Trials / Completed
CompletedNCT02710084
Piloting Treatment With Intranasal Oxytocin in Phelan-McDermid Syndrome
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 18 (actual)
- Sponsor
- Alexander Kolevzon · Academic / Other
- Sex
- All
- Age
- 5 Years – 17 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Oxytocin | Intranasal oxytocin |
| DRUG | Saline | Placebo |
Timeline
- Start date
- 2016-04-29
- Primary completion
- 2020-07-29
- Completion
- 2020-07-29
- First posted
- 2016-03-16
- Last updated
- 2021-12-06
- Results posted
- 2021-12-06
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02710084. Inclusion in this directory is not an endorsement.