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Clinical Trial Results:
Prospective, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial With an Open-label Period to Investigate the Efficacy and Safety of NT201 in the Unilateral and Bilateral Treatment of Essential Tremor of the Upper Limb

Summary
EudraCT number	2021-001988-24
Trial protocol	PL
Global end of trial date	21 Nov 2023

Results information
Results version number	v2(current)
This version publication date	26 Mar 2025
First version publication date	05 Dec 2024
Other versions	v1
Version creation reason	Correction of full data set Corrections: - Title of 3rd endpoint - Number of investigational sites

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

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Trial information

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Sponsor protocol code

M602011069

ISRCTN number

US NCT number

NCT04766723

WHO universal trial number (UTN)

Sponsor organisation name

Merz Pharmaceuticals GmbH

Sponsor organisation address

Eckenheimer Landstrasse 100, Frankfurt, Germany, 60318

Public contact

Public Disclosure Manager, Merz Pharmaceuticals GmbH, +49 69 1503 1, clinicaltrials@merz.de

Scientific contact

Public Disclosure Manager, Merz Pharmaceuticals GmbH, +49 69 1503 1, clinicaltrials@merz.de

Is trial part of an agreed paediatric investigation plan (PIP)

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Analysis stage

Final

Date of interim/final analysis

25 Jan 2024

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

21 Nov 2023

Was the trial ended prematurely?

Main objective of the trial

The purpose of this study was to determine whether a single treatment with administration of NT 201 (botulinum toxin) was superior to placebo (no medicine) for one-sided treatment of essential tremor in the arm (Unilateral Period).

Protection of trial subjects

The study was conducted in accordance with GCP as required by ICH‑GCP, applicable regulatory requirements in the USA, Canada, and Poland, and standard operating procedures for clinical investigation and documentation in force at Merz Pharmaceuticals GmbH, hereinafter referred to as Merz. Compliance with these requirements also constitutes conformity with the ethical principles of the Declaration of Helsinki.

Background therapy

Evidence for comparator

Actual start date of recruitment

24 Feb 2021

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Number of subjects enrolled per country

Country: Number of subjects enrolled

United States: 38

Country: Number of subjects enrolled

Canada: 5

Country: Number of subjects enrolled

Poland: 35

Worldwide total number of subjects

EEA total number of subjects

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

Subjects were recruited at 14 investigational sites in the United States, Poland and Canada.

Screening details

A total of 114 subjects were screened, out of which 78 subjects were randomized, and 77 subjects were treated in this study.

Period 1 title

Unilateral Treatment: Cycle 1 (24 weeks)

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator

Are arms mutually exclusive

Yes

Unilateral Treatment Period: NT 201

Arm description

Subjects were randomized to receive unilateral intramuscular injections of NT 201 into the muscles of the motor-dominant upper limb on Day 1 of Cycle 1 (Cycle length = 24 weeks).

Arm type

Experimental

Investigational medicinal product name

NT 201

Investigational medicinal product code

Other name

Incobotulinumtoxin A, IncobotulinumtoxinA, Xeomin, Botulinum toxin type A (150 kiloDalton), free from complexing proteins

Pharmaceutical forms

Solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

Subjects received solution for the injection from the reconstituted powder of NT 201 (130-165 units [U]) into the muscles of motor-dominant upper limb on Day 1 in Cycle 1 (Cycle length = 24 Weeks) according to the semi-flexible dosing scheme.

Unilateral Treatment Period: Placebo

Arm description

Subjects were randomized to receive unilateral intramuscular injections of placebo into the muscles of the motor-dominant upper limb on Day 1 of Cycle 1 (Cycle length = 24 weeks).

Arm type

Placebo

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

Subjects received solution for the injection from the reconstituted placebo (with an injection volume corresponding to 130-165 U for treatment with NT201), into the muscles of the motor-dominant upper limb on Day 1 in Cycle 1 (Cycle length = 24 Weeks) according to the semi-flexible dosing scheme.

Number of subjects in period 1	Unilateral Treatment Period: NT 201	Unilateral Treatment Period: Placebo
Started	51	27
Completed	48	26
Not completed	3	1
Consent withdrawn by subject	1	-
Adverse event, non-fatal	1	-
Other	1	1

Period 2 title

Bilateral treatment: Cycle 2 (12 weeks)

Is this the baseline period?

Allocation method

Not applicable

Blinding used

Not blinded

Bilateral Treatment Period: NT 201

Arm description

Subjects received NT201 or placebo in the unilateral treatment period, transitioned to bilateral treatment period and who were eligible for re-injection, received bilateral intramuscular injections of NT 201 into the muscles of both upper limbs on Day 1 of Cycle 2 (Cycle length = 12 weeks).

Arm type

Experimental

Investigational medicinal product name

NT 201

Investigational medicinal product code

Other name

Incobotulinumtoxin A, IncobotulinumtoxinA, Xeomin, Botulinum toxin type A (150 kiloDalton), free from complexing proteins

Pharmaceutical forms

Solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

Subjects received solution for the injection from the reconstituted powder of NT 201 (130-165 U per upper limb or 260-330 U per both upper limbs), into the muscles of both upper limbs on Day 1 in Cycle 2 (Cycle length = 12 Weeks) according to the semi-flexible dosing scheme.

Number of subjects in period 2 ^[1]	Bilateral Treatment Period: NT 201
Started	72
Completed	71
Not completed	1
Consent withdrawn by subject	1

Notes
[1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
Justification: Among the 74 subjects who completed unilateral treatment period (Cycle 1), 2 subjects did not meet all re-injection criteria for Cycle 2 and therefore discontinued the study after end of Cycle 1 (no need for re-injection was reported as reason for both subjects). Therefore, only 72 subjects entered the bilateral treatment period (Cycle 2).

