The effect of insulin nasal spray on development and behaviour of children with Phelan-McDermid syndrome

• Conditions: Phelan-McDermid syndrome; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2012-002873-77-NL
• Lead Sponsor: niversity Medical Center Groningen, Department of Genetics

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11-01
• Last Update Posted: 11 February 2013

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Age between 12 months and 18 years 0 months old at 1-1-2013
Proven SHANK3 deletion by array-comparative genomic hybridization (array-CGH)
Parents need to speak and understand Dutch

Are the trial subjects under 18? yes
Number of subjects for this age range: 20
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

A contra-indication for the use of intranasal application (e.g. anatomical obstruction)
Severe perinatal brain damage (e.g. asphyxia, haemorrhage, infection)
A metabolic or muscle disease responsible for neurological symptoms, independent of the 22q13 deletion

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified