| CTRI Number |
CTRI/2018/01/011571 [Registered on: 25/01/2018] Trial Registered Prospectively |
| Last Modified On: |
16/11/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Effectiveness of the drug Trihexyphenidyl for abnormal movements in children with Cerebral Palsy |
|
Scientific Title of Study
|
EFFECTIVENESS OF TRIHEXYPHENIDYL FOR TREATMENT OF DYSTONIA IN CHILDREN WITH CEREBRAL PALSY |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Monica Juneja |
| Designation |
Director Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Pediatrics
Maulana Azad Medical College
New Delhi
New Delhi
DELHI
110002
India |
| Phone |
9968604311 |
| Fax |
|
| Email |
drmonicajuneja@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Monica Juneja |
| Designation |
Director Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Pediatrics
Maulana Azad Medical College
New Delhi
New Delhi
DELHI
110002
India |
| Phone |
9968604311 |
| Fax |
|
| Email |
drmonicajuneja@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Lavanya R A |
| Designation |
Post graduate |
| Affiliation |
Maulana Azad Medical College |
| Address |
#332 Lok Nayak Resident Doctor Hospital
MAMC Campus
department of pediatrics
MAMC
New Delhi
DELHI
110002
India |
| Phone |
8553527790 |
| Fax |
|
| Email |
lavanyamaulanaazaddelhi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Child Development Centre
Department of Pediatrics
Maulana Azad Medical College
New Delhi |
|
|
Primary Sponsor
|
| Name |
Maulana Azad Medical College |
| Address |
2 Bahadur Shah Zafar Marg Balmiki Basti
New Delhi
110002 |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Dr MONICA JUNEJA |
LOK NAYAK HOSPITAL |
315 Child Development Centre
Department of Pediatrics
Maulana Azad Medical College
2,Bahadur Shah Zafar Marg
Balmiki Basti
New Delhi
New Delhi
DELHI |
8527202227
drmonicajuneja@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G00-G99||Diseases of the nervous system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
comparator not applicable |
comparator not applicable |
| Intervention |
open labelled intervention trial |
Baseline evaluation: Following Tools would be administered to assess the severity of dystonia and motor functions. Each tool takes around 30 mins for administration.
Global Dystonia scale20
Gross Motor Function Measure-88(GMFM-88)21
Fine motor/perceptual sub scale of Early Developmental Profile 2 (EDP-2)22
Intervention: The subjects would be started on Trihexyphenidyl as per the following protocol.
The schedule of the medicine would be explained in detail to parents including the side effects. The parents will be advised to contact the investigator in case of side effects.
Follow up Visits : Follow Up would be done at 3 weeks and 6 weeks, during which the following would be done :
Drug dispensing
Drug increment as per the protocol
Monitoring of side effects : Parents would be enquired about the side effects e.g. Dryness of mouth, irritability or visual difficulties , drowsiness or dizziness, difficulty urinating or constipation which would be documented .
Final assessment would be done at12 weeks during which all the tools would be re-administered.
No change in the occupational therapy / physiotherapy or that of Baclofen dose would be done in this 12 weeks study period
At the end of study period, medication will be prescribed to patients who wish to continue it. In others, it will be gradually withdrawn over next 3 weeks.
The subjects would be started on oral Trihexyphenidyl as per the following protocol.
Duration AGE 3yrs. AGE more than3yrs
WEEK 1 0.5mg tid 1mg tid
WEEK 2 1mg tid 2mg tid
WEEK 3 1.5mg tid 3mg tid
WEEK 4 2mg tid 4mg tid
WEEK 5 2.5mg tid 4.5mg tid
WEEK 6 3mg tid 5mg tid |
|
|
Inclusion Criteria
|
| Age From |
6.00 Month(s) |
| Age To |
5.00 Year(s) |
| Gender |
Both |
| Details |
Children with Cerebral Palsy diagnosed as per American Academy of Neurology criteria 2006 with :
1.Presence of predominant dystonia
2.Age 6 months to 5 years
|
|
| ExclusionCriteria |
| Details |
1.Children who have received Trihexyphenidyl 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. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Change in score on Global Dystonia Scale
2.Change in score on Gross Motor Function Measure-88 (GMFM-88)
3.Change in score on Fine motor/perceptual sub scale of Early Developmental Profile 2 (EDP-2)
|
Score will be assessed after 12 weeks that is 3months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Change in score on Global Dystonia Scale
2.Change in score on Gross Motor Function Measure-88 (GMFM-88)
3.Change in score on Fine motor/perceptual sub scale of Early Developmental Profile 2 (EDP-2)
|
score will be assessed after 12 weeks that is after 3months |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
01/04/2018 |
| 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
|
Effectiveness of Trihexyphenidyl for dystonia in children with Cerebral Palsy PLACE OF STUDY The proposed study will be conducted in Department of Pediatrics Maulana Azad Medical College and associated Lok Nayak Hospital, New Delhi STUDY DESIGN Open-labelled Intervention trial STUDY POPULATION
Children with Cerebral Palsy with predominant dystonia Children full filling the inclusion criteria will be included in the study after taking the informed consent and started on the proposed drug protocol and follow up is Done after 3 weeks 6 weeks and final assessment done after 12 weeks ,outcome variables are measured using Global Dystonia Scale,Gross Motor Function Measure 88,Early Developmental Profile.
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