Studies at UToledo: Neurology
Epilepsy
Study Title: A Randomized, Double-blind, Placebo-controlled, Parallel Group, Multicenter Trial
of CVL-865 as Adjunctive Therapy in Adults With Drug-Resistant Focal Onset Seizures
(REALIZE Trial)
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Identifier: NCT04244175
Study Purpose: The purpose of this study is to assess the efficacy, safety, and tolerability profile
of CVL-865 as adjunctive treatment in participants with drug-resistant focal onset
seizures.
Principal Investigator: Imran I. Ali, MD
Study Coordinator: Andrea Korsnack, RN, 419.383.3801
Huntington's Disease
There are no studies in this area currently
Parkinson's
Study Title: Phase 3, Double-Blind, Randomized, Placebo‑Controlled, Parallel ‑ Group, 27‑Week Study
of the Efficacy, Safety, and Tolerability of Two Fixed Doses of Tavapadon in Early
Parkinson’s Disease
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Identifier: NCT04201093
Study Purpose: The purpose of this study is to evaluate the clinical efficacy, safety and pharmacokinetics
(PK) of 2 fixed doses of tavapadon and placebo in participants with early PD.
Principal Investigator: Lawrence Elmer, MD, PhD
Study Coordinator:Stephanie Wilson, MSN, APRN, CCRC , 419.383.6721
Study Title: A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Flexible-Dose,
27-Week Trial to Evaluate the Efficacy, Safety, and Tolerability of Tavapadon as Adjunctive
Therapy for Parkinson's Disease in Levodopa-Treated Adults With Motor Fluctuations
(TEMPO-3 Trial)
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Identifier: NCT04542499
Study Purpose: The purpose of this study is to assess the effect of tavapadon on the change from
baseline in total daily hours of "on" time without troublesome dyskinesia in L-Dopa-treated
participants with Parkinson's Disease (PD) who are experiencing motor fluctuations.
Principal Investigator: Lawrence Elmer, MD, PhD
Study Coordinator:Stephanie Wilson, MSN, APRN, CCRC , 419-383-6721
Study Title: Phase 2b/3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter
Study to Evaluate the Safety and Efficacy of Dipraglurant (ADX48621) for the Treatment
of Dyskinesia in Patients with Parkinson's Disease Receiving Levodopa-based Therapy
With or Without Concomitant Dopaminergic Medications
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Identifier: NCT05116813
Study Purpose:This open-label study is designed to assess the long-term safety and tolerability
of dipraglurant in PD patients for up to 52 weeks (1 week at 150 mg per day and 11
weeks at 300 mg per day) for patients that have completed an Addex sponsored double-blind
clinical trial of dipraglurant.
Principal Investigator: Lawrence Elmer, MD, PhD
Study Coordinator:Stepahnie Wilson, MSN, APRN, CCRC , 419-383-6721
Study Title: 58-Week Open-label Trial of Tavapadon in Parkinson's Disease (TEMPO-4 Trial)
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Identifier: NCT04760769
Study Purpose: The purpose of this study is to evaluate the safety and efficacy of long-term administration
of flexible doses of tavapadon in participants with Parkinson's Disease.
Principal Investigator: Lawrence Elmer, MD, PhD
Study Coordinator:Stephanie Wilson, MSN, APRN, CCRC , 419-383-6721
Study Title: A Double-Blind, Placebo-Controlled, Safety, Tolerability, and Pharmacokinetics Study
in Parkinson's Disease (PD) Participants Treated With Carbidopa/Levodopa and NE3107
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Identifier: NCT05083260
Study Purpose: A 28-day phase 2a, double-blind, placebo-controlled (1:1), multi-center study of
20 mg NE3107, twice daily of safety, potential drug-drug interactions, and MDS-UPDRS
defined activity in patients with Parkinson's disease . Study will enroll 40 patients
that are currently taking immediate release levodopa/ carbidopa (IRLC) and have a
practically defined off-state for IRLC. Day one- baseline UPDRS and IRLC PK sampling;
day 2- start NE3107 dosing, assess UPDRS during onset and NE3107 PK sampling, rescue
meds as needed after 4 hours; day 3 and 14- NE3107 + IRLC UPDRS assessment and PK
sampling; day 28- NE3107 + IRLC UPDRS assessments. Overnight stays in clinic prior
to Day 1-3, 14, and 28.
Principal Investigator: Lawrence Elmer, MD, PhD
Study Coordinator:Stephanie Wilson,MSN, APRN, CCRC , 419-383-6721
