Investigation of the Efficacy and Safety of IncobotulinumtoxinA (Xeomin) in Parkinson's Tremor: A Customized Approach

Yale University

Status and phase: Completed; Phase 2

Conditions: Tremor; Parkinson

Treatments: Drug: Saline; Drug: incobotulinumtoxinA

Study type: Interventional

Funder types: Other

Identifiers

NCT02419313

1206010370

Details and patient eligibility

About

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.

Full 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.

Enrollment: 33 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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33 participants in 2 patient groups

Placebo, then Xeomin

Active Comparator group

Description:

Subjects randomized to receive the placebo ( saline) will receive an equivalent volume as the active study drug (1cc). The injections will be into -10 hand and forearm muscles. A series of rating scale and an examination will take place prior to treatment and at 4 and 8 weeks post treatment. The subject will then cross over to an Active Intervention arm to receive incobotulinumtoxinA which will be injected in the same pattern as the saline.

Treatment:

Drug: incobotulinumtoxinA

Drug: Saline

Xeomin, then Placebo

Active Comparator group

Description:

Subjects will all receive injections with incobotulinumtoxinA injections, 100unit/cc into 6-10 muscles of the forearm. A series of rating scale and an examination will take place prior to treatment and at 4 and 8 weeks post treatment. These subjects will then cross over and receive placebo ( saline) in the same distribution as their second treatment.

Treatment:

Drug: incobotulinumtoxinA

Drug: Saline