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Essential Tremor of the Upper LimbsPhase 2NCT02207946

Botulinum Toxin A to Treat Arm Tremor

A Phase 2 study testing IncobotulinumtoxinA in people with Essential Tremor of the Upper Limbs, run by Merz Pharmaceuticals GmbH at 6 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Essential Tremor of the Upper Limbs
What is being tested?
IncobotulinumtoxinA
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
30 participants
Where
6 sitesin 2 countries
Study dates
5 Dec 2014to 26 Sep 2016
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Main 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.

Main 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.

Trial locations and contacts

6 sites in 2 countries.

6 sites in 2 countries

Canada5 sites

  • Merz Investigational Site #0010089

    Halifax, Nova Scotia, B3P 1M3

  • Merz Investigational Site #0010078

    Toronto, Ontario, M5T 2S8

  • Merz Investigational Site #0010305/1

    Toronto, Ontario, M6M 2J5

  • Merz Investigational Site #0010305/2

    Toronto, Ontario, M6M 2J5

  • Merz Investigational Site #0010317

    Winnipeg, Manitoba, R3J2H7

Other trials in Canada

United States1 site

  • Merz Investigational Site #0010191

    New York, New York, 10029

Other trials in United States

About this study

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

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.

Being tested
IncobotulinumtoxinA, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IncobotulinumtoxinADrug

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

    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).

  • PlaceboDrug

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

Study groups in NCT02207946
Study groupRoleWhat they receive
200 Units incobotulinumtoxinA (Xeomin)ExperimentalSingle injection cycle, total dose of up to 200 Units, intramuscular injection into muscles of wrist (mandatory) and shoulder and/or elbow (both optional).
Receives: Drug: IncobotulinumtoxinA
PlaceboPlacebo comparatorSingle injection cycle, intramuscular injection into muscles of wrist (mandatory) and shoulder and/or elbow (both optional).
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline up to Week 4

Secondary outcomes (5)

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

    TremorTek is a tremor kinematic analytics investigational device which is used to measure maximum log-transformed accelerometric tremor amplitude at wrist level of the injected limb (unit: meter per square second [m/s˄2]). Log-transformed accelerometric tremor amplitude is a measure of tremor severity reflecting the non-vectoral intensity of tremor. Reduction of log-transformed accelerometric tremor amplitude at wrist level of the injected limb represents a tremor improvement.

    Measured: Baseline up to Week 4

  2. 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])

    The FTM tremor rating scale is used for evaluation of tremor severity and function and consists of three parts (A, B, C). For this outcome measure the score of FTM scale item 5 ("right upper extremity") or item 6 ("left upper extremity") is used (both items are from part A). The outcome values are calculated as the sum of the three functions "at rest", "with posture holding", and "with action and intention". The score for each item ranges from 0 (normal) to 4 (severe), that is, the possible values range from 0 to 12.

    Measured: Baseline up to Week 4

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

    The FTM tremor rating scale was used for evaluation of tremor severity and function. This investigator-assessed scale consists of 3 parts (A, B and C). Part A: Tremor location/Severity rating (items 1-10); Part B: Specific motor tasks / Function rating (items 11-15). Ratings for five motor tasks (handwriting, drawing [large/small spiral, line], and pouring); and Part C: Functional disabilities resulting from tremor/activities of daily living (items 16-23). For this outcome measure, the sum of the five FTM motor performance items (from Part B) were used: item 11 ('handwriting for dominant hand only' - irrespective of its injection or non-injection), items 12 to 15 ('drawing large and small spiral', 'line drawing', 'pouring' for the injected upper limb). The score for each item ranges from 0 (normal) to 4 (severe). Possible values range for total FTM motor performance score: 0-20.

    Measured: Baseline up to Week 4

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

    The GICS was used to measure the participant's impression of change due to treatment. The response option was a common 7-point Likert scale, with the following values: +3 (very much improved); +2 (much improved); +1 (minimally improved); 0 (no change); -1 (minimally worse); -2 (much worse); -3 (very much worse).

    Measured: Week 4

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

    The GICS was used to measure the investigator's impression of change due to treatment. The response option was a common 7-point Likert scale, with the following values: +3 (very much improved); +2 (much improved); +1 (minimally improved); 0 (no change); -1 (minimally worse); -2 (much worse); -3 (very much worse).

    Measured: Week 4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Aug 2014 (estimated)
  2. Study start5 Dec 2014
  3. Primary completion9 May 2016
  4. Study completion26 Sep 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02207946
Sponsor's protocol ID
MRZ60201_2094_1
Status last verified
Feb 2021
First submitted
1 Aug 2014
Last updated
18 Feb 2021
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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.

    PubMed 33419261

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing IncobotulinumtoxinA in people with Essential Tremor of the Upper Limbs, run by Merz Pharmaceuticals GmbH at 6 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Canada, United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline to Week 4 in Maximum Angular Tremor Amplitude of the Wrist (Injected Limb) (time frame: Baseline up to Week 4). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02207946, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2021; AzTrials last refreshed its copy on 26 Oct 2026.

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