Trial Outcomes & Findings for A Study to Investigate the Efficacy and Safety of NT 201 (Botulinum Toxin) Compared With Placebo for the Treatment of Adult Participants With Essential Tremor in the Arm (NCT NCT04766723)

Last Updated: 2026-04-28

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

78 participants

Primary outcome timeframe

Baseline up to Week 6

Results posted on

2026-04-28

Participant Flow

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

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

Participant milestones

Participant milestones
Measure	Unilateral Treatment Period: NT 201 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).	Unilateral Treatment Period: Placebo 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).	Bilateral Treatment Period: NT 201 Subjects who 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).
Unilateral Treatment: Cycle 1 (24 Weeks) STARTED	51	27	0
Unilateral Treatment: Cycle 1 (24 Weeks) COMPLETED	48	26	0
Unilateral Treatment: Cycle 1 (24 Weeks) NOT COMPLETED	3	1	0
Bilateral Treatment: Cycle 2 (12 Weeks) STARTED	0	0	72
Bilateral Treatment: Cycle 2 (12 Weeks) COMPLETED	0	0	71
Bilateral Treatment: Cycle 2 (12 Weeks) NOT COMPLETED	0	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Unilateral Treatment Period: NT 201 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).	Unilateral Treatment Period: Placebo 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).	Bilateral Treatment Period: NT 201 Subjects who 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).
Unilateral Treatment: Cycle 1 (24 Weeks) Withdrawal by Subject	1	0	0
Unilateral Treatment: Cycle 1 (24 Weeks) Adverse Event	1	0	0
Unilateral Treatment: Cycle 1 (24 Weeks) Other	1	1	0
Bilateral Treatment: Cycle 2 (12 Weeks) Withdrawal by Subject	0	0	1

Baseline Characteristics

A Study to Investigate the Efficacy and Safety of NT 201 (Botulinum Toxin) Compared With Placebo for the Treatment of Adult Participants With Essential Tremor in the Arm

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Unilateral Treatment Period: NT 201 n=51 Participants 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).	Unilateral Treatment Period: Placebo n=27 Participants 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).	Total n=78 Participants Total of all reporting groups
Age, Customized 18-64 years	18 Participants n=9 Participants	11 Participants n=24 Participants	29 Participants n=23 Participants
Age, Customized 65-84 years	32 Participants n=9 Participants	15 Participants n=24 Participants	47 Participants n=23 Participants
Age, Customized >= 85 years	1 Participants n=9 Participants	1 Participants n=24 Participants	2 Participants n=23 Participants
Sex: Female, Male Female	25 Participants n=9 Participants	12 Participants n=24 Participants	37 Participants n=23 Participants
Sex: Female, Male Male	26 Participants n=9 Participants	15 Participants n=24 Participants	41 Participants n=23 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=9 Participants	1 Participants n=24 Participants	2 Participants n=23 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	50 Participants n=9 Participants	26 Participants n=24 Participants	76 Participants n=23 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=9 Participants	0 Participants n=24 Participants	0 Participants n=23 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=9 Participants	1 Participants n=24 Participants	1 Participants n=23 Participants
Race (NIH/OMB) Asian	0 Participants n=9 Participants	0 Participants n=24 Participants	0 Participants n=23 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=9 Participants	0 Participants n=24 Participants	0 Participants n=23 Participants
Race (NIH/OMB) Black or African American	1 Participants n=9 Participants	0 Participants n=24 Participants	1 Participants n=23 Participants
Race (NIH/OMB) White	49 Participants n=9 Participants	26 Participants n=24 Participants	75 Participants n=23 Participants
Race (NIH/OMB) More than one race	0 Participants n=9 Participants	0 Participants n=24 Participants	0 Participants n=23 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=9 Participants	0 Participants n=24 Participants	1 Participants n=23 Participants

PRIMARY outcome

Timeframe: Baseline up to Week 6

Population: FAS-UP was subset of subjects in safety evaluation set (SES-UP) 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. "Overall number of participants analyzed" signifies subjects evaluable for this outcome measure. The analysis was performed by randomized treatment (one subject randomized to NT 201 was erroneously treated with placebo and one subject randomized to placebo was not treated).

