Anticipatory and Consummatory Interpersonal Pleasure Scale (ACIPS)
Change on Anticipatory and Consummatory Interpersonal Pleasure Scale Adolescent (ACIPS-A)
+5 more

Side effects data

From 2006 Phase 4 trial • 107 Patients • NCT00183625
29%
Hospitalization
100%
80%
60%
40%
20%
0%
Study treatment Arm
Risperidone Treatment
Olanzapine Treatment

ACEP4 Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Social SkillsExperimental Treatment2 Interventions
All participants will receive 16-week manualized social skills training.
Group II: L-DOPA versus PlaceboActive Control2 Interventions
L-DOPA or placebo (1:1 randomization). Dosing will begin at 25mg carbidopa/100mg L-DOPA in 3 divided doses, with a fixed-flexible titration schedule, allowing dose increases once per week of 100mg L-DOPA. Maximum dose is 600mg/d.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Social Skills Training
2022
Completed Phase 4
~2680

Find a Location

Who is running the clinical trial?

University of California, Los AngelesLead Sponsor
1,518 Previous Clinical Trials
10,278,704 Total Patients Enrolled
25 Trials studying Autism Spectrum Disorder
4,349 Patients Enrolled for Autism Spectrum Disorder
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,951 Previous Clinical Trials
2,660,730 Total Patients Enrolled
35 Trials studying Autism Spectrum Disorder
9,802 Patients Enrolled for Autism Spectrum Disorder
James T McCracken, MDPrincipal InvestigatorUniversity of California, Los Angeles

Media Library

L-DOPA (Dopamine Precursor) Clinical Trial Eligibility Overview. Trial Name: NCT03243552 — Phase 2
Autism Spectrum Disorder Research Study Groups: L-DOPA versus Placebo, Social Skills
Autism Spectrum Disorder Clinical Trial 2023: L-DOPA Highlights & Side Effects. Trial Name: NCT03243552 — Phase 2
L-DOPA (Dopamine Precursor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03243552 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment open to the public for this research trial?

"Affirmative. Clinicaltrials.gov indicates that the present recruitment of participants for this clinical trial commenced on June 1st, 2017 and was last modified on October 13th, 2022. 56 patients must be enrolled from a single site to complete the study."

Answered by AI

For whom is this clinical trial open to enrollment?

"To partake in this trial, applicants must have anhedonia and range between the ages of 13 to 30. Approximately 56 participants are required for successful completion."

Answered by AI

What is the uppermost limit of participants in this trial?

"Affirmative. The trial data available on clinicaltrials.gov confirms that recruitment for this medical study, which launched June 1st 2017, is still ongoing. 56 participants need to be gathered from a single site location."

Answered by AI

Are geriatric patients excluded from participation in this clinical research?

"The study's inclusion criteria state that the age range of enrollees should span from 13 to 30 years old. For people below 18, there are 16 other studies available; conversely, those above 65 can avail themselves of 13 different alternatives."

Answered by AI

Is Social Skills Training a secure intervention for individuals?

"Since Social Skills Training is currently in Phase 2 of its clinical trial, there is some evidence for safety but still a lack for efficacy. For this reason, our team at Power has assigned it an intermediate score of 2 on the safety scale from 1-3."

Answered by AI
~7 spots leftby Mar 2025