NCT05613114

Effect of Dalfampridine in Patients With Hereditary Spastic Paraplegia

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: European University of Lefke · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2020-08-03
• Primary completion: 2021-03-12
• Completion: 2021-03-12
• First posted: 2022-11-14
• Last updated: 2022-11-22

Locations

1 site across 1 country: Cyprus