Outcome measures

Outcome measures
Measure	Unilateral Treatment Period: NT 201 n=46 Participants 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).	Unilateral Treatment Period: Placebo n=26 Participants 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).	Bilateral Treatment Period: NT 201 Subjects who 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).
Unilateral Treatment Period: Change From Baseline to Week 6 in Maximum Tremor Amplitude of the Wrist	-0.25 degrees of arc Standard Error 0.140	-0.46 degrees of arc Standard Error 0.180	—

SECONDARY outcome

Timeframe: Baseline up to Week 6

Population: Full analysis set for unilateral treatment period (FAS-UP) was subset of subjects in SES-UP 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. The analysis was performed by randomized treatment (one subject randomized to NT 201 was erroneously treated with placebo and one subject randomized to placebo was not treated).

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. 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 indicated more severe tremor.

Outcome measures

Outcome measures
Measure	Unilateral Treatment Period: NT 201 n=50 Participants 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).	Unilateral Treatment Period: Placebo n=26 Participants 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).	Bilateral Treatment Period: NT 201 Subjects who 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).
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	-2.3 score on a scale Standard Deviation 2.60	-0.9 score on a scale Standard Deviation 1.56	—

SECONDARY outcome

Timeframe: Baseline up to Week 6

Population: FAS-UP was subset of subjects in SES-UP 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. The analysis was performed by randomized treatment (one subject randomized to NT 201 was erroneously treated with placebo and one subject randomized to placebo was not treated).

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 indicated greater tremor severity.

Outcome measures

Outcome measures
Measure	Unilateral Treatment Period: NT 201 n=50 Participants 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).	Unilateral Treatment Period: Placebo n=26 Participants 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).	Bilateral Treatment Period: NT 201 Subjects who 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).
Unilateral Treatment Period: Change From Baseline to Week 6 in the TETRAS Activities of Daily Living (ADL) UL Score	-3.7 score on a scale Standard Deviation 5.00	-3.8 score on a scale Standard Deviation 4.46	—

SECONDARY outcome

Timeframe: Baseline up to Week 6

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.

Outcome measures

Outcome measures
Measure	Unilateral Treatment Period: NT 201 n=50 Participants 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).	Unilateral Treatment Period: Placebo n=26 Participants 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).	Bilateral Treatment Period: NT 201 Subjects who 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).
Unilateral Treatment Period: Change From Baseline to Week 6 in TETRAS ADL Functional Impact Score	-1.2 score on a scale Standard Deviation 1.87	-1.3 score on a scale Standard Deviation 1.83	—

SECONDARY outcome

Timeframe: Week 6

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). A higher score indicated improvements.

Outcome measures

Outcome measures
Measure	Unilateral Treatment Period: NT 201 n=50 Participants 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).	Unilateral Treatment Period: Placebo n=26 Participants 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).	Bilateral Treatment Period: NT 201 Subjects who 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).
Unilateral Treatment Period: Subject's Global Impression of Change Scale (GICS) Score of Motor-dominant UL at Week 6	0.9 score on a scale Standard Deviation 1.27	0.8 score on a scale Standard Deviation 1.14	—

SECONDARY outcome

Timeframe: Week 6

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). A higher score indicated improvements.

Outcome measures

Outcome measures
Measure	Unilateral Treatment Period: NT 201 n=50 Participants 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).	Unilateral Treatment Period: Placebo n=26 Participants 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).	Bilateral Treatment Period: NT 201 Subjects who 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).
Unilateral Treatment Period: Investigator's GICS Score of Motor-dominant UL at Week 6	1.2 score on a scale Standard Deviation 1.36	0.8 score on a scale Standard Deviation 1.03	—

SECONDARY outcome

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

Population: 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.

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 indicated more severe tremor.

Outcome measures

Outcome measures
Measure	Unilateral Treatment Period: NT 201 n=64 Participants 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).	Unilateral Treatment Period: Placebo 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).	Bilateral Treatment Period: NT 201 Subjects who 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).
Bilateral Treatment Period: Change From Cycle 2 Baseline to Week 6 in TETRAS Performance Dominant UL Score	-2.8 score on a scale Standard Deviation 2.62	—	—

SECONDARY outcome

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

Population: The FAS-BP was the subset of subjects in the 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.

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 indicated greater tremor severity.

Outcome measures

Outcome measures
Measure	Unilateral Treatment Period: NT 201 n=64 Participants 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).	Unilateral Treatment Period: Placebo 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).	Bilateral Treatment Period: NT 201 Subjects who 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).
Bilateral Treatment Period: Change From Cycle 2 Baseline to Week 6 in TETRAS Performance Subscale Score	-5.6 score on a scale Standard Deviation 5.14	—	—

SECONDARY outcome

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

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 indicated greater tremor severity.

