Effect of Dalfampridine in Treatment of Spinal Cord Injury

Evaluation of the Efficacy of Dalfampridine on Walking Impairments in Acute Traumatic Cervical Spinal Cord Injury

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20231019059767N2

Enrollment

Registered

2025-06-30

Start date

2025-07-06

Completion date

Unknown

Last updated

2025-07-21

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

Conditions

Cervical Spinal Cord Injury. Injury of spinal cord, level unspecified

Interventions

Intervention 1: Intervention group: In the intervention group, patients after spinal cord injury receive routine high-dose Prednisolone treatment for 24 to 48 hours. Thereafter patients take Dalfampri

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: All Patients with Traumatic Cervical Spinal Cord Injury Patients with ASIA Scale C or D Patients without any Contraindications for Dalfampridine Prescription Patients having 18 to 70 Years of Age Patients who have GCS 15

Exclusion criteria

Exclusion criteria: Any History of Seizure in Patien Pregnancy Glomerular Filtration Rate Lower than 50 ml/min

Design outcomes

Primary

Measure	Time frame
Timed 25-Foot Walk Test. Timepoint: At the beginning of study (Before Treatment), 30, and 60 days after initiation of treatment. Method of measurement: Chronometer watch.;Dynamic Balance Test. Timepoint: At the beginning of study (Before Treatment), 30, and 60 days after initiation of treatment. Method of measurement: Chronometer watch.;Disability Index. Timepoint: At the beginning of study (Before Treatment), 30, and 60 days after initiation of treatment. Method of measurement: Disability Index Questionnare.;American Spinal Injury Association Impairment Scale. Timepoint: At the beginning of study (Before Treatment), 30, and 60 days after initiation of treatment. Method of measurement: American Spinal Injury Association Impairment Scale chart.;Oswestry Disability Index. Timepoint: At the beginning of study (Before Treatment), 30, and 60 days after initiation of treatment. Method of measurement: Oswestry Disability Questionnaire.;Lower Extremity Pain Visual Analogue Scale. Timepoint: At the beginning of study (Before Treatment), 30, and 60 days after initiation of treatment. Method of measurement: Visual Analogue Scale Diagram.;Back Pain Visual Analogue Scale. Timepoint: At the beginning of study (Before Treatment), 30, and 60 days after initiation of treatment. Method of measurement: Visual Analogue Scale Diagram.	—

Measure

Time frame

Timed 25-Foot Walk Test. Timepoint: At the beginning of study (Before Treatment), 30, and 60 days after initiation of treatment. Method of measurement: Chronometer watch.;Dynamic Balance Test. Timepoint: At the beginning of study (Before Treatment), 30, and 60 days after initiation of treatment. Method of measurement: Chronometer watch.;Disability Index. Timepoint: At the beginning of study (Before Treatment), 30, and 60 days after initiation of treatment. Method of measurement: Disability Index Questionnare.;American Spinal Injury Association Impairment Scale. Timepoint: At the beginning of study (Before Treatment), 30, and 60 days after initiation of treatment. Method of measurement: American Spinal Injury Association Impairment Scale chart.;Oswestry Disability Index. Timepoint: At the beginning of study (Before Treatment), 30, and 60 days after initiation of treatment. Method of measurement: Oswestry Disability Questionnaire.;Lower Extremity Pain Visual Analogue Scale. Timepoint: At the beginning of study (Before Treatment), 30, and 60 days after initiation of treatment. Method of measurement: Visual Analogue Scale Diagram.;Back Pain Visual Analogue Scale. Timepoint: At the beginning of study (Before Treatment), 30, and 60 days after initiation of treatment. Method of measurement: Visual Analogue Scale Diagram.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactBabak Ganjeifar

Mashhad University of Medical Sciences

b.ganjeifar@gmail.com+98 51 3841 3493

Outcome results

None listed

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