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

NCT04277247 | Unknown Phase 2

• 1 other identifier: REB19-1645
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Dystonia Disorder; Parkinson Disease

Outcome Measures

Primary Outcomes (2)

• Change in King's Parkinson's disease pain scale score

  The measure foot dystonia-associated pain change perceived by the patients. The scale is composed of 14 questions exploring the frequency and severity of different pain syndromes that are frequently observed in Parkinson's disease patients, which can be summed to form an overall pain intensity score. Each item is scored by severity (0-3) multiplied by frequency (0-4), resulting in a subscore of 0 to 12, with a total possible score range from 0 to 168. Higher scores are indicative of worse outcomes.

  6 and 12 weeks during the parallel group phase and at 24 weeks during the open-label phase

• Change in Likert Visual Analogue Scale

  The measure of foot dystonia-associated pain change perceived by the patients. The most simple Likert Visual Analogue Scale is a straight horizontal line of fixed length, usually 100 mm. The ends are defined as the extreme limits of the parameter to be measured (symptom, pain, health) orientated from the left (worst) to the right (best). There are no numerical values on this scale however, a positioning towards the left of the scale indicates a worse outcome.

  6 and 12 weeks during the parallel group phase and at 24 weeks during the open-label phase

Secondary Outcomes (5)

• Change in Clinical Global Impression Scale

  6 and 12 weeks during the parallel group phase

• Change in Movement Disorder Society Unified Parkinson Disease Rating Scale Parts 1-4 (MDS-UPDRS) ON medication

  6 and 12 weeks during the parallel group phase

• Change in gait

  6 and 12 weeks during the parallel group phase

• Change in Parkinson's Disease 39 item Quality of life questionnaire

  6 and 12 weeks during the parallel group phase

• Number of adverse events

  6 and 12 weeks during the parallel group phase. Adverse events will be also documented 24 weeks during the open-label phase.

Study Arms (2)

Botulinum Toxin Type A Treatment

EXPERIMENTAL

Injections

Drug: Botulinum toxin type A

Placebo

PLACEBO COMPARATOR

Injections

Drug: Placebo

Interventions

Botulinum toxin type A 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.

Also known as: BTXA

Botulinum Toxin Type A Treatment

Placebo DRUG

0.9% saline placebo injection

Also known as: Saline

Placebo

Eligibility Criteria

• Age: 30 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Calgary: lead
• Allergan: collaborator

Study Sites (1)

Movement Disorder Program, Foothills Medical Center, Alberta Health Services

Calgary, Alberta, T2N4Z1, Canada

RECRUITING

MeSH Terms

Conditions

Dystonic Disorders; Parkinson Disease

Interventions

Botulinum Toxins, Type A; Sodium Chloride

Condition Hierarchy (Ancestors)

Movement Disorders; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Veronica Bruno, MD, MPH

  University of Calgary

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Veronica Bruno, MD, MPH

CONTACT

403-220-7572; veronica.bruno@ucalgary.ca

Beatrice Anghelescu

CONTACT

403-210-7542; bamanghe@ucalgary.ca

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Upon entry to the study, all subjects will be assigned to a subject number. Eligible subjects will be randomized to receive either BTXA injections or placebo on VISIT 1 in a double-blind manner according to a randomization schedule using computerized randomization tables as prepared by a blinded clinical nurse. All patients will receive BTXA injections on VISIT 4 in an open-label phase. The specific type of randomization used will be block randomization to ensure equal sample sizes of the BTXA and placebo groups.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Model Details: We will perform a double-blind, randomized, parallel group study evaluating the safety and efficacy of BTXA injections vs. placebo injections, targeted at painful muscles, followed by an open-label phase when all participants will receive BTXA. Subjects, caregivers, and the investigators will be blinded to assignment.

Study Record Dates

• First Submitted: February 10, 2020
• First Posted: February 20, 2020
• Study Start: January 12, 2021
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: May 17, 2022

Record last verified: 2022-05

Locations

CA (1)