Botulinum Toxin A to Treat Arm Tremor

NCT02207946 | Completed Phase 2 Results

• 1 other identifier: MRZ60201_2094_1
• Study Type: interventional
• Target: 30
• Locations: 2 countries
• Sites: 6

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

Outcome Measures

Primary Outcomes (1)

• Change From Baseline to Week 4 in Maximum Angular Tremor Amplitude of the Wrist (Injected Limb)

  No primary efficacy variables are defined for this study. One of the secondary outcome measures is used for CTgov protocol registration and results reporting purposes only. TremorTek is a tremor kinematic analytics investigational device which is used to measure maximum angular tremor amplitude at wrist of the injected limb (unit: degrees). Angular tremor amplitude is the measure of tremor severity. Reduction of angular tremor amplitude at wrist of the injected limb represents tremor improvement.

  Baseline up to Week 4

Secondary Outcomes (5)

• Change From Baseline to Week 4 in Maximum Log-transformed Accelerometric Tremor Amplitude at Wrist Level (Injected Limb)

  Baseline up to Week 4

• Change From Baseline to Week 4 in Fahn-Tolosa-Marin (FTM) Tremor Score in Injected Limb (Item 5 [Right Upper Extremity] or 6 [Left Upper Extremity])

  Baseline up to Week 4

• Change From Baseline to Week 4 in FTM Motor Performance Score (Items 11-15)

  Baseline up to Week 4

• Participant's Global Impression of Change Scale (GICS) at Week 4

  Week 4

• Investigator's Global Impression of Change Scale (GICS) at Week 4

  Week 4

Study Arms (2)

200 Units incobotulinumtoxinA (Xeomin)

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

IncobotulinumtoxinA 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).

Also known as: Xeomin, NT 201, Botulinum toxin type A (150 kiloDalton), free from complexing proteins

200 Units incobotulinumtoxinA (Xeomin)

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Merz Pharmaceuticals GmbH: lead

Study Sites (6)

Merz Investigational Site #0010191

New York, New York, 10029, United States

Location

Merz Investigational Site #0010317

Winnipeg, Manitoba, R3J2H7, Canada

Location

Merz Investigational Site #0010089

Halifax, Nova Scotia, B3P 1M3, Canada

Location

Merz Investigational Site #0010078

Toronto, Ontario, M5T 2S8, Canada

Location

Merz Investigational Site #0010305/1

Toronto, Ontario, M6M 2J5, Canada

Location

Merz Investigational Site #0010305/2

Toronto, Ontario, M6M 2J5, Canada

Location

Related Publications (1)

• 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.

  PMID: 33419261 RESULT

MeSH Terms

Interventions

incobotulinumtoxinA; Botulinum Toxins, Type A

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Results Point of Contact

• Title: Public Disclosure Manager
• Organization: Merz Pharmaceuticals GmbH

clinicaltrials@merz.com

+49 69 1503 1

Study Officials

• Merz Medical Expert

  Merz Pharmaceuticals GmbH

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2014
• First Posted: August 4, 2014
• Study Start: December 5, 2014
• Primary Completion: May 9, 2016
• Study Completion: September 26, 2016
• Last Updated: February 18, 2021
• Results First Posted: February 18, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (5); US (1)