Effect of Dalfampridine in Patients With Hereditary Spastic Paraplegia

European University of Lefke

Status: Completed

Conditions: Hereditary Spastic Paraplegia

Treatments: Drug: Dalfampridine 10 MG; Behavioral: Physiotherapy; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT05613114

45/20

Details and patient eligibility

About

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.

Enrollment: 8 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of Hereditary Spastic Paraplegia at least 1 year ago

Exclusion criteria

• Having another neurological disorder
• An orthopedic deformity in the lower extremity
• Having a serious cognitive impairment

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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8 participants in 2 patient groups, including a placebo group

Medication

Experimental group

Description:

Dalfampridine plus physiotherapy

Treatment:

Drug: Dalfampridine 10 MG

Behavioral: Physiotherapy

No Medication

Placebo Comparator group

Description:

Placebo plus physiotherapy

Treatment:

Behavioral: Physiotherapy

Drug: Placebo