The Neurology Department is dedicated to advancing research in the prevention, detection and treatment of neurological diseases in areas such as Movement/Parkinson’s, Epilepsy, Multiple Sclerosis, and Neuromuscular disorders. We have numerous clinical trials currently being conducted to help us do just that. If you or anyone you know would be interested in participating in one of these clinical trials, please contact us at neurotrials@neurology.wisc.edu or 608-263-5421. To view a full listing of our clinical trials, search clinicaltrials.gov.
CHILD NEUROLOGY
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Prospective Long-Term Registry of Patients with a Diagnosis of Spinal Muscular Atrophy (SMA)
Researcher: | Jennifer Kwon, MD |
Sponsor: | AveXis, Inc. |
Protocol No: | AVXS-101-RG-001 |
IRB No: | 2018-1013 |
Objective: | The purpose of this registry is to assess the long-term outcomes of participants with SMA in the context of advances in treatment options. |
Description: | Your child will not be asked to come for any additional clinical visits or have any other laboratory tests done as part of participation in this registry. All data that is collected as part of this registry is taken from the information your child’s study doctor has documented in their medical notes during their normal doctors’ visits, questionnaires for the study that you will be asked to complete during your normal doctors’ visits, as well as tests that were performed during these visits. SMA treatments will be reviewed to see what effect they have on your child as follows:–To assess the effectiveness of treatments for SMA –To assess long-term safety Information about your child’s SMA treatment will be collected for the registry for a period of up to 15 years. |
Key Eligibility: | Participants must meet the following criteria;–Subjects with genetic confirmation of SMA |
Compensation: | You/your child will be compensated $25 as reimbursement for your time completing the questionnaires and travel related to participation in the registry. |
Site Contact: | Neurology Trials |
EPILEPSY
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New-onset refractory status epilepticus (NORSE)
Researcher: Aaron Struck, MD
Sponsor: Yale University
IRB No: 2018-0175
Objective:
To learn more about the cause of new-onset refractory status epilepticus (NORSE), to identify why NORSE affects different people differently and to find the best management strategy to treat patients who have the condition.
Description:
This is a data/sample repository study. Information from the medical record and samples will be collected during regular hospitalization and at 3 standard care follow up clinic visits within 2 years. Subjects will answer questions about quality of life at these 3 timepoints as well.
Key Eligibility:
–Status Epilepticus refractory to first and second‐line therapy
–No etiology found in the first 24 hours despite extensive work‐up
–Age at least 6 years old
Site Contact:
To use [F-18]-FEPPA to evaluate if focal epilepsy patients have increased inflammation ipsilateral to hemisphere of seizure generation relative to age-matched healthy controls and to determine if the time since last seizure correlates with severity of inflammation to test the hypothesis that seizures are temporally related to changes in inflammation.
Researcher: Dr. Aaron F. Struck, MD
IRB No: 2017-0458
Objective: To use [F-18]-FEPPA to evaluate if focal epilepsy patients have increased inflammation ipsilateral to hemisphere of seizure generation relative to age-matched healthy controls and to determine if the time since last seizure correlates with severity of inflammation to test the hypothesis that seizures are temporally related to changes in inflammation.
Description: A total of 40 subjects, 20 patients and 20 healthy controls will be enrolled in this research.
The following data will be obtained from the research participants:
(1) informed consent
(2) PET and MR imaging using [F-18]-FEPPA tracer
(3) blood sample for testing of FEPPA binding
(4) subject-completed questionnaires to provide information regarding frequency and nature of seizures, seizure medications, and cause/onset of seizures, clinical EEG data in the seizure group.
