| CTRI Number |
CTRI/2008/091/000229 [Registered on: 19/01/2009] |
| Last Modified On: |
07/05/2023 |
| Post Graduate Thesis |
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| Type of Trial |
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Type of Study
|
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| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A clinical trial to study the effect of drug on IQ and behavioral problem in Children with Fragile X Syndrome |
|
Scientific Title of Study
|
A Randomized, Double-Blind, Placebo-Controlled Study of Donepezil on Cognitive Function and Behaviour in Children with Fragile X Syndrome |
| Trial Acronym |
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Jitendra Kumar Sahu |
| Designation |
|
| Affiliation |
|
| Address |
Department of pediatrics, AIIMS
New Delhi
DELHI
110029
India |
| Phone |
09810648079 |
| Fax |
|
| Email |
jsh2003@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jitendra Kumar Sahu |
| Designation |
|
| Affiliation |
|
| Address |
Department of pediatrics, AIIMS
New Delhi
DELHI
110029
India |
| Phone |
09810648079 |
| Fax |
|
| Email |
jsh2003@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jitendra Kumar Sahu |
| Designation |
|
| Affiliation |
|
| Address |
Department of pediatrics, AIIMS
New Delhi
DELHI
110029
India |
| Phone |
09810648079 |
| Fax |
|
| Email |
jsh2003@gmail.com |
|
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Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, New Delhi |
|
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Primary Sponsor
|
| Name |
Dr Jitendra Kumar Sahu |
| Address |
|
| Type of Sponsor |
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Details of Secondary Sponsor
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Countries of Recruitment
|
India |
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Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Jitendra Sahu |
Dept. Pediatrics, AIIMS |
Ansari Nagar,-110029
New Delhi
DELHI |
09810648079
jsh2003@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS |
Approved |
|
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Fragile X syndrome , (1) ICD-10 Condition: F79||Unspecified intellectual disabilities, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Donepezil |
2.5mg od for the first 4 weeks than 5 mg od for the next 8 weeks |
| Comparator Agent |
Placebo |
2.5mg od for the first 4 weeks than 5 mg od for the next 8 weeks |
|
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Inclusion Criteria
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| Age From |
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| Age To |
|
| Gender |
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| Details |
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 |
|
| ExclusionCriteria |
| Details |
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 |
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Method of Generating Random Sequence
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Computer generated randomization |
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Method of Concealment
|
Pharmacy-controlled Randomization |
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Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
| Intelligence Quotient by Kulshreshta adaptation of the Stanford - Binet Test |
Baseline & 12 week |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| Childhood Autism Rating Scale |
Baseline, 12 Week |
|
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Target Sample Size
|
Total Sample Size="0"
Sample Size from India=""
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
Date Missing |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
20/08/2008 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
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Estimated Duration of Trial
|
Years=""
Months="0"
Days="0" |
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Recruitment Status of Trial (Global)
|
Completed |
| Recruitment Status of Trial (India) |
|
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Publication Details
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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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. |