NCT02551848

Brief Summary

The primary objective is to study the efficacy of botulinum toxin type A (Xeomin®) injected utilizing kinematically-based injection parameters for the treatment of upper extremity essential tremor (ET). Additional objectives are to study the benefit of kinematic assessment tools in determining injection parameters and to study the composition of tremor using kinematics.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Aug 2014

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2014

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

September 11, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 16, 2015

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

June 22, 2020

Status Verified

June 1, 2020

Enrollment Period

6.1 years

First QC Date

September 11, 2015

Last Update Submit

June 18, 2020

Conditions

Essential Tremor

Keywords

Movement disordersBotulinum toxin type AKinematics

Outcome Measures

Primary Outcomes (1)

  • Kinematic tremor severity

    Change from pre to post-BoNT-A treatments in maximum angular tremor amplitude at the wrist in each treated arm. Angular tremor amplitude is one parameter reflecting the vectoral intensity of tremor segmented at each arm joint

    72 weeks

Secondary Outcomes (3)

  • Clinical tremor severity

    72 weeks

  • Accelerometric kinematic tremor severity

    72 weeks

  • Quality of life measures

    72 weeks

Study Arms (1)

Essential tremor treatment

EXPERIMENTAL

A serotype of botulinum toxin type A (BoNT-A) that has specificity for cleavage of SYNAPTOSOMAL-ASSOCIATED PROTEIN 25 (SNAP-25). BoNT-A's pharmacological action is to inhibit the release of acetylcholine from the neuromuscular junction. Participants will be treated by BoNT-A injections every 12 weeks over 72 weeks. BoNT-A parameters will be determined solely by biomechanical analysis of tremulous movements in both upper extremity BoNT-A dose will range from 50-300 U per arm

Drug: Botulinum toxin type A

Interventions

Botulinum toxin type ADRUG
Also known as: IncobotulinumtoxinA, BoNT-A, Xeomin
Essential tremor treatment

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Consenting male and female participants
  • Diagnosis of 'definite essential tremor' in accordance with the TRIG criteria including: ET individuals diagnosed with upper limb tremor in their motor dominant and non-dominant hands
  • Stable ET medication management for the 3 month duration prior to their enrollment in the study
  • Participants who are botulinum toxin naïve for tremor management
  • Patients will be screened for pregnancy by the physician

You may not qualify if:

  • History of stroke
  • Muscle weakness or any related compartmental muscle syndrome
  • Smoking
  • History of ALS or Myasthenia Gravis
  • Offending medications (Lithium, valproate, steroids, amiodarone, beta-adrenergic agonists (e.g. salbutamol)
  • Persons prescribed zonisamide
  • History of allergic or side effect reaction to botulinum toxin
  • Contraindications per the Xeomin® drug monograph
  • Women reporting that they are pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

London Health Sciences Centre

London, Ontario, N6A5A5, Canada

Location

Related Publications (8)

  • Schantz EJ, Johnson EA. Properties and use of botulinum toxin and other microbial neurotoxins in medicine. Microbiol Rev. 1992 Mar;56(1):80-99. doi: 10.1128/mr.56.1.80-99.1992.

    PMID: 1579114BACKGROUND

  • Evidente VG, Adler CH. An update on the neurologic applications of botulinum toxins. Curr Neurol Neurosci Rep. 2010 Sep;10(5):338-44. doi: 10.1007/s11910-010-0129-z.

    PMID: 20567945BACKGROUND

  • Benito-Leon J, Louis ED. Essential tremor: emerging views of a common disorder. Nat Clin Pract Neurol. 2006 Dec;2(12):666-78; quiz 2p following 691. doi: 10.1038/ncpneuro0347.

    PMID: 17117170BACKGROUND

  • Gironell A, Kulisevsky J. Diagnosis and management of essential tremor and dystonic tremor. Ther Adv Neurol Disord. 2009 Jul;2(4):215-22. doi: 10.1177/1756285609104791.

    PMID: 21179530BACKGROUND

  • Jankovic J, Schwartz K, Clemence W, Aswad A, Mordaunt J. A randomized, double-blind, placebo-controlled study to evaluate botulinum toxin type A in essential hand tremor. Mov Disord. 1996 May;11(3):250-6. doi: 10.1002/mds.870110306.

    PMID: 8723140BACKGROUND

  • Brin MF, Lyons KE, Doucette J, Adler CH, Caviness JN, Comella CL, Dubinsky RM, Friedman JH, Manyam BV, Matsumoto JY, Pullman SL, Rajput AH, Sethi KD, Tanner C, Koller WC. A randomized, double masked, controlled trial of botulinum toxin type A in essential hand tremor. Neurology. 2001 Jun 12;56(11):1523-8. doi: 10.1212/wnl.56.11.1523.

    PMID: 11402109BACKGROUND

  • Adler CH, Bansberg SF, Hentz JG, Ramig LO, Buder EH, Witt K, Edwards BW, Krein-Jones K, Caviness JN. Botulinum toxin type A for treating voice tremor. Arch Neurol. 2004 Sep;61(9):1416-20. doi: 10.1001/archneur.61.9.1416.

    PMID: 15364688BACKGROUND

  • Zesiewicz TA, Elble R, Louis ED, Hauser RA, Sullivan KL, Dewey RB Jr, Ondo WG, Gronseth GS, Weiner WJ; Quality Standards Subcommittee of the American Academy of Neurology. Practice parameter: therapies for essential tremor [RETIRED]: report of the Quality Standards Subcommittee of the American Academy of Neurology. Neurology. 2005 Jun 28;64(12):2008-20. doi: 10.1212/01.WNL.0000163769.28552.CD. Epub 2005 Jun 22.

    PMID: 15972843BACKGROUND

MeSH Terms

Conditions

Essential TremorMovement Disorders

Interventions

Botulinum Toxins, Type AincobotulinumtoxinA

Condition Hierarchy (Ancestors)

Central Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Botulinum ToxinsMetalloendopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesMetalloproteasesBacterial ProteinsProteinsAmino Acids, Peptides, and ProteinsBacterial ToxinsToxins, BiologicalBiological Factors

Study Officials

  • Mandar Jog, MD

    LHSC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 11, 2015

First Posted

September 16, 2015

Study Start

August 1, 2014

Primary Completion

September 1, 2020

Study Completion

December 1, 2021

Last Updated

June 22, 2020

Record last verified: 2020-06

Locations

CA(1)