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- Check4 days agoChange DetectedThe study has been updated to version v2.10.0 and now includes 7 locations, replacing the previous version v2.9.7.SummaryDifference0.3%
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- Check32 days agoChange DetectedThe value 'Show more Show more Revision: v2.9.0' has recently changed to 'Show less MedlinePlus Genetics related topics: Autism spectrum disorder Drug Information available for: Oxytocin FDA Drug and Device Resources Show less Design Details Primary Purpose : Treatment Allocation : Randomized Interventional Model : Parallel Assignment Interventional Model Description: Randomized, Double-blind, placebo-controlled clinical trial for 24 weeks. Followed by 24 week open label treatment period in which ALL participants receive Oxytocin Masking : Quadruple ( Participant Care Provider Investigator Outcomes Assessor ) Masking Description: Quadruple Arms and Interventions Participant Group/Arm Intervention/Treatment Placebo Comparator : DB Placebo Nasal Spray Placebo treatment during weeks 0-24 double blind phase Drug : Double blind phase Placebo Nasal Spray This nasal spray will contain all of the ingredients that are in the active oxytocin spray in the same quantities, except oxytocin will NOT be added to the solution. It will be packaged using the same container system as the active oxytocin nasal spray. Each bottle's label will have its own unique nonsequential randomly assigned number and not a lot number to facilitate masking. Dose titration will occur using exactly the same criteria and procedures as for active study drug. Other Names: DB Placebo (PL) Active Comparator : DB Oxytocin Nasal Spray DB Oxytocin- quadruply masked treatment with intranasal oxytocin during weeks 0-24 of study during double blind phase of study Drug : double Blind Oxytocin Nasal Spray Each insufflation will deliver 8 IU or 24 IU of oxytocin. A maximum of 3 insufflations at a time will be required. Dosing will be flexible between 8 IU/day and 80 IU/day, typically in two divided doses delivered in the morning and in the afternoon. Doses will typically increase by 8 IU twice daily (BID) at week 2 and weeks 4 and 8 until achieving the target dose of 24 IU BID at week 8. Subsequently doses may be increased in 8 IU BID increments ONLY at each visit until a maximum dose of 40 IU BID is achieved. Each bottle's label will have its own unique nonsequential randomly assigned number and not a lot number to facilitate masking. During the open label phase after approximately March 2019 the study used only the 24 IU /0.10 ml formulation and the maximum dose was 72 IU per day. Other Names: DB Intranasal Oxytocin (OT) Active Comparator : open label intranasal oxytocin non masked treatment with intranasal oxytocin from weeks 24-48 in those participants who completed first 24 weeks of double blind treatment Drug : Open Label intranasal oxytocin All participants who completed the 24 week double blind phase were eligible to join a 24 week open label phase in which all participants received intranasal oxytocin Other Names: open label treatment'SummaryDifference100%
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