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Folinic Acid for Language Impairment in Autism Spectrum Disorder

Phase 2
Recruiting
Led By Richard Frye, MD, PhD
Research Sponsored by Phoenix Children's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Weight ≥ 15 kg
Stable educational plan (one month) with no planned changes in the intensity of treatment for 12 weeks
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre-treatment, 12 weeks(optional), and 24weeks (or early termination)
Awards & highlights

Study Summary

This trial will test if folinic acid can help improve language skills in children with autism spectrum disorder.

Who is the study for?
This trial is for children aged 5 to less than 17.5 years with Autism Spectrum Disorder and language impairment, who speak English at home and have an IQ of at least 40 or a mental age of at least 18 months. They must be on stable speech therapy and educational plans, not planning medication changes for the study's duration, and not taking certain medications that affect folate metabolism.Check my eligibility
What is being tested?
The trial tests if folinic acid (leucovorin) can improve language problems in autistic children compared to a placebo. Folinic acid is FDA-approved for reducing chemotherapy side effects but its effectiveness in autism-related language issues is being investigated here over a period of up to 24 weeks.See study design
What are the potential side effects?
While the specific side effects are not listed here, as folinic acid is generally used during cancer treatment to reduce side effects from chemotherapy, it may be well-tolerated. However, potential risks will likely be monitored given its investigational use.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I weigh at least 15 kilograms.
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My educational or treatment plan will not change for the next 3 months.
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English is spoken at home and at least one parent can read, write, and speak English.
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My medications have been the same for the last 6 weeks and won't change during the study.
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I have been in a stable speech therapy program for at least a month with no changes expected for the next 12 weeks.
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I am between 5 and 17 years old.
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I have been in a stable speech therapy program for at least a month with no changes expected for the next 12 weeks.
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I am between 5 and 17 years old.
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I weigh at least 15 kilograms.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-treatment, 12 weeks(optional), and 24weeks (or early termination)
This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-treatment, 12 weeks(optional), and 24weeks (or early termination) 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 Clinical Evaluation of Language Fundamentals 4 (CELF-4) Score.
Change in Clinical Evaluation of Language Fundamentals Preschool (CELF-P) score
Secondary outcome measures
Change in Clinician Global Impression for Improvement (CGI-I) Score
Other outcome measures
Change in Aberrant Behavior Checklist (ABC) Score
Change in folate gene expression
Change in in methylation
+3 more

Side effects data

From 2016 Phase 3 trial • 1072 Patients • NCT01183780
60%
Diarrhoea
50%
Nausea
48%
Fatigue
38%
Decreased appetite
35%
Neutropenia
34%
Epistaxis
31%
Stomatitis
30%
Constipation
29%
Alopecia
29%
Vomiting
28%
Hypertension
26%
Neutrophil count decreased
23%
Abdominal pain
22%
Oedema peripheral
18%
Anaemia
18%
Proteinuria
17%
Mucosal inflammation
16%
Pyrexia
15%
Thrombocytopenia
15%
Headache
15%
Platelet count decreased
14%
Asthenia
14%
Weight decreased
13%
Cough
13%
Palmar-plantar erythrodysaesthesia syndrome
11%
Dyspnoea
9%
White blood cell count decreased
9%
Insomnia
8%
Back pain
8%
Rash
8%
Malaise
8%
Dysgeusia
7%
Blood alkaline phosphatase increased
7%
Hypoalbuminaemia
7%
Pain in extremity
7%
Upper respiratory tract infection
7%
Hypokalaemia
7%
Dizziness
6%
Hiccups
6%
Aspartate aminotransferase increased
6%
Dehydration
6%
Arthralgia
6%
Dysphonia
6%
Urinary tract infection
6%
Peripheral sensory neuropathy
5%
Haemorrhoids
5%
Alanine aminotransferase increased
5%
Dry skin
5%
Proctalgia
5%
Dyspepsia
4%
Abdominal distension
3%
Febrile neutropenia
2%
Intestinal obstruction
2%
Pulmonary embolism
1%
International normalised ratio increased
1%
Fall
1%
Nephrotic syndrome
1%
Renal failure acute
1%
Sepsis
1%
Haematemesis
1%
Ileus
1%
Small intestinal obstruction
1%
Blood bilirubin increased
1%
Pneumonia
1%
Large intestinal obstruction
1%
Large intestine perforation
1%
Venous thrombosis
1%
Clostridium difficile colitis
1%
Gastritis
1%
Intestinal perforation
1%
General physical health deterioration
100%
80%
60%
40%
20%
0%
Study treatment Arm
FOLFIRI + Ramucirumab
FOLFIRI + Placebo

