Holland Bloorview Kids Rehabilitation Hospital
Toronto, Ontario, M5G1R8, Canada
NCT Number: NCT06341127
This is a single patient study of oral powdered fluoxetine to target developmental outcomes in a child with KCNC1-related disorder. This trial will be conducted at Holland Bloorview Kids Rehabilitation Hospital over 32 to 42 weeks, using a quasi experimental ABA phase design (placebo-fluoxetine-placebo) with randomized and blinded active treatment start and stop moments.
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Notify MeUp to 18 year
All sexes
Interventional
Not applicable
Toronto, Ontario, M5G1R8, Canada
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Oral fluoxetine daily, 2.5 to 5 mg.
Time frame: Weekly from date of randomization to up to 42 weeks
Parent report on the Early Motor Questionnaire
Time frame: From date of randomization to up to 42 weeks
Adverse event reporting
Time frame: Week 1, 13, 29 and 37
Vineland Adaptive Behavior Scale
Time frame: Week 1, 13, 29 and 37
Mullen Scales of Early Learning
Time frame: Weekly from date of randomization to up to 42 weeks
Measure Your Own Medical Profile- 2
Time frame: Every 4 weeks from date of randomization to up to 42 weeks
Clinician assessment of overall development
Holland Bloorview Kids Rehabilitation Hospital
Other
A Single Patient Trial of Fluoxetine in KCNC1-related Disorder
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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