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NCT00001658 · ClinicalTrials.gov registry record · Phase 4

Amoxicillin for the Treatment of Pediatric Autoimmune Disorders Associated With Streptococcal Infections

A Phase 4 study, sponsored by National Institute of Mental Health (NIMH).

Completed
Registry status
Phase 4
Development phase
30
Enrollment target

NCT00001658: Completed Phase 4 study, sponsored by National Institute of Mental Health (NIMH).

NCT00001658 is a Phase 4 study that has completed, run by National Institute of Mental Health (NIMH). The registered enrollment target is 30 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00001658, a Phase 4 study, has completed, sponsored by National Institute of Mental Health (NIMH).

COMPLETED
Registry status
Phase 4
Development phase
30 participants
Enrollment target

Study Summary

Bacteria carry substances on their surface called antigens. When antigens come into contact with the right kinds of cells in the body an immune reaction is caused. This reaction is often the symptoms of sickness that a patient feels. In order for the body to fight off the attack of antigens, it creates substances called antibodies. Antibodies counter the action of antigens and make the bacteria harmless. However, the immune system must learn how to make the right antibodies for the right antigens. Sometimes the body creates antibodies that confuse normal tissues as foreign and attack them. This is called an autoimmune reaction and sometimes occurs when the body is exposed to certain bacteria. One bacteria known for causing autoimmune reactions is Group A beta-hemolytic Streptococcus (GABHS). This bacteria often causes throat infections commonly known as "strep throat". Some researchers believe that the autoimmune reaction associated with strep throat infections may cause neuropsychiatric disorders, like obsessive-compulsive disorder and/or tic disorder in children. As a result, each time a child with one of these disorders experiences an infection with GABHS his/her symptoms can reoccur or worsen. Researchers believe that by giving patients a certain antibiotic, they can prevent GABHS infection and thus prevent the return of symptoms. This study is designed to test the effectiveness of the antibiotic Amoxicillin for the treatment of Pediatric Autoimmune Neuropsychiatric Disorders Associated with Streptococcal infections (PANDAS). Patients will receive Amoxicillin for six weeks and placebos "inactive sugar pills" for six weeks in order to see if the medication is truly working. Effectiveness of the treatment will be based on the presence or absence of symptoms. If at the end of the study Amoxicillin is proven to be effective treatment for PANDAS patients may be offered the opportunity to continue taking the medication for an additional six months.

Interventions

  • DRUG Amoxicillin

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 1997-07
Est. Completion 2001-06
Phase Phase 4

What the finished NCT00001658 record still lists

NCT00001658 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (94% lower).

The record links to 0 conditions, and to 1 intervention - of which Amoxicillin is the first listed.

NCT00001658 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00001658 about?

NCT00001658 is a clinical study titled "Amoxicillin for the Treatment of Pediatric Autoimmune Disorders Associated With Streptococcal Infections". Bacteria carry substances on their surface called antigens. When antigens come into contact with the right kinds of cells in the body an immune reaction is caused. This reaction is often the symptoms of sickness that a patient feels. In order for the body to fight off the attack of antigens, it cre...

What is the current status of trial NCT00001658?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 30 participants. The study started on 1997-07. Estimated completion is 2001-06.

What interventions are being tested in trial NCT00001658?

The interventions under investigation include: Amoxicillin (DRUG).

Who is sponsoring clinical trial NCT00001658?

This trial is sponsored by National Institute of Mental Health (NIMH), which has 343 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00001658's enrollment target sits among peer trials

30 1552nd of 2000 higher than 367 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00001658, the US trial registry maintained by the National Library of Medicine. NCT00001658 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.