Effect of Dalfampridine in Patients With Hereditary Spastic Paraplegia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-03

Study Completion Date

2021-03-12

Brief Summary

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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.

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Detailed Description

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Conditions

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Hereditary Spastic Paraplegia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Medication

Dalfampridine plus physiotherapy

Group Type EXPERIMENTAL

Dalfampridine 10 MG

Intervention Type DRUG

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

Physiotherapy

Intervention Type BEHAVIORAL

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.

No Medication

Placebo plus physiotherapy

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Physiotherapy

Intervention Type BEHAVIORAL

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.

Interventions

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Dalfampridine 10 MG

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

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.

Intervention Type BEHAVIORAL