drugset / Trial / NCT05613114

Effect of Dalfampridine in Patients With Hereditary Spastic Paraplegia

NCT05613114 ↗

Completed 8 enrolled European University of Lefke
RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

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

Outcome

Met primary endpoint

paper The improvement in the T25FWT values was significantly higher in the experimental group than in the control group (p < 0.05). PMID 37804674 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Dalfampridine Unknown 10 mg —