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Folinic AcidExperimental Treatment1 Intervention
Subjects randomized to receive Folinic Acid will take Liquid levo-leucovorin via oral route. The target dose is 1 mg/kg/day with a maximum of 25 mg/day, divided in two daily doses. A two- to four-week supply of 15 ml vials will be dispensed in line with the visit schedule. With the exception of children in the lowest weight group (≥ 15 - < 20 kg) from days 1-14, parents will administer the prescribed dose twice a day at the same time each day.
Group II: Placebo ControlPlacebo Group1 Intervention
Subjects randomized to receive placebo will take placebo twice a day (Exception: children in the lowest weight group ( ≥ 15 - < 20 kg) will start once a day for Days1-13). The pattern of dose escalation will be the same as the active compound. After 12 weeks, the blind will not be broken and subjects will be offered treatment for a 12-week open-label extension phase.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Folinic Acid
2015
Completed Phase 3
~4380

Find a Location

Who is running the clinical trial?

Phoenix Children's HospitalLead Sponsor
73 Previous Clinical Trials
5,013,873 Total Patients Enrolled
5 Trials studying Autism Spectrum Disorder
720 Patients Enrolled for Autism Spectrum Disorder
AprofolUNKNOWN
State University of New York - Downstate Medical CenterOTHER
65 Previous Clinical Trials
12,417 Total Patients Enrolled
3 Trials studying Autism Spectrum Disorder
660 Patients Enrolled for Autism Spectrum Disorder

Media Library

Folinic Acid (Other) Clinical Trial Eligibility Overview. Trial Name: NCT02839915 — Phase 2
Autism Spectrum Disorder Research Study Groups: Folinic Acid, Placebo Control
Autism Spectrum Disorder Clinical Trial 2023: Folinic Acid Highlights & Side Effects. Trial Name: NCT02839915 — Phase 2
Folinic Acid (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02839915 — Phase 2

Frequently Asked Questions

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

Am I qualified to join this medical experiment?

"Those wishing to partake in this research trial must have autism spectrum disorder and be between 5-17 years old. 134 individuals are required for the entirety of the study."

Answered by AI

Are there still openings to join this clinical experiment?

"Unfortunately, this clinical trial is not currently enrolling patients. According to the data hosted on clinicialtrials.gov, it was posted on August 13th 2020 and last updated September 28th 2022. For those searching for other studies, there are 293 trials recruiting individuals with autism spectrum disorder and 265 seeking volunteers for Folinic Acid research."

Answered by AI

How many individuals are being monitored in this medical experiment?

"This drug trial is no longer taking on new patients; it was first posted in August of 2020 and the last update to its profile happened at the end of September 2022. If you are looking for alternative studies, 293 clinical trials related to autism spectrum disorder and 265 involving Folinic Acid have open recruitment periods right now."

Answered by AI

What conditions can be treated with Folinic Acid?

"Folinic Acid is the traditional therapeutic approach for managing methotrexate toxicity, though it has also proven effective in treating normochromic anemia, advanced esophageal cancers and folate deficiencies."

Answered by AI

Has Folinic Acid obtained clearance from the Food and Drug Administration?

"Despite the lack of evidence for efficacy, Folinic Acid has a safety rating of 2 due to existing data that suggests it is relatively safe."

Answered by AI

How many establishments are currently administering this trial?

"This trial is accepting participants from the Phoenix Children's Hospital in Arizona, Southwestern Research and Resource Centre in California, Stanford University Department of Psychiatry and Behavioural Sciences in Massachusetts as well as 6 additional medical sites."

Answered by AI

Is the sample population for this study limited to those older than 30 years?

"To meet the eligibility criteria for this study, individuals must be aged between 5 and 17. There are 273 studies that focus on subjects younger than 18 years old and 285 targeting those above 65 years of age."

Answered by AI

What other experiments have centered around Folinic Acid?

"Currently, there are 265 trials assessing Folinic Acid's efficacy. Of these studies, 84 are in the last phase of clinical research with many located at Woolloongabba, Queensland. Across 15022 sites worldwide, this acid is being subjected to further medical scrutiny."

Answered by AI

Who else is applying?

What state do they live in?
California
Massachusetts
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
What site did they apply to?
Stanford University Department of Psychiatry and Behavioral Sciences
State University of New York, Downstate

Why did patients apply to this trial?

.my son is non verbal and needs language badly. I am hoping that this trial is the answer to our childrens'battle with autism.
PatientReceived 1 prior treatment
Applied on behalf of my son who has been I speech therapy for over a year with insignificant gains.
PatientReceived 1 prior treatment
My son recently got his FRAT test done and his pcp prescribed him Leucovorin 25mg/ml . We are going to put him on the medicine from tomorrow. While search more about this drug came across the research which is happening about the same drug , thought will be helpful .
PatientReceived 2+ prior treatments
Recent research and studies
~23 spots leftby Jan 2025