Baseline characteristics

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Reporting group title

Unilateral Treatment Period: NT 201

Reporting group description

Subjects were randomized to receive unilateral intramuscular injections of NT 201 into the muscles of the motor-dominant upper limb on Day 1 of Cycle 1 (Cycle length = 24 weeks).

Reporting group title

Unilateral Treatment Period: Placebo

Reporting group description

Subjects were randomized to receive unilateral intramuscular injections of placebo into the muscles of the motor-dominant upper limb on Day 1 of Cycle 1 (Cycle length = 24 weeks).

Reporting group values	Unilateral Treatment Period: NT 201	Unilateral Treatment Period: Placebo	Total
Number of subjects	51	27	78
Age categorical
Units: Subjects
In utero	0	0	0
Preterm newborn infants (gestational age < 37 wks)	0	0	0
Newborns (0-27 days)	0	0	0
Infants and toddlers (28 days-23 months)	0	0	0
Children (2-11 years)	0	0	0
Adolescents (12-17 years)	0	0	0
Adults (18-64 years)	18	11	29
From 65-84 years	32	15	47
85 years and over	1	1	2
Gender categorical
Units: Subjects
Female	25	12	37
Male	26	15	41

End points

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Reporting group title

Unilateral Treatment Period: NT 201

Reporting group description

Subjects were randomized to receive unilateral intramuscular injections of NT 201 into the muscles of the motor-dominant upper limb on Day 1 of Cycle 1 (Cycle length = 24 weeks).

Reporting group title

Unilateral Treatment Period: Placebo

Reporting group description

Subjects were randomized to receive unilateral intramuscular injections of placebo into the muscles of the motor-dominant upper limb on Day 1 of Cycle 1 (Cycle length = 24 weeks).

Reporting group title

Bilateral Treatment Period: NT 201

Reporting group description

Primary: Unilateral Treatment Period: Change From Baseline to Week 6 in Maximum Tremor Amplitude of the Wrist

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End point title

Unilateral Treatment Period: Change From Baseline to Week 6 in Maximum Tremor Amplitude of the Wrist

End point description

TremorTek kinematic analytic investigational device is combination of computer software and wearable movement sensors that allows to collect motion data when placed on individual's arm to quantify tremor in various muscle groups that impact shoulder, elbow, wrist. This assessment system was used to measure maximum angular tremor amplitude at wrist of injected limb (unit: degrees). Angular tremor amplitude was measure of tremor severity. Reduction of maximum angular tremor amplitude at wrist of injected limb represented tremor improvement. Full analysis set for unilateral treatment period (FAS-UP) was subset of subjects in safety evaluation set (SES-UP, that is, all subjects who received NT201/placebo during unilateral treatment period) for whom at least one score of tremor amplitude at wrist level (injected UL) at study baseline and at least at one post-baseline score was available. “N”= subjects who were evaluable for this endpoint. The analysis was performed by randomized treatment.

End point type

Primary

End point timeframe

Baseline up to Week 6

End point values	Unilateral Treatment Period: NT 201	Unilateral Treatment Period: Placebo
Number of subjects analysed	46	26
Units: degrees of arc
least squares mean (standard error)	-0.25 ( 0.140 )	-0.46 ( 0.180 )

Unilateral Treatment Period: NT 201 vs Placebo

Comparison groups

Unilateral Treatment Period: NT 201 v Unilateral Treatment Period: Placebo

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority ^[1]

Method

Parameter type

Least Square Mean Difference

Point estimate

0.21

Confidence interval

level

95%

sides

2-sided

lower limit

-0.18

upper limit

0.61

Variability estimate

Standard error of the mean

Dispersion value

0.196

Notes
[1] - Analysis of covariance adjusting for baseline value and study site.

Secondary: Unilateral Treatment Period: Change From Baseline to Week 6 in the Essential Tremor Rating Assessment Scale (TETRAS) Performance Dominant Upper Limb (UL) Score as Assessed by Investigator

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End point title

Unilateral Treatment Period: Change From Baseline to Week 6 in the Essential Tremor Rating Assessment Scale (TETRAS) Performance Dominant Upper Limb (UL) Score as Assessed by Investigator

End point description

The Essential Tremor Rating Assessment Scale (TETRAS) was a validated clinical scale for the assessment of essential tremor severity. The TETRAS performance subscale was utilized by the qualified investigators to assess the tremor severity. The TETRAS Performance dominant UL score included TETRAS Performance items 4 (including subitems a, b, c for 3 manoeuvres), 6 to 8 of dominant UL. Each individual item score ranged from 0 to 4. The performance dominant UL score ranged from 0 to 24. Higher scores=more severe tremor. The FAS-UP was the subset of subjects in the SES-UP (all subjects who received NT201 or placebo during the unilateral treatment period) for whom at least one score of tremor amplitude at wrist level (injected UL) at the study baseline and at least at one post-baseline score was available. The analysis was performed by randomized treatment.

End point type

Secondary

End point timeframe

Baseline up to Week 6

End point values	Unilateral Treatment Period: NT 201	Unilateral Treatment Period: Placebo
Number of subjects analysed	50	26
Units: score on a scale
arithmetic mean (standard deviation)	-2.3 ( 2.60 )	-0.9 ( 1.56 )

No statistical analyses for this end point

Secondary: Unilateral Treatment Period: Change From Baseline to Week 6 in the TETRAS Performance Activities of Daily Living (ADL) UL Score

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End point title

Unilateral Treatment Period: Change From Baseline to Week 6 in the TETRAS Performance Activities of Daily Living (ADL) UL Score

End point description

TETRAS ADL subscale was another component of TETRAS. ADL subscale of TETRAS was completed by study subjects through an interview procedure to assess impact of tremor on activities of daily living. TETRAS ADL UL score was the sum of eight ADL items (on UL tremor [items 2-9]). Items were rated on a 5-point response scale each ranged from 0 (normal status/impact) to 4 (severe status/impact). The ADL UL score ranged from 0 to 32. Higher scores = greater tremor severity. The FAS-UP was subset of subjects in the SES-UP (all subjects who received NT201 or placebo during the unilateral treatment period) for whom at least one score of tremor amplitude at wrist level (injected UL) at the study baseline and at least at one post-baseline score was available. The analysis was performed by randomized treatment.

