Status:
UNKNOWN
Botulinum Toxin Type A for Foot Dystonia-associated Pain in Parkinson's Disease
Lead Sponsor:
University of Calgary
Collaborating Sponsors:
Allergan
Conditions:
Dystonia Disorder
Parkinson Disease
Eligibility:
All Genders
30-100 years
Phase:
PHASE2
PHASE3
Brief 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 ab...
Eligibility Criteria
Inclusion
- Subjects with PD according to the MDS Clinical diagnostic criteria for Parkinson's disease
- Participants with foot dystonia not responding to antiparkinsonian agents or changes in antiparkinsonian medications schedule sufficiently as per Movement Disorders Specialist. Subjects with bilateral foot dystonia will be injected in the side where the 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
- Subjects with a primary cause of pain in the lower limbs unrelated to PD foot dystonia and associated with another medical condition, e.g. severe arthritis.
- Subjects that because of the severity or refractory pain are under an unfixed analgesic schedule.
- Subjects who are unable to self- report pain severity in the selected scales. Patients that may require a translator or are illiterate will be included as long as they can self-report pain severity.
- Subjects who are undergoing acute infections or other acute intercurrence.
- Any contraindication to receiving BTXA injections:
- Subjects who are hypersensitive to any BTXA or any ingredient in the formulation or component of the container (Clostridium Botulinum toxin type A neurotoxin complex 900 kD, Human Serum Albumin and Sodium Chloride).
- The presence of infection at the proposed injection site(s).
- We decided to exclude patients with high risk cardiovascular disease in the case of severe orthostatic 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 the cases in the literature are children. In order to absolutely avoid this potential complication, we will exclude patients who report sickness/infections during the study visit
Key Trial Info
Start Date :
January 12 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2022
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04277247
Start Date
January 12 2021
End Date
December 1 2022
Last Update
May 17 2022
Active Locations (1)
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1
Movement Disorder Program, Foothills Medical Center, Alberta Health Services
Calgary, Alberta, Canada, T2N4Z1