Medicine for tightness of limbs in cerebral palsy

Comparison of efficacy and safety of oral tizanidine and baclofen in reducing spasticity in children with spastic diplegia aged 2-10 years: a single-blind, randomized controlled trial - TBSD

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/11/059687

Enrollment

170

Registered

2023-11-08

Start date

Unknown

Completion date

Unknown

Last updated

2023-11-13

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

Conditions

Health Condition 1: G801- Spastic diplegic cerebral palsy

Interventions

Intervention1: baclofen: 5 mg twice daily orally for 24 weeks Control Intervention1: tizanidine: 1 mg twice daily orally for 24 weeks

Eligibility

Inclusion criteria

Inclusion criteria: Diagnosed with spastic diplegia

Exclusion criteria

Exclusion criteria: History of allergy to either tizanidine or baclofen

Design outcomes

Primary

Measure	Time frame
Spasticity in bilateral lower limbs measured by modified Asworth scaleTimepoint: At 0 week (baseline) and at 24 weeks	—

Secondary

Measure	Time frame
change in motor function as measured by Gross Motor Functional Measure (GMFM)Timepoint: At baseline (0 week) and 24 weeks	—

Countries

India

Contacts

Public ContactPRATEEK KUMAR PANDA

AIIMS, RISHIKESH

drprateekpanda@gmail.com9650149735

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026