Clinical Trials
The Dept. is at the forefront of innovating patient care, which is realized in the pioneering of new interventions. These Clinical Trials are currently being led by our faculty.
Essential Tremor: A Phase 2 Multicenter, Randomized, Double-blind, Placebo controlled Study of BOTOX® for the Treatment of Upper Limb Essential Tremor
Principal Investigator: Michael Munin
Co-Investigator: Valerie Suski
Sponsor: AbbVie
Summary: Essential tremor is a movement disorder that causes involuntary shaking. It can make everyday tasks such as writing, pouring, and eating difficult. The sponsor is evaluating an investigational option for people living with essential tremor. We are conducting a clinical research study to evaluate the investigational use of an existing medication (Onabotulinumtoxin A) for people living with essential tremor. While this medication has been approved for other conditions, it has not yet been approved for people with essential tremor. The purpose of this study is to see if the study drug is safe and if it helps to reduce upper limb essential tremor in adults (18 to 80 years of age) who experience persistent, bilateral tremor during movement, involving hands and forearms.
Participation Requirements: You may qualify for this study if you have been medically diagnosed and living with essential tremor for at least three years.
Qualified Participants
- Will receive all study-related care at no cost
- Will receive all study-related investigational medication at no cost
- May receive compensation for travel.
Prospective, Randomized, Double-Blind, Placebo-Controlled Multi-Center Study to Investigate the Efficacy and Safety of NT 201 in the Treatment of Lower Limb Spasticity Caused by stroke or Traumatic Brain Injury in Adult Subjects, Followed by an Open Label Extension with or without Combined Upper Limb Treatment
Principal Investigator: Michael Munin
Co-Investigator: Kali Webb
Sponsor: Merz Pharmaceuticals
Summary: The purpose of this study is to determine whether a single treatment with administration of 400 units NT 201 (botulinum toxin) is superior to placebo (no medicine) for the treatment of lower limb spasticity caused by stroke or traumatic brain injury (Main Period). Participants will be assigned to the treatment groups by chance and neither the participants nor the research staff who interact with them will know the allocation. The following four to five treatment cycles will investigate the safety and tolerabilty of treatment with NT 201 (botulinum toxin) when administered in doses between 400 and 800 units (Open Label Extension Period). All participants will receive the treatment and the dose will depend on whether only lower limb spasticity or combined upper and lower limb spasticity are treated).
A Multicentre, Interventional, Post-marketing, Randomized, Double-blind, Crossover Study to Evaluate the Clinical Safety and Efficacy of AbobotulinumtoxinA (Dysport®) in Comparison with OnabotulinumtoxinA (Botox®) when Treating Adults with Upper Limb Spasticity
Principal Investigator: Michael Munin
Co-Investigator: Kali Webb
Sponsor: Ipsen
Summary: Spasticity is an increase in velocity-dependent stretch reflexes, with exaggerated tendon jerks, resulting from hyperexcitability of the stretch reflex, as one component of the upper motor neuron syndrome. The purpose of this study is to compare the clinical safety and efficacy of aboBoNT-A and onaBoNT-A in adults with upper limb spasticity (ULS). The study is designed to address real-world questions of interest about the two BoNT-A marketed products for the first time in a large, multicentre, randomized, double-blind crossover study. This is a multicentre, interventional, post-marketing, randomized, double-blind, crossover study to evaluate the clinical safety and efficacy of aboBoNT-A (Dysport®) in comparison with onaBoNT-A (Botox®) when treating male and female adult participants 18-80 years of age inclusive with upper limb spasticity (ULS).
Participation requirements: You may be qualified to participate in this study if you have had medically diagnosed stable upper limb spasticity for at least 3 months.
Qualified participants:
- Will receive all study-related care at no cost
- Will receive all study-related investigational medication at no cost
For more information, contact Jessica Eldridge (412) 648-6035.