drugset / Trial / NCT02472210

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

NCT02472210

Phase 4 Unknown 14 enrolled University Health Network, Toronto
RandomizedCrossoverDouble-blindTreatment

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.

Timeline

Start
2014-07
Primary completion
2015-07
Completion
2015-09

Drugs

EvaluationDrugModalityDoseRoute
Comparator Botulinum toxin Protein / enzyme biologic 25 iu Intramuscular

Indications