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Dalfampridine in improving spasticity in patients with severe brain trauma

Investigating the effectiveness of dalfampridine in improving spasticity in patients with severe brain trauma

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20221108056446N2
Enrollment
80
Registered
2023-05-08
Start date
2023-05-22
Completion date
Unknown
Last updated
2023-05-29

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

Conditions

Severe traumatic brain injury. Diffuse traumatic brain injury

Interventions

Intervention 1: Intervention group: Dalfampridine receptor (this drug is prescribed to the patient at a dose of 10 mg twice a day (every 12 hours)). Intervention 2: Control group: Placebo.

Sponsors

Esfahan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Being between 18 and 65 years old More than a month has passed since the beginning of the trauma Having a level of consciousness less than 9 Not having a neurological or psychological disease before the trauma Presence of spasticity in the upper or lower limbs according to the Ashworth criteria

Exclusion criteria

Exclusion criteria: Lack of consent of the patient's companion to enter the study Having a level of consciousness higher than 9 at the beginning of the trauma History of seizures, kidney and liver diseases

Design outcomes

Primary

MeasureTime frame
Severity of muscle spasms. Timepoint: Before treatment, three and six months after the intervention. Method of measurement: Ashworth scale.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactEsfahan University of Medical Sciences

Esfahan University of Medical Sciences

mahmoodkhani@mui.ac.ir+98 31 3233 0091

Outcome results

None listed

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