Abstract
Background
In essential tremor and Parkinson disease (PD) tremor, administration of onabotulinumtoxinA
via a fixed injection approach improves the tremor, but many patients (30%-70%) develop
moderate to severe hand weakness, limiting the use of onabotulinumtoxinA in clinical
practice.
Objective
To evaluate the safety and efficacy of incobotulinumtoxinA (IncoA) injection for the
treatment of tremor in PD.
Patients and Methods
In this double-blind, placebo-controlled, crossover trial, 30 patients each received
7 to 12 (mean, 9) IncoA injections into hand and forearm muscles using a customized
approach. The study was performed from June 1, 2012, through June 30, 2015, and participants
were followed for 24 weeks. Treatment efficacy was evaluated by the tremor subsets
of the Unified Parkinson's Disease Rating Scale and the Patient Global Impression
of Change 4 and 8 weeks after each of the 2 sets of treatments. Hand strength was
assessed using an ergometer.
Results
There was a statistically significant improvement in clinical rating scores of rest
tremor and tremor severity 4 and 8 weeks after the IncoA injection and of action/postural
tremor at 8 weeks. There was a significant improvement in patient perception of improvement
at 4 and 8 weeks in the IncoA group. There was no statistically significant difference
in grip strength at 4 weeks between the 2 groups.
Conclusion
Injection of IncoA via a customized approach improved PD tremor on a clinical scale
and patient perception, with a low occurrence of significant hand weakness.
Trial Registration
clinicaltrials.gov Identifier: NCT02419313.
Abbreviations and Acronyms:
AboA (abobotulinumtoxinA), BoNT (botulinum neurotoxin), DyT (dystonic tremor), EMG (electromyography), ET (essential tremor), IncoA (incobotulinumtoxinA), NIHCGC (National Institutes of Health Collaborative Genetic Criteria), OL (open label), OnaA (onabotulinumtoxinA), PD (Parkinson disease), PDQL (Parkinson's Disease Quality of Life Questionnaire), PGIC (Patient Global Impression of Change), R DB PC (randomized, double blind, placebo controlled), UPDRS (Unified Parkinson's Disease Rating Scale)To read this article in full you will need to make a payment
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References
- The prevalence of Parkinson's disease: a systematic review and meta-analysis.Mov Disord. 2014; 29: 1583-1590
- Tremor.JAMA. 2014; 311: 948-954
- Tremor-related quality of life: a comparison of essential tremor vs. Parkinson's disease patients.Parkinsonism Relat Disord. 2015; 21: 729-735
- Practice parameter: initiation of treatment for Parkinson's disease: an evidence-based review: report of the Quality Standards Subcommittee of the American Academy of Neurology.Neurology. 2002; 58: 11-17
- Parkinson's disease symptoms: the patient's perspective.Mov Disord. 2010; 25: 1646-1651
- Anticholinergics for symptomatic management of Parkinson's disease.Cochrane Database Syst Rev. 2003; 2: CD003735
- Treatment strategies in early and advanced Parkinson disease.Neurol Clin. 2015; 33: 19-37
- Deep brain stimulation: current and future clinical applications.Mayo Clin Proc. 2011; 86: 662-672
- Cognitive declines following bilateral subthalamic nucleus deep brain stimulation for the treatment of Parkinson's disease.J Neurol Neurosurg Psychiatry. 2008; 79: 789-795
- Efficacy and safety of incobotulinumtoxinA (NT 201, XEOMIN(R), botulinum neurotoxin type A, without accessory proteins) in patients with cervical dystonia.J Neurol Sci. 2011; 308: 103-109
- Treatment of refractory pain with botulinum toxins: an evidence-based review.Pain Med. 2011; 12: 1594-1606
- Botulinum toxin treatment of tremors.Neurology. 1991; 41: 1185-1188
- Botulinum toxin A injections for the treatment of hand tremors.Mov Disord. 1994; 9: 601-609
- Approach to the treatment of limb disorders with botulinum toxin A. Experience with 187 patients.Arch Neurol. 1996; 53: 617-624
- Effective management of upper limb Parkinsonian tremor by IncobotulinumtoxinA Injections using SENSOR-based biomechanical patterns.Tremor Other Hyperkinet Mov (N Y). 2015; 5: 348
- The Unified Parkinson's Disease Rating Scale (UPDRS): status and recommendations.Mov Disord. 2003; 18: 738-750
- Methodological issues in clinical drug development for essential tremor.Tremor Other Hyperkinet Mov (N Y). 2012; : 2
- Quality of life in patients with Parkinson's disease: development of a questionnaire.J Neurol Neurosurg Psychiatry. 1996; 61: 70-74
- A randomized, double masked, controlled trial of botulinum toxin type A in essential hand tremor.Neurology. 2001; 56: 1523-1528
- A randomized, double-blind, placebo-controlled study to evaluate botulinum toxin type A in essential hand tremor.Mov Disord. 1996; 11: 250-256
- Botulinum toxin treatment for functional disability induced by essential tremor.Neurol Sci. 2000; 21: 349-353
Article Info
Publication History
Published online: August 05, 2017
Footnotes
Grant Support: This study was funded by Merz Pharmaceuticals.
Identification
Copyright
© 2017 Mayo Foundation for Medical Education and Research
