Trials / Completed
CompletedNCT02207946
Botulinum Toxin A to Treat Arm Tremor
Prospective, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of the Efficacy and Safety of NT 201 in the Unilateral Treatment of Essential Tremor of the Upper Limb
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 30 (actual)
- Sponsor
- Merz Pharmaceuticals GmbH · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The objective of this study is to assess the efficacy and safety of a single, kinematic-analysis-based intramuscular injection of NT 201, compared with placebo, in moderate to marked essential tremor of the upper limb.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | IncobotulinumtoxinA | Active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins. Solution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl). |
| DRUG | Placebo | Solution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl). |
Timeline
- Start date
- 2014-12-05
- Primary completion
- 2016-05-09
- Completion
- 2016-09-26
- First posted
- 2014-08-04
- Last updated
- 2021-02-18
- Results posted
- 2021-02-18
Locations
6 sites across 2 countries: United States, Canada
Source: ClinicalTrials.gov record NCT02207946. Inclusion in this directory is not an endorsement.