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Effect of giving Gabapentin and trihexphenidyl when compared to Trihexphenidyl alone for reducing dystonia in children with cerebral palsy

Gabapentin as add on therapy to Trihexyphenidyl in children with dyskinetic cerebral palsy: A pilot study - GBP Vs THP

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/04/018603
Enrollment
60
Registered
2019-04-15
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: G808- Other cerebral palsy

Interventions

Intervention1: Gabapentin and trihexyphenidyl: Gabapentin 15-20 mg/kg/day in single dosage and trihexyphenidyl 0.2-2 mg/kg/day in three divided dosages (with upward dose escalation as 0.2 mg/kg/day in

Sponsors

JAYA SHANKAR KAUSHIK
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Children aged between 3-9 years with dyskinetic cerebral palsy (Gross Motor Functional Classification System 4-5).

Exclusion criteria

Exclusion criteria: I. Children who have undergone any surgical such as orthopedic surgery or botulinum toxin injection in the preceding six months. II. A neurological or neurodegenerative condition known to mimic cerebral palsy including those with diurnal variations, parkinsonian features, suspected inborn errors of metabolism, or those with presumed genetic causes. III. Children with known renal, pulmonary, cardiac or hepatic dysfunction. IV. Children with associated drug-resistant epilepsy. V. Children with known hypersensitivity to the study drugs.

Design outcomes

Primary

MeasureTime frame
Total Dyskinesia impairment scale scoreTimepoint: Baseline, 4 weeks and 12 weeks

Secondary

MeasureTime frame
3. International Classification of Functioning, Disability and Health-Children and Youth Version gradesTimepoint: baseline, 4 weeks and 12 weeks;Total dystonia severity assessment plan scoreTimepoint: baseline, 4 weeks and 12 weeks

Countries

India

Contacts

Public ContactSonu Kumar

Pt .B .D .Sharma, PGIMS

jayashankarkaushik@gmail.com9871174069

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 14, 2026