Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Use of Botox in Advanced Parkinson's Patients Experiencing Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02472210
Recruitment Status : Unknown
Verified June 2015 by Susan Fox, University Health Network, Toronto.
Recruitment status was:  Active, not recruiting
First Posted : June 15, 2015
Last Update Posted : June 26, 2015
Sponsor:
Information provided by (Responsible Party):
Susan Fox, University Health Network, Toronto

Brief Summary:
Most Parkinsonism related pain can be assigned to one or more of five categories: musculoskeletal pain, neuritic or radicular pain, dystonia associated pain, primary or central pain, and akathitic discomfort. In PD pain tends to affect the side of the body that was initially, or more severe affected by the motor symptoms. Botulinum toxins are an effective treatment modality for a growing number of neurological conditions. They have been studied for a variety of conditions associated with PD including dystonia, jaw tremor, apraxia of eyelid opening, camptocormia, dyskinesias, freezing of gait, sialhorrea, overactive bladder and constipation. There are no studies for the use of Botulinum Toxin for pain in PD. The investigators will perform a double-blind, randomized cross-over study evaluating the efficacy and safety of an individual pattern of BTXA injections targeted at painful muscles vs. placebo injection.

Condition or disease Intervention/treatment Phase
Parkinson's Disease Drug: Botulinum Toxin Phase 4

Detailed Description:

The investigators will perform a double-blind, randomized cross-over study evaluating the efficacy and safety of an individual pattern of BTXA injections targeted at painful muscles vs. placebo injection. Primary outcome will be a measure of global pain as perceived by the participants. To assess this endpoint the investigators will use:1.

change in pain on a Numeric Rating Scale (NRS) by telephone between BTXA and placebo injections at 4 week post injection and 2.change in Visual Analogue Scale (Edmonton Symptom Assessment System: Numerical Scale) at study visits.

Secondary outcomes will be the percentage of responders, Physician rated Clinical Global Impression (CGI), Unified Parkinson Disease Rating Scale (MDS-UPDRS) on medication, quality of life by Parkinson Disease Questionnaire (PDQ-39) and adverse events as assessed at each study visit.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Study of the Utility of Botulinum Toxin Type A for Pain in Advanced Parkinson's Disease Double Blind Placebo Control Crossover Pilot Study
Study Start Date : July 2014
Estimated Primary Completion Date : July 2015
Estimated Study Completion Date : September 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo
Saline IM Injection
Drug: Botulinum Toxin
An individualized dose will be injected in the painful limbs: up to 200 units in the upper limbs or up to 300 units in the lower limbs according to the average doses that subjects with PD pain in the limbs received in our clinic, as per our retrospective study. Each injection will contain 25 Units of Botulinum Toxin this way the number of injections will be from 1 to 8 for the upper limbs and from 1 to 12 in the lower limbs. The pattern of injections will be decided by the study investigator according to the localization. The involved muscles will be targeted using EMG guidance. of pain and will be the same at visit 2 and 3.
Other Name: Botox

Active Comparator: Onabotulinum Toxin A
IM Injection
Drug: Botulinum Toxin
An individualized dose will be injected in the painful limbs: up to 200 units in the upper limbs or up to 300 units in the lower limbs according to the average doses that subjects with PD pain in the limbs received in our clinic, as per our retrospective study. Each injection will contain 25 Units of Botulinum Toxin this way the number of injections will be from 1 to 8 for the upper limbs and from 1 to 12 in the lower limbs. The pattern of injections will be decided by the study investigator according to the localization. The involved muscles will be targeted using EMG guidance. of pain and will be the same at visit 2 and 3.
Other Name: Botox




Primary Outcome Measures :
  1. Change of patient rated pain on NRS scale [ Time Frame: 3 months ]
    1. change in pain on a Numeric Rating Scale (NRS) by telephone between BTXA and placebo injections at 4 week post injection and
    2. change in Visual Analogue Scale (Edmonton Symptom Assessment System: Numerical Scale) at study visits.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects with advanced PD (Hoehn and Yahr 3-5) and painful limbs not responding to antiparkinsonian agents sufficiently.
  • BTXA treatment naÃ-ve patients or not received any within last 12 months (including other indications).
  • Stable PD and pain medications for at least 30 days
  • Competence to self-report pain severity in a Visual Analogue Scale (VAS)

Exclusion Criteria:

  • Subjects with a primary cause of pain unrelated with PD 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 unable to self- report pain severity in a VAS
  • Subjects undergoing acute infections or other acute intercurrences.
  • Any contraindication to receiving BTXA injections:

    1. Subjects who are hypersensitive to any BTXA or to 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).

Layout table for additonal information
Responsible Party: Susan Fox, Neurologist, Movement Disorders Clinic, University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT02472210     History of Changes
Other Study ID Numbers: 14-7474
First Posted: June 15, 2015    Key Record Dates
Last Update Posted: June 26, 2015
Last Verified: June 2015

Additional relevant MeSH terms:
Layout table for MeSH terms
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Botulinum Toxins
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs