Research Projects & Grants

Federal

• DNA Methylation Patterns Provide Information Regarding Susceptibility to and Protection Against Parkinson's Disease, Role: PD/PI, National Institute of Neurological Disorders and Stroke/NIH/DHHS, (04/2016 - 03/2018) Status: Closed

For Profit Organization

• Investigation of the occurence of serotonin toxicity in Parkinson's Disease (PD) patients treated concomitantly with rasagiline and antidepressants, using restrospective chart review. STACCATO-Serotonin Toxicity Association with ConComitant AnTidepressants and Rasagiline Treatment: RetrOspective chart review. Protocol #: TVP-1012/PM102 CR, version 1.0, May 28, 2009. Azilect package insert., Role: Investigator, Teva Neuroscience, (10/2009 - 10/2010) Status: Completed
• An open-label, multi-center, follow-up study designed to evaluate the long-term effects of Rasagiline in Parkinson's Disease subjects who participated in the ADAGIO study. Protocol number: TVP-1012/501 (ADAGIO follow-up) version dated May 3, 2009. Informed consent version dated 14 May 2009., Role: PI, Teva Pharmaceutical Industries, Ltd., (09/2012 - 09/2013) Status: Completed
• Cervical Dystonia- patient registry for observation of BOTOX efficacy (CD- PROBE). Protocol: MedAffBTX-0718, Amendment #2 dated February 12, 2009. Informed consent version dated April 01, 2009., Role: Investigator, Allergan Inc., (08/2011 - 08/2012) Status: Completed
• Botulism antitoxin effects on paralysis induced by type A and type B botulinum neurotoxins in the extensor digitorum brevis muscle. Protocol number BT-002, version 3.0, dated October 07, 2008. Investigator's brochure edition #4.0, dated 11/2007., Role: Investigator, Cangene Corporation, (10/2009 - 10/2010) Status: Completed
• A multicenter, randomized, double-blind, placebo-controlled, 5-arm, parallel-group study to assess rotigotine transdermal system dose response in subjects with advanced-stage Parkinson's Disease. Protocol number: SP921 dated 01June2007. Consent version dated: 02Jul2007. Investigator's brochure version dated 02 June 2006., Role: Investigator, Schwarz Biosciences, Inc., (08/2010 - 08/2011) Status: Completed
• A multicenter, double-blind, randomized, placebo-controlled, single treatment cycle, parallel evaluation of the safety, efficacy and immunogenicity of two formulations of BOTOX® (Botulinum Toxin Type A) purified neurotoxin complex (Formulation Nos. 9060X and 9525X), followed by a blinded active treatment extension of up two additional treatment cycles in patients with cervical dystonia. PROTOCOL NUMBER : 191622-90 version #1.0, dated 01/Jul/2007. Investigator Brochure edition 4 updated July 10, 2007. Informed consent version #2 dated 27/AUG/07., Role: Investigator, Allergan Inc., (08/2009 - 08/2010) Status: Completed
• A multicenter study evaluating the efficacy and safety of BOTOX® (Botulinum Toxin Type A) purified neurotoxin complex as headache prophylaxis in migraine patients with 15 or more headache days per 4-week period in a 24-week, double-blind, randomized, placebo-controlled, parallel-group phase followed by a 32-week open-label extension phase. Protocol Number: 191622-079-00, Role: PI, Allergan Inc., (08/2008 - 07/2009) Status: Completed
• A clinical evaluation of bilateral stimulation of the ventral intermediate nucleus (VIM) of thalamus implantable deep brain stimulation system as an adjunctive treatment for reducing some of the symptoms of advanced essential tremor that are not adequately controlled with medication, Role: PI, Advanced Neuromodulation Systems, Inc., (07/2013 - 07/2014) Status: Completed
• A multi-center, randomized, double-blind, placebo-controlled, parallel-group, study of the efficacy, safety, and tolerability of E2007 in levodopa treated Parkinson's disease with motor fluctuations protocol number: E2007-A001-302. Dated Dec. 15, 2005. Investigator's brochure Ed.5 dated Oct.18, 2005, Role: Investigator, Eisai Medical Research, Inc., (03/2008 - 03/2009) Status: Completed
