Clinical trial NCT02419313: Investigation of the Efficacy and Safety of IncobotulinumtoxinA (Xeomin) in Parkinson's Tremor: A Customized Approach
Official title: Investigation of the Efficacy and Safety of IncobotulinumtoxinA (Xeomin) in Parkinson's Disease Tremor: A Customized Approach
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Parkinson
Tremor
Keywords: Tremor
Parkinson
botulinum
Xeomin
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2015-04-17
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The scientific aim of this study is to investigate the efficacy and safety of incobotulinumtoxinA (Xeomin-Merz Pharmaceuticals) in the tremor of Parkinson"s disease. Our hypothesis is that injection of Xeomin into the muscles of arm, forearm and hand decreases the tremor amplitude and frequency leading to improvement of the patient"s function.

Detailed description: This is an investigator initiated, randomized, double blind, placebo controlled, cross over study which is supported by Merz pharmaceuticals. Patients with Parkinson"s disease (at Yale Neurology and Movement disorders clinics) will be approached by the members of the research team (PI and sub-investigators) to see if they meet inclusion and exclusion criteria and wish to participate in the study.

If eligible and consented to participate in the study, there will be a series of questionaires, examinations and treatment sessions.

Eligibility criteria: Inclusion Criteria.

1. Age more than 18 years
2. Both sexes
3. all races/ethnic groups.
4. Meeting the clinical diagnosis of Parkinson's disease with presence of moderate to severe Parkinson tremor that is refractory to standard medical treatments and which limits the patient"s functionality and/or poses significant discomfort.
5. Subjects who are able to read, speak, and understand English.

Exclusion Criteria.

1. Existing significant acute medical condition (i.e. cardiovascular, endocrine, hematologic, neoplastic, infectious, or autoimmune disorders) or significant swallowing or breathing difficulties.
2. Pregnancy or planned pregnancy (determined by urine pregnancy test).
3. Active breast feeding.
4. Enrollment in any clinical trial (currently or within the past 3 months) in which treatments are imposed by a protocol.
5. Any subject for whom botulinum toxin treatment would be contraindicated; known allergy or sensitivity to medication.
6. Subjects who are younger than 18 years of age. Neuromuscular-junction disorders.
7. Evidence of acute pathology in neuro-imaging.
8. Axis I diagnosis determined by a neurologist or psychiatrist.
9. Use of Anesthetic medications within two weeks and corticosteroid injections within 4 weeks of enrollment.
10. Those who received botulinum toxin injections in the past 4 months.

Primary outcomes:
measure: Unified Parkinsons Disease Rating Scale (UPDRS) Tremor Scale
timeFrame: 4 weeks
Secondary outcomes:
measure: Number of Patients Whose Patient Global Impression of Change (PGIC) Improved
timeFrame: 4 weeks
measure: Patients With Significant Improvement in Unified Parkinsons Disease Rating Tremor Scale
timeFrame: 4 Weeks
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale Neurology
state: Connecticut
Study officials:
affiliation: Yale University
name: Bahman Jabbari, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mittal SO, Machado D, Richardson D, Dubey D, Jabbari B. Botulinum Toxin in Parkinson Disease Tremor: A Randomized, Double-Blind, Placebo-Controlled Study With a Customized Injection Approach. Mayo Clin Proc. 2017 Sep;92(9):1359-1367. doi: 10.1016/j.mayocp.2017.06.010. Epub 2017 Aug 5.