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

Primary Purpose

Parkinson, Tremor

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
incobotulinumtoxinA
Saline
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson focused on measuring Tremor, Parkinson, botulinum, Xeomin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Yale Neurology

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Placebo, then Xeomin

Xeomin, then Placebo

Arm 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.

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.

Outcomes

Primary Outcome Measures

Unified Parkinsons Disease Rating Scale (UPDRS) Tremor Scale
The primary outcome measure in this protocol is significant improvement of tremor (equal or over 2 grade improvement) of the Unified Parkinson's Disease Rating Scale 4 weeks after Xeomin injection. The score is 0 to 4 , ) being no tremor and 4 severe tremor. The higher the score, the more severe the tremor.

Secondary Outcome Measures

Number of Patients Whose Patient Global Impression of Change (PGIC) Improved
The PGIC is a 7 point scale that requires the clinician to assess how much the patient's pain has improved or worsened relative to a baseline state at the beginning of the intervention. and rated as: No change (or condition has gotten worse) (1) Almost the same, hardly any change at all (2) A little better, but no noticeable change (3) Somewhat better, but the change has not made any real difference (4) Moderately better, and a slight but noticeable change (5) Better and a definite improvement that has made a real and worthwhile difference (6) A great deal better and a considerable improvement that has made all the difference (7)improved This outcome is number of patients who chose a 6 or above on the PGIC 6 weeks after treatment.
Patients With Significant Improvement in Unified Parkinsons Disease Rating Tremor Scale
This scale measures the amplitude of the tremor. For instance tremor of more than 4cm oscillation is grade 4. UPDRS tremor scale is 0-4 , 4 being severe tremor. Significant improvement for this protocol considered two grades of improvement .

Full Information

First Posted
January 27, 2014
Last Updated
February 15, 2016
Sponsor
Yale University
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1. Study Identification

Unique Protocol Identification Number
NCT02419313
Brief Title
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

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson, Tremor
Keywords
Tremor, Parkinson, botulinum, Xeomin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo, then Xeomin
Arm Type
Active Comparator
Arm 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.
Arm Title
Xeomin, then Placebo
Arm Type
Active Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
incobotulinumtoxinA
Other Intervention Name(s)
Xeomin
Intervention Description
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
Intervention Name(s)
Saline
Other Intervention Name(s)
Placebo
Intervention Description
same volume as injected for incobotulinum toxin A into forearm muscles under EMG guidance.
Primary Outcome Measure Information:
Title
Unified Parkinsons Disease Rating Scale (UPDRS) Tremor Scale
Description
The primary outcome measure in this protocol is significant improvement of tremor (equal or over 2 grade improvement) of the Unified Parkinson's Disease Rating Scale 4 weeks after Xeomin injection. The score is 0 to 4 , ) being no tremor and 4 severe tremor. The higher the score, the more severe the tremor.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Number of Patients Whose Patient Global Impression of Change (PGIC) Improved
Description
The PGIC is a 7 point scale that requires the clinician to assess how much the patient's pain has improved or worsened relative to a baseline state at the beginning of the intervention. and rated as: No change (or condition has gotten worse) (1) Almost the same, hardly any change at all (2) A little better, but no noticeable change (3) Somewhat better, but the change has not made any real difference (4) Moderately better, and a slight but noticeable change (5) Better and a definite improvement that has made a real and worthwhile difference (6) A great deal better and a considerable improvement that has made all the difference (7)improved This outcome is number of patients who chose a 6 or above on the PGIC 6 weeks after treatment.
Time Frame
4 weeks
Title
Patients With Significant Improvement in Unified Parkinsons Disease Rating Tremor Scale
Description
This scale measures the amplitude of the tremor. For instance tremor of more than 4cm oscillation is grade 4. UPDRS tremor scale is 0-4 , 4 being severe tremor. Significant improvement for this protocol considered two grades of improvement .
Time Frame
4 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria. Age more than 18 years Both sexes all races/ethnic groups. 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. Subjects who are able to read, speak, and understand English. Exclusion Criteria. Existing significant acute medical condition (i.e. cardiovascular, endocrine, hematologic, neoplastic, infectious, or autoimmune disorders) or significant swallowing or breathing difficulties. Pregnancy or planned pregnancy (determined by urine pregnancy test). Active breast feeding. Enrollment in any clinical trial (currently or within the past 3 months) in which treatments are imposed by a protocol. Any subject for whom botulinum toxin treatment would be contraindicated; known allergy or sensitivity to medication. Subjects who are younger than 18 years of age. Neuromuscular-junction disorders. Evidence of acute pathology in neuro-imaging. Axis I diagnosis determined by a neurologist or psychiatrist. Use of Anesthetic medications within two weeks and corticosteroid injections within 4 weeks of enrollment. Those who received botulinum toxin injections in the past 4 months.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bahman Jabbari, MD
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale Neurology
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28789780
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.
Results Reference
derived

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

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