End point type

Secondary

End point timeframe

Baseline up to Week 6

End point values	Unilateral Treatment Period: NT 201	Unilateral Treatment Period: Placebo
Number of subjects analysed	50	26
Units: score on a scale
arithmetic mean (standard deviation)	-3.7 ( 5.00 )	-3.8 ( 4.46 )

No statistical analyses for this end point

Secondary: Unilateral Treatment Period: Change From Baseline to Week 6 in TETRAS ADL Functional Impact Score

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End point title

Unilateral Treatment Period: Change From Baseline to Week 6 in TETRAS ADL Functional Impact Score

End point description

TETRAS ADL Functional Impact score was the sum of the following three ADL items: occupational impairment (item 10), overall disability (item 11), and social impact (item 12) of ET. The items are rated on a 5-point response scale each ranged from 0 (normal status/impact) to 4 (severe status/impact). The ADL Functional Impact score ranged from 0 to 12. Higher scores indicated greater tremor severity. The FAS-UP was the subset of subjects in the SES-UP (all subjects who received NT201 or placebo during the unilateral treatment period) for whom at least one score of tremor amplitude at wrist level (injected UL) at the study baseline and at least at one post-baseline score was available. The analysis was performed by randomized treatment.

End point type

Secondary

End point timeframe

Baseline up to Week 6

End point values	Unilateral Treatment Period: NT 201	Unilateral Treatment Period: Placebo
Number of subjects analysed	50	26
Units: score on a scale
arithmetic mean (standard deviation)	-1.2 ( 1.87 )	-1.3 ( 1.83 )

No statistical analyses for this end point

Secondary: Unilateral Treatment Period: Subject's Global Impression of Change Scale (GICS) Score of Motor-dominant UL at Week 6

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End point title

Unilateral Treatment Period: Subject's Global Impression of Change Scale (GICS) Score of Motor-dominant UL at Week 6

End point description

The GICS was used to evaluate overall clinical impression of change after treatment by the subject. The response option was a common 7-point Likert scale ranged from ‑4 to +4, with the following values: +4 (very much improved); +3 (much improved); +2 (improved); +1 (minimally improved); 0 (no change); -1 (minimally worse); -2 (worse); -3 (much worse); ‑4 (very much worse). The FAS-UP was the subset of subjects in the SES-UP (all subjects who received NT201 or placebo during the unilateral treatment period) for whom at least one score of tremor amplitude at wrist level [injected UL] at the study baseline and at least at one post-baseline score was available. The analysis was performed by randomized treatment.

End point type

Secondary

End point timeframe

Week 6

End point values	Unilateral Treatment Period: NT 201	Unilateral Treatment Period: Placebo
Number of subjects analysed	50	26
Units: score on a scale
arithmetic mean (standard deviation)	0.9 ( 1.27 )	0.8 ( 1.14 )

No statistical analyses for this end point

Secondary: Unilateral Treatment Period: Investigator's GICS Score of Motor-dominant UL at Week 6

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End point title

Unilateral Treatment Period: Investigator's GICS Score of Motor-dominant UL at Week 6

End point description

The GICS was used to evaluate the overall clinical impression of change after treatment by the investigator. The response option was a common 7-point Likert scale ranged from ‑4 to +4, with the following values: +4 (very much improved); +3 (much improved); +2 (improved); +1 (minimally improved); 0 (no change); -1 (minimally worse); -2 (worse); -3 (much worse); ‑4 (very much worse). The FAS-UP was the subset of subjects in the SES-UP (all subjects who received NT201 or placebo during the unilateral treatment period) for whom at least one score of tremor amplitude at wrist level (injected UL) at the study baseline and at least at one post-baseline score was available. The analysis was performed by randomized treatment.

End point type

Secondary

End point timeframe

Week 6

End point values	Unilateral Treatment Period: NT 201	Unilateral Treatment Period: Placebo
Number of subjects analysed	50	26
Units: score on a scale
arithmetic mean (standard deviation)	1.2 ( 1.36 )	0.8 ( 1.03 )

No statistical analyses for this end point

Secondary: Bilateral Treatment Period: Change From Cycle 2 Baseline to Week 6 in TETRAS Performance Dominant UL Score

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End point title

Bilateral Treatment Period: Change From Cycle 2 Baseline to Week 6 in TETRAS Performance Dominant UL Score

End point description

TETRAS was a validated clinical scale for the assessment of essential tremor severity. The TETRAS performance subscale was utilized by the qualified investigators to assess the tremor severity. The TETRAS Performance dominant UL score included TETRAS Performance items 4 ((including subitems a, b, c for 3 manoeuvres), 6 to 8 of dominant UL. Each individual item score ranged from 0 to 4. The performance dominant UL score ranged from 0 to 24. Higher scores=more severe tremor. The full analysis set for the bilateral treatment period (FAS-BP) was the subset of subjects in the safety evaluation set for the bilateral treatment period (SES-BP that is, all subjects who received NT 201 during the bilateral treatment period) for whom at least one score of tremor amplitude at wrist level at the Cycle 2 baseline visit and at least at one post-baseline score.

