Naproxen Sodium for Autoimmune Diseases

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
Autoimmune Diseases+5 More
Naproxen Sodium - Drug
Eligibility
< 18
All Sexes
What conditions do you have?
Select

Study Summary

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

Eligible Conditions
  • Autoimmune Diseases
  • Obsessive-Compulsive Disorder
  • PANDAS
  • Anxiety Disorders

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Study Objectives

2 Primary · 2 Secondary · Reporting Duration: Pre- to Post-8 week treatment

Week 8
Changes in C reactive protein pre- and post-treatment between groups
Changes in erythrocyte sedimentation rate pre- and post-treatment between groups
Children's Yale-Brown Obsessive-Compulsive Scale, 1st Edition (CY-BOCS-I)
Children's Yale-Brown Obsessive-Compulsive Scale, 2nd Edition (CY-BOCS-II)

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Side Effects for

Naproxen Sodium
5%Wisdom Teeth Extraction Pain
5%Vomiting
5%Left Arm Numbness
5%Kidney Stone Pain Flare
5%Back Pain
5%Left Hand Numbness
5%Right Chest Wall Pain
5%Neck Pain
5%Left Arm Pain
5%Sinusitis
This histogram enumerates side effects from a completed 2012 Phase 4 trial (NCT01300546) in the Naproxen Sodium ARM group. Side effects include: Wisdom Teeth Extraction Pain with 5%, Vomiting with 5%, Left Arm Numbness with 5%, Kidney Stone Pain Flare with 5%, Back Pain with 5%.

Trial Design

2 Treatment Groups

Intervention
1 of 2
Placebo
1 of 2
Experimental Treatment
Non-Treatment Group

70 Total Participants · 2 Treatment Groups

Primary Treatment: Naproxen Sodium · Has Placebo Group · Phase 4

Intervention
Drug
Experimental Group · 1 Intervention: Naproxen Sodium · Intervention Types: Drug
Placebo
Other
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Naproxen
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: pre- to post-8 week treatment

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
2,673 Previous Clinical Trials
30,828,586 Total Patients Enrolled
1 Trials studying Autoimmune Diseases
10 Patients Enrolled for Autoimmune Diseases

Eligibility Criteria

Age < 18 · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
A symptom that starts during the prepubertal stage.
The symptoms get worse very quickly, within 24 to 48 hours, and they keep coming back.
patients and their family members Researchers found a link between the occurrence of GAS infections and the periods when patients experienced symptoms
There are neurological abnormalities present, such as deterioration in handwriting and choreiform movements.
Obsessive-compulsive disorder can significantly interfere with your life.
Symptoms of OCD that started within the last 18 months.
A parent or legal guardian who can provide informed consent is eligible to participate in the study.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 21st, 2021

Last Reviewed: October 11th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

Who else is applying?

What state do they live in?
New York20.0%
Texas20.0%
Maryland20.0%
Other40.0%
How old are they?
18 - 65100.0%
What site did they apply to?
Massachusetts General Hospital100.0%
What portion of applicants met pre-screening criteria?
Met criteria80.0%
Did not meet criteria20.0%