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Autism Spectrum DisorderPhase 2NCT05067582

A 12-Week Crossover Study to Assess the Efficacy, Safety and Tolerability of L1-79 in Subjects Aged 12-21 Years With Autism Spectrum Disorder

A Phase 2 study testing L1-79 in people with Autism Spectrum Disorder and Autism, run by Yamo Pharmaceuticals LLC at 8 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study will investigate the efficacy, safety and tolerability of L1-79 in participants aged 12-21 years who have been diagnosed with ASD with a score of >/= 70 on the Wechsler Abbreviated Scale of Intelligence (WASI-II), and a score of >/= 4 on the Clinical Global Impression of Severity of Illness (CGI-S) weighted… Read more about this study

Who is it for?
Ages 12 to 21 years
Conditions the study is for
Autism Spectrum Disorder, Autism
What is being tested?
L1-79
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
58 participants
Where
8 sitesUnited States
Study dates
25 Jan 2022to 21 Jun 2024
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 21 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Male or female adolescents or young adults between 12 and 21 years of age.
  • WASI-II standard score with 95% CI containing 70 or greater at screening or within the last 12 months prior to screening.
  • Fulfill language criteria required to complete ADOS-2 Modules 2, 3 or 4.
  • Diagnosis of ASD based on tool that utilizes the DSM-5 criteria, confirmed with ADOS-2.
  • CGI-S (weighted for socialization) of 4 or greater.
  • A female is eligible to enter and participate in the study if she is of non-childbearing potential or childbearing potential, has negative pregnancy test at screening and, if sexually active, agrees to use acceptable contraception methods (defined in protocol), for the duration of the study and for at least 30 days after the last dose of study drug.
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  • Male subjects if sexually active and female partners of childbearing potential must agree to use acceptable contraceptive methods (defined in protocol), for the duration of the study and for at least 30 days after the last dose of study drug.
  • Subjects and caregiver must be willing and able to participate in the testing procedures sufficient to obtain valid scores on the tests used herein.
  • Must live with a parent/primary caregiver, or if not, during each week he/she must either spend at least 3 hours a day for at least 4 days or, spend the weekend with a parent/primary caregiver.
  • In the opinion of the Investigator, be sufficiently tolerant and capable of complying with the requirements of this trial.
  • Able to swallow study medication whole and self-administer medication if living independently or have a parent/caregiver be able to administer medication.
  • Subjects or their legal guardians must be willing to sign informed consent and/or assent and caregivers participating in the study must be willing to sign informed consent.

Who cannot join

  • Pregnancy or breastfeeding, or intention to become pregnant during the study.
  • Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, symptomatic cardio-vascular disease, hepatic disease, renal disease, musculo skeletal or rheumatologic disease, human immunodeficiency virus (HIV), hemorrhagic cerebrovascular accident (HCVA), hepatitis B virus (HBV), or psychiatric illness/social situations that would limit compliance with study requirements.
  • Any disease that requires treatment with immunosuppressive drugs.
  • A diagnosis of Fragile-X syndrome or Rett syndrome.
  • A DSM-5 diagnosis of schizophrenia, schizoaffective disorder, alcohol use disorder, current or lifetime diagnosis of severe psychiatric disorder (e.g., bipolar disorder, etc.).
  • Subjects at risk of suicidal behavior or with a history alcohol or substance abuse/dependence.
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  • Presence of any active chronic medical problem including, but not limited to uncontrolled: seizure disorder, heart disease, cancer, asthma, genetic disease.
  • Requiring more than 3 medications for the treatment of autism, ADHD, seizures, depression, anxiety, aggression, agitation, obsessive compulsive disorder, tic disorder, or other disorder commonly co-occurring with ASD.
  • Initiation of new or major change in psychosocial intervention within 12 weeks prior to screening and throughout the duration of the study.
  • School or academic setting are expected to change during the course the study.
  • Clinically significant ECG abnormalities including subjects with baseline QTc prolongation (QTcF >450 msec for males and >470 msec in females).
  • On concomitant medications known to prolong the QTc interval.
  • Presence of out of range hepatic or renal function tests or other unexplained abnormal laboratory value that is deemed clinically significant by the Investigator.
  • On any of the following medications: alpha-2 agonists (including, but not limited to clonidine and guanfacine), beta-blockers, anti-hypertensives, and antipsychotics not approved for use in ASD.
  • Taking disallowed concomitant medications within 2 months (antipsychotics) and 1 month (all other medications) prior to Baseline.
  • Any subject or caregiver who is unwilling or unable to give informed consent.
  • Participated in an investigational drug study within 90 days prior to Baseline.

