EUCTR2020-000867-21-SE进行中（未招募）1 期
A superiority Phase III study to compare the effect of Panzyga versus placebo in patients with pediatric acute-onset neuropsychiatric syndrome - N/A
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 92
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •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
- •3. Signed informed consent of patient’s legal representative(s)/guardians(s). If patients are old enough to understand the risks and benefits of the study (as determined by each institution), they should provide written assent/consent.
- •4. Legal representative(s)/guardians(s) must be capable of understanding and complying with the relevant aspects of the study protocol.
- •Patients who will additionally meet the following optional inclusion criteria will be identified as patients with Pediatric autoimmune neuropsychiatric disorders associated with streptococcal infection (PANDAS):
- •1. An episodic (relapsing-remitting) course of symptom severity
- •2. Temporal association between symptoms onset or exacerbation and infections with group A streptococcal infection (GAS, positive throat culture and/or anti-GAS antibody titers)
- •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
排除标准
- •1.Onset of current PANS episode more than 12 months prior to first investigational medicinal product (IMP) treatment.
- •2.a. In patients with relapsing episodes: Onset of initial PANS episode more than 24 months prior to first IMP treatment
- •b. In patients with relapsing episodes: Absence of significant improvement and stabilization between the episodes according to investigator's judgment.
- •3.Contraindications to receiving intravenous immunoglobulin (IVIG), including:
- •a.History of severe hypersensitivity, e.g. anaphylaxis or severe systemic response, to immunoglobulin, blood or plasma derived products, or any component of Panzyga.
- •b.Immunoglobulin (Ig) A deficiency with antibodies to IgA (<7 mg/dL).
- •c.Hyperviscosity syndromes or known or suspected hypercoagulable conditions as inferred from clinical history, which can increase risks of thrombosis associated with IVIG administration.
- •d.History of arterial or venous thrombotic or thromboembolic events (TEEs) within the last year prior to Baseline. History of acquired or inherited thrombophilia any time prior to Baseline.
- •e.Need for live virus vaccine within three months after receiving study drug.
- •f.Renal dysfunction (creatinine >120 µmol/L or 1.36 mg/dL), history of renal dysfunction, or known risk factor for renal dysfunction (chronic renal insufficiency, diabetes mellitus, taking known nephrotoxic medication).
- •4.Severely restricted food intake likely to require parenteral nutrition, and <5th percentile BMI-for-age (BMI Percentile Calculator for Child and Teen based on Centers for Disease Control and Prevention growth charts for children and teens ages 2 through 19 years)
- •5.Body mass index = 40 kg/m2
- •6.Presence of symptoms consistent with autism or schizophrenia, bipolar disorder, or other psychotic disorder (unless psychotic symptoms have onset coincident with PANS).
- •7.Presence of serious or unstable medical illness, psychiatric (e.g. high suicide risk) or behavioral symptoms that would make participation unsafe or study procedures too difficult to tolerate.
- •8.Treatment with systemic corticosteroids within eight weeks before randomization.
- •9. Treatment with NSAIDs within five days before randomization.
- •10. Treatment with melatonin within one week before randomization.
- •11.History of rheumatic fever, including SC (neurological manifestation).
- •12.Past treatment of neuropsychiatric symptoms with immunomodulatory therapy (such as IVIG, rituximab or mycophenolate mofetil) or plasmapheresis.
- •13.Initiation of cognitive behavioral therapy (CBT) within eight weeks before randomization.
- •14.Start of treatment or change in dosing with selective serotonin reuptake inhibitors [SSRIs] within eight weeks before randomization.
- •15.Treatment with alpha-2 agonists or antipsychotics within eight weeks before randomization.
- •16.Start of treatment or change in dosing with stimulants (Methylphenidate, Amphetamine and similar products) for Attention-Deficit Hyperactivity Disorder (ADHD) within four weeks prior to randomization.
- •17.Active use of tetrahydrocannabinol (THC) containing agents within four weeks prior to enrollment or during the trial. Use of cannabidiol- (CBD) / cannabimovone- (CBM) containing agents without THC is allowed if started more than eight weeks before enrollment in a stable dose/frequency.
- •18.Use of antibiotics or antiviral drugs at therapeutic dose within one week before randomization. Use of antibiotics at a prophylactic dose is allowed if started at least fou
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