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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
1
Oral fluoxetine daily, 2.5 to 5 mg.
Holland Bloorview Kids Rehabilitation Hospital
Toronto, Ontario, Canada
Motor development
Parent report on the Early Motor Questionnaire
Time frame: Weekly from date of randomization to up to 42 weeks
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Adverse event reporting
Time frame: From date of randomization to up to 42 weeks
Adaptive skills
Vineland Adaptive Behavior Scale
Time frame: Week 1, 13, 29 and 37
Cognitive skills
Mullen Scales of Early Learning
Time frame: Week 1, 13, 29 and 37
Family priority outcome targets
Measure Your Own Medical Profile- 2
Time frame: Weekly from date of randomization to up to 42 weeks
Clinical Global Impression- Improvement Scale (CGI-I)
Clinician assessment of overall development
Time frame: Every 4 weeks from date of randomization to up to 42 weeks
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