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

NCT02419313 | Completed Phase 2 Results DMC

• 1 other identifier: 1206010370
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson; Tremor

Keywords

Tremor; Parkinson; botulinum; Xeomin

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Number of Patients Whose Patient Global Impression of Change (PGIC) Improved

  4 weeks

• Patients With Significant Improvement in Unified Parkinsons Disease Rating Tremor Scale

  4 Weeks

Study Arms (2)

Placebo, then Xeomin

ACTIVE COMPARATOR

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.

Drug: incobotulinumtoxinA; Drug: Saline

Xeomin, then Placebo

ACTIVE COMPARATOR

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.

Drug: incobotulinumtoxinA; Drug: Saline

Interventions

incobotulinumtoxinA 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.

Also known as: Xeomin

Placebo, then Xeomin; Xeomin, then Placebo

Saline DRUG

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

Also known as: Placebo

Placebo, then Xeomin; Xeomin, then Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Yale Neurology

New Haven, Connecticut, 06520, United States

Location

Related Publications (1)

• 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.

  PMID: 28789780 DERIVED

MeSH Terms

Conditions

Tremor

Interventions

incobotulinumtoxinA; Sodium Chloride

Condition Hierarchy (Ancestors)

Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Bahman Jabbari M.D , Professor Emeritus- Neurology
• Organization: Yale-Department of Neurology

bahman.jabbari@yale.edu

914-482-8542

Study Officials

• Bahman Jabbari, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2014
• First Posted: April 17, 2015
• Study Start: August 1, 2012
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: March 14, 2016
• Results First Posted: March 14, 2016

Record last verified: 2016-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)