Effects of Combination Therapy of Baclofen & Trihexyphenidyl on Spasticity in Brain Injury Patients

Effects of Combination Therapy of Baclofen & Trihexyphenidyl on Early Onset Spasticity in Post Traumatic Brain Injury Patients

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT20200415047096N1

Enrollment

Registered

2020-09-09

Start date

2020-03-31

Completion date

Unknown

Last updated

2020-10-06

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

Conditions

Spasticity in Post Traumatic Brain Injury Patients. G80.3

Interventions

Intervention 1: Intervention group: In addition to baclofen, Trihexyphenidyl 1 mg per day with increasing dose of Trihexyphenidyl up to a maximum of 8 mg per day if no response and the initial dose

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Early Onset Spasticity in Post Traumatic Brain Injury Patients

Exclusion criteria

Exclusion criteria: The level of consciousness (GCS) is equal to 3 out of 15 Severe drug side effects following baclofen or Trihexyphenidyl History of severe allergy to baclofen or Trihexyphenidyl

Design outcomes

Primary

Measure	Time frame
Spasm in the muscles of the wrist flexor muscles on one side. Timepoint: Spasm in the flexor muscles of the wrist on one side (left hand) is recorded on First day, third day, seventh day, first month, third month, and sixth month after administration. Method of measurement: Modified Ashworth Scale.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactPedram Arfa

Kerman University of Medical Sciences

parfaf@gmail.com+98 34 3223 5011

Outcome results

None listed

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