Botulinum Toxin A to Treat Arm Tremor

NCT ID: NCT02207946

Last Updated: 2021-02-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-05
• Study Completion Date: 2016-09-26

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.

Conditions

Essential Tremor of the Upper Limbs

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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).

Group Type: EXPERIMENTAL

IncobotulinumtoxinA

Intervention Type: DRUG

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).

Placebo

Single injection cycle, intramuscular injection into muscles of wrist (mandatory) and shoulder and/or elbow (both optional).

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Solution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl).

Interventions

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).

Intervention Type: DRUG

Placebo

Solution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl).

Intervention Type: DRUG

Other Intervention Names

Xeomin; NT 201; Botulinum toxin type A (150 kiloDalton), free from complexing proteins

Eligibility 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 16-23) 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merz Pharmaceuticals GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Merz Medical Expert

Role: STUDY_DIRECTOR

Merz Pharmaceuticals GmbH

Locations

Merz Investigational Site #0010191

New York, New York, United States

Merz Investigational Site #0010317

Winnipeg, Manitoba, Canada

Merz Investigational Site #0010089

Halifax, Nova Scotia, Canada

Merz Investigational Site #0010078

Toronto, Ontario, Canada

Merz Investigational Site #0010305/1

Toronto, Ontario, Canada

Merz Investigational Site #0010305/2

Toronto, Ontario, Canada

Countries

United States; Canada

References

Jog M, Lee J, Scheschonka A, Chen R, Ismail F, Boulias C, Hobson D, King D, Althaus M, Simon O, Dersch H, Frucht S, Simpson DM. Tolerability and Efficacy of Customized IncobotulinumtoxinA Injections for Essential Tremor: A Randomized, Double-Blind, Placebo-Controlled Study. Toxins (Basel). 2020 Dec 20;12(12):807. doi: 10.3390/toxins12120807.

Reference Type: RESULT

PMID: 33419261 (View on PubMed)

Other Identifiers

MRZ60201_2094_1

Identifier Type: -

Identifier Source: org_study_id