A RANDOMISED CONTROLLED TRIAL ON THE SAFETY AND EFFICACY OF BACLOFEN WITH THAT OF DIAZEPAM IN SPASTICITY DUE TO ACQUIRED SPINAL CORD INJURIES

A RANDOMISED CONTROLLED COMPARATIVE OPEN LABEL TRIAL ON THE SAFETY AND EFFICACY OF BACLOFEN WITH THAT OF DIAZEPAM IN SPASTICITY DUE TO ACQUIRED SPINAL CORD INJURIES

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2014/10/005150

Enrollment

Registered

2014-10-28

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: G839- Paralytic syndrome, unspecified Health Condition 2: null- SPASTICITY IN ACQUIRED SPINAL CORD INJURIES

Interventions

Intervention1: BACLOFEN 5mg: BACLOFEN 5mg TDS FOR 3 MONTHS Intervention2: BACLOFEN 5mg TDS ORALLY AFTER FOOD FOR 3 MONTHS: BACLOFEN AS THE INTERVENTION AGENT FOR THE MANAGEMENT OF SPASTICITY FOR THREE

Eligibility

Inclusion criteria

Inclusion criteria: 1.Written informed consent 2.Age 18 years and above 3.Patients after two months of spinal cord injury with established spasticity and not in spinal shock 4.Spasticity due to spinal cord injury of all grades 5.Spasticity interfering with sleep and functional capacity

Exclusion criteria

Exclusion criteria: 1.Significant history of Hypersensitivity to the study drugs 2.Respiratory disorders like COPD, Sleep apnoea 3.Chronic liver disease 4.Renal disease 5.With psychiatric illness of any kind 6.Broken skin and any infections trigerring spasticity 7.Patients receiving drugs interfering significantly with the study drugs 8.Patients planned for surgical intervention 9.Glaucoma 10.Myasthenia gravis

Design outcomes

Primary

Measure	Time frame
IMPROVEMENT IN SPASTICITY AS OBTAINED BY IMPROVEMENT IN FUNCTIONAL INDEPENDENCE MEASURE SCORE;MONITORING ADVERSE DRUG REACTION DURING STUDY PERIODTimepoint: DAY 0,DAY 7,DAY 14,DAY 28,DAY 56,DAY 90	—

Secondary

Measure	Time frame
TO COMPARE THE ADVERSE DRUG PROFILE OF BACLOFEN WITH THAT OF DIAZEPAMTimepoint: DAY 0,DAY 7,DAY 14,DAY 28,DAY 56,DAY 90	—

Countries

India

Contacts

Public ContactHEMALATHA T

GOVERNMENT MEDICAL COLLEGE,KOZHIKODE

narayananpv55@gmail.com9946316580

Outcome results

None listed

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