Pediatric acute-onset neuropsychiatric syndrome (PANS)
Conditions
Brief summary
Improvement of neuropsychiatric symptomatology and behavior in PANS patients determined by clinician-rated CY-BOCS score. The mean changes in the total CY-BOCS score from Baseline to Week 9 will be compared between Panzyga and placebo treatment to demonstrate superiority.
Detailed description
1. To assess the durability of the clinical benefit associated with Panzyga treatment, the CY-BOCS score at the end of the follow-up period at Week 18 will be compared to the Week 9 scores within the (Panzyga – Placebo) treatment sequence group to assess the durability of the clinical benefit associated with Panzyga treatment, 2. Clinical Global Impression (CGI), 3. Parent & Child OC Impact Scale – Revised (COIS-RP and COIS-RC), 4. The Swanson, Nolan, and Pelham Rating Scale (SNAP-IV, 26 item), 5. Parent Tic Questionnaire (PTQ)
Interventions
DRUG0.9% w/v sodium chloride solution for intravenous infusion
Sponsors
Octapharma Pharmazeutika Produktionsgesellschaft mbH
Eligibility
Sex/Gender
All
Age
0 Years to 17 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement of neuropsychiatric symptomatology and behavior in PANS patients determined by clinician-rated CY-BOCS score. The mean changes in the total CY-BOCS score from Baseline to Week 9 will be compared between Panzyga and placebo treatment to demonstrate superiority. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To assess the durability of the clinical benefit associated with Panzyga treatment, the CY-BOCS score at the end of the follow-up period at Week 18 will be compared to the Week 9 scores within the (Panzyga – Placebo) treatment sequence group to assess the durability of the clinical benefit associated with Panzyga treatment, 2. Clinical Global Impression (CGI), 3. Parent & Child OC Impact Scale – Revised (COIS-RP and COIS-RC), 4. The Swanson, Nolan, and Pelham Rating Scale (SNAP-IV, 26 item), 5. Parent Tic Questionnaire (PTQ) | — |
Countries
Italy, Sweden
Outcome results
None listed