Kinematic-based BoNT-A Injections for Bilateral ET

Western University, Canada

Status and phase: Unknown; Phase 2

Conditions: Essential Tremor

Treatments: Drug: Botulinum toxin type A

Study type: Interventional

Funder types: Other

Identifiers

NCT02551848

104584

Details and patient eligibility

About

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.

Enrollment: 25 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

Essential tremor treatment

Experimental group

Description:

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

Treatment:

Drug: Botulinum toxin type A