Esomeprazole for Autism
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether Esomeprazole, a medication typically used for stomach issues, can improve social communication in children with Autism Spectrum Disorder (ASD). The study spans 12 weeks and focuses on the treatment's impact on children's interaction abilities. Participants will take a daily dose of Esomeprazole. Children aged 2 to 6 years, diagnosed with ASD, and in good physical health may be suitable candidates for this trial. As a Phase 2 trial, the research measures the treatment's effectiveness in an initial, smaller group.
Do I have to stop taking my current medications for the trial?
You can continue taking your current medications as long as they have been stable for at least 2 weeks (or 4 weeks if you're taking fluoxetine). There should be no planned changes in your psychosocial treatments during the trial.
Is there any evidence suggesting that Esomeprazole is likely to be safe for humans?
Research has shown that esomeprazole, also known as Nexium, is generally safe for use. The FDA has already approved it for treating conditions like acid reflux, confirming its safety for these uses. Studies involving children aged 12 and up have found esomeprazole to be safe and effective. However, this trial will investigate its use in younger children with autism, which is a new application for the drug.
Esomeprazole, like any medication, can cause side effects. Common side effects include headaches, nausea, and stomach pain, while serious side effects are rare. This trial aims to provide more information about its safety for children with autism. Consulting a doctor about any concerns before joining a trial is advisable.12345Why do researchers think this study treatment might be promising for Autism?
Researchers are excited about Esomeprazole for autism because it offers a novel approach compared to traditional therapies. While most current treatments for autism focus on behavioral therapy or medications targeting neurotransmitter levels, Esomeprazole is a proton pump inhibitor typically used for acid reflux. The excitement lies in its potential to address underlying inflammation and oxidative stress, which are thought to play a role in autism symptoms. This could pave the way for a new therapeutic strategy that complements existing treatments, providing a more comprehensive approach to managing autism.
What evidence suggests that Esomeprazole might be an effective treatment for Autism Spectrum Disorder?
Research on Esomeprazole, a common treatment for GERD (acid reflux), shows it effectively addresses digestive problems. One study found that 93% of patients with esophageal damage from acid healed after using Esomeprazole. However, no direct evidence supports Esomeprazole's effectiveness for social communication issues in children with Autism Spectrum Disorder (ASD). This trial investigates whether Esomeprazole might help with autism symptoms, based on its effects in other conditions. The goal is to determine if the drug can affect autism symptoms, but this remains under investigation.678910
Who Is on the Research Team?
Antonio Hardan, MD
Principal Investigator
Stanford University
Are You a Good Fit for This Trial?
This trial is for children aged 2-6 with Autism Spectrum Disorder who are physically healthy and can swallow the medication. They must have a reliable caregiver, no changes in their treatments planned, and stable medications for at least 2 weeks.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Esomeprazole for 12 weeks to evaluate its efficacy on social communication deficits in children with ASD
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Esomeprazole
Trial Overview
The study tests Esomeprazole's effectiveness on social communication in autistic children over a 12-week period. It's an open-label trial, meaning everyone knows they're getting the drug, involving 25 participants.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Esomeprazole Dosage (Weight Less Than 20 kg) -- 10 mg QD for 8 weeks Esomeprazole Dosage (Weight 20 kg or Greater) -- 10 mg QD for 4 weeks followed by 20 mg QD for 4 weeks
Esomeprazole is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:
- Gastroesophageal reflux disease (GERD)
- Stomach ulcers
- Duodenal ulcers
- Zollinger-Ellison Syndrome
- Gastroesophageal reflux disease (GERD)
- Stomach ulcers
- Duodenal ulcers
- Zollinger-Ellison Syndrome
- Pathological hypersecretory conditions
- Gastroesophageal reflux disease (GERD)
- Stomach ulcers
- Duodenal ulcers
- Zollinger-Ellison Syndrome
- Gastroesophageal reflux disease (GERD)
- Stomach ulcers
- Duodenal ulcers
- Gastroesophageal reflux disease (GERD)
- Stomach ulcers
- Duodenal ulcers
- Gastroesophageal reflux disease (GERD)
- Stomach ulcers
- Duodenal ulcers
- Zollinger-Ellison Syndrome
Find a Clinic Near You
Who Is Running the Clinical Trial?
Stanford University
Lead Sponsor
SPARK (Stanford University)
Collaborator
Citations
Efficacy and Safety of Esomeprazole for the Treatment of ...
Esomeprazole treatment yielded a significant improvement in clinical signs and symptoms of GERD compared to placebo group.
Healing of EE | NEXIUMยฎ (esomeprazole magnesium)
In GERD patients with varying grades of EE through 8 weeks, 93% of patients were healed with NEXIUM 40 mg QD (n=2624) vs 89% with omeprazole 30 mg QD (n=2617) ( ...
Efficacy and safety of esomeprazole compared with ...
The results of this study indicate that esomeprazole provides a significant advantage over omeprazole in terms of esophageal healing and relief of heartburn in ...
A review of esomeprazole in the treatment ...
Despite some controversy, data from clinical trials and meta-analyses indicate that esomeprazole 40 mg od for up to 8 weeks provided higher rates of healing of ...
5.
journals.lww.com
journals.lww.com/ajg/fulltext/2014/10002/short_term_esomeprazole_treatment_resolves_reflux.45.aspxShort-term Esomeprazole Treatment Resolves Reflux ...
Results: At end of week 2, complete resolution of HB (i.e., no HB on prior 7 consecutive days) was achieved by a substantially greater proportion of subjects ...
6.
ema.europa.eu
ema.europa.eu/en/documents/product-information/nexium-control-epar-product-information_en.pdfNexium Control, INN-Esomeprazole Magnesium
5.3 Preclinical safety data. Non-clinical data reveal no particular hazard for humans based on conventional studies of safety pharmacology, repeated dose ...
7.
astrazeneca.com.au
astrazeneca.com.au/content/dam/az-au/Material%20Safety%20Data/Nexiumltsupgt174ltsupgt-Tablets.pdfSAFETY DATA SHEET
Description of first aid measures. Inhalation. : Remove patient from exposure. Obtain medical attention if ill effects occur. Skin Contact.
8.
accessdata.fda.gov
accessdata.fda.gov/drugsatfda_docs/label/2014/022101s014021957s017021153s050lbl.pdfNEXIUM (esomeprazole magnesium) Label
Risk Summary. There are no adequate and well-controlled studies with NEXIUM in pregnant women. Esomeprazole is the S-isomer of omeprazole. Available ...
9.
dailymed.nlm.nih.gov
dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f4853677-1622-4037-688b-fdf533a11d96esomeprazole magnesium capsule, delayed release NEXIUM
The safety and effectiveness of NEXIUM delayed-release capsules and NEXIUM for delayed-release oral suspension have been established in pediatric patients 12 ...
Esomeprazole (Nexium) - Uses, Side Effects, and More
Find patient medical information for Esomeprazole (Nexium) on WebMD including its uses, side effects and safety, interactions, pictures, ...
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.