End point type

Secondary

End point timeframe

Baseline of Cycle 2 up to Week 6 (Cycle length = 12 weeks)

End point values	Bilateral Treatment Period: NT 201
Number of subjects analysed	64
Units: score on a scale
arithmetic mean (standard deviation)	-2.8 ( 2.62 )

No statistical analyses for this end point

Secondary: Bilateral Treatment Period: Change From Cycle 2 Baseline to Week 6 in TETRAS Performance Subscale Score

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End point title

Bilateral Treatment Period: Change From Cycle 2 Baseline to Week 6 in TETRAS Performance Subscale Score

End point description

The TETRAS was a validated clinical scale for the assessment of essential tremor severity. The TETRAS performance subscale was utilized by the qualified investigators to assess the tremor severity. TETRAS performance subscale consisted of 9 items: head, face, and voice tremor (items 1-3), UL tremor of right and left UL (item 4) in three tasks (forward outstretched postural tremor, lateral “wing-beating” postural tremor, kinetic tremor), Archimedes spirals with both hands, handwriting with motor-dominant hand, and dot approximation task with both hands (items 6-8), and lower limb tremor and standing tremor (items 5 and 9). Each item was rated from 0 (no tremor) to 4 (severe tremor) with overall performance score of 0 to 64, calculated as the sum of subscale items. Higher scores = greater tremor severity. The FAS-BP was the subset of subjects in the safety evaluation set for the SES-BP (that is, all subjects who received NT 201 during bilateral treatment.

End point type

Secondary

End point timeframe

Baseline of Cycle 2 up to Week 6 (Cycle length =12 weeks)

End point values	Bilateral Treatment Period: NT 201
Number of subjects analysed	64
Units: score on a scale
arithmetic mean (standard deviation)	-5.6 ( 5.14 )

No statistical analyses for this end point

Secondary: Bilateral Treatment Period: Change From Cycle 2 Baseline to Week 6 in TETRAS ADL UL Score

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End point title

Bilateral Treatment Period: Change From Cycle 2 Baseline to Week 6 in TETRAS ADL UL Score

End point description

TETRAS ADL subscale was another component of TETRAS. ADL subscale of TETRAS was completed by study subjects through an interview procedure to assess impact of tremor on activities of daily living. TETRAS ADL UL score was the sum of eight ADL items on UL tremor (items 2-9). Items were rated on a 5-point response scale each ranged from 0 (normal status/impact) to 4 (severe status/impact). The ADL UL score ranged from 0 to 32. Higher scores = greater tremor severity. The FAS-BP was the subset of subjects in the SES-BP (all subjects who received NT 201 during the bilateral treatment period) for whom at least one score of tremor amplitude at wrist level at the Cycle 2 baseline visit and at least at one post-baseline score.

End point type

Secondary

End point timeframe

Baseline of Cycle 2 up to Week 6 (Cycle length = 12 weeks)

End point values	Bilateral Treatment Period: NT 201
Number of subjects analysed	64
Units: score on a scale
arithmetic mean (standard deviation)	-4.4 ( 4.07 )

No statistical analyses for this end point

Secondary: Bilateral Treatment Period: Change From Cycle 2 Baseline to Week 6 in TETRAS ADL Functional Impact Score

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End point title

Bilateral Treatment Period: Change From Cycle 2 Baseline to Week 6 in TETRAS ADL Functional Impact Score

End point description

TETRAS ADL Functional Impact score was the sum of the following three ADL items: occupational impairment (item 10), overall disability (item 11), and social impact (item 12) of ET. The items are rated on a 5-point response scale each ranged from 0 (normal status/impact) to 4 (severe status/impact). The ADL Functional Impact score ranged from 0 to 12. Higher scores indicated greater tremor severity. The FAS-BP was the subset of subjects in SES-BP (all subjects who received NT 201 during the bilateral treatment period) for whom at least one score of tremor amplitude at wrist level at the Cycle 2 baseline visit and at least at one post-baseline score.

End point type

Secondary

End point timeframe

Baseline of Cycle 2 up to Week 6 (Cycle length = 12 weeks)

End point values	Bilateral Treatment Period: NT 201
Number of subjects analysed	64
Units: score on a scale
arithmetic mean (standard deviation)	-1.4 ( 1.42 )

No statistical analyses for this end point

Secondary: Percentage of Subjects With At-least One Treatment Related Treatment-emergent AEs (TEAEs)

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End point title

Percentage of Subjects With At-least One Treatment Related Treatment-emergent AEs (TEAEs)

End point description

An adverse event (AE) is any untoward medical occurrence in subject administered pharmaceutical product. TEAEs of unilateral treatment period (Cycle 1) = AEs from first injection up to injection in the bilateral treatment period (Week 24). TEAEs of bilateral treatment period (Cycle 2) = AEs from injection in bilateral treatment period up to end of study (Week 36). The safety evaluation set for the SES-UP included all subjects who received NT 201 or placebo during the unilateral treatment period and for SES-BP included all subjects who received NT 201 during the bilateral treatment period. For the unilateral treatment period, the analysis performed according to actual treatment.

End point type

Secondary

End point timeframe

Unilateral Treatment Period: From first injection in unilateral treatment period up to re-injection in Bilateral Treatment Period (Week 24); Bilateral Treatment Period: From re-injection in Bilateral Treatment Period at Week 24 up to end of study(Week 36)

End point values	Unilateral Treatment Period: NT 201	Bilateral Treatment Period: NT 201	Unilateral Treatment Period: Placebo
Number of subjects analysed	50	72	27
Units: percentage of subjects
number (not applicable)	30.0	30.6	3.7

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

26.1

Reporting group title

Unilateral Treatment Period: NT 201

Reporting group description

Subjects received unilateral intramuscular injections of NT 201 into the muscles of the motor-dominant upper limb on Day 1 of Cycle 1 (Cycle length = 24 weeks).

