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

Parkinson Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02419313
• Other study ID #: 1206010370
• Status: Completed
• Phase: Phase 2
• First received: January 27, 2014
• Last updated: February 15, 2016
• Start date: August 2012
• Est. completion date: September 2015

Study information

• Verified date: February 2016
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Parkinson
• Parkinson Disease
• Tremor

Intervention

Drug:
• 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.
• Saline
same volume as injected for incobotulinum toxin A into forearm muscles under EMG guidance.

Locations

Country	Name	City	State
United States	Yale Neurology	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	4 weeks	No
Secondary	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.	4 weeks	No
Secondary	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 .	4 Weeks	No