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Nonsteroidal Anti-inflammatory Drug

Naproxen Sodium for OCD in PANDAS

Phase 4
Recruiting
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
ages 6- to 15-years-old
presence of neurological abnormalities (e.g. handwriting deterioration, choreiform movements).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre- to post-8 week treatment
Awards & highlights
Drug Has Already Been Approved
Pivotal Trial

Study Summary

This trial will study whether the anti-inflammatory drug Naproxen Sodium can help treat symptoms of OCD in children with PANDAS.

Who is the study for?
This trial is for children aged 6-15 with PANDAS-related OCD, showing severe symptoms like anxiety, emotional changes, learning difficulties, sleep disorders, and motoric dysfunction. They must have had a recent strep infection and not be on certain medications or treatments.Check my eligibility
What is being tested?
The study tests Naproxen Sodium against a placebo in kids with PANDAS to see if it reduces inflammation-related OCD symptoms. It's a double-blind trial meaning neither the participants nor the researchers know who gets the real medicine or placebo.See study design
What are the potential side effects?
Naproxen may cause digestive issues like ulcers, liver or kidney problems, bleeding disorders, asthma exacerbation and could affect fluid balance. Not all children will experience these side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 6 and 15 years old.
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I have noticed changes in my handwriting or involuntary movements.
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I am between 6 and 15 years old.
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I can take medication in pill form.
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My symptoms started before puberty.
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My symptoms worsened quickly within 1-2 days or come and go over time.
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I have noticed changes in my handwriting or involuntary movements.
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I have OCD with increased anxiety, mood swings, learning issues, regression, sleep problems, handwriting changes, and urinary issues.
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My symptoms worsened significantly within 24-48 hours when my OCD started.
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My symptoms get worse when I have a strep throat infection.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre- to post-8 week treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and pre- to post-8 week treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Children's Yale-Brown Obsessive-Compulsive Scale, 1st Edition (CY-BOCS-I)
Children's Yale-Brown Obsessive-Compulsive Scale, 2nd Edition (CY-BOCS-II)
Secondary outcome measures
Changes in C reactive protein pre- and post-treatment between groups
Changes in erythrocyte sedimentation rate pre- and post-treatment between groups

Side effects data

From 2012 Phase 4 trial • 40 Patients • NCT01300546
5%
Cough
5%
Allodynia
5%
Diarrhea
5%
Nasal Congestion
5%
Allergic Rhinitis
5%
Fever
5%
Insomnia
5%
Root Canal Pain
5%
Sinusitis
5%
Stiffness in neck
5%
Weight Gain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Sumatriptan/Naproxen Sodium
Naproxen Sodium

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: InterventionExperimental Treatment1 Intervention
Participants receive Naproxen Sodium.
Group II: PlaceboPlacebo Group1 Intervention
Participants receive placebo.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Naproxen Sodium
2006
Completed Phase 4
~400

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
2,901 Previous Clinical Trials
13,185,524 Total Patients Enrolled
1 Trials studying Autoimmune Diseases
10 Patients Enrolled for Autoimmune Diseases

Media Library

Naproxen Sodium (Nonsteroidal Anti-inflammatory Drug) Clinical Trial Eligibility Overview. Trial Name: NCT04015596 — Phase 4
Autoimmune Diseases Research Study Groups: Intervention, Placebo
Autoimmune Diseases Clinical Trial 2023: Naproxen Sodium Highlights & Side Effects. Trial Name: NCT04015596 — Phase 4
Naproxen Sodium (Nonsteroidal Anti-inflammatory Drug) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04015596 — Phase 4
Autoimmune Diseases Patient Testimony for trial: Trial Name: NCT04015596 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?
Texas
Maryland
Wisconsin
Other
How old are they?
18 - 65
What site did they apply to?
Massachusetts General Hospital
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

Explore a therapeutic option that may aid in addressing my health issue and contribute to the efforts of the scientific community in seeking a remedy for this disease.
PatientReceived no prior treatments
~12 spots leftby Oct 2024