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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
ages 6- to 15-years-old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre- to post-8 week treatment
Awards & highlights
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 belowSelect...
I am between 6 and 15 years old.
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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 have OCD with increased anxiety, mood swings, learning issues, regression, sleep problems, handwriting changes, and urinary issues.
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I have noticed changes in my handwriting or involuntary movements.
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My symptoms started before puberty.
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I can take medication in pill form.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ pre- to post-8 week treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre- to post-8 week treatment
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 • NCT013005465%
Allergic Rhinitis
5%
Allodynia
5%
Sinusitis
5%
Cough
5%
Root Canal Pain
5%
Stiffness in neck
5%
Diarrhea
5%
Nasal Congestion
5%
Fever
5%
Insomnia
5%
Weight Gain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Sumatriptan/Naproxen Sodium
Naproxen Sodium
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
2,933 Previous Clinical Trials
13,198,411 Total Patients Enrolled
26 Trials studying Obsessive-Compulsive Disorder
1,562 Patients Enrolled for Obsessive-Compulsive Disorder
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 6 and 15 years old.My child is currently experiencing severe mental health issues.I am between 6 and 15 years old.Obsessive-compulsive disorder can significantly interfere with your life.My symptoms get worse when I have a strep throat infection.You have a history of limiting how much fluid you drink, which could make side effects worse.I have noticed changes in my handwriting or involuntary movements.The child has a severe condition affecting the brain, such as brain damage, blindness, deafness, intellectual disability or autism.My symptoms worsened significantly within 24-48 hours when my OCD started.My dose for depression or anxiety medication has been stable for at least 6 weeks.My symptoms worsened quickly within 1-2 days or come and go over time.I have OCD with increased anxiety, mood swings, learning issues, regression, sleep problems, handwriting changes, and urinary issues.You have severe symptoms of Obsessive-Compulsive Disorder (OCD) that may affect your ability to participate in the study.I am not taking any psychotropic or anti-inflammatory medications that aren't approved.You have a history of severe asthma or your asthma is not currently under control.I do not have liver, kidney, or bleeding disorders.I have noticed changes in my handwriting or involuntary movements.My symptoms worsened rapidly within 1-2 days or come and go over time.Symptoms of OCD that started within the last 18 months.I have had ulcers in my digestive system before.I am currently in a weekly or more frequent cognitive behavioral therapy program.My symptoms started before puberty.I can take medication in pill form.I have received treatments to modulate my immune system for OCD/PANDAS.I am currently on antibiotics or have been in the last week.My symptoms get worse when I have a strep throat infection.You have experienced new OCD symptoms in the last 18 months.
Research Study Groups:
This trial has the following groups:- Group 1: Intervention
- Group 2: Placebo
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Obsessive-Compulsive Disorder 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
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