Inclusion criteria for healthy control: 1) Chronological age between 18 and 65 years 2) Able to safely undergo an MR Scan
Inclusion Criteria for patient: Patients diagnosed with epilepsy includes: (1) chronologic age between 18 and 65 years, inclusive (2) no gross abnormalities on MRI other than hippocampal sclerosis based on prior clinical imaging (3) no other neurologic disorder, and (4) estimated premorbid IQ (AMNART) ≥ 70. (5) Focal epilepsy
Compensation: Subjects are paid $100
Site Contact: Mariel Kalkach – kalkach@neurology.wisc.edu
NEUROMUSCULAR
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Expanded Access Trial of AMX0035 for Amyotrophic Lateral Sclerosis (ALS)
Researcher: | Stephanie Gardon |
Sponsor: | Amylyx Pharmaceuticals Inc. |
Protocol No: | A35-006 |
Objective: | The primary objective of this program is to provide access to AMX0035 for the treatment of patients with ALS and to assess safety. |
Description: | In this expanded access program, approximately 250 participants with ALS will be enrolled from approximately 25 sites in the United States (US). Participants determined eligible at the Screening Visit will be considered enrolled and continue to the Baseline Visit which will include the first dose of AMX0035. Enrolled participants will be resupplied with drug approximately every 12 weeks (±4 weeks) after the Baseline Visit. |
Key Eligibility: |
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Compensation: | You will not receive any payment for taking part in the Program. |
Link: | clinicaltrials.gov |
Site Contact: | Neurology Trials |
PEDIATRICS
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International Pedatric Stroke Study (IPSS)
Researcher: | Hrissanthi Ikonomidou |
Sponsor: | The Hospital for Sick Children ‘Sickkids’ |
IRB No: | 2020-1472 |
Objective: | This is the first multi-center, multi-national study of children with stroke. It seeks to build a network of investigators and high-quality disease data to enable population-based studies, natural history studies, and clinical trials to improve the care of children with stroke. |
Description: | The International Pediatric Stroke Study (IPSS) was established in 2003 as a multi-center, multi-national clinical research registry. Over the years, it has grown to become a highly successful study vehicle for pediatric stroke research across over 100 institutions worldwide. Today, The IPSS continues to serve as the global data and imaging core for multi-disciplinary pediatric experts who perform international collaborative research in an effort to better understand, prevent, and improve outcomes in pediatric stroke. The robust dataset and cohesive network enable high caliber and ground-breaking research in the field. Participating sites enroll neonates or children who have had an ischemic stroke or are at high risk of having a stroke into the registry. Participants have their medical and research records reviewed for information about their stroke and abstracted into a secure electronic database called REDCap. The IPSS also provides an attractive imaging platform (through the Stroke Imaging Lab for Children, SILC, housed at SickKids) for sites to share clinically acquired brain images that will complement the clinical dataset. The clinical and imaging datasets will improve our understanding of the processes underlying plasticity and recovery in childhood stroke. All information captured in the study is de-identified. This study does not require any interventions or additional visits for research. Two outcome measures are typically administered during a follow-up clinic visit: the Paediatric Stroke Outcome Measure (PSOM) and the Recovery and Recurrence Questionnaire (RRQ). The PSOM is used during clinic visits by the study PI or co-investigator; the RRQ is a parental questionnaire that can be completed during clinic visits or by telephone interview for those parents who cannot attend the follow up appointment. Both measures assess neurological function in the following 5 domains: sensory, motor, language, cognition and behavior. Participating investigators will retain ownership of their own (single-site) data. However, by entering data into the IPSS, co-investigators give implicit permission for the IPSS to analyze the collective dataset. These contributing investigators are recognized through authorship. |
