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Effect of Dalfampridine in Patients With Hereditary Spastic Paraplegia

NCT05613114 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2022-11-22

No results posted yet for this study

Summary

There are limited but encouraging results supporting the use of dalfampridine in patients with hereditary spastic paraplegia. The investigators aimed to investigate the effects of dalfampridine on walking speed, muscle length, spasticity, functional strength, and functional mobility in patients with hereditary spastic paraplegia. In this triple-blinded, randomized, placebo-controlled trial, 4 patients with hereditary spastic paraplegia received dalfampridine (10 mg twice daily) plus physiotherapy (2 times per week), and 4 patients received placebo plus physiotherapy for a total duration of 8 weeks. The assessor and treating physiotherapists, and patients were masked to the group allocation. The primary outcome was Timed 25-foot Walk Test at the end of the 8-week treatment. The secondary outcome measures were functional mobility, functional muscle strength, muscle length, and spasticity.

Conditions

  • Hereditary Spastic Paraplegia

Interventions

DRUG

Dalfampridine 10 MG

The participants in the experimental group received dalfampridine administered as 10 mg extended-release tablets every twelve hours for 8 weeks.

DRUG

Placebo

Control group received a placebo drug with the same administration method (2 times per week for the total duration of 8 weeks).

BEHAVIORAL

Physiotherapy

Conventional physiotherapy program including stretching and flexibility, strengthening, walking and balance exercises which were mainly focused on the lower limbs and improving walking. The program was applied 2 times per week for the total duration of 8 weeks.

Sponsors & Collaborators

  • European University of Lefke

    lead OTHER

Principal Investigators

  • Ferda Selcuk · European University of Lefke

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-03
Primary Completion
2021-03-12
Completion
2021-03-12

Countries

  • Cyprus

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05613114 on ClinicalTrials.gov