Objective: To evaluate the safety and efficacy of incobotulinumtoxinA (IncoA) injection in the tremor of Parkinson’s disease (PD).

Background: Unlike other cardinal motor features of bradykinesia and rigidity, PD tremor may be refractory to pharmacological treatment with dopamine agonists. >25% of PD patients have psychosocial stress due to tremor and 1/3rd patients have clear tremor-related quality of life issues which interfere with daily activities. Botulinum neurotoxins are effective treatment for dystonia, spasticity, and other movement disorders. In essential tremor and PD tremor, a fixed injection approach improves the tremor but high percentage of the patients (>30%) developed hand weakness.

Methods: This is the first, double-blind, placebo-controlled, crossover trial of incoA versus placebo (Saline). Injections (customized approach) were given into 8-10 hand and forearm muscles guided by presence of EMG tremor-related activity. Dose varied from 80-120 units/session. Patients were followed at 4, 8 and 12 weeks after the injection. The efficacy of treatment was evaluated by clinical rating scales using Unified Parkinson’s disease rating scale (UPDRS) tremor questions and NIH tremor score, Patient global impression of change (PGIC), and Parkinson’s disease quality of life questionnaire (PDQL). Hand strength was evaluated by dynamometer.

Results: Thirty patients completed the study. At 4 weeks, NIH tremor score improved in 73% vs 17% at 4 weeks in IncoA and Placebo group respectively (p=0.0001). UPDRS tremor scale improved in 77% vs 10% in IncoA and placebo groups (p=0.0001). On PGIC scale, 27% in IncoA reported much improvement compared to none in the placebo group at 4 weeks (p=0.007). On PDQL score, subjects who received IncoA showed significant change in quality of life at 8 weeks (p=0.042). Adverse reactions consisted of hand weakness (IncoA 6.5%, saline 3.3 %), not statistically significant (p=0.1028).

Conclusions: In this customized injection study, IncoA treatment of hand and forearm muscles resulted in significant improvement of clinical tremor scales, PGIC and quality of life with low occurrence of significant weakness. Botulinum neurotoxin should be considered as a potential therapeutic option for tremor in PD patients refractory or having dyskinesia with dopaminergic therapy.

Submitted to American Academy of Neurology 2016 conference in Vancouver, Canada.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/a-double-blind-investigation-of-efficacy-and-safety-of-incobotulinumtoxina-in-parkinsons-disease-tremor-a-customized-injection-approach/