Key Eligibility: | Arterial Ischemic Stroke (AIS): – Event diagnosis: Diagnosed after Jan 1, 2003 – Age: Patient between >36 weeks and 18 years of age Notes: preterm included if stroke onset was in childhood – Clinical Criteria: Focal neurological deficit of acute onset lasting greater than 20 minutes – Radiological Criteria: CT /MRI showing infarct in location consistent with neurological signs and symptoms Notes: Can include Hypoxic ischemic event with diffuse or bilateral infarction if there is a definite focal, single arterial infarct in a specified vascular territory.Cerebral Sinovenous Thrombosis (CSVT): – Event diagnosis: Diagnosed after January 1, 2003 – Age: Patient pre-term to 18 years of age Notes: pre-term babies <36 according to IPSS definition, included – Clinical Criteria: Any transient neurological dysfunction including headache, seizure, decreased level of consciousness, focal neurological signs consistent with CSVT – Radiological Criteria: Thrombosis of cerebral veins or venous sinus seen on MRI, MR venography or CT venography Notes: CT alone if definite is acceptable for older infants and children, but not for neonates under 1 month of ageCerebral Vascular Conditions (other than CSVT/AIS): – Presumed Perinatal Ischemic Strokes: Infants and children whose stroke is presumed to have occurred in the prenatal or perinatal period Notes: – These patients have normal development history up until 4-8 months of age, when they present with early hand preference. – Arteriopathy without stroke – Arteritis, vasculitis, vasculopathy, Moya Moya with no clinical events or TIA – Dissections without stroke (can also include those from traumatic brain injury) – Watershed infarct with Sickle Cell Disease |
Link: | clinicaltrials.gov |
Site Contact: | Neurology Trials |
MOVEMENT DISORDERS
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PROSEEK: A Phase 2 Study In Early Parkinson's Disease Patients Evaluating The Safety And Efficacy Of Abl Tyrosine Kinase Inhibition Using K0706)
Researcher: | Kathleen Shannon |
Sponsor: | Sun Pharma Advanced Research Company Limited (SPARC) |
Protocol No: | CLR-18-06 |
IRB No: | 2020-0457 |
Objective: | To determine if K0706 reduces the rate of progression of early-stage Parkinson’s disease (PD) versus placebo over 40 weeks, as defined by the sum of the MDS-UPDRS (Movement Disorder Society – Unified Parkinson’s Disease Rating Scale) Parts 2 and 3 scores. |
Description: | This is a study to evaluate the efficacy, safety and tolerability of two doses of K0706 compared to placebo in subjects with early PD who are not receiving dopaminergic therapy. A subset of eligible subjects may participate in a “Biomarker substudy”. Subjects will visit the clinic for a screening visit, regular assessments and to receive the study drug for 44 weeks. Subjects will provide blood to measure standard safety labs and K0706 levels. If subjects consent, additional blood will be collected, processed, and frozen for future analyses of emerging tests related to PD progression and K0706 target engagement (e.g., proteins, genetic markers). Subjects may also be provided with a smartphone with software they will use to record performance of a series of motor tasks at, and / or between visits. Subjects in the Biomarker substudy will have 3mm skin punch biopsies, DaT SPECT, and CSF collected as exploratory measures of PD progression; CSF will be used to measure K0706 level, and frozen for later analysis of emerging biomarkers (e.g., proteins) associated with PD progression and K0706 target engagement. |
Key Eligibility: |
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Compensation: | You will be paid $47 after each completed in-person study visit. |
Link: | clinicaltrials.gov |
Site Contact: | Neurology Trials |
Trial of Parkinson’s And Zoledronic Acid (TOPAZ)
Researcher: | Dr. Kathleen Shannon |
Sponsor: | National Institute of Aging |
IRB No.: | 1928009 |
Objective: | The primary aim of the study is to evaluate the efficacy of a single infusion of zoledronic acid (ZA, 5mg) to reduce the risk of clinical fractures in Parkinson’s Disease or neurodegenerative parkinsonism. |
Description: | This home-based randomized clinical trial is designed to test the efficacy of ZA-5 mg in Parkinson’s disease (PD) and parkinsonism patients. This trial will also address barriers to treatment of patients with PD and parkinsonism by providing rigorous evidence about whether ZA reduces fracture risk in patients with PD and parkinsonism, simplifying treatment by giving ZA at home without extra medical visits and BMD testing, and overcoming poor persistence with oral therapies because one infusion may prevent bone loss for at least 2 years. The outcome of this trial will demonstrate how a home-based fracture prevention can reach older PD patients who would not otherwise receive treatment to reduce their high risk of fractures. Patients with PD will be recruited throughout the US by participating neurologists and health networks as well as the Parkinson’s Foundation. Patients may also self-refer to the study. Interested patients can access study information on a study website (topaz.eurekaplatform.org) as well as through the Parkinson’s Foundation Helpline. Patients who wish to