Reporting group title

Bilateral Treatment Period: NT 201

Reporting group description

Reporting group title

Unilateral Treatment Period: Placebo

Reporting group description

Subjects received unilateral intramuscular injections of placebo into the muscles of the motor-dominant upper limb on Day 1 of Cycle 1 (Cycle length = 24 weeks).

Serious adverse events	Unilateral Treatment Period: NT 201	Bilateral Treatment Period: NT 201	Unilateral Treatment Period: Placebo
Total subjects affected by serious adverse events
subjects affected / exposed	3 / 50 (6.00%)	2 / 72 (2.78%)	2 / 27 (7.41%)
number of deaths (all causes)	0	0	0
number of deaths resulting from adverse events	0	0	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
subjects affected / exposed	1 / 50 (2.00%)	0 / 72 (0.00%)	0 / 27 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Papillary thyroid cancer
subjects affected / exposed	0 / 50 (0.00%)	0 / 72 (0.00%)	1 / 27 (3.70%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Injury, poisoning and procedural complications
Skull fracture
subjects affected / exposed	0 / 50 (0.00%)	1 / 72 (1.39%)	0 / 27 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Subdural haematoma
subjects affected / exposed	0 / 50 (0.00%)	1 / 72 (1.39%)	0 / 27 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cardiac disorders
Atrial fibrillation
subjects affected / exposed	0 / 50 (0.00%)	1 / 72 (1.39%)	0 / 27 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Nervous system disorders
Subarachnoid haemorrhage
subjects affected / exposed	0 / 50 (0.00%)	1 / 72 (1.39%)	0 / 27 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
General disorders and administration site conditions
Condition aggravated
subjects affected / exposed	1 / 50 (2.00%)	0 / 72 (0.00%)	0 / 27 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Ear and labyrinth disorders
Deafness unilateral
subjects affected / exposed	0 / 50 (0.00%)	1 / 72 (1.39%)	0 / 27 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hepatobiliary disorders
Cholelithiasis
subjects affected / exposed	1 / 50 (2.00%)	0 / 72 (0.00%)	0 / 27 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Respiratory, thoracic and mediastinal disorders
Aspiration
subjects affected / exposed	0 / 50 (0.00%)	0 / 72 (0.00%)	1 / 27 (3.70%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Dyspnoea
subjects affected / exposed	0 / 50 (0.00%)	0 / 72 (0.00%)	1 / 27 (3.70%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Infections and infestations
Pneumonia
subjects affected / exposed	1 / 50 (2.00%)	0 / 72 (0.00%)	0 / 27 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0

