Botulinum Toxin A to Treat Arm Tremor (NCT02207946) | Clinical Trial Compass
CompletedPhase 2
Botulinum Toxin A to Treat Arm Tremor
United States, Canada30 participantsStarted 2014-12-05
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Main Inclusion Criteria:
* Diagnosis of 'definite essential tremor' in accordance with modified TRIG criteria, as follows:
* Bilateral postural tremor with or without kinetic tremor, involving hands and forearms, that is visible and persistent.
* It is to be noted that:
* Tremor of other body parts may be present in addition to upper limb tremor.
* Bilateral tremor may be asymmetric.
* Tremor is reported by patient to be persistent, although the amplitude may fluctuate.
* First onset of essential tremor at least 6 months before screening with stability of the tremor symptoms over 4 weeks and in the opinion of the investigator definite diagnosis of essential tremor.
* Moderate-to-marked upper-limb postural and/or kinetic tremor at wrist level, corresponding to Fahn-Tolosa-Marin upper-limb tremor rating of at least 2 categories (scale part C, items 16-23) in the limb to be treated between of 2 or higher.
* Visible tremor at wrist level in at least one of the four positions/tasks used in kinematic assessments
* Tremor deemed by the investigator to require a treatment with 30 - 200 U NT 201 for a treatment of up to three joints of the selected upper limb (wrist treatment mandatory).
* Stable concomitant anti-tremor medication and no clinically relevant findings in routine laboratory examinations.
Main Exclusion Criteria:
* Any neurological signs abnormal for the subject's age, other than the tremor itself and Froment's maneuver.
* Exposure to the following tremoroge…
What they're measuring
1
Change From Baseline to Week 4 in Maximum Angular Tremor Amplitude of the Wrist (Injected Limb)