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

United States8 sites

  • Rush University

    Chicago, Illinois, 60612

  • Thompson Center for Autism and Neurodevelopmental Disorders

    Columbia, Missouri, 65211

  • Ohio State University

    Columbus, Ohio, 43210

  • Red Oak Psychiatry Associates

    Houston, Texas, 77090

  • Thompson Autism Center CHOC

    Orange, California, 92868

  • Southwest Autism Research and Resource Center

    Phoenix, Arizona, 85006

  • Cortica

    San Rafael, California, 94093

  • Center for Autism and The Developing Brain

    White Plains, New York, 10032

Other trials in United States

About this study

Official title: A Randomized, Double-Blind, Chronic Dosing (12-weeks), Two-Period, Placebo-Controlled, Crossover, Multi-Center Study to Assess the Efficacy, Safety, and Tolerability of Two Doses of L1-79 for the Treatment of the Core Deficits in Social-Communication Interaction in Adolescents and Young Adults With Autism Spectrum Disorder

This study will investigate the efficacy, safety and tolerability of L1-79 in participants aged 12-21 years who have been diagnosed with ASD with a score of >/= 70 on the Wechsler Abbreviated Scale of Intelligence (WASI-II), and a score of >/= 4 on the Clinical Global Impression of Severity of Illness (CGI-S) weighted for socialization.

Being tested
L1-79
Medical subject headings
Autism Spectrum Disorder, Autistic Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • L1-79Drug

    Also called DL-alpha-Methyltyrosine

    tyrosine hydroxylase inhibitor

Study groups in NCT05067582
Study groupRoleWhat they receive
Placebo CapsulesPlacebo comparator1 capsule twice daily
Receives: Drug: L1-79
L1-79 200 mg or 300 mg CapsulesExperimental1 capsule twice daily
Receives: Drug: L1-79

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Vineland Adaptive Behavior Scale, Third Edition (Vineland-3), Responder Analysis

    at least 1 point improvement in 2/3 socialization subdomains or at least 3 point improvement in socialization domain

    Measured: Week 12

Secondary outcomes (16)

  1. Vineland-3 Socialization Domain, Standard Score

    Measured: Week 12

  2. V-scale Score for Each of the 3 Socialization Subdomains of the Vineland-3

    Measured: Week 12

  3. Clinical Global Impression of Severity of Illness (CGI-S) Weighted for Socialization

    Measured: Week 12

  4. Clinical Global Impression of Change (CGI-C) Weighted for Socialization

    Measured: Week 12

  5. Growth Scale Value (GSV) of Each of the 3 Socialization Subdomains of the Vineland-3

    Measured: Week 12

  6. Caregiver Global Impression of Change of 3 Most Bothersome Symptoms of ASD (CGI-3P)

    Measured: Week 12

  7. Social Responsiveness Scale, Second Edition (SRS-2) Social-Communication and Interaction - DSM-5 Composite T-score

    Measured: Week 12

  8. Social Responsiveness Scale, Second Edition (SRS-2) Social Awareness T-score

    Measured: Week 12

  9. Social Responsiveness Scale, Second Edition (SRS-2) Social Cognition T-score

    Measured: Week 12

  10. Social Responsiveness Scale, Second Edition (SRS-2) Social Motivation T-score

    Measured: Week 12

  11. Social Responsiveness Scale, Second Edition (SRS-2) Social Communication T-score

    Measured: Week 12

  12. Social Responsiveness Scale, Second Edition (SRS-2) Total T-score

    Measured: Week 12

  13. Parent-rated Anxiety Scale for ASD (PRAS-ASD)

    Measured: Week 12

  14. Aberrant Behavior Checklist, Second Edition (ABC-2) Social Withdrawal/Lethargy Subscale

    Measured: Week 12

  15. Aberrant Behavior Checklist, Second Edition (ABC-2) Inappropriate Speech Subscale

    Measured: Week 12

  16. Child's Sleep Habits Questionnaire (CSHQ)

    Measured: Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Oct 2021
  2. Study start25 Jan 2022
  3. Primary completion18 Jun 2024
  4. Study completion21 Jun 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Model description
Two Period Crossover
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
58 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05067582
Sponsor's protocol ID
Y202
Status last verified
Jul 2024
First submitted
22 Sep 2021
Last updated
31 Jul 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing L1-79 in people with Autism Spectrum Disorder and Autism, run by Yamo Pharmaceuticals LLC at 8 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Vineland Adaptive Behavior Scale, Third Edition (Vineland-3), Responder Analysis (time frame: Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05067582.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2024.

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