Trial · NCT02207946

Botulinum Toxin A to Treat Arm Tremor

NCT02207946, Phase 2, Completed, Merz Pharmaceuticals GmbH; results first posted 2021-02-18

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Botulinum Toxin A to Treat Arm Tremor. Trials, record NCT02207946. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02207946

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Botulinum Toxin A to Treat Arm Tremor
NCT number: NCT02207946
Status: Completed
Phases: Phase 2
Enrollment: 30 participants, actual
Lead sponsor: Merz Pharmaceuticals GmbH
Conditions: Essential Tremor of the Upper Limbs
Interventions: IncobotulinumtoxinA, Placebo
First posted: 2014-08-04
Last updated: 2021-02-18
Results first posted: 2021-02-18

Source ClinicalTrials.gov

Registered outcomes6

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change From Baseline to Week 4 in Maximum Angular Tremor Amplitude of the Wrist (Injected Limb)	Baseline up to Week 4	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.
Secondary	Change From Baseline to Week 4 in Maximum Log-transformed Accelerometric Tremor Amplitude at Wrist Level (Injected Limb)	Baseline up to Week 4	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.
Secondary	Change From Baseline to Week 4 in Fahn-Tolosa-Marin (FTM) Tremor Score in Injected Limb (Item 5 [Right Upper Extremity] or 6 [Left Upper Extremity])	Baseline up to Week 4	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.
Secondary	Change From Baseline to Week 4 in FTM Motor Performance Score (Items 11-15)	Baseline up to Week 4	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.
Secondary	Participant's Global Impression of Change Scale (GICS) at Week 4	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).
Secondary	Investigator's Global Impression of Change Scale (GICS) at Week 4	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).

Source ClinicalTrials.gov

Outcomes6

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline to Week 4 in Maximum Angular Tremor Amplitude of the Wrist (Injected Limb)	Baseline up to Week 4	The full analysis set (FAS) was defined as the subset of participants who received study medication (incobotulinumtoxinA or placebo) at least once, and for whom a post-baseline value of any efficacy variable was measured.	degree	MEAN
SECONDARY	Change From Baseline to Week 4 in Maximum Log-transformed Accelerometric Tremor Amplitude at Wrist Level (Injected Limb)	Baseline up to Week 4	The FAS was defined as the subset of participants who received study medication (incobotulinumtoxinA or placebo) at least once, and for whom a post-baseline value of any efficacy variable was measured.	log[m/s˄2]	MEAN
SECONDARY	Change From Baseline to Week 4 in Fahn-Tolosa-Marin (FTM) Tremor Score in Injected Limb (Item 5 [Right Upper Extremity] or 6 [Left Upper Extremity])	Baseline up to Week 4	The FAS was defined as the subset of participants who received study medication (incobotulinumtoxinA or placebo) at least once, and for whom a post-baseline value of any efficacy variable was measured.	score on a scale	MEAN
SECONDARY	Change From Baseline to Week 4 in FTM Motor Performance Score (Items 11-15)	Baseline up to Week 4	The FAS was defined as the subset of participants who received study medication (incobotulinumtoxinA or placebo) at least once, and for whom a post-baseline value of any efficacy variable was measured.	score on a scale	MEAN
SECONDARY	Participant's Global Impression of Change Scale (GICS) at Week 4	Week 4	The FAS was defined as the subset of participants who received study medication (incobotulinumtoxinA or placebo) at least once, and for whom a post-baseline value of any efficacy variable was measured.	score on a scale	MEAN
SECONDARY	Investigator's Global Impression of Change Scale (GICS) at Week 4	Week 4	The FAS was defined as the subset of participants who received study medication (incobotulinumtoxinA or placebo) at least once, and for whom a post-baseline value of any efficacy variable was measured.	score on a scale	MEAN

Source ClinicalTrials.gov

Results by group12

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Change From Baseline to Week 4 in Maximum Angular Tremor Amplitude of the Wrist (Injected Limb)	IncobotulinumtoxinA 30 to 200 U	-0.47	Standard Deviation 0.63	degree
Change From Baseline to Week 4 in Maximum Angular Tremor Amplitude of the Wrist (Injected Limb)	Placebo	0.07	Standard Deviation 0.88	degree
Change From Baseline to Week 4 in Maximum Log-transformed Accelerometric Tremor Amplitude at Wrist Level (Injected Limb)	IncobotulinumtoxinA 30 to 200 U	-0.73	Standard Deviation 0.63	log[m/s˄2]
Change From Baseline to Week 4 in Maximum Log-transformed Accelerometric Tremor Amplitude at Wrist Level (Injected Limb)	Placebo	0.05	Standard Deviation 0.38	log[m/s˄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])	IncobotulinumtoxinA 30 to 200 U	-1.9	Standard Deviation 1.9	score on a scale
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])	Placebo	-0.5	Standard Deviation 1.8	score on a scale
Change From Baseline to Week 4 in FTM Motor Performance Score (Items 11-15)	IncobotulinumtoxinA 30 to 200 U	-2.8	Standard Deviation 1.6	score on a scale
Change From Baseline to Week 4 in FTM Motor Performance Score (Items 11-15)	Placebo	-0.8	Standard Deviation 2.0	score on a scale
Participant's Global Impression of Change Scale (GICS) at Week 4	IncobotulinumtoxinA 30 to 200 U	0.6	Standard Deviation 0.6	score on a scale
Participant's Global Impression of Change Scale (GICS) at Week 4	Placebo	0.3	Standard Deviation 0.6	score on a scale

1 to 10 of 12Source ClinicalTrials.gov

See all 12 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	IncobotulinumtoxinA 30 to 200 Units	19
Overall Study	STARTED	Placebo	11
Overall Study	COMPLETED	IncobotulinumtoxinA 30 to 200 Units	18
Overall Study	COMPLETED	Placebo	10
Overall Study	NOT COMPLETED	IncobotulinumtoxinA 30 to 200 Units	1
Overall Study	NOT COMPLETED	Placebo	1

Source ClinicalTrials.gov

Adverse events66

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Upper respiratory tract infection	Infections and infestations	IncobotulinumtoxinA 30 to 200 U	2	19
other	Upper respiratory tract infection	Infections and infestations	Placebo	2	11
other	Cystitis	Infections and infestations	IncobotulinumtoxinA 30 to 200 U	1	19
other	Cystitis	Infections and infestations	Placebo	0	11
other	Eyelid infection	Infections and infestations	IncobotulinumtoxinA 30 to 200 U	1	19
other	Eyelid infection	Infections and infestations	Placebo	0	11
other	Genital infection	Infections and infestations	IncobotulinumtoxinA 30 to 200 U	1	19
other	Genital infection	Infections and infestations	Placebo	0	11
other	Nail infection	Infections and infestations	IncobotulinumtoxinA 30 to 200 U	1	19
other	Nail infection	Infections and infestations	Placebo	0	11

1 to 10 of 66Source ClinicalTrials.gov

See all 66 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	IncobotulinumtoxinA 30 to 200 U	0	19
Total, all-cause mortality	Placebo	0	11
Total, other adverse events	IncobotulinumtoxinA 30 to 200 U	9	19
Total, other adverse events	Placebo	6	11
Total, serious adverse events	IncobotulinumtoxinA 30 to 200 U	0	19
Total, serious adverse events	Placebo	2	11

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
33419261	RESULT

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
IncobotulinumtoxinA 30 to 200 U vs Placebo: deaths from any cause	Trial comparisons
IncobotulinumtoxinA 30 to 200 U vs Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02207946

GET https://conductscience.org/api/trials/v1/NCT02207946/events?page=2

API reference For AI assistants