Multiple Sclerosis

Multiple Sclerosis

A Placebo-Controlled, Randomized Withdrawal Evaluation of the Efficacy and Safety of Baclofen ER Capsules (GRS) in Subjects with Spasticity Due to Multiple Sclerosis

Purpose of the Study: The primary objectives are to compare the continued treatment with Baclofen ER Capsules (GRS) versus down-titration to placebo in subjects stabilized on Baclofen ER Capsules (GRS) for the purposes of:

  • Demonstrating efficacy of Baclofen ER Capsules (GRS) in the treatment of spasticity indirectly demonstrating long-term efficacy over >12 weeks
  • Determining the safety profile when administered over >12 weeks

Inclusion:

  1. Men and women age 18 years and older
  2. Known history of spasticity due to MS prior to starting baclofen
  3. Clinically acceptable symptom control but with evidence of some residual spasticity associated with MS (meaning a modified Ashworth score of 1 on at least one lower extremity movement and no movement with a score of 4)
  4. A stable daily dose of Baclofen IR, ranging from 30 to 60 mg/day (i.e., same dose given in the same schedule for the past 30 days)

Exclusion:

  1. In relapse or history of unstable course over the prior 30 days prior to the screening visit
  2. Concomitant neurologic conditions causing spasticity (e.g., stroke, cerebral palsy, traumatic brain injury) or rigidity (e.g., Parkinson’s disease, contractures that confound assessment of spasticity)
  3. Advanced arthritis or any other cause of clinically significant limitation of passive range of motion around any of the joints being assessed in this study
  4. Receipt of systemic corticosteroid therapy within the 30 days prior to the screening visit
  5. Use of medications that could influence muscle tone, such as benzodiazepines (within 21 days of screening visit), and the following medications within 3 days of screening visit: anti-spasticity medication and muscle relaxants, and methocarbamol, meprobamate, chlorzoxazone and chlormezanone, and GABAergic drugs
  6. Treated with Botulinum Toxin Type A or B within the previous 6 months, or Phenol or therapeutic alcohol nerve block within 12 months

Study Status: Enrolling


Principal Investigator: Michael Racke, MD


Contact:
Misty Green
Phone: 614-293-6486


Funding: Sun Pharma

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Long-Term Efficacy and Safety of Prolonged Release Fampridine (BIIB041) 10 mg Administered Twice Daily in Subjects With Multiple Sclerosis (ENHANCE)

Purpose of the Study: The primary objective is to determine whether prolonged-release fampridine 10 mg BID has a clinically meaningful effect on patient-reported walking ability over a 24-week study period.


Inclusion:

  1. Aged 18 to 70 years, inclusive, at the time of informed consent
  2. Must have a diagnosis of primary-progressive, secondary-progressive, progressive-relapsing or relapsing-remitting MS at least 3 months duration
  3. Must have an EDSS score of 4 to 7, inclusive
  4. Must have walking impairment, as deemed by the investigator

Exclusion:

  1. Known allergy to fampridine, pyridine-containing substances or any of the inactive ingredients in the prolonged-release fampridine tablet
  2. Any history of seizure, epilepsy or other convulsive disorder, with the exception of febrile seizures in childhood
  3. Pulsed steroid treatment within the 60 days prior to the Screening visit or at any time during the screening period
  4. Any change in the subject’s medication dose or regimen for the treatment of fatigue or depression within the 30 days prior to the screening visit or at any time during the screening period
  5. Any change in prophylactic treatment for pain with antidepressants or anticonvulsants prescribed for this purpose within 30 days prior to the screening visit or at any time during the screening period
  6. Any change in the subject’s dose or regimen of antispastic agents within the 7 days prior to the screening visit or at any time during the screening period
  7. Treatment with any aminopyridine (fampridine, 4-AP, or 3,4-diaminopyridine [DAP] in any formulation) within the 30 days prior to the screening visit or at any time during the screening period

Study Status: Enrolling


Principal Investigator: Michael Racke, MD


Contact:
Stephanie Scarberry, RN, CCRC
Phone: 614-688-4678


Funding: Biogen

A 12-Month, Randomized, Rater- and Dose-Blinded Study to Compare the Efficacy and Safety of Fingolimod 0.25 Mg and 0.5 Mg Administered Orally Once Daily With Glatiramer Acetate 20 Mg Administered Subcutaneously Once Daily in Patients With Relapsing-Remitting Multiple Sclerosis

Purpose of the Study: The purpose of this study is to compare 2 doses (0.25 mg and 0.50 mg) of fingolimod to copaxone (20 mg) and to evaluate the efficacy and safety of fingolimod 0.25 mg for the treatment of patients with relapsing-remitting MS (RRMS) as part of a post-approval commitment for the FDA.


Inclusion:

  1. Male and female patients 18 to 65 years of age, inclusive
  2. Patients with RRMS
  3. No onset of relapse within 30 days of randomization
  4. Patients with at least 1 documented relapse during the previous year or 2 documented relapses during the previous 2 years before randomization
  5. Patients with an EDSS score of 0 to 6.0 inclusive at screening

Exclusion:

  1. Patients with an active chronic disease (or stable but treated with immune therapy) of the immune system other than MS
  2. Patients who have been treated with:
  • IVIG within 2 months before randomization
  • Immunosuppressive or chemotherapeutic medications within 6 months before randomization
  • Monoclonal antibodies (including natalizumab) within 6 months before randomization
  • Rituximab, alemtuzumab, ofatumumab, ocrelizumab, mitoxantrone or cladribine at any time before randomization
  1. Patients with severe active bacterial, viral or fungal infections
  2. Patients receiving current treatment with beta blockers, heart-rate slowing calcium channel blockers or other substances that may decrease heart rate
  3. Patients who have previously been treated with glatiramer acetate but discontinued treatment due to lack of efficacy or tolerability
  4. Patients with a history of treatment with fingolimod

Study Status: Enrolling


Principal Investigator: Michael Racke, MD


Contact:
Stephanie Scarberry, RN CCRC
Phone: 614-688-4678


Funding: Novartis

Open-Label, Single-Arm Extension Study to the Double-Blind, Randomized, Multicenter, Placebo-Controlled, Parallel-Group Study Comparing the Efficacy and Safety