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Botulinum Toxin A to Treat Arm Tremor

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ClinicalTrials.gov Identifier: NCT02207946
Recruitment Status : Completed
First Posted : August 4, 2014
Last Update Posted : April 27, 2017
Sponsor:
Information provided by (Responsible Party):
Merz Pharmaceuticals GmbH

Brief Summary:
The objective of this study is to assess the efficacy and safety of a single, kinematic-analysis-based intramuscular injection of NT 201, compared with placebo, in moderate to marked essential tremor of the upper limb.

Condition or disease Intervention/treatment Phase
Essential Tremor of the Upper Limbs Drug: IncobotulinumtoxinA Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Prospective, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of the Efficacy and Safety of NT 201 in the Unilateral Treatment of Essential Tremor of the Upper Limb
Study Start Date : September 2014
Actual Primary Completion Date : May 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tremor

Arm Intervention/treatment
Experimental: 200 Units incobotulinumtoxinA (Xeomin)
Single injection cycle, total dose of up to 200 Units, intramuscular injection into muscles of wrist (mandatory) and shoulder and/or elbow (both optional).
Drug: IncobotulinumtoxinA
Active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins. Solution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl).
Other Names:
  • Xeomin
  • NT 201
  • Botulinum toxin type A (150 kiloDalton), free from complexing proteins

Placebo Comparator: Placebo
Single injection cycle, intramuscular injection into muscles of wrist (mandatory) and shoulder and/or elbow (both optional).
Drug: Placebo
Solution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl).




Primary Outcome Measures :
  1. Change from baseline to week 4 in maximum angular tremor amplitude of the wrist (injected limb) [ Time Frame: Baseline to week 4 ]
    No primary efficacy variables are defined for this study. One of the secondary outcome measure is used for protocol registration purposes only


Secondary Outcome Measures :
  1. Change from baseline to week 4 in maximum log-transformed accelerometric tremor amplitude at wrist level (injected limb) [ Time Frame: Baseline to week 4 ]
    Log-transformed accelerometric tremor amplitude is one parameter reflecting the non-vectoral intensity of tremor.

  2. Change from baseline to week 4 in Fahn-Tolosa-Marin [FTM] tremor score in the injected limb (item 5 or 6) [ Time Frame: Baseline to week 4 ]
    Tremor severity rating in left or right arm.

  3. Change from baseline to week 4 in FTM motor performance score (sum of items 11 and 12 to 15) [ Time Frame: Baseline to week 4 ]
    FTM motor performance score (sum of items 11 {dominant hand irrespective of its injection or non-injection} and 12 to 15 (injected limb only).

  4. Outcome of subject's and investigator's Global Impression of Change scales (GICS) in week 4 [ Time Frame: Week 4 ]
    The GICS is used to measure the investigator's impression of change due to treatment. The response option is a common 7-point Likert scale that ranges from -3 = very much worse to +3 = very much improved.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of 'definite essential tremor' in accordance with modified TRIG criteria, as follows:

    • Bilateral postural tremor with or without kinetic tremor, involving hands and forearms, that is visible and persistent.
    • It is to be noted that:
    • Tremor of other body parts may be present in addition to upper limb tremor.
    • Bilateral tremor may be asymmetric.
    • Tremor is reported by patient to be persistent, although the amplitude may fluctuate.
  • First onset of essential tremor at least 6 months before screening with stability of the tremor symptoms over 4 weeks and in the opinion of the investigator definite diagnosis of essential tremor.
  • Moderate-to-marked upper-limb postural and/or kinetic tremor at wrist level, corresponding to Fahn-Tolosa-Marin upper-limb tremor rating of at least 2 categories (scale part C, items 17-23) in the limb to be treated between of 2 or higher.
  • Visible tremor at wrist level in at least one of the four positions/tasks used in kinematic assessments
  • Tremor deemed by the investigator to require a treatment with 30 - 200 U NT 201 for a treatment of up to three joints of the selected upper limb (wrist treatment mandatory).
  • Stable concomitant anti-tremor medication and no clinically relevant findings in routine laboratory examinations.

Exclusion Criteria:

  • Any neurological signs abnormal for the subject's age, other than the tremor itself and Froment's maneuver.
  • Exposure to the following tremorogenic drugs: Lithium, Valproic acid, Amiodarone, typical and atypical neuroleptics. Exposure to other than the listed tremorogenic or potentially tremorogenic drugs is allowed only if, in the opinion of the investigator, this will not interfere with the study drug evaluation. In these cases, a stable medication should be reached 4 weeks before screening and intended for the time during the study drug evaluation.
  • Trauma to the central nervous system or the nerves of the target limb within the three months preceding the onset of tremor.
  • Evidence of psychogenic origins of tremor.
  • Life habits (e.g. smoking, alcohol or substance abuse) prejudicial to study participation.
  • Prior surgery to treat tremor
  • Recent (16 weeks) treatment with any Botulinum toxin product for any reason.
  • Relevant recent or planned surgery or other specified relevant treatments and/or concomitant disorders.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02207946


Locations
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United States, New York
Merz Investigational Site #0010191
New York, New York, United States, 10029
Canada, Manitoba
Merz Investigational Site #0010317
Winnipeg, Manitoba, Canada, R3J2H7
Canada, Nova Scotia
Merz Investigational Site #0010089
Halifax, Nova Scotia, Canada, B3P 1M3
Canada, Ontario
Merz Investigational Site #0010078
Toronto, Ontario, Canada, M5T 2S8
Merz Investigational Site #0010305/1
Toronto, Ontario, Canada, M6M 2J5
Merz Investigational Site #0010305/2
Toronto, Ontario, Canada, M6M 2J5
Sponsors and Collaborators
Merz Pharmaceuticals GmbH
Investigators
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Study Director: Merz Medical Expert Merz Pharmaceuticals GmbH

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Responsible Party: Merz Pharmaceuticals GmbH
ClinicalTrials.gov Identifier: NCT02207946     History of Changes
Other Study ID Numbers: MRZ60201_2094_1
First Posted: August 4, 2014    Key Record Dates
Last Update Posted: April 27, 2017
Last Verified: April 2017

Additional relevant MeSH terms:
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Tremor
Essential Tremor
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Movement Disorders
Central Nervous System Diseases
Botulinum Toxins
Botulinum Toxins, Type A
abobotulinumtoxinA
incobotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents