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Neurotoxin

Botulinum toxin type A for Parkinson's Disease

Phase 2 & 3
Recruiting
Led By Veronica Bruno, MD, MPH
Research Sponsored by University of Calgary
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 and 12 weeks during the parallel group phase and at 24 weeks during the open-label phase
Awards & highlights

Study Summary

This trial is studying whether botulinum toxin type A can help relieve pain in the feet caused by dystonia in Parkinson's disease.

Eligible Conditions
  • Parkinson's Disease
  • Dystonia

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 and 12 weeks during the parallel group phase and at 24 weeks during the open-label phase
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 and 12 weeks during the parallel group phase and at 24 weeks during the open-label phase for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in King's Parkinson's disease pain scale score
Change in Likert Visual Analogue Scale
Secondary outcome measures
Change in Clinical Global Impression Scale
Change in Movement Disorder Society Unified Parkinson Disease Rating Scale Parts 1-4 (MDS-UPDRS) ON medication
Change in Parkinson's Disease 39 item Quality of life questionnaire
+2 more

Side effects data

From 2016 Phase 4 trial • 42 Patients • NCT02321436
7%
Head injury
7%
Insomnia
4%
Pain
4%
Asthma
4%
Tachycardia
4%
Constipation
4%
Pyrexia
4%
Cough
4%
Hypertensive crisis
4%
Pneumonia
4%
Vomiting
4%
Fall
4%
Hypokalaemia
4%
Urinary tract infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Dysport ® 500 U
Placebo

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Botulinum Toxin Type A TreatmentExperimental Treatment1 Intervention
Injections
Group II: PlaceboPlacebo Group1 Intervention
Injections
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Botulinum toxin type A
2011
Completed Phase 4
~2730

Find a Location

Who is running the clinical trial?

University of CalgaryLead Sponsor
780 Previous Clinical Trials
841,694 Total Patients Enrolled
AllerganIndustry Sponsor
781 Previous Clinical Trials
275,753 Total Patients Enrolled
Veronica Bruno, MD, MPHPrincipal InvestigatorUniversity of Calgary
2 Previous Clinical Trials
80 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there comparable studies to this one that use Botulinum toxin type A?

"69 clinical trials involving Botulinum toxin type A are currently ongoing, with 23 in Phase 3. Most of these trials are based in Farmington Hills, Michigan, but there are 787 locations running these trials in total."

Answered by AI

What medical conditions are most often treated with Botulinum toxin type A?

"Botulinum toxin type A is most commonly used to treat urinary incontinence. It can also be prescribed to treat other conditions such as spinal cord, botox, overactive bladder syndrome (OABs)."

Answered by AI

Does this research allow for patients who are elderly to participate?

"The current study is looking for individuals that are over 30 and younger than 100."

Answered by AI

How can I sign up to participate in this clinical trial?

"40 individuals with a diagnosis of parkinson disease, aged between 30 and 100 years old, who have not received botulinum toxin type A (BTXA) treatment in the last 6 months are needed for this study. Applicants must also be stable on their PD and pain medications for at least 30 days and have unresponsive foot dystonia that is not helped by changes to their antiparkinsonian medication schedule. Subjects with bilateral foot dystonia will be injected in the side where the symptoms are more severe."

Answered by AI

Is this experiment recruiting new participants at this time?

"Yes, the most recent information on clinicaltrials.gov suggests that this study is still recruiting patients. The listing was first posted on January 12th, 2021 and was updated on May 16th, 2022."

Answered by AI

How many people are part of this research project?

"That is correct. Currently, the clinical trial is recruiting patients. It was originally posted on 2021-01-12, and the most recent update was on 2022-05-16. The trial is seeking 40 patients from 1 site."

Answered by AI

What are we hoping to learn from this clinical trial?

"The goal of this trial is to Change in Likert Visual Analogue Scale, which will be evaluated over a 6 and 12 weeks during the parallel group phase and at 24 weeks during the open-label phase. Secondary outcomes include Change in Parkinson's disease 39 item Quality of life questionnaire and Change in Movement Disorder Society Unified Parkinson disease Rating Scale Parts 1-4 (MDS-UPDRS) ON medication. The study also aims to measure Change in Clinical Global Impression Scale."

Answered by AI
~10 spots leftby Mar 2025