Trials / Unknown
UnknownNCT03348618
A Study to Evaluate the Benefit of Octagam 5%® in Subjects With Pediatric Acute-onset Neuropsychiatric Syndrome (PANS)
A Multi-site, Open-Label, Pilot Study to Evaluate the Benefit of Octagam 5%® in Subjects With Pediatric Acute-onset Neuropsychiatric Syndrome (PANS)
- Status
- Unknown
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 21 (estimated)
- Sponsor
- IMMUNOe Research Centers · Industry
- Sex
- All
- Age
- 4 Years – 16 Years
- Healthy volunteers
- Not accepted
Summary
This study will evaluate the use of intravenous immunoglobulins (IVIG) at a dose of 1g/Kg/body weight given every three weeks for 6 infusions in pediatric subjects ages 4 - 16 years with moderate to severe PANS. The study will compare biomarkers and behavioral scales before treatment, after the last infusion, 2 months, and at a minimum 6 months post-treatment.
Detailed description
IVIG at an immunomodulatory dose of 1 g/Kg body weight has been known to induce suppression of systemic inflammation and has been used in the treatment of autoimmune diseases. It has been proven beneficial in inflammatory conditions affecting the nervous system.
Conditions
- Pediatric Acute-Onset Neuropsychiatric Syndrome
- Pediatric Autoimmune Neuropsychiatric Disorders Associated With Streptococcal Infections
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | IVIG | Intravenous immunoglobulin |
Timeline
- Start date
- 2017-11-24
- Primary completion
- 2019-11-01
- Completion
- 2020-03-01
- First posted
- 2017-11-21
- Last updated
- 2019-11-19
Locations
3 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03348618. Inclusion in this directory is not an endorsement.