18 and older, any sex, with Essential Tremor of the Upper Limbs. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change From Baseline to Week 4 in Maximum Angular Tremor Amplitude of the Wrist (Injected Limb)Primary· 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.
Group
Value
95% CI
IncobotulinumtoxinA 30 to 200 U
-0.47
± 0.63
Placebo
0.07
± 0.88
Change From Baseline to Week 4 in Maximum Log-transformed Accelerometric Tremor Amplitude at Wrist Level (Injected Limb)Secondary· 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.
Group
Value
95% CI
IncobotulinumtoxinA 30 to 200 U
-0.73
± 0.63
Placebo
0.05
± 0.38
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])Secondary· 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.
Group
Value
95% CI
IncobotulinumtoxinA 30 to 200 U
-1.9
± 1.9
Placebo
-0.5
± 1.8
Change From Baseline to Week 4 in FTM Motor Performance Score (Items 11-15)Secondary· 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 han
Group
Value
95% CI
IncobotulinumtoxinA 30 to 200 U
-2.8
± 1.6
Placebo
-0.8
± 2.0
Participant's Global Impression of Change Scale (GICS) at Week 4Secondary· 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).
Group
Value
95% CI
IncobotulinumtoxinA 30 to 200 U
0.6
± 0.6
Placebo
0.3
± 0.6
Investigator's Global Impression of Change Scale (GICS) at Week 4Secondary· 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).
Group
Value
95% CI
IncobotulinumtoxinA 30 to 200 U
0.8
± 0.7
Placebo
0.1
± 0.7
Adverse events — posted to ClinicalTrials.gov
Time frame: From screening up to Week 24.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The objective of this study is to assess the efficacy and safety of a single, kinematic-analysis-based intramuscular injection of NT 201, compared with placebo, in moderate to marked essential tremor of the upper limb.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
NCT06604832 — Effects of Microtox on Facial Skin Quality, Fine Wrinkles, and Texture
· Phase 1
· completed
NCT06091020 — A Clinical Trial to Investigate Efficacy and Safety of NT 201 Injections Compared With Placebo Injections in Participant
· Phase 2
· completed
NCT05222607 — Longitudinal Evaluation and Real-world Evidence of NT201
· terminated
NCT05585398 — A Study to Evaluate the Distribution of Botulinum Neurotoxin Type A Administered as Intradermal Injections, Comparing Di
· Phase 1
· completed
NCT04290169 — Effect of Video Game-assisted and BoNT-A Injection Therapy on Spasticity, Activity and Participation in CP Patients
· NA
· unknown
Other Merz Pharmaceuticals GmbH trials
Trials by the same sponsor.
NCT05585398 — A Study to Evaluate the Distribution of Botulinum Neurotoxin Type A Administered as Intradermal Injections, Comparing Di
· Phase 1
· completed
NCT04766723 — A Study to Investigate the Efficacy and Safety of NT 201 (Botulinum Toxin) Compared With Placebo for the Treatment of Ad
· Phase 2
· completed
NCT03986424 — Local Study of Akatinol Memantine in VaD in Russia
· Phase 3
· completed
NCT03256942 — Evaluation of the Sensitivity of Merz Lips Fullness Assessment Scale Following Etermis 4® Treatment for Lips Volume Augm
· NA
· completed
NCT04210258 — Post-Market Clinical Follow-up Performance and Safety Study of Etermis 3 and 4 in the Face
· completed
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Merz Pharmaceuticals GmbH
Last refreshed: 18 February 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02207946.