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

NCT02472210 | Unknown Phase 4

• 1 other identifier: 14-7474
• Study Type: interventional
• Target: 14
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Parkinson's Disease

Outcome Measures

Primary Outcomes (1)

• Change of patient rated pain on NRS scale

  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.

  3 months

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Saline IM Injection

Drug: Botulinum Toxin

Onabotulinum Toxin A

ACTIVE COMPARATOR

IM Injection

Drug: Botulinum Toxin

Interventions

Botulinum Toxin DRUG

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.

Also known as: Botox

Onabotulinum Toxin A; Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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).

Sponsors & Collaborators

• University Health Network, Toronto: lead

MeSH Terms

Conditions

Parkinson Disease

Interventions

Botulinum Toxins; Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Neurologist, Movement Disorders Clinic

Study Record Dates

• First Submitted: June 11, 2015
• First Posted: June 15, 2015
• Study Start: July 1, 2014
• Primary Completion: July 1, 2015
• Study Completion: September 1, 2015
• Last Updated: June 26, 2015

Record last verified: 2015-06