Last updated: February 23, 2021
Sponsor: David M. Simpson
Overall Status: Active - Recruiting
Phase
4
Condition
Dystonia
Treatment
N/AClinical Study ID
NCT03136341
GCO 17-0592
Ages 18-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Patients with task-dependent essential tremor in upper limb. Tremor is present duringat least one of the study functional tasks i. pointing task (touch between nose and apen held 2 ft. in front. ii. pouring task (cup: pouring water out/in). iii. feedingtask (weighted fork from plate on table to mouth). iv. string instrument bowing orholding instrument in static position. v. computer mouse (simple vertical orhorizontal movements).
- Patients must be capable of performing informed consent.
- Patients on stable medications for treatment of task-dependent essential tremor for 1month prior to study entry and maintain them throughout the study.
- Patients previously treated with BoNT of any type must have occurred no sooner than 12weeks prior to study entry.
Exclusion
Exclusion Criteria:
- Patients with no presence of tremor during study functional tasks.
- Presence of tremor during the functional task is below minimum amplitude required tobe considered for injection based upon investigator's clinical judgment.
- Patients with unstable medical conditions or psychiatric conditions.
- Patients with a medical condition that precludes them from receiving BoNT injections.
- Pregnant women, or premenopausal women not willing to use contraceptive measuresthroughout the duration of the study.
- Lithium, Valproic acid, Amiodarone, typical and atypical neuroleptics. Exposure toother than the listed tremorogenic or potentially tremorogenic drugs is allowed onlyif, in the opinion of the investigator, this will not interfere with the study drugevaluations.
Study Design
Total Participants: 25
Study Start date:
December 04, 2018
Estimated Completion Date:
December 31, 2022
Connect with a study center
Icahn School of Medicine at Mount Sinai
New York, New York 10029
United StatesActive - Recruiting
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