NCT04277247

Botulinum Toxin Type A for Foot Dystonia-associated Pain in Parkinson's Disease

Botulinum Toxin A (Onabotulinumtoxin A) for Foot Dystonia-associated Pain in Parkinson's Disease: A Randomized, Double-blind Placebo Control Study

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: University of Calgary · Academic / Other
• Sex: All
• Age: 30 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

To study the effects of Botulinum toxin type A (BTXA) in the treatment of foot dystonia-associated pain in Parkinson's disease

Detailed description

Dystonia-associated pain, particularly in the lower limbs is the second most common type of pain in Parkinson's disease (PD). Involuntary muscle contractions that cause slow repetitive movements or abnormal postures are common. The movements may be painful and present in different ways, from just foot inversion or hallux extension to complex forms. They may affect the quality of life of patients in different ways during both ON and OFF periods. Cures for foot dystonia symptoms in PD are not yet available. Yet, improving pain symptoms can improve patients' quality of life. BTXA has been proposed as a safe and useful option for the treatment of PD patients affected by foot dystonia as it could improve symptoms locally without modifying any antiparkinsonian medications. Injected into muscles, BTXA could reduce rigidity, stiffness and improve abnormal postures that may cause foot pain. Recognizing different uses of BTXA will help to understand the symptomatic treatment for each patient in any stage of the disease. The results will help doctors to use new tools to treat foot-dystonia pain in patients with PD.

Conditions

• Dystonia Disorder
• Parkinson Disease

Interventions

Type	Name	Description
DRUG	Botulinum toxin type A	A standardized dose will be injected in each muscle: 25 Units of BTXA in the extensor hallucis longus in 1 site, 50 Units of BTXA in the flexor digitorum brevis in 2 sites and 25 Units of BTXA in the tibialis posterior in 1 site.
DRUG	Placebo	0.9% saline placebo injection

Timeline

• Start date: 2021-01-12
• Primary completion: 2022-12-01
• Completion: 2022-12-01
• First posted: 2020-02-20
• Last updated: 2022-05-17

Locations

1 site across 1 country: Canada