enroll will be directed to an interactive electronic consent (eConsent). Following eConsent, participants complete a screening questionnaire (to confirm eligibility), followed by a baseline questionnaire. If a participant is determined to be eligible following these steps, they may be scheduled for a Telemedicine assessment to further confirm the PD or parkinsonism diagnosis, unless they have been referred directly from a participating neurologist. If confirmed, the participant will be mailed a supply of vitamin D3 800-1000 IU and instructed to take one vitamin D tablet every day for 2 months. Lastly, a Nurse Home Visit will be scheduled and conducted to confirm final eligibility, randomization, and administration of the study drug, if appropriate. Participants who are randomized will be contacted every 4 months for at least 2 years to determine if they have had any fractures. |
Key Eligibility: |
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Compensation: | Participants who complete a Nurse Home Visit and are randomized will be offered an honorarium (for time and effort) of a $100 gift card, a $50 gift card upon completion of the measures in the 1st year of follow-up (through Month 12), another $50 gift card upon completion of the measures in the 2nd year of follow-up (through Month 24), and a $50 gift card for each completed year of follow-up thereafter, as appropriate. |
Link: | clinicaltrials.gov |
Site Contact: | neurotrials@neurology.wisc.edu |
STROKE
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C3FIT (Coordinated, Collaborative, Comprehensive, Family-based, Integrated and Technology-enabled care): A Comparative Effectiveness Randomized Trial to Improve Stroke Care Delivery
Researcher: | Eric Adelman |
Sponsor: | The Patient Centered Outcomes Research Institute (PCORI) |
Protocol No: | PCS-2017C3-9081 |
IRB No: | 190704 |
Objective: | The current standard of stroke care is the JC-certified CSC/PSC care system, a collection of proven individual processes of care, but a system that lacks coordination for the post-stroke care of patients. The C3FIT trial serves as the opportunity to assess potential impact on patient quality of life and functional outcomes resulting from the improved integration of care provided by the ISPU approach. C3FIT’s overall goal is to assess if patient outcomes are improved when the CSC/PSC system is supplemented with an Integrated Stroke Practice Unit (ISPU) system of care, a patient-centric model of care involving the patient and caregiver/family that coordinates care from the acute management through the rehabilitation and recovery of the patient. |
Description: | C3FIT is a pragmatic randomized trial of 18 Joint Commission-certified Comprehensive or Primary Stroke Centers (CSC/PSC) throughout the United States. C3FIT’s specific aim is to assess the superiority of patient-centered outcomes between CSC/PSC and Integrated Stroke Practice Unit (ISPU) models to determine if integrated care models are more effective in nodes of care across the patient recovery continuum. Vanderbilt University Medical Center (VUMC) will guide C3FIT as the Clinical Coordinating Center. |
Eligibility: |
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Link: | ClinicalTrials.gov |
Contact: | Neuro Trials |
Study to Evaluate the Efficacy and Safety of Intravenous BIIB093 (Glibenclamide) for Severe Cerebral Edema following Large Hemispheric Infarction (CHARM)
Researcher: | Jamie Elliot |
Sponsor: | Biogen |
Protocol No.: | 252LH301 |
IRB No.: | 20181333 |
Objective: | The primary objective is to determine if BIIB093 improves functional outcome at Day 90 as measured by the modified Rankin Scale (mRS) when compared with placebo in subjects with LHI (large hemispheric infarction). |
Description | This is a Phase 3 study of subjects aged 18 to 85. Following a 3-stage 72-hour continuous infusion of BIIB093 or matching placebo, subjects will receive efficacy and safety evaluations for 90 days. The primary efficacy assessment will be the mRS at Day 90. The study will be conducted as a single study in two parts. Part 1 of the study is comprised of the baseline visit, Study Drug infusion and efficacy and safety period through Study Day 90 (primary endpoint). Part 2 will be a LHI follow-up period from Day 91 to Month 12. |
Key Eligibility: |
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Compensation: | You will receive a stipend of $55.44 per visit for specific visits and may also be reimbursed for travel costs. |
Link: | clinicaltrials.gov |
Site Contact: | neurotrials@neurology.wisc.edu |
MULTIPLE SCLEROSIS
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Determining the Effectiveness of early Intensive versus escalation approaches for the treatment of relapsing-remitting Multiple Sclerosis (DELIVER-MS).
