Study of Fluconazole in Children With Autism Spectrum Disorder

Recruiting at 2 trial locations

Overseen By Scott Allen

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: The Center for Autism and Related Disorders

Must not be taking: Terfenadine, Cisapride, Phenytoin, others

Disqualifiers: Allergy to fluconazole, Uncontrolled epilepsy, others

Approved in 5 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

50 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests if fluconazole, a medication for fungal infections, can improve behavior in children with Autism Spectrum Disorders (ASD). Children will receive either fluconazole or another treatment, and their behavior will be compared over time. Fluconazole has been used to prevent invasive fungal infections in high-risk, very low birth weight infants.

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications, such as terfenadine, cisapride, phenytoin, cyclosporine, rifampin, theophylline, astemizole, rifabutin, or tacrolimus. If you are on any of these, you would need to stop them to participate.

Is Fluconazole (Diflucan) generally safe for humans?

Fluconazole, also known as Diflucan, is a medication that has been used for various conditions. While specific safety data for Fluconazole is not detailed in the provided research, it is important to note that all medications can have potential side effects. It's always best to discuss any concerns with a healthcare provider who can provide information based on the most current and comprehensive data. ^{1 2 3 4 5}

How does the drug Fluconazole differ from other treatments for fungal infections?

Fluconazole is unique because it can be taken both orally and intravenously, and it works by inhibiting the production of ergosterol, a key component of fungal cell membranes. It is effective against a wide range of fungi, has a favorable safety profile, and is absorbed well regardless of food intake, allowing for once-daily dosing. ^{6 7 8 9 10}

Eligibility Criteria

Inclusion Criteria

Male or female participants, three to ten years of age.

Meets clinical criteria for an autism spectrum disorder.

No antifungal use in the preceding 3 months.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either fluconazole or placebo daily for 30 days

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Fluconazole

Participant Groups

Group I: Fluconazole Experimental Treatment 1 Intervention

Group II: Placebo Placebo Group 1 Intervention

Placebo capsule daily for 30 days

Fluconazole is already approved in European Union, United States, Canada, Japan, China for the following indications:

Approved in European Union as Diflucan for:

• Candidiasis
• Cryptococcosis
• Histoplasmosis
• Coccidioidomycosis

Approved in United States as Diflucan for:

• Vaginal candidiasis
• Oropharyngeal candidiasis
• Esophageal candidiasis
• Cryptococcal meningitis

Approved in Canada as Diflucan for:

• Vaginal candidiasis
• Oropharyngeal candidiasis
• Esophageal candidiasis
• Cryptococcal meningitis

Approved in Japan as Diflucan for:

• Candidiasis
• Cryptococcosis
• Histoplasmosis
• Coccidioidomycosis

Approved in China as Diflucan for:

• Vaginal candidiasis
• Oropharyngeal candidiasis
• Esophageal candidiasis
• Cryptococcal meningitis

Who Is Running the Clinical Trial?

The Center for Autism and Related Disorders

Lead Sponsor

Trials

2

Recruited

90+

Thoughtful House

Collaborator

Trials

2

Recruited

80+

The International Child Development Resource Center

Collaborator

Trials

3

Recruited

100+

Findings from Research

The safety of marketed drugs is a significant concern, as some commonly prescribed medications can lead to serious or life-threatening side effects in patients.

The ChEMBL resource will provide a curated drug safety data set, including toxicity classifications and black box warnings, which will be freely available and regularly updated to aid in drug safety research and discovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Drug Safety Data Curation and Modeling in ChEMBL: Boxed Warnings and Withdrawn Drugs. Hunter, FMI., Bento, AP., Bosc, N., et al.[2023]

The FDA's adverse drug reaction reporting system is designed to identify rare and unexpected reactions to medications, but the data collected is voluntary and spontaneous, leading to potential biases.

Using this spontaneous reporting data to calculate actual adverse reaction rates or to compare the safety of different drugs is inappropriate, as it does not accurately reflect the true incidence of these reactions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An evaluation of spontaneous adverse drug reaction monitoring systems. Sachs, RM., Bortnichak, EA.[2013]

The study analyzed 345,662 spontaneous reports of adverse drug reactions (ADRs) submitted to the German Federal Institute for Drugs and Medical Devices, revealing a steady increase in reports since 1978, primarily due to stricter legal reporting requirements.

The most commonly reported ADRs were linked to drugs for nervous system disorders, with significant differences in reporting patterns between physicians and patients, suggesting a need for better patient education on potential ADRs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Frequent Adverse Drug Reactions, and Medication Groups under Suspicion. Dubrall, D., Schmid, M., Alešik, E., et al.[2023]

A new computer-based system has been developed for managing reports of adverse drug reactions and serious adverse events, featuring a network of three regional centers and a central database for efficient data handling.

This system is designed to be secure, reliable, and cost-effective, making it a potential model for future clinical health information networks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Putting the pieces together: using "off-the-shelf" software to safely transfer medical data. Swoboda, WJ., Göttler, M., Zinnhobler, K., et al.[2017]

References

1. United States pubmed.ncbi.nlm.nih.gov

Drug Safety Data Curation and Modeling in ChEMBL: Boxed Warnings and Withdrawn Drugs. [2023]

2. Netherlands pubmed.ncbi.nlm.nih.gov

[Registration of suspected adverse effects by the Bureau Adverse Effects Drugs; research activities in 1993]. [2013]

3. United States pubmed.ncbi.nlm.nih.gov

An evaluation of spontaneous adverse drug reaction monitoring systems. [2013]

4. Germany pubmed.ncbi.nlm.nih.gov

Frequent Adverse Drug Reactions, and Medication Groups under Suspicion. [2023]

5. Germany pubmed.ncbi.nlm.nih.gov

Putting the pieces together: using "off-the-shelf" software to safely transfer medical data. [2017]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Fluconazole (Diflucan): a review. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Discovery of fluconazole, a novel antifungal agent. [2019]

8. Norway pubmed.ncbi.nlm.nih.gov

[Fluconazole--a new antifungal agent]. [2013]

9. England pubmed.ncbi.nlm.nih.gov

Fluconazole for the treatment of candidiasis: 15 years experience. [2019]

10. Germany pubmed.ncbi.nlm.nih.gov

Comparison of the in vitro activity of fluconazole against Candida albicans and dermatophytes. [2013]