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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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3 August 2015 |
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Main ID: |
NCT02472210 |
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Date of registration:
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11/06/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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The Use of Botox in Advanced Parkinson's Patients Experiencing Pain
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Scientific title:
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A Study of the Utility of Botulinum Toxin Type A for Pain in Advanced Parkinson's Disease Double Blind Placebo Control Crossover Pilot Study |
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Date of first enrolment:
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July 2014 |
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Target sample size:
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14 |
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Recruitment status: |
Active, not recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02472210 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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Phase:
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Phase 4
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Key inclusion & exclusion criteria
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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).
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Parkinson's Disease
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Intervention(s)
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Drug: Botulinum Toxin
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Primary Outcome(s)
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Change of patient rated pain on NRS scale
[Time Frame: 3 months]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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