• A multicenter, double-blind, randomized start, placebo-controlled, parallel-group study to assess rasagiline as a disease modifying therapy in early Parkinson's disease subjects. Protocol No.: TVP-1012/500 (ADAGIO), Role: Investigator, Teva Pharmaceutical Industries, Ltd., (09/2007 - 09/2008) Status: Completed
• A Multicenter, 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. Protocol: CLIN-52120-452, Role: PI, Ipsen Pharma SAS, (12/2023 - 12/2024) Status: Approved
• An Open-Label, Multicenter Study to Evaluate the Safety and Efficacy of Repeat Intramuscular ABP-450 (prabotulinumtoxinA) Injection for the Treatment of Cervical Dystonia. Protocol Number: ABP-19002, Role: PI, Aeon Biopharma, (12/2022 - 12/2023) Status: Completed
• A Phase 2, Randomized, Double-Blind, Multicenter, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Intramuscular ABP-450 (prabotulinumtoxinA) Injection for the Treatment of Cervical Dystonia. Protocol Number: ABP-19000, Role: PI, Aeon Biopharma, (06/2022 - 06/2023) Status: Completed
• Rostock International Parkinson's Disease Study - An international, multi-center, epidemiological observational study. Protocol: ROPAD 01-2019, Role: PI, Centogene AG, (07/2020) Status: Completed
• A Phase 3, open-label, multi-center trial to evaluate the long-term safety and efficacy of repeat treatment of DaxibotulinumtoxinA for injection in adult with isolated cervical dystonia (ASPEN-OLS). Protocol: 1720304, Role: PI, Revance Therapeutics, Inc., (04/2021 - 04/2022) Status: Completed
• A Phase 3, randomized, double-blind, placebo-controlled, parallel group, multi-center trial to evaluate the efficacy and safety of a single treatment of DaxibotulinumtoxinA for injection in adults with isolated cervical dystonia (ASPEN-1). Protocol: 1720302, Role: Investigator, Revance Therapeutics, Inc., (11/2019 - 11/2020) Status: Completed
• Evaluation of the safety and pharmacodynamic effect of AGN-151607 by measuring the compound muscle action potential (CMAP) of the extensor digitorum brevis ( EDB) muscle following a single injection in healthy subjects. Protocol 1925-101-008, dated 18 August 2017. Informed consent form version dated 30 August 2017, Role: Investigator, Allergan Inc., (08/2018 - 08/2019) Status: Completed
• A phase III multi-center randomized double-bind double-dummy active-controlled study comparing the efficacy and safety of gastric retentive controlled release accordion pill™ carbidopa/levodopa (AP-CD/LD) to immediate release CD/LD in fluctuating Parkinson's Disease patients Protocol Number: IN 11004, Role: PI, Intec Pharma Ltd., (04/2019 - 04/2020) Status: Completed
• A phase 3, open-label study of the safety, efficacy, and tolerability of apomorphine administered by continuous subcutaneous infusion in advanced Parkinson's disease patients with unsatisfactory control on available therapy, Role: Investigator, U.S. World Meds, (11/2021 - 11/2022) Status: Completed
• RESTORE: A clinical study of patients with symptomatic neuRogenic orthostatic hypotEnsion assess sustained effecTs of dRoxidopa therapy, Role: PI, Lundbeck Inc., (02/2022 - 02/2023) Status: Completed
• A phase 3, long-term, open-label and single-arm study of MYOBLOC® in the treatment of troublesome sialorrhea in adult subjects. Protocol Number: SN-SIAL-351, Role: PI, U.S. World Meds, (03/2017 - 03/2018) Status: Completed
• A phase 3, multicenter, randomized, double-blinded, placebo controlled study with an open label phase to determine the efficacy and safety of tozadenant as adjunctive therapy in levodopa-treated patients with Parkinson's Disease experiencing end of dose "wearing off" (TOZ-PD). Protocol #: TOZ-CL05, Role: PI, Biotie Therapies Inc, (07/2017 - 07/2018) Status: Completed
• A 12-month, dose-level blinded study investigating the safety and efficacy of CVT-301 (Levodopa inhalation powder) in Parkinson's Disease patients with motor response fluctuations (off phenomena). protocol number: CVT-301-004E, Role: PI, Civitas Therapeutics, Inc., (03/2018 - 03/2019) Status: Completed