Frequency threshold for reporting non-serious adverse events: 0%

Non-serious adverse events	Unilateral Treatment Period: NT 201	Bilateral Treatment Period: NT 201	Unilateral Treatment Period: Placebo
Total subjects affected by non serious adverse events
subjects affected / exposed	29 / 50 (58.00%)	29 / 72 (40.28%)	5 / 27 (18.52%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
subjects affected / exposed	1 / 50 (2.00%)	0 / 72 (0.00%)	0 / 27 (0.00%)
occurrences all number	1	0	0
Metastases to lung
subjects affected / exposed	0 / 50 (0.00%)	0 / 72 (0.00%)	1 / 27 (3.70%)
occurrences all number	0	0	1
Rectal neoplasm
subjects affected / exposed	0 / 50 (0.00%)	1 / 72 (1.39%)	0 / 27 (0.00%)
occurrences all number	0	1	0
Vascular disorders
Hypertension
subjects affected / exposed	3 / 50 (6.00%)	0 / 72 (0.00%)	0 / 27 (0.00%)
occurrences all number	3	0	0
Essential hypertension
subjects affected / exposed	1 / 50 (2.00%)	0 / 72 (0.00%)	0 / 27 (0.00%)
occurrences all number	1	0	0
Peripheral venous disease
subjects affected / exposed	1 / 50 (2.00%)	0 / 72 (0.00%)	0 / 27 (0.00%)
occurrences all number	1	0	0
General disorders and administration site conditions
Injection site haemorrhage
subjects affected / exposed	2 / 50 (4.00%)	0 / 72 (0.00%)	1 / 27 (3.70%)
occurrences all number	2	0	1
Inflammation
subjects affected / exposed	1 / 50 (2.00%)	0 / 72 (0.00%)	0 / 27 (0.00%)
occurrences all number	1	0	0
Injection site nodule
subjects affected / exposed	1 / 50 (2.00%)	0 / 72 (0.00%)	0 / 27 (0.00%)
occurrences all number	1	0	0
Fatigue
subjects affected / exposed	0 / 50 (0.00%)	0 / 72 (0.00%)	1 / 27 (3.70%)
occurrences all number	0	0	1
Influenza like illness
subjects affected / exposed	0 / 50 (0.00%)	0 / 72 (0.00%)	1 / 27 (3.70%)
occurrences all number	0	0	1
Injection site pain
subjects affected / exposed	0 / 50 (0.00%)	2 / 72 (2.78%)	0 / 27 (0.00%)
occurrences all number	0	2	0
Gait disturbance
subjects affected / exposed	0 / 50 (0.00%)	1 / 72 (1.39%)	0 / 27 (0.00%)
occurrences all number	0	1	0
Psychiatric disorders
Depression
subjects affected / exposed	1 / 50 (2.00%)	0 / 72 (0.00%)	0 / 27 (0.00%)
occurrences all number	1	0	0
Negative thoughts
subjects affected / exposed	1 / 50 (2.00%)	0 / 72 (0.00%)	0 / 27 (0.00%)
occurrences all number	1	0	0
Investigations
Blood creatine phosphokinase increased
subjects affected / exposed	1 / 50 (2.00%)	0 / 72 (0.00%)	0 / 27 (0.00%)
occurrences all number	1	0	0
Blood pressure increased
subjects affected / exposed	1 / 50 (2.00%)	0 / 72 (0.00%)	0 / 27 (0.00%)
occurrences all number	1	0	0
Gamma-glutamyltransferase increased
subjects affected / exposed	1 / 50 (2.00%)	0 / 72 (0.00%)	0 / 27 (0.00%)
occurrences all number	1	0	0
Injury, poisoning and procedural complications
Arthropod bite
subjects affected / exposed	1 / 50 (2.00%)	0 / 72 (0.00%)	0 / 27 (0.00%)
occurrences all number	1	0	0
Contusion
subjects affected / exposed	1 / 50 (2.00%)	1 / 72 (1.39%)	1 / 27 (3.70%)
occurrences all number	1	1	1
Fall
subjects affected / exposed	1 / 50 (2.00%)	3 / 72 (4.17%)	2 / 27 (7.41%)
occurrences all number	1	4	2
Craniofacial fracture
subjects affected / exposed	0 / 50 (0.00%)	0 / 72 (0.00%)	1 / 27 (3.70%)
occurrences all number	0	0	1
Craniofacial injury
subjects affected / exposed	0 / 50 (0.00%)	0 / 72 (0.00%)	1 / 27 (3.70%)
occurrences all number	0	0	1
Ligament sprain
subjects affected / exposed	0 / 50 (0.00%)	1 / 72 (1.39%)	0 / 27 (0.00%)
occurrences all number	0	1	0
Post-traumatic pain
subjects affected / exposed	0 / 50 (0.00%)	1 / 72 (1.39%)	0 / 27 (0.00%)
occurrences all number	0	1	0
Congenital, familial and genetic disorders
Type V hyperlipidaemia
subjects affected / exposed	0 / 50 (0.00%)	1 / 72 (1.39%)	0 / 27 (0.00%)
occurrences all number	0	1	0
Cardiac disorders
Arrhythmia
subjects affected / exposed	0 / 50 (0.00%)	1 / 72 (1.39%)	0 / 27 (0.00%)
occurrences all number	0	1	0
Hypertensive heart disease
subjects affected / exposed	0 / 50 (0.00%)	1 / 72 (1.39%)	0 / 27 (0.00%)
occurrences all number	0	1	0
Nervous system disorders
Cervical radiculopathy
subjects affected / exposed	1 / 50 (2.00%)	0 / 72 (0.00%)	0 / 27 (0.00%)
occurrences all number	1	0	0
Dizziness
subjects affected / exposed	1 / 50 (2.00%)	2 / 72 (2.78%)	0 / 27 (0.00%)
occurrences all number	1	2	0
Facial paralysis
subjects affected / exposed	1 / 50 (2.00%)	0 / 72 (0.00%)	0 / 27 (0.00%)
occurrences all number	1	0	0
Headache
subjects affected / exposed	1 / 50 (2.00%)	1 / 72 (1.39%)	0 / 27 (0.00%)
occurrences all number	1	1	0
Fine motor skill dysfunction
subjects affected / exposed	0 / 50 (0.00%)	1 / 72 (1.39%)	0 / 27 (0.00%)
occurrences all number	0	1	0
Hypoaesthesia
subjects affected / exposed	0 / 50 (0.00%)	1 / 72 (1.39%)	0 / 27 (0.00%)
occurrences all number	0	1	0
Monoparesis
subjects affected / exposed	0 / 50 (0.00%)	1 / 72 (1.39%)	0 / 27 (0.00%)
occurrences all number	0	1	0
Paresis
subjects affected / exposed	0 / 50 (0.00%)	1 / 72 (1.39%)	0 / 27 (0.00%)
occurrences all number	0	2	0
Gastrointestinal disorders
Colitis
subjects affected / exposed	1 / 50 (2.00%)	0 / 72 (0.00%)	0 / 27 (0.00%)
occurrences all number	1	0	0
Dyspepsia
subjects affected / exposed	1 / 50 (2.00%)	0 / 72 (0.00%)	0 / 27 (0.00%)
occurrences all number	1	0	0
Gastritis
subjects affected / exposed	1 / 50 (2.00%)	0 / 72 (0.00%)	1 / 27 (3.70%)
occurrences all number	1	0	1
Peritoneal adhesions
subjects affected / exposed	1 / 50 (2.00%)	0 / 72 (0.00%)	0 / 27 (0.00%)
occurrences all number	1	0	0
Diarrhoea
subjects affected / exposed	0 / 50 (0.00%)	0 / 72 (0.00%)	1 / 27 (3.70%)
occurrences all number	0	0	1
Chronic gastritis
subjects affected / exposed	0 / 50 (0.00%)	1 / 72 (1.39%)	0 / 27 (0.00%)
occurrences all number	0	1	0
Retching
subjects affected / exposed	0 / 50 (0.00%)	1 / 72 (1.39%)	0 / 27 (0.00%)
occurrences all number	0	1	0
Skin and subcutaneous tissue disorders
Ecchymosis
subjects affected / exposed	0 / 50 (0.00%)	1 / 72 (1.39%)	0 / 27 (0.00%)
occurrences all number	0	1	0
Rash pruritic
subjects affected / exposed	1 / 50 (2.00%)	0 / 72 (0.00%)	0 / 27 (0.00%)
occurrences all number	1	0	0
Renal and urinary disorders
Nephrolithiasis
subjects affected / exposed	0 / 50 (0.00%)	1 / 72 (1.39%)	0 / 27 (0.00%)
occurrences all number	0	1	0
Haematuria
subjects affected / exposed	1 / 50 (2.00%)	0 / 72 (0.00%)	0 / 27 (0.00%)
occurrences all number	1	0	0
Hydronephrosis
subjects affected / exposed	1 / 50 (2.00%)	0 / 72 (0.00%)	0 / 27 (0.00%)
occurrences all number	1	0	0
Musculoskeletal and connective tissue disorders
Bursitis
subjects affected / exposed	0 / 50 (0.00%)	1 / 72 (1.39%)	0 / 27 (0.00%)
occurrences all number	0	1	0
Arthritis
subjects affected / exposed	0 / 50 (0.00%)	1 / 72 (1.39%)	0 / 27 (0.00%)
occurrences all number	0	1	0
Spinal osteoarthritis
subjects affected / exposed	0 / 50 (0.00%)	0 / 72 (0.00%)	1 / 27 (3.70%)
occurrences all number	0	0	1
Intervertebral disc disorder
subjects affected / exposed	1 / 50 (2.00%)	0 / 72 (0.00%)	0 / 27 (0.00%)
occurrences all number	1	0	0
Muscular weakness
subjects affected / exposed	12 / 50 (24.00%)	17 / 72 (23.61%)	0 / 27 (0.00%)
occurrences all number	12	20	0
Pain in extremity
subjects affected / exposed	2 / 50 (4.00%)	1 / 72 (1.39%)	0 / 27 (0.00%)
occurrences all number	2	1	0
Back pain
subjects affected / exposed	3 / 50 (6.00%)	0 / 72 (0.00%)	0 / 27 (0.00%)
occurrences all number	3	0	0
Arthralgia
subjects affected / exposed	1 / 50 (2.00%)	2 / 72 (2.78%)	0 / 27 (0.00%)
occurrences all number	1	2	0
Musculoskeletal chest pain
subjects affected / exposed	0 / 50 (0.00%)	1 / 72 (1.39%)	0 / 27 (0.00%)
occurrences all number	0	1	0
Muscle fatigue
subjects affected / exposed	0 / 50 (0.00%)	1 / 72 (1.39%)	0 / 27 (0.00%)
occurrences all number	0	1	0
Joint swelling
subjects affected / exposed	0 / 50 (0.00%)	1 / 72 (1.39%)	0 / 27 (0.00%)
occurrences all number	0	1	0
Coccydynia
subjects affected / exposed	0 / 50 (0.00%)	1 / 72 (1.39%)	0 / 27 (0.00%)
occurrences all number	0	1	0
Infections and infestations
Influenza
subjects affected / exposed	1 / 50 (2.00%)	0 / 72 (0.00%)	0 / 27 (0.00%)
occurrences all number	1	0	0
Upper respiratory tract infection
subjects affected / exposed	1 / 50 (2.00%)	2 / 72 (2.78%)	0 / 27 (0.00%)
occurrences all number	1	2	0
COVID-19
subjects affected / exposed	0 / 50 (0.00%)	1 / 72 (1.39%)	1 / 27 (3.70%)
occurrences all number	0	1	1
Conjunctivitis
subjects affected / exposed	0 / 50 (0.00%)	0 / 72 (0.00%)	1 / 27 (3.70%)
occurrences all number	0	0	1
Viral upper respiratory tract infection
subjects affected / exposed	0 / 50 (0.00%)	0 / 72 (0.00%)	1 / 27 (3.70%)
occurrences all number	0	0	1
Paronychia
subjects affected / exposed	0 / 50 (0.00%)	1 / 72 (1.39%)	0 / 27 (0.00%)
occurrences all number	0	1	0
Helicobacter infection
subjects affected / exposed	1 / 50 (2.00%)	0 / 72 (0.00%)	0 / 27 (0.00%)
occurrences all number	1	0	0
Ear infection
subjects affected / exposed	1 / 50 (2.00%)	0 / 72 (0.00%)	0 / 27 (0.00%)
occurrences all number	1	0	0
Cellulitis
subjects affected / exposed	1 / 50 (2.00%)	0 / 72 (0.00%)	0 / 27 (0.00%)
occurrences all number	1	0	0
Bronchitis
subjects affected / exposed	1 / 50 (2.00%)	0 / 72 (0.00%)	0 / 27 (0.00%)
occurrences all number	1	0	0
Herpes zoster
subjects affected / exposed	2 / 50 (4.00%)	0 / 72 (0.00%)	0 / 27 (0.00%)
occurrences all number	2	0	0
Metabolism and nutrition disorders
Gout
subjects affected / exposed	0 / 50 (0.00%)	1 / 72 (1.39%)	0 / 27 (0.00%)
occurrences all number	0	1	0

