A Phase 2/3 interventional study of Botulinum toxin type A and Placebo in Dystonia Disorder and Parkinson Disease, sponsored by University of Calgary. Status unknown at 1 site in Canada. Open to participants aged 30 Years to 100 Years. Per ClinicalTrials.gov, last updated 2022-05-17.
Sponsored by University of Calgary · Phase 2/3, Interventional, and Treatment
To study the effects of Botulinum toxin type A (BTXA) in the treatment of foot dystonia-associated pain in Parkinson's disease
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.
239 studies on the registry are indexed under Dystonic Disorders; 31 are open to participants now.
This study's planned enrollment of 40 is above the median of 28 across 143 interventional studies indexed under Dystonic Disorders.
Browse Dystonic Disorders studies →University of Calgary is the lead sponsor of 699 studies on the registry; 192 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 2 (20%) have results posted.
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Exclusion Criteria:
Any contraindication to receiving BTXA injections:
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
Injections
Drug: Botulinum toxin type A
Injections
Drug: Placebo
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
0.9% saline placebo injection
Also known as: Saline
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.
Time frame: 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.
Time frame: 6 and 12 weeks during the parallel group phase and at 24 weeks during the open-label phase
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.
Time frame: 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
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.
Time frame: 6 and 12 weeks during the parallel group phase
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.
Time frame: 6 and 12 weeks during the parallel group phase
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.
Time frame: 6 and 12 weeks during the parallel group phase
Number of adverse events
Adverse events assessed for safety purposes at each study visit.
Time frame: 6 and 12 weeks during the parallel group phase. Adverse events will be also documented 24 weeks during the open-label phase.
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Studies of the drug tested here: Botulinum toxin type A