At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 83 enrolled
Drug / intervention
SPD503 (extended-release Guanfacine hydrochloride) +1 moredrug
Likely dose
SPD503 (extended-release Guanfacine hydrochloride) 6 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Assess the Safety and Tolerability of SPD503 in Subjects Aged 6-17 Years With Generalized Anxiety Disorder (GAD), Separation Anxiety Disorder (SAD), or Social Phobia (SoP).
In Brief
A Phase 2 clinical trial evaluating SPD503 (extended-release Guanfacine hydrochloride) and Placebo for Generalized Anxiety Disorder (GAD) and 2 related conditions. Completed, enrolled 83 participants across 33 sites.
Detailed Summary
This study will evaluate the safety and tolerability of SPD503 in subjects aged 6-17 years with GAD, SAD, or SoP based on treatment emergent adverse events (TEAEs), vital signs and ECGs.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedNov 2011
Enrollment StartJan 2012
Primary CompletionJul 2013
TodayJul 2026
First PostedNov 11, 2011
Enrollment StartJan 4, 2012
Primary CompletionJul 15, 2013
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 14.6 years ago
Interventions
SPD503 (extended-release Guanfacine hydrochloride)drug
Once-daily oral dosing of SPD503 in the evening ranging from 1-6 mg for 12 weeks (6 week dose optimization and 6 week dose maintenance).
Placebodrug
Once-daily oral dosing in the evening for 12 weeks.