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

Primary Purpose

Parkinson's Disease

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Botulinum Toxin
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson's Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Placebo Comparator

    Active Comparator

    Arm Label

    Placebo

    Onabotulinum Toxin A

    Arm Description

    Saline IM Injection

    IM Injection

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Full Information

    First Posted
    June 11, 2015
    Last Updated
    June 25, 2015
    Sponsor
    University Health Network, Toronto
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02472210
    Brief Title
    The Use of Botox in Advanced Parkinson's Patients Experiencing Pain
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2015
    Overall Recruitment Status
    Unknown status
    Study Start Date
    July 2014 (undefined)
    Primary Completion Date
    July 2015 (Anticipated)
    Study Completion Date
    September 2015 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University Health Network, Toronto

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Parkinson's Disease

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    14 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Saline IM Injection
    Arm Title
    Onabotulinum Toxin A
    Arm Type
    Active Comparator
    Arm Description
    IM Injection
    Intervention Type
    Drug
    Intervention Name(s)
    Botulinum Toxin
    Other Intervention Name(s)
    Botox
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Change of patient rated pain on NRS scale
    Description
    change in pain on a Numeric Rating Scale (NRS) by telephone between BTXA and placebo injections at 4 week post injection and change in Visual Analogue Scale (Edmonton Symptom Assessment System: Numerical Scale) at study visits.
    Time Frame
    3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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: 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). The presence of infection at the proposed injection site(s).

    12. IPD Sharing Statement

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

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