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

Last updated: May 16, 2022
Sponsor: University of Calgary
Overall Status: Active - Recruiting

Phase

2/3

Condition

Dystonia

Dyskinesias

Treatment

N/A

Clinical Study ID

NCT04277247
REB19-1645
  • Ages 30-100
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Subjects with PD according to the MDS Clinical diagnostic criteria for Parkinson'sdisease
  • Participants with foot dystonia not responding to antiparkinsonian agents or changesin antiparkinsonian medications schedule sufficiently as per Movement DisordersSpecialist. Subjects with bilateral foot dystonia will be injected in the side wherethe symptoms are more severe.
  • BTXA treatment naïve subjects or not received any within the last six months (including other indications).
  • Stable PD and pain medications for at least 30 days.
  • Competence to self-report pain severity in the King's Parkinson's disease pain scale (KPPS) and a Likert Visual Analogue Scale (VAS)

Exclusion

Exclusion Criteria:

  • Subjects with a primary cause of pain in the lower limbs unrelated to PD foot dystoniaand associated with another medical condition, e.g. severe arthritis.
  • Subjects that because of the severity or refractory pain are under an unfixedanalgesic schedule.
  • Subjects who are unable to self- report pain severity in the selected scales. Patientsthat may require a translator or are illiterate will be included as long as they canself-report pain severity.
  • Subjects who are undergoing acute infections or other acute intercurrence.
  • Any contraindication to receiving BTXA injections:
  1. Subjects who are hypersensitive to any BTXA or any ingredient in the formulationor component of the container (Clostridium Botulinum toxin type A neurotoxincomplex 900 kD, Human Serum Albumin and Sodium Chloride).
  2. The presence of infection at the proposed injection site(s). We decided to exclude patients with high risk cardiovascular disease in the case of severeorthostatic hypotension occurring secondary to the BTXA injections (reported in less than 1% of treated cases). Systemic toxic effects of BTXA are rarely reported and most of thecases in the literature are children. In order to absolutely avoid this potentialcomplication, we will exclude patients who report sickness/infections during the studyvisit

Study Design

Total Participants: 40
Study Start date:
January 12, 2021
Estimated Completion Date:
December 31, 2022

Study 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.

Connect with a study center

  • Movement Disorder Program, Foothills Medical Center, Alberta Health Services

    Calgary, Alberta T2N4Z1
    Canada

    Active - Recruiting

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