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

NCT ID: NCT02419313

Last Updated: 2016-03-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-08-31
• Study Completion Date: 2015-09-30

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.

Conditions

Parkinson; Tremor

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Placebo, then Xeomin

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.

Group Type: ACTIVE_COMPARATOR

incobotulinumtoxinA

Intervention Type: DRUG

Subjects randomized to the active drug intervention arm will receive incobotulinumtoxinA (Xeomin). A series of rating scales and examinations will take place prior to treatment and for 24 weeks after treatment. At 12 weeks the subjects will cross over to the placebo (saline) arm.

Saline

Intervention Type: DRUG

same volume as injected for incobotulinum toxin A into forearm muscles under EMG guidance.

Xeomin, then Placebo

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.

Group Type: ACTIVE_COMPARATOR

incobotulinumtoxinA

Intervention Type: DRUG

Subjects randomized to the active drug intervention arm will receive incobotulinumtoxinA (Xeomin). A series of rating scales and examinations will take place prior to treatment and for 24 weeks after treatment. At 12 weeks the subjects will cross over to the placebo (saline) arm.

Saline

Intervention Type: DRUG

same volume as injected for incobotulinum toxin A into forearm muscles under EMG guidance.

Interventions

incobotulinumtoxinA

Subjects randomized to the active drug intervention arm will receive incobotulinumtoxinA (Xeomin). A series of rating scales and examinations will take place prior to treatment and for 24 weeks after treatment. At 12 weeks the subjects will cross over to the placebo (saline) arm.

Intervention Type: DRUG

Saline

same volume as injected for incobotulinum toxin A into forearm muscles under EMG guidance.

Intervention Type: DRUG

Other Intervention Names

Xeomin; Placebo

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bahman Jabbari, MD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

Yale Neurology

New Haven, Connecticut, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 28789780 (View on PubMed)

Other Identifiers

1206010370

Identifier Type: -

Identifier Source: org_study_id