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NCT Number: NCT02419313

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Yale Neurology

New Haven, Connecticut, 06520, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Xeomin

Saline

Drug

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

Other names: Placebo

Primary outcomes

  1. Unified Parkinsons Disease Rating Scale (UPDRS) Tremor Scale

    Time frame: 4 weeks

    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 outcomes

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

    Time frame: 4 weeks

    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.

  2. Patients With Significant Improvement in Unified Parkinsons Disease Rating Tremor Scale

    Time frame: 4 Weeks

    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 .

Sponsors and collaborators

Lead sponsor

Yale University

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Apr 17, 2015
Registry last updated
Mar 14, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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