Esomeprazole for Autism

Overseen By Briana Hernandez

Age: < 18

Sex: Any

Trial Phase: Phase 2

Sponsor: Stanford University

Disqualifiers: Schizophrenia, Schizoaffective, Psychotic, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 6 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

Duration: 12 weeks

25 Participants Needed

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. ^{1 2 3 4 5}

Why 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. ^{6 7 8 9 10}

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

no planned changes in psychosocial interventions during the open-label trial.

I am between 2 and 6 years old.

I am physically healthy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Esomeprazole for 12 weeks to evaluate its efficacy on social communication deficits in children with ASD

12 weeks

Baseline, 4 weeks, 8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

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?

Group I: Esomeprazole Experimental Treatment 1 Intervention

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:

Approved in European Union as Nexium for:

• Gastroesophageal reflux disease (GERD)
• Stomach ulcers
• Duodenal ulcers
• Zollinger-Ellison Syndrome

Approved in United States as Nexium for:

• Gastroesophageal reflux disease (GERD)
• Stomach ulcers
• Duodenal ulcers
• Zollinger-Ellison Syndrome
• Pathological hypersecretory conditions

Approved in Canada as Nexium for:

• Gastroesophageal reflux disease (GERD)
• Stomach ulcers
• Duodenal ulcers
• Zollinger-Ellison Syndrome

Approved in Japan as Nexium for:

• Gastroesophageal reflux disease (GERD)
• Stomach ulcers
• Duodenal ulcers

Approved in China as Nexium for:

• Gastroesophageal reflux disease (GERD)
• Stomach ulcers
• Duodenal ulcers

Approved in Switzerland as Nexium for:

• Gastroesophageal reflux disease (GERD)
• Stomach ulcers
• Duodenal ulcers
• Zollinger-Ellison Syndrome

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

SPARK (Stanford University)

Collaborator

Trials

1

Recruited

30+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8215048/

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.

2. purplepill.com purplepill.com/hcp/healing-of-ee.html

Healing of EE | NEXIUM® (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) ( ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0002927000023935

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 ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2374928/

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.aspx

Short-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.pdf

Nexium 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.pdf

SAFETY 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.pdf

NEXIUM (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-fdf533a11d96

esomeprazole 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 ...

10. webmd.com webmd.com/drugs/2/drug-20536/nexium-oral/details

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, ...