A Superiority Study To Compare The Effect of Panzyga Versus Placebo in Patients with Pediatric Acute-onset Neuropsychiatric Syndrome

Octapharma Pharmazeutika Produktionsges.m.b.H.0 个研究点开始时间: 2021年8月16日最近更新: 2021年8月24日

适应症

试验速览

暂无简介。

•1. Patients =6 to =17 years of age.
•2. Confirmed diagnosis of moderate to severe PANS with prominent and stable obsessive-compulsive disorder (OCD) symptoms (i.e. Clinical Global Impression (CGI)—Severity-OCD rating of = 4 or higher on 2 ratings without a change of more than 1 unit between measurements) based on the following criteria :
•a. Abrupt dramatic onset of OCD meeting DSM-5 diagnostic criteria for OCD as confirmed by the MINI-KID-7
•b. Concurrent presence of additional neuropsychiatric symptoms, with similarly severe and acute onset, from at least two of the following seven categories, that are not better explained by a known neurologic or medical disorder, such as Sydenham chorea (SC), systemic lupus erythematosus, Tourette disorder, or other:
•Anxiety (particularly, separation anxiety)
•Emotional lability (extreme mood swings) and/or depression
•Irritability, aggression and/or severely oppositional behaviors
•Behavioral (developmental) regression (examples, talking baby talk, throwing temper tantrums, etc.)
•Deterioration in school performance Sensory or motor abnormalities
•Somatic signs and symptoms, including sleep disturbances, bed wetting or urinary frequency
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 92
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•1. Onset of initial PANS symptoms more than six months prior to Screening. In patients with relapsing symptoms, initial symptoms may not have been more than 12 months prior to Screening, must have fully resolved based on investigator’s judgment, and their recurrence must be less than 6 months prior to Screening.
•5. Presence of symptoms consistent with autism or schizophrenia, bipolar disorder, or other psychotic disorder.
•7. Treatment with systemic corticosteroids within eight weeks before randomization.
•8. History of rheumatic fever, including SC (neurological manifestation).
•9. Past treatment of neuropsychiatric symptoms with immunomodulatory therapy (such as systemic corticosteroids, IVIG or plasmapheresis).
•10. Initiation of cognitive behavioral therapy (CBT) within eight weeks before randomization.
•11. Start of treatment or change in dosing with selective serotonin reuptake inhibitors [SSRIs] within eight weeks before randomization. Treatment with alpha-2 agonists or antipsychotics within eight weeks before randomization.
•12. Completion of antibiotics or antiviral drugs course for acute infection within one week before randomization. Use of antibiotics at a prophylactic dose is allowed if started at least eight weeks before randomization.

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