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

NCT ID: NCT04277247

Last Updated: 2022-05-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-12
• Study Completion Date: 2022-12-31

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 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Botulinum Toxin Type A Treatment

Injections

Group Type: EXPERIMENTAL

Botulinum toxin type A

Intervention Type: DRUG

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.

Placebo

Injections

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

0.9% saline placebo injection

Interventions

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.

Intervention Type: DRUG

Placebo

0.9% saline placebo injection

Intervention Type: DRUG

Other Intervention Names

BTXA; Saline

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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:

1. 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).

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 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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Allergan

INDUSTRY

Sponsor Role: collaborator

University of Calgary

OTHER

Sponsor Role: lead

Responsible Party

Veronica Bruno

Clinical Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Veronica Bruno, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Calgary

Locations

Movement Disorder Program, Foothills Medical Center, Alberta Health Services

Calgary, Alberta, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Veronica Bruno, MD, MPH

Role: CONTACT

veronica.bruno@ucalgary.ca

403-220-7572

Beatrice Anghelescu

Role: CONTACT

bamanghe@ucalgary.ca

403-210-7542

Facility Contacts

Veronica Bruno, MD, MPH

Role: primary

veronica.bruno@ucalgary.ca

403-2220-7572

Other Identifiers

REB19-1645

Identifier Type: -

Identifier Source: org_study_id