Folinic Acid for Autism Spectrum Disorder

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Autism Spectrum Disorder+4 More
Folinic Acid - Drug
Eligibility
< 18
All Sexes
What conditions do you have?
Select

Study Summary

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

Eligible Conditions
  • Autism Spectrum Disorder
  • Autism Spectrum Disorders

Treatment Effectiveness

Effectiveness Progress

1 of 3

Similar Trials

Study Objectives

2 Primary · 1 Secondary · Reporting Duration: Pre-treatment, 12 weeks(optional), and 24weeks (or early termination)

Week 12
Change in in methylation
Week 12
Change in folate gene expression
Pre-treatment, and 24weeks (or early termination)
CELF Proteins
Screening, Week 12
Change in Clinical Evaluation of Language Fundamentals 4 (CELF-4) Score.
Change in Clinical Evaluation of Language Fundamentals Preschool (CELF-P) score
Up to 12 Weeks
Change in Aberrant Behavior Checklist (ABC) Score
Change in Clinician Global Impression for Improvement (CGI-I) Score
Children's Yale-Brown Obsessive-Compulsive Scales-ASD (CYBOCS-ASD)
Home Situations Questionnaire- Modified for ASD (HSQ-ASD)

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Similar Trials

Side Effects for

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

Trial Design

2 Treatment Groups

Folinic Acid
1 of 2
Placebo Control
1 of 2

Experimental Treatment

Non-Treatment Group

134 Total Participants · 2 Treatment Groups

Primary Treatment: Folinic Acid · Has Placebo Group · Phase 2

Folinic Acid
Drug
Experimental Group · 1 Intervention: Folinic Acid · Intervention Types: Drug
Placebo Control
Other
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Leucovorin
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: pre-treatment, 12 weeks(optional), and 24weeks (or early termination)

Who is running the clinical trial?

Rossignol Medical CenterLead Sponsor
4 Previous Clinical Trials
710 Total Patients Enrolled
4 Trials studying Autism Spectrum Disorder
710 Patients Enrolled for Autism Spectrum Disorder
Phoenix Children's HospitalLead Sponsor
68 Previous Clinical Trials
5,011,499 Total Patients Enrolled
5 Trials studying Autism Spectrum Disorder
720 Patients Enrolled for Autism Spectrum Disorder
State University of New York - Downstate Medical CenterOTHER
58 Previous Clinical Trials
9,780 Total Patients Enrolled
2 Trials studying Autism Spectrum Disorder
160 Patients Enrolled for Autism Spectrum Disorder
Harvard UniversityOTHER
213 Previous Clinical Trials
18,228,428 Total Patients Enrolled
1 Trials studying Autism Spectrum Disorder
61 Patients Enrolled for Autism Spectrum Disorder
AprofolUNKNOWN
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,809 Previous Clinical Trials
2,235,338 Total Patients Enrolled
27 Trials studying Autism Spectrum Disorder
7,458 Patients Enrolled for Autism Spectrum Disorder
Southwest Autism Research & Resource CenterOTHER
4 Previous Clinical Trials
252 Total Patients Enrolled
4 Trials studying Autism Spectrum Disorder
252 Patients Enrolled for Autism Spectrum Disorder
Emory UniversityOTHER
1,503 Previous Clinical Trials
2,706,453 Total Patients Enrolled
20 Trials studying Autism Spectrum Disorder
19,006 Patients Enrolled for Autism Spectrum Disorder
Richard Frye, MD, PhDPrincipal InvestigatorPhoenix Children's Hospital
Richard E Frye, MD, PhDPrincipal InvestigatorRossignol Medical Center
5 Previous Clinical Trials
720 Total Patients Enrolled
5 Trials studying Autism Spectrum Disorder
720 Patients Enrolled for Autism Spectrum Disorder

Eligibility Criteria

Age < 18 · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have ASD and communication delay.
You are able to read, write and speak English.
You are taking a stable medication for a stable condition.
You are between 5 and 17 years and 5 months of age.
You have a clinical diagnosis of autism spectrum disorder.
You have a score of less than 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).
You have an IQ of at least 40 and a mental age of at least 18 months.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: November 3rd, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

Who else is applying?

What state do they live in?
Massachusetts100.0%
How old are they?
18 - 65100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%
References