Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Could a cancer drug help kids with autism speak better?

NCT ID NCT02839915

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether folinic acid (leucovorin), a drug already used to reduce side effects from chemotherapy, can improve language skills in children with autism spectrum disorder. Researchers will give the drug or a placebo to 56 children aged 5 to 17 for 12 to 24 weeks and measure changes in language tests. The goal is to see if this drug can help with a core challenge of autism.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
folinic acid (leucovorin)
What this could lead to
If it works, this could point toward a treatment to improve language skills in children with autism.
What could go wrong
This is a small, early-phase trial with only 56 participants. The drug is not proven for this use, and results may not apply to all children with autism.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

56 people

The number who actually took part.

Started

Aug 2020

Expected to finish

Jul 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

5 to 17 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Boys and girls ≥ 5 years and \< 17 years 5 months of age; * Weight ≥ 15 kg; * DSM-5 diagnosis of Autism Spectrum Disorder as established by clinical assessment, corroborated by the Social Communication Questionnaire and the Autism Diagnostic Observational Schedule. * A score \< 80 on the Core Language score of the Clinical Evaluation of Language Fundamentals -4 (CELF)- 4 or the Second Edition of the CELF-Preschool test (CELF-P). * Current Clinical Global Impression Severity score ≥ 4 on ASD + communication delay. * IQ at least 40 as measured by the Leiter-3 or mental age at least 18 months as measured on the Receptive Language Scale of the Mullen. * Stable educational plan (one month) with no planned changes in the intensity of treatment for 12 weeks. (Otherwise eligible subjects with anticipated changes in their school program in the near term will be invited to return when the transition has been accomplished. * Stable speech therapy program in the community (one month) with no planned changes for 12 weeks. * English is spoken in the home and at least one parent is able to read, write and speak English. * Stable medication (no changes in past 6 weeks and no planned changes for the next 6 months (duration of the study). Exclusion Criteria: * IQ below 40 as measured by the Leiter-3 or below a mental age of 18 months on the Receptive Language Scale of Mullen. (N.B. subjects who test below 18 months of age, but are otherwise eligible, may be enrolled following a case review by the Steering Committee - e.g., child's uncooperative behavior resulted in a likely underestimate of intellectual ability); * Is within the scorable range of the CELF-4 or CELF-P as detailed in the Language Algorithm; * Current DSM-IV diagnosis requiring alternative pharmacotherapy, e.g., Major Depression, Bipolar Disorder, a psychotic disorder (based on clinical assessment assisted by the Child and Adolescent Symptom Inventory); * Presence of serious behavioral problems (tantrums, aggression, self-injury) for which another treatment is warranted. * Significant medical condition by history or by physical examination or lab tests that would be incompatible with the study drug. * Children taking anticonvulsant medication for seizures. * Children taking Bactrim (trimethoprim + sulfamethoxazole) because Bactrim can interfere with folate metabolism. Children who discontinue use of Bactrim for 2 months may be re-evaluated for the study. Caregivers will be advised not to use any of these medications during the trial. * Children taking valproic acid or derivatives or lamotrigine for any purpose will be excluded because these drugs can interfere with folate metabolism. Caregivers will be advised not to use any of these medications during the trial. * Children on mineral or vitamin supplements that exceed the Recommended Daily Allowance set by the IOM.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Autism spectrum disorder are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Children's Healtcare of Atlanta

    Atlanta, Georgia, 30322, United States

  • Harvard University

    Lexington, Massachusetts, 02421, United States

  • Southwestern Research and Resource Center

    Phoenix, Arizona, 85016, United States

  • State University of New York, Downstate

    Brooklyn, New York, 11203, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.