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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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4 April 2022 |
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Main ID: |
NCT02895906 |
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Date of registration:
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29/08/2016 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Safety and Efficacy Study of NFC-1 in Subjects Aged 12-17 Years With 22q11.2DS & Associated Neuropsychiatric Conditions
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Scientific title:
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A 5-Week, Multi-center, Open-label Study to Assess the Safety and Efficacy of NFC-1 in Subjects Aged 12-17 Years With 22q11.2 Deletion Syndrome and Commonly Associated Neuropsychiatric Conditions (Anxiety, ADHD, ASD) |
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Date of first enrolment:
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November 28, 2016 |
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Target sample size:
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2 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02895906 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 1
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Countries of recruitment
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United States
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Subject has a diagnosis of a 22q11.2 deletion prior to screening.
- Subject has a diagnosis of anxiety disorder and/or ADHD and/or ASD based upon
diagnostic evaluations performed at screening, history, and clinical judgement.
- Subject is judged to be in general good health, other than having anxiety disorder
and/or ADHD and/or ASD and 22q11DS. Medical conditions related to 22q11DS must be
clinically stable post surgical correction and/or medical management.
- Subject has no clinically significant abnormality on 12-lead electrocardiogram (ECG)
performed at screening or baseline such as serious arrhythmia, bradycardia,
tachycardia, cardiac conduction problems, or other abnormalities deemed to be a
potential safety issue.
- Subject and parent/legal guardian understand the study procedures and agree to the
subject's participation in the study as indicated by parental/legal guardian signature
on the subject informed consent form and subject's signature on the assent form.
Exclusion Criteria:
- Subject has a diagnosis of co-morbid major psychiatric disorders (ie, aside from
anxiety disorder, ADHD, and/or ASD), including major depression, bipolar disease,
schizophrenia (or any psychotic disorder), and moderate or severe intellectual
disability, which in the opinion of the investigator may interfere with the conduct of
study evaluations.
- Subject has an IQ < 65 as determined by the Wechsler Abbreviated Scale of
Intelligence.
- Subject has a history of any illness that, in the opinion of the study investigator,
might confound the results of the study or pose an additional risk to the subject by
his/her participation in the study.
- Subject has a history of clinically significant endocrine, gastrointestinal,
cardiovascular, hematological, hepatic, immunological, renal, respiratory, or
genitourinary abnormalities or disease which is not currently stable clinically.
Subjects with a history of uncomplicated kidney stones may be enrolled in the study at
the discretion of the investigator.
- Subject has a history of stroke, chronic seizures, or other major neurological
disorder which, in the opinion of the investigator, would interfere with the subject's
ability to participate and/or be evaluated in the trial.
- Subject is currently considered at risk for suicide (in the opinion of the
investigator), has previously made a suicide attempt, or is currently demonstrating
active suicidal ideation.
- Subject has taken any antidepressants, antipsychotics, anxiolytics, or non-stimulant
ADHD medication within 30 days of the Screening Visit.
- Subject is taking a prohibited medication
Age minimum:
12 Years
Age maximum:
17 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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22q11.2 Deletion Syndrome
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Intervention(s)
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Drug: NFC-1
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Primary Outcome(s)
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Time to symptom relapse
[Time Frame: Through study completion, up to 5 weeks]
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Secondary Outcome(s)
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Safety and tolerability as determined by AEs, laboratory results, C-SSRS, and K-SADS
[Time Frame: Through study completion, up to 5 weeks]
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Response to treatment based on Clinical Global Impression - Improvement scale
[Time Frame: Through study completion, up to 5 weeks]
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Secondary ID(s)
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MDGN-NFC1-22Q-101
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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