• A phase 3, randomized, double-blind, placebo-controlled study investigating the efficacy and safety of CVT-301 (Levodopa inhalation powder) in Parkinson's Disease patients with motor response fluctuations (OFF Phenomena). (SPAN-PD TM), Role: PI, Civitas Therapeutics, Inc., (12/2016 - 12/2017) Status: Completed
• A phase 3, multi-center, double-blind, placebo-controlled, single-treatment efficacy and safety study of MYOBLOC® (Part A) followed by open-label, multiple-treatment with MYOBLOC® (Part B) in the treatment of troublesome Sialorrhea in adult subjects. Protocol number: SN-SIAL-301, Role: PI, U.S. World Meds, (12/2016 - 12/2017) Status: Completed
• ASPIRE: Adult spasticity international registry on BOTOX treatment, Role: PI, Allergan Inc., (10/2017 - 10/2018) Status: Completed
• A phase IIIb, multicentre, randomised, double-blind, placebo-controlled study evaluating the efficacy and safety of Dysport® using 2 mL dilution in adults with cervical dystonia. Protocol A-TL-52120-169, Role: PI, Ipsen Biopharmaceuticals, Inc., (03/2015 - 03/2016) Status: Completed
• A phase IIIb, prospective, multicentre, open-label extension study to assess long term safety and effectiveness of Dysport® using 2 mL dilution in adults with cervical dystonia. Protocol A-TL-52120-170, Role: PI, Ipsen Biopharmaceuticals, Inc., (03/2015 - 03/2016) Status: Completed
• An open-label, non-inferiority study evaluating the efficacy and safety of two injection schedules of xeomin (incobotulinumtoxinA) [short flex vs. long flex] in subjects with cervical Dystonia with < 10 weeks of benefit from onabotulinumtoxinA treatment. Protocol #MUS 60201 4073 1 dated 01Sep2011. Informed consent version dated 23Nov2011., Role: PI, Merz Pharmaceuticals, LLC, (01/2016 - 01/2017) Status: Completed
• A double-blind, randomized, placebo-controlled study of the safety and efficacy of SYN115 as adjunctive therapy in levodopa-treated Parkinson's subjects with end of dose wearing off. Protocol number: SYN115-CL02, amendment 1 dated 14Dec2010. Informed consent version 1, dated 02Feb2011. Investigator's brochure, ed. 4.0, dated August 30, 2010., Role: Investigator, Synosia Therapeutics, Inc., (01/2012 - 01/2013) Status: Completed
• A multi-center, double-blind, randomized, placebo-controlled, repeat treatment (two-cycle) study of the safety of AGN-214868 in patients with postherpetic Neuralgia. Protocol number: 214868-002, 6 July 30, 2007. Investigator's brochure edition 5, dated 01Jun2010. Informed consent form and HIPAA form version 1.0, dated 16Jul2010, Role: PI, Allergan Inc., (07/2011 - 07/2012) Status: Completed
• A 6-week, double-blind, placebo-controlled, randomized, multicenter study to explore the efficacy and safety of AFQ056 when combined with increased doses of L-dopa in Parkinson's disease patients with OFF time and moderate-severe L-dopa induced dyskinesia. Protocol CAFQ056A2216, v. 11/18/09. Informed consent form dated 11/20/09. Investigator's brochure v. 6, 06/26/07 released date 12/18/08; Inv. brochure #1, 03/23/08; Supplement #2, 06/18/09; and Supplement #3, 11/17/09., Role: Investigator, Novartis Pharmaceuticals Corporation, (01/2011 - 01/2012) Status: Completed
• A long-term follow-up study of the patients who underwent unilateral or bilateral stimulation of the (VIM) using the Libra deep brain stimulation system for the suppression of tremor in the upper extremities of patients with essential tremor. Protocol #C-06-03, dated 16OCT2009., Role: PI, Advanced Neuromodulation Systems, Inc., (06/2015 - 06/2016) Status: Completed
• A long-term follow-up study of the patients who underwent bilateral stimulation of the subthalamic nucleus (STN) using the Libra™/Libra™ XP deep brain stimulation system as an adjunctive treatment for reducing some of the symptoms of advanced, levodopa-responsive Parkinson's disease that are not adequately controlled with medication. Protocol #C-06-04, dated 22DEC2009., Role: PI, Advanced Neuromodulation Systems, Inc., (06/2015 - 06/2016) Status: Completed

