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NCT01281969 · ClinicalTrials.gov registry record · Phase 3
Intravenous Immunoglobulin for PANDAS
A Phase 3 study, sponsored by National Institute of Mental Health (NIMH).
- Completed
- Registry status
- Phase 3
- Development phase
- 48
- Enrollment target
NCT01281969 is a Phase 3 study that has completed, run by National Institute of Mental Health (NIMH). The registered enrollment target is 48 participants.
The verdict
NCT01281969, a Phase 3 study, has completed, sponsored by National Institute of Mental Health (NIMH).
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 48 participants
- Enrollment target
Study Summary
Background: \- Some children experience a sudden onset of symptoms similar to those found in obsessive-compulsive disorder that may be caused by the body s reaction to an infection with streptococcal bacteria, most commonly seen as strep throat or scarlet fever. When the body s immune system reacts against brain cells following a streptococcal infection, the condition is known as PANDAS (pediatric autoimmune neuropsychiatric disorders associated with streptococcal infections). The immune system response can be inactivated by treatment with a drug known as intravenous immunoglobulin (IVIG). Because there is insufficient research on IVIG s effects on the immune system of children with PANDAS, including whether IVIG is helpful in treating obsessive-compulsive symptoms related to PANDAS, researchers are interested in examining whether IVIG is an appropriate treatment for PANDAS and its associated symptoms. Objectives: \- To test the safety and effectiveness of intravenous immunoglobulin for the treatment of obsessive-compulsive disorder in children with PANDAS (pediatric autoimmune neuropsychiatric disorder associated with streptococcal infection). Eligibility: \- Children between 4 and 12 years of age who have obsessive-compulsive disorder (with or without a tic disorder) with sudden onset of symptoms following Group A streptococcal bacterial infections. Design: * Participants will be screened by telephone to obtain medical history and other information, followed by in-person screening at the National Institutes of Health Clinical Center. * Participants will be admitted to the hospital to receive 2 days of infusions of either IVIG or a placebo. Frequent blood samples, imaging studies, and other tests will be performed during this visit. * Six weeks after the inpatient stay, participants will return for further blood samples and other tests. Participants who did not receive the study drug, or who received the drug but did not respond to the initial IVIG infusion,
Interventions
- DRUG Placebo
- DRUG Gamunex Intravenous Immunoglobulin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2011-01 |
| Est. Completion | 2018-08-13 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01281969
The ClinicalTrials.gov registry entry for NCT01281969 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 48 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Mental Health (NIMH), which has 343 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01281969 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01281969 about?
NCT01281969 is a clinical study titled "Intravenous Immunoglobulin for PANDAS". Background: \- Some children experience a sudden onset of symptoms similar to those found in obsessive-compulsive disorder that may be caused by the body s reaction to an infection with streptococcal bacteria, most commonly seen as strep throat or scarlet fever. When the body s immune system reacts...
What is the current status of trial NCT01281969?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 48 participants. The study started on 2011-01. Estimated completion is 2018-08-13.
What interventions are being tested in trial NCT01281969?
The interventions under investigation include: Placebo (DRUG), Gamunex Intravenous Immunoglobulin (DRUG).
Who is sponsoring clinical trial NCT01281969?
This trial is sponsored by National Institute of Mental Health (NIMH), which has 343 total clinical trials registered on ClinicalTrials.gov.
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