Outcome measures

Outcome measures
Measure	Unilateral Treatment Period: NT 201 n=64 Participants 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).	Unilateral Treatment Period: Placebo 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).	Bilateral Treatment Period: NT 201 Subjects who 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).
Bilateral Treatment Period: Change From Cycle 2 Baseline to Week 6 in TETRAS ADL UL Score	-4.4 score on a scale Standard Error 4.07	—	—

SECONDARY outcome

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

Outcome measures

Outcome measures
Measure	Unilateral Treatment Period: NT 201 n=64 Participants 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).	Unilateral Treatment Period: Placebo 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).	Bilateral Treatment Period: NT 201 Subjects who 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).
Bilateral Treatment Period: Change From Cycle 2 Baseline to Week 6 in TETRAS ADL Functional Impact Score	-1.4 score on a scale Standard Deviation 1.42	—	—

SECONDARY outcome

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)

Population: The safety evaluation set for unilateral treatment period (SES-UP) included all subjects who received NT 201 or placebo during the unilateral treatment period and 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 (one subject was treated with placebo even so randomized to NT 201 and one subject was not treated even so randomized to placebo).

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).

Outcome measures

Outcome measures
Measure	Unilateral Treatment Period: NT 201 n=50 Participants 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).	Unilateral Treatment Period: Placebo n=27 Participants 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).	Bilateral Treatment Period: NT 201 n=72 Participants Subjects who 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).
Percentage of Subjects With At-least One Treatment Related Treatment-emergent Adverse Events (TEAEs)	30.0 percentage of subjects	3.7 percentage of subjects	30.6 percentage of subjects

Adverse Events

Unilateral Treatment Period: NT 201

Serious events: 3 serious events

Other events: 29 other events

Deaths: 0 deaths

Unilateral Treatment Period: Placebo

Serious events: 2 serious events

Other events: 5 other events

Deaths: 0 deaths

Bilateral Treatment Period: NT 201

Serious events: 2 serious events

Other events: 29 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Unilateral Treatment Period: NT 201 n=50 participants at risk 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).	Unilateral Treatment Period: Placebo n=27 participants at risk 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).	Bilateral Treatment Period: NT 201 n=72 participants at risk Subjects who 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).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer	2.0% 1/50 • Number of events 1 • 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)	0.00% 0/27 • 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)	0.00% 0/72 • 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)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Papillary thyroid cancer	0.00% 0/50 • 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)	3.7% 1/27 • Number of events 1 • 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)	0.00% 0/72 • 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)
Injury, poisoning and procedural complications Skull fracture	0.00% 0/50 • 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)	0.00% 0/27 • 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)	1.4% 1/72 • Number of events 1 • 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)
Injury, poisoning and procedural complications Subdural haematoma	0.00% 0/50 • 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)	0.00% 0/27 • 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)	1.4% 1/72 • Number of events 1 • 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)
Cardiac disorders Atrial fibrillation	0.00% 0/50 • 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)	0.00% 0/27 • 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)	1.4% 1/72 • Number of events 2 • 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)
Nervous system disorders Subarachnoid haemorrhage	0.00% 0/50 • 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)	0.00% 0/27 • 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)	1.4% 1/72 • Number of events 1 • 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)
General disorders Condition aggravated	2.0% 1/50 • Number of events 1 • 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)	0.00% 0/27 • 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)	0.00% 0/72 • 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)
Ear and labyrinth disorders Deafness unilateral	0.00% 0/50 • 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)	0.00% 0/27 • 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)	1.4% 1/72 • Number of events 1 • 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)
Hepatobiliary disorders Cholelithiasis	2.0% 1/50 • Number of events 1 • 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)	0.00% 0/27 • 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)	0.00% 0/72 • 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)
Respiratory, thoracic and mediastinal disorders Aspiration	0.00% 0/50 • 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)	3.7% 1/27 • Number of events 1 • 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)	0.00% 0/72 • 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)
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/50 • 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)	3.7% 1/27 • Number of events 1 • 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)	0.00% 0/72 • 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)
Infections and infestations Pneumonia	2.0% 1/50 • Number of events 1 • 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)	0.00% 0/27 • 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)	0.00% 0/72 • 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)

Other adverse events

Additional Information

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