At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 18 enrolled
Drug / intervention
Oxytocin +1 moredrug
Likely dose
Not stated in 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.
Piloting Treatment With Intranasal Oxytocin in Phelan-McDermid Syndrome
In Brief
A Phase 2 clinical trial evaluating Oxytocin and Saline for Phelan-McDermid Syndrome. Completed, enrolled 18 participants across 1 site.
Detailed Summary
This is a pilot study examining the efficacy, safety and tolerability of intranasal oxytocin as a novel treatment in Phelan-McDermid syndrome (PMS). This study will utilize a randomized, placebo-controlled design for 12 weeks (phase 1), followed by an open-label extension for 12 weeks (phase 2). The purpose is to evaluate the effect of intranasal oxytocin on impairments in attention, social memory, socialization, language, and repetitive behaviors.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPhelan-McDermid Syndrome
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedMar 2016
Enrollment StartApr 2016
Primary CompletionJul 2020
TodayJul 2026
First PostedMar 16, 2016
Enrollment StartApr 29, 2016
Primary CompletionJul 29, 2020
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 10.3 years ago
Interventions
Oxytocindrug
Intranasal oxytocin
Salinedrug
Placebo