Effect of Dalfampridine in Treatment of Spinal Cord Injury

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20231019059767N1

Enrollment

Registered

2024-01-17

Start date

2024-01-20

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

Thoracic 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 Thoracic 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 Patient Pregnancy GFR Lower than 50 ml/min

Design outcomes

Primary

Measure	Time frame
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.	—

Secondary

Measure	Time frame
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

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