A clinical trial to study the effect of drug on IQ and behavioral problem in Children with Fragile X Syndrome

Phase 2/3

• Conditions: Unspecified intellectual disabilities,

• Registration Number: CTRI/2008/091/000229
• Lead Sponsor: Dr Jitendra Kumar Sahu

Brief Summary

The study is a randomized, double blind, parallel group trial evaluating effect of Donepezil on cognitive function and behavior over 12 weeks period. The primary outcome measure will be change in Stanford-Binet intelligence scale from baseline to 12 weeks.

Detailed Description

Not available

Recruitment & Eligibility

• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

• 1.Confirmed genetic diagnosis of fragile X syndrome by PCR & Southern blot; 2.
• Age 6-15 yrs; 3.Regardless of their IQ level if they were able to complete the required neuropsychological testing.

Exclusion Criteria

• 1.Children below 6 years and beyond 15 years of age; 2.
• Currently taking any anticholinergic medications or known hypersensitivity to anticholinergic drugs;3.Seizure disorder requiring the use of anticonvulsant medications;4.Clinically significant uncontrolled cardiovascular, renal, hepatic, pulmonary, gastrointestinal, endocrine, metabolic or hematologic conditions.

Study & Design

• Study Type: Not specified
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Intelligence Quotient by Kulshreshta adaptation of the Stanford - Binet Test	Baseline & 12 week

Secondary Outcome Measures

Name	Time	Method
Childhood Autism Rating Scale	Baseline, 12 Week

Trial Locations

Locations (1)

Dept. Pediatrics, AIIMS; 🇮🇳 Delhi, DELHI, India

Dept. Pediatrics, AIIMS

🇮🇳Delhi, DELHI, India

Dr Jitendra Sahu

Principal investigator

09810648079

jsh2003@gmail.com