NCT03136341 A Cross Over Pilot Study of Abobotulinum Toxin A (Dysport) as a Treatment for Task-dependent Upper Limb Tremor
| NCT ID | NCT03136341 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | David M. Simpson |
| Condition | Tremor, Limb |
| Study Type | INTERVENTIONAL |
| Enrollment | 25 participants |
| Start Date | 2018-12-04 |
| Primary Completion | 2022-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 25 participants in total. It began in 2018-12-04 with a primary completion date of 2022-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Task-dependent upper limb tremor is a disorder that frequently impairs patients' function and quality of life. Few studies exist that quantify the improvements in motor performance and disability with botulinum toxin (injections). The study team aims to perform an exploratory pilot trial using toxin Type A (Dysport) in 25 patients with task-dependent upper limb tremor, to refine quantitative measures of performance using blinded video analysis, demonstrate efficacy and tolerability of injections, and provide power calculations for a potential future multi-centered double blinded clinical trial.
Eligibility Criteria
Inclusion Criteria: * Patients with task-dependent essential tremor in upper limb. Tremor is present during at least one of the study functional tasks i. pointing task (touch between nose and a pen held 2 ft. in front. ii. pouring task (cup: pouring water out/in). iii. feeding task (weighted fork from plate on table to mouth). iv. string instrument bowing or holding instrument in static position. v. computer mouse (simple vertical or horizontal movements). * Patients must be capable of performing informed consent. * Patients on stable medications for treatment of task-dependent essential tremor for 1 month prior to study entry and maintain them throughout the study. * Patients previously treated with BoNT of any type must have occurred no sooner than 12 weeks prior to study entry. Exclusion Criteria: * Patients with no presence of tremor during study functional tasks. * Presence of tremor during the functional task is below minimum amplitude required to be 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 measures throughout the duration of the study. * Lithium, Valproic acid, Amiodarone, typical and atypical neuroleptics. Exposure to other than the listed tremorogenic or potentially tremorogenic drugs is allowed only if, in the opinion of the investigator, this will not interfere with the study drug evaluations.
Contact & Investigator
David M Simpson, MD
PRINCIPAL INVESTIGATOR
Icahn School of Medicine at Mount Sinai
Frequently Asked Questions
Who can join the NCT03136341 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Tremor, Limb. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03136341 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT03136341 currently recruiting?
Yes, NCT03136341 is actively recruiting participants. Contact the research team at Mary-Catherine.George@mssm.edu for enrollment information.
Where is the NCT03136341 trial being conducted?
This trial is being conducted at New York, United States.
Who is sponsoring the NCT03136341 clinical trial?
NCT03136341 is sponsored by David M. Simpson. The principal investigator is David M Simpson, MD at Icahn School of Medicine at Mount Sinai. The trial plans to enroll 25 participants.