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Dystonia DisorderPhase 2/3NCT04277247

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

A Phase 2/3 study testing Botulinum toxin type A in people with Dystonia Disorder and Parkinson Disease, run by University of Calgary at 1 site in Canada.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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

Who is it for?
Ages 30 to 100 years
Conditions the study is for
Dystonia Disorder, Parkinson Disease
What is being tested?
Botulinum toxin type A
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
40 participants
Where
1 siteCanada
Study dates
12 Jan 2021to Dec 2022
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Veronica Bruno, MD, MPH contact

403-220-7572

veronica.bruno@ucalgary.ca

Beatrice Anghelescu contact

403-210-7542

bamanghe@ucalgary.ca

Canada1 site, 1 recruiting

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

    Calgary, Alberta, T2N4Z1

    Veronica Bruno, MD, MPH, 403-2220-7572, veronica.bruno@ucalgary.ca

    Veronica Bruno, MD, MPH

    Recruiting

Other trials in Canada

About this study

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

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

Read the 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.

Being tested
Botulinum toxin type A, Placebo
Medical subject headings
Dystonic Disorders, Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Botulinum toxin type ADrug

    Also called BTXA

    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.

  • PlaceboDrug

    Also called Saline

    0.9% saline placebo injection

Study groups in NCT04277247
Study groupRoleWhat they receive
Botulinum Toxin Type A TreatmentExperimentalInjections
Receives: Drug: Botulinum toxin type A
PlaceboPlacebo comparatorInjections
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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.

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

Secondary outcomes (5)

  1. Change in Clinical Global Impression Scale

    Changes in scores on the Clinical Global Impression (CGI) scale. CGI is rated on a 7-point scale, with the severity of illness scale using a range of responses from 1 (normal) through to 7 (amongst the most severely ill patients).CGI scores range from 1 (very much improved) through to 7 (very much worse). Treatment response ratings should take account of both therapeutic efficacy and treatment-related adverse events and range from 0 (marked improvement and no side-effects) and 4 (unchanged or worse and side-effects outweigh the therapeutic effects). Each component of the CGI is rated separately; the instrument does not yield a global score.

    Measured: 6 and 12 weeks during the parallel group phase

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

    Measures changes of symptom severity, treatment response and the efficacy of treatments. Part 1 (non-motor experiences of daily living), Part 2 (motor experiences of daily living), Part 3 (motor examination) and Part 4 (motor complications). The maximum score for all the parts is 272. Higher scores are indicative of worse outcomes.

    Measured: 6 and 12 weeks during the parallel group phase

  3. Change in gait

    Changes in gait will be assessed according to the sections Postural Instability/Gait Difficulty sub-score of the Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS UPDRS) part 3. Higher score indicative or worse outcomes.

    Measured: 6 and 12 weeks during the parallel group phase

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

    This 39 - item questionnaire assesses Parkinson's disease-specific health-related quality over the last month. It assesses how often patients experience difficulties across 8 quality of life dimensions including functioning and well being. Scores can range from 0 to 100. The higher score is indicative of worse quality of life.

    Measured: 6 and 12 weeks during the parallel group phase

  5. Number of adverse events

    Adverse events assessed for safety purposes at each study visit.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Feb 2020
  2. Study start12 Jan 2021
  3. Primary completionDec 2022 (estimated)
  4. Study completionDec 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04277247
Sponsor's protocol ID
REB19-1645
Status last verified
May 2022
First submitted
10 Feb 2020
Last updated
17 May 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Mahjoub Y, Achen B, Alizadeh P, Abusrair A, Amorelli G, Cieslak A, Labelle N, Hammer T, Pantella C, Bruno V. OnabotulinumtoxinA for Painful Foot Dystonia in Parkinson Disease: A Randomized, Double-Blind, Placebo-Controlled Trial. Neurol Clin Pract. 2026 Dec;16(6):e200659. doi: 10.1212/CPJ.0000000000200659. Epub 2026 Sep 17.

    PubMed 42753227

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Botulinum toxin type A in people with Dystonia Disorder and Parkinson Disease, run by University of Calgary at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 17 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Veronica Bruno, MD, MPH (403-220-7572, veronica.bruno@ucalgary.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in King's Parkinson's disease pain scale score (time frame: 6 and 12 weeks during the parallel group phase and at 24 weeks during the open-label phase). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04277247, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2022.

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