More information

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Were there any global substantial amendments to the protocol? Yes

31 May 2021

Protocol amendment version 3.0: The amendment was designed in order to add Poland in the list of countries where the study was performed and to eliminate some minor discrepancies in the content of the protocol.

26 May 2023

Protocol amendment version 1.0 to 3.0: The amendment was created in order to reduce the workload of the Independent Rater Panel (IRP). According to the amendment the IRP performed the TETRAS Performance subscale ratings based on videos from all subjects at Baseline (V2), and at Week 6 (V4).

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

None reported

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Clinical trials

Clinical Trial Results:
Prospective, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial With an Open-label Period to Investigate the Efficacy and Safety of NT201 in the Unilateral and Bilateral Treatment of Essential Tremor of the Upper Limb

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Unilateral Treatment Period: Change From Baseline to Week 6 in Maximum Tremor Amplitude of the Wrist

Primary: Unilateral Treatment Period: Change From Baseline to Week 6 in Maximum Tremor Amplitude of the Wrist

Secondary: Unilateral Treatment Period: Change From Baseline to Week 6 in the Essential Tremor Rating Assessment Scale (TETRAS) Performance Dominant Upper Limb (UL) Score as Assessed by Investigator

Secondary: Unilateral Treatment Period: Change From Baseline to Week 6 in the Essential Tremor Rating Assessment Scale (TETRAS) Performance Dominant Upper Limb (UL) Score as Assessed by Investigator

