|
|
View Clinical Trial (Medical Research Study)
|
Study of Fluconazole in Children With Autism Spectrum Disorder - NCT00936182-91356 (Clinical Trial 301247)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy301247.aspx
|
** Please review additional "Nearby Studies" on right ----->
|
|
 |
 |
|
| City: |
|
Tarzana |
|
State:
|
|
CA |
| Zip Code: |
|
91356 |
| Conditions: |
|
Autism Spectrum Disorder |
| Purpose: |
|
Antifungal therapy is widely used for individuals with Autism Spectrum Disorders (ASD). The
current investigation will examine the effects of fluconazole on behavioral functioning
among children with ASD. This is a double-blind, randomized, placebo-controlled study of
oral fluconazole in children who meet criteria for ASD. Pre- and post-treatment behavioral
ratings will be used to evaluate the efficacy of fluconazole therapy. In addition, children
will undergo comprehensive medical history, physical examination, and laboratory analyses.
Our objective is to quantify differences in behavioral functioning between the fluconazole
treatment and a placebo. Our primary hypothesis is that, on average and relative to the
placebo, children with ASD who receive fluconazole will show greater improvements in
symptoms of autism.
|
| Study summary: |
|
|
| Criteria: |
|
Inclusion Criteria:
1. Male or female participants, three to ten years of age.
2. Meets clinical criteria for an autism spectrum disorder.
3. No antifungal use in the preceding 3 months.
4. Results of pyrosequencing analysis that have identified yeast
5. Each legal guardian must have a level of understanding sufficient to agree to all
required tests and examinations. Each legal guardian must understand the nature of
the study and must provide written consent to study protocol.
Exclusion Criteria:
1. History of allergic reaction to fluconazole or other azole antifungal agents
2. Current use of terfenadine, cisapride, phenytoin, cyclosporine, rifampin,
theophylline, terfenadine, cisapride, astemizole, rifabutin, or tacrolimus
3. History of uncontrolled epilepsy
4. Weight less than 15 kg at screening
5. Presence of a chronic medical condition that might interfere with study participation
or where study participation would be contraindicated or clinically significant
abnormal baseline laboratory results.
6. Recent (less than two months prior to study entry) initiation of behavior therapy
A child will be excluded at any point during the study if it is revealed that a major
change (either addition or deletion) of treatment or service provision has occurred. |
|
|
|
| Study is available at: |
|
Center for Autism and Related Disorders
Tarzana, CA 91356
United States
Primary Contact:
Scott Allen
Email: M.Allen@centerforautism.com
Phone: (866) 833-3898 |
|
|
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
|
| Trials Alerts: |
|
If you would like to be
notified of new clinical trials as they become available please
register for a free account.
|
|
| Data Source: |
|
ClinicalTrials.gov |
| Date Processed: |
|
March 16, 2010 |
Modifications to
this listing: |
|
Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
|
|
| |
|
|
| |
|
|
| |
|
|
| |
|
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
|
|
|
|
|
|
|
|