Researcher: | Natasha Frost |
Sponsor: | PCORI (Patient-Centered Outcomes Research Institute) |
Protocol No: | DELIVER-MS-01 |
IRB No: | 2019-0405 |
Objective: | To determine whether early treatment with a highly effective disease modifying therapy (DMT), such as monoclonal antibodies, improve prognisis for people with MS. |
Description: | The DELIVER-MS study seeks to answer the question: Does early treatment with highly effective DMT improve the prognosis for people with MS? This is an area of significant controversy and no data currently exist to guide treatment choices for patients and clinicians. The study results will help guide overall treatment philosophy and will be applicable not only to a wide range of existing therapies but also to new therapies, meeting a significant unmet need in patient decision making and aiding the decision for medication approval by third parties. Visits will include a Screening Visit, Randomization and Baseline Visit, in-person visits at 6, 12, 24 and 36 months and telephone visits at 3, 9, 15, 18, 21, 27, 30, 33 months. |
Eligibility: |
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Link: | ClinicalTrials.gov |
Contact: | Neuro Trials |
A Multicenter, Longitudinal, Open-Label, Single-Arm Study Describing Cognitive Processing Speed Changes in Relapsing Multiple Sclerosis Subjects Treated with Ozanimod (RPC-1063)
Researcher: | Natasha Frost |
Sponsor: | Celgene International |
Protocol No.: | RPC-1063-MS-001 |
IRB No.: | 20192310 |
Objective: | The purpose of this study is to describe clinically meaningful changes in performance on the SDMT (Symbol Digit Modalities Test) over a 3-year period in subjects with early MS receiving ozanimod HCl 1 mg. |
Description: | This is a multicenter, longitudinal, single-arm, open-label study to describe the change from baseline in cognitive processing speed, measured by the SDMT, in subjects with relapsing multiple sclerosis (RMS) treated with ozanimod HCl 1 mg at 3 years. All subjects will receive orally administered ozanimod HCl 1 mg. The primary efficacy endpoint is the proportion of subjects with a clinically meaningful increase in raw score of ≥ 4 points or 10% from baseline (improved). The treatment period is 36 months. For all subjects who finish the subject and for those who discontinue, there will be a 30-day (± 15 days) and a 90-day (± 10 days) Safety Follow-up Visit. There is no planned protocol extension following the end of the study. Approximately 250 subjects with RMS will be recruited for this study. Subjects with RMS will be enrolled in this study if they have received ≤ 1 DMT, have an EDSS ≤ 3.5, and have been diagnosed with RMS within 5 years of study entry. |
Key Eligibility: |
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Compensation: | You will receive up to a maximum of $40 per completed study visit for your travel time. If you do not complete the entire study, you will be paid for each study visit you do complete. |
Link: | clinicaltrials.gov |
Site Contact: | neurotrials@neurology.wisc.edu |