Secondary: Unilateral Treatment Period: Change From Baseline to Week 6 in the TETRAS Performance Activities of Daily Living (ADL) UL Score

Secondary: Unilateral Treatment Period: Change From Baseline to Week 6 in the TETRAS Performance Activities of Daily Living (ADL) UL Score

Secondary: Unilateral Treatment Period: Change From Baseline to Week 6 in TETRAS ADL Functional Impact Score

Secondary: Unilateral Treatment Period: Change From Baseline to Week 6 in TETRAS ADL Functional Impact Score

Secondary: Unilateral Treatment Period: Subject's Global Impression of Change Scale (GICS) Score of Motor-dominant UL at Week 6

Secondary: Unilateral Treatment Period: Subject's Global Impression of Change Scale (GICS) Score of Motor-dominant UL at Week 6

Secondary: Unilateral Treatment Period: Investigator's GICS Score of Motor-dominant UL at Week 6

Secondary: Unilateral Treatment Period: Investigator's GICS Score of Motor-dominant UL at Week 6

Secondary: Bilateral Treatment Period: Change From Cycle 2 Baseline to Week 6 in TETRAS Performance Dominant UL Score

Secondary: Bilateral Treatment Period: Change From Cycle 2 Baseline to Week 6 in TETRAS Performance Dominant UL Score

Secondary: Bilateral Treatment Period: Change From Cycle 2 Baseline to Week 6 in TETRAS Performance Subscale Score

Secondary: Bilateral Treatment Period: Change From Cycle 2 Baseline to Week 6 in TETRAS Performance Subscale Score

Secondary: Bilateral Treatment Period: Change From Cycle 2 Baseline to Week 6 in TETRAS ADL UL Score

Secondary: Bilateral Treatment Period: Change From Cycle 2 Baseline to Week 6 in TETRAS ADL UL Score

Secondary: Bilateral Treatment Period: Change From Cycle 2 Baseline to Week 6 in TETRAS ADL Functional Impact Score

Secondary: Bilateral Treatment Period: Change From Cycle 2 Baseline to Week 6 in TETRAS ADL Functional Impact Score

Secondary: Percentage of Subjects With At-least One Treatment Related Treatment-emergent AEs (TEAEs)

Secondary: Percentage of Subjects With At-least One Treatment Related Treatment-emergent AEs (TEAEs)

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

Austria
Belgium
Bulgaria
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
United Kingdom
Outside EU/EEA

Clinical trials

Clinical Trial Results: Prospective, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial With an Open-label Period to Investigate the Efficacy and Safety of NT201 in the Unilateral and Bilateral Treatment of Essential Tremor of the Upper Limb

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Unilateral Treatment Period: Change From Baseline to Week 6 in Maximum Tremor Amplitude of the Wrist

Primary: Unilateral Treatment Period: Change From Baseline to Week 6 in Maximum Tremor Amplitude of the Wrist

Secondary: Unilateral Treatment Period: Change From Baseline to Week 6 in the Essential Tremor Rating Assessment Scale (TETRAS) Performance Dominant Upper Limb (UL) Score as Assessed by Investigator

Secondary: Unilateral Treatment Period: Change From Baseline to Week 6 in the Essential Tremor Rating Assessment Scale (TETRAS) Performance Dominant Upper Limb (UL) Score as Assessed by Investigator

Secondary: Unilateral Treatment Period: Change From Baseline to Week 6 in the TETRAS Performance Activities of Daily Living (ADL) UL Score

Secondary: Unilateral Treatment Period: Change From Baseline to Week 6 in the TETRAS Performance Activities of Daily Living (ADL) UL Score

Secondary: Unilateral Treatment Period: Change From Baseline to Week 6 in TETRAS ADL Functional Impact Score

Secondary: Unilateral Treatment Period: Change From Baseline to Week 6 in TETRAS ADL Functional Impact Score

Secondary: Unilateral Treatment Period: Subject's Global Impression of Change Scale (GICS) Score of Motor-dominant UL at Week 6

Secondary: Unilateral Treatment Period: Subject's Global Impression of Change Scale (GICS) Score of Motor-dominant UL at Week 6

Secondary: Unilateral Treatment Period: Investigator's GICS Score of Motor-dominant UL at Week 6

Secondary: Unilateral Treatment Period: Investigator's GICS Score of Motor-dominant UL at Week 6

Secondary: Bilateral Treatment Period: Change From Cycle 2 Baseline to Week 6 in TETRAS Performance Dominant UL Score

Secondary: Bilateral Treatment Period: Change From Cycle 2 Baseline to Week 6 in TETRAS Performance Dominant UL Score

Secondary: Bilateral Treatment Period: Change From Cycle 2 Baseline to Week 6 in TETRAS Performance Subscale Score

Secondary: Bilateral Treatment Period: Change From Cycle 2 Baseline to Week 6 in TETRAS Performance Subscale Score

Secondary: Bilateral Treatment Period: Change From Cycle 2 Baseline to Week 6 in TETRAS ADL UL Score

Secondary: Bilateral Treatment Period: Change From Cycle 2 Baseline to Week 6 in TETRAS ADL UL Score

Secondary: Bilateral Treatment Period: Change From Cycle 2 Baseline to Week 6 in TETRAS ADL Functional Impact Score

Secondary: Bilateral Treatment Period: Change From Cycle 2 Baseline to Week 6 in TETRAS ADL Functional Impact Score

Secondary: Percentage of Subjects With At-least One Treatment Related Treatment-emergent AEs (TEAEs)

Secondary: Percentage of Subjects With At-least One Treatment Related Treatment-emergent AEs (TEAEs)

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

Clinical Trial Results:
Prospective, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial With an Open-label Period to Investigate the Efficacy and Safety of NT201 in the Unilateral and Bilateral Treatment of Essential Tremor of the Upper Limb