52-week, open-label extension study of double-blind study ACP-103-069 to determine the long-term safety and tolerability of pimavanserin for the treatment of irritability associated with ASD in children and adolescents (aged 5 to 17 years). ACP-103-069 is a 6-week, randomized, double-blind, fixed-dose, placebo controlled, parallel group study of pimavanserin in children and adolescents with irritability associated with autism spectrum disorder (ASD).
This study will be conducted as a 52-week, open-label extension study of the antecedent double-blind study to determine the long-term safety and tolerability of pimavanserin for the treatment of irritability associated with ASD in children and adolescents (5 through 17 years old at the time of enrolling into the antecedent double-blind study).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
209
Pimavanserin given once daily, as capsule of 10, 20, or 34 mg dose strength, respectively, according to the patient's age
Treatment-emergent Adverse Events
Number (%) of patients with treatment emergent adverse events
Time frame: 52 weeks
Aberrant Behavior Checklist-Irritability (ABC-I) and Clinical Global Impression-Improvement (CGI-I) Response Rate
The response rate was defined as the proportion of patients with at least 25% reduction from baseline to Week 52 in ABC-I and a CGI-I of irritability score of 1 (very much improved) or 2 (much improved) at Week 52, compared to baseline. Baseline was the baseline of the antecedent double-blind study APC-103-069. The ABC is a parent/caregiver-rated scale comprised of 5 subscales encompassing 58 items. Subscales are irritability, lethargy, stereotypic behavior, hyperactivity, and inappropriate speech. Items are rated on a 4-point Likert scale ranging from 0 (not at all a problem) to 3 (the problem is severe), with higher scores indicating more severe problems. Subscale scores are calculated by summing the items within that subscale. The CGI-I is a clinician-rated, 7-point scale to assess how much the patient's illness (here: the patient's irritability) has changed relative to baseline. Scores range from 1 (very much improved) to 7 (very much worse).
Time frame: 52 weeks
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