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

Sponsor

University Health Network, Toronto (Other)

Overall Status

Unknown status

CT.gov ID

NCT02472210

Collaborator

(none)

Enrollment

Arms

Duration (Months)

Study Details

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.

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.

Study Design

Study Type:

Interventional

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 :

Jul 1, 2014

Anticipated Primary Completion Date :

Jul 1, 2015

Anticipated Study Completion Date :

Sep 1, 2015

Arms and Interventions

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 Names: 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 Names: Botox

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 Names:

Botox

Active Comparator: Onabotulinum Toxin A

IM Injection

Drug: Botulinum Toxin

Other Names:

Botox

Outcome Measures

Primary Outcome Measures

Change of patient rated pain on NRS scale [3 months]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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:

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).

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University Health Network, Toronto

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Susan Fox, Neurologist, Movement Disorders Clinic, University Health Network, Toronto

ClinicalTrials.gov Identifier:

NCT02472210

Other Study ID Numbers:

14-7474

First Posted:

Jun 15, 2015

Last Update Posted:

Jun 26, 2015

Last Verified:

Jun 1, 2015

Additional relevant MeSH terms:

Parkinson Disease

Botulinum Toxins

Study Results

No Results Posted as of Jun 26, 2015