| CTRI Number |
CTRI/2019/02/017481 [Registered on: 05/02/2019] Trial Registered Prospectively |
| Last Modified On: |
29/07/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Comparison of drug effect with placebo in children with abnormal movements |
|
Scientific Title of Study
|
TRIHEXYPHENIDYL FOR TREATMENT OF DYSTONIA IN CHILDREN WITH CEREBRAL PALSY: A RANDOMIZED PLACEBO CONTROLLED TRIAL. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Abhishek |
| Designation |
Post graduate student in Department of Pediatrics |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Pediatrics,
Maulana Azad Medical College,
New Delhi
Maulana Azad Medical College,
Bahadur shah zafar marg,
New Delhi
Central
DELHI
110002
India |
| Phone |
8553153305 |
| Fax |
|
| Email |
abhisrinivas1068@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Monica Juneja |
| Designation |
Director Professor in Department of Pediatrics |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Pediatrics,
Maulana Azad Medical College,
New Delhi
Maulana Azad Medical College,
Bahadur shah zafar marg,
New Delhi
Central
DELHI
110002
India |
| Phone |
9968604311 |
| Fax |
|
| Email |
drmonicajuneja@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Abhishek |
| Designation |
Post graduate student in Department of Pediatrics |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Pediatrics,
Maulana Azad Medical College,
New Delhi
Maulana Azad Medical College,
Bahadur shah zafar marg,
New Delhi
Central
DELHI
110002
India |
| Phone |
8553153305 |
| Fax |
|
| Email |
abhisrinivas1068@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maulana Azad Medical College,
Bahadur shah zafar marg,
New Delhi |
|
|
Primary Sponsor
|
| Name |
Abhishek S |
| Address |
Maulana Azad Medical College,
Bahadur shah zafar marg,
New Delhi |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Abhishek S |
Maulana Azad Medical College |
Child Developmental Center
Lok Nayak Hosital
Bahadur shah zafar marg,
New Delhi
Central
DELHI |
8553153305
abhisrinivas1068@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G808||Other cerebral palsy, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
CONTROL ARM |
After baseline evaluation, the subjects in the control arm would be started on placebo (1mg/kg/day) orally in 3 divided doses,for duration of 12weeks.
The Placebo will be an inert substance with similar shape, size, colour, taste and smell as Trihexyphenidyl tablets.
The schedule would be explained in detail to the parents. |
| Intervention |
INTERVENTION ARM |
After baseline evaluation, the subjects in the intervention arm will be started on trihexyphenidyl according to weight maximum dose upto 1mg/kg/day in divided 3 doses orally, for duration of 12 weeks. |
|
|
Inclusion Criteria
|
| Age From |
6.00 Month(s) |
| Age To |
5.00 Year(s) |
| Gender |
Both |
| Details |
Residents of Delhi NCR |
|
| ExclusionCriteria |
| Details |
1.Children who have received Trihexyphenidyl, any other anti-cholinergic or levodopa in last 3 months.
2.Children who have required titration in their baclofen dosage in last 3 months.
3.Poorly controlled epilepsy.
4.Diagnosed cases of Glaucoma or Congenital Heart block.
5.History of allergy or adverse reaction to anti-cholinergic drugs in the past.
6.History of orthopedic surgery or botulinum injection in last 6 months.
7.Presence of features of contractures or hip dislocation. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
OUTCOME VARIABLES
Change in score on Global Dystonia Scale.
Change in score on Gross Motor Function Measure-88 (GMFM-88).
Fine motor/perceptual sub scale of Early Developmental Profile 2 (EDP-2). |
Follow Up would be done at 3 weeks and 6 weeks and final assessment would be done after 12 weeks during which all the scales would be re administered. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
OUTCOME VARIABLES
Change in score on Global Dystonia Scale.
Change in score on Gross Motor Function Measure-88 (GMFM-88).
Fine motor/perceptual sub scale of Early Developmental Profile 2 (EDP-2). |
Follow Up would be done at 3 weeks and 6 weeks.
Final assessment would be done after 12 weeks during which all the scales would be re administered. |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/04/2019 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
Children aged 6 months to 5 years attending Child Developmental center, Department of pediatrics, on 2 predesignated days would be evaluated for Dyskinetic cerebral palsy. Those fulfilling inclusion/exclusion criteria will be recruited. Baseline evaluation using Global Dystonia Scale, Gross motor function measure 88, Early Developmental profile 2 will be done. Following which the enrolled children will be randomised into intervention arm and control arm. The subjects would be started on trihexyphenidyl in the intervention arm and placebo in the control arm for 12 weeks. Occupational and physical therapy will also be given to both the arms. Follow up would be done at 3rd weeks, 6th weeks and final assessment at 12 week where all scales will be readministered. Statistical analysis will be done using unpaired test to compare continues variables and fischer exact test for catogorical variable at baseline and after intervention. |