Internal

• Clinical features of patients with Parkinson's Disease (PD) displaying REM sleep behavior disorder (RBD) and constipation, Role: PI, LLU Dept. of Neurology, (10/2011 - 10/2012) Status: Completed
• Longitudinal morphological analysis at different stages of Parkinson's disease, Role: PI, LLU Dept. of Neurology, (06/2016 - 06/2017) Status: Completed
• Evaluation of safety in patients receiving quetiapine and pimavanserin for Parkinson Disease related psychosis, Role: Investigator, LLU Dept. of Pharmacy Practice, (07/2023) Status: Approved
• Correlation of spirituality and Parkinson's disease, Role: PI, LLU Dept. of Neurology, (05/2023) Status: Approved
• Evaluation of Risk Factors for Development of Drug-Induced Parkinsonism (DIP), Role: Investigator, LLU Dept. of Pharmacy Practice, (10/2022) Status: Approved
• Access to Opicapone and Istradefylline in adult patients with Parkinson's disease, Role: Investigator, LLU Dept. of Pharmacy Practice, (10/2022) Status: Approved
• Do Therapist Led Exercise Groups Improve Quality of Life in People with Parkinson's Disease? A Pilot Study, Role: Investigator, LLU Dept. of Physical Therapy, (11/2021) Status: Approved
• A retrospective study to investigate the effect of VMAT-2 inhibitors on Tardive Dyskinesia, Role: Investigator, LLU Dept. of Pharmacy Practice, (06/2021) Status: Approved
• Clinical outcomes in patients with Parkinson Disease (PD) treated with a MonoAmine Oxidase type-B Inhibitor (MAOB-1), Role: PI, LLU Dept. of Neurology, (07/2013) Status: Completed
• Impact of exercise on the motor and non-motor symptoms of parkinson's disease, Role: PI, LLU Dept. of Neurology, (10/2012 - 10/2013) Status: Completed
• DNA methylation patterns and susceptibility of Parkinson's Disease, Role: PD/PI, LLU School of Medicine, (01/2016 - 12/2017) Status: Closed

Non-Profit Organization

• Clinimetric studies of a new scale for Parkinson's disease, Role: Investigator, Self Sponsored, (02/2008 - 02/2009) Status: Completed
• A Phase 2 Multicenter, Randomized, Double-blind, Placebo-controlled Study of BOTOX® for the Treatment of Upper Limb Essential Tremor. Protocol: M21-471, Role: PI, AbbVie, Inc., (10/2023 - 10/2024) Status: Approved
• An Open-Label Extension of Studies M15-736 and M20-339 to Evaluate the Safety and Tolerability Of 24-Hour Daily Exposure of ABBV-951 in Subjects with Advanced Parkinson's Disease, Role: PI, AbbVie, Inc., (09/2023 - 09/2024) Status: Approved
• A Randomized, Double-Blind, Double-Dummy, Active-Controlled Study Comparing the Efficacy, Safety and Tolerability of ABBV-951 to Oral Carbidopa/Levodopa in Advanced Parkinson’s Disease Patients. Protocol: M15-736, Role: PI, AbbVie, Inc., (02/2021 - 02/2022) Status: Completed
• An open-label study in subjects with Parkinson's disease to evaluate the safety and tolerability of titration and continuous subcutaneous infusion of ABBV-951 for up to 4 weeks in an outpatient environment. Protocol: M15-739, Role: PI, AbbVie, Inc., (11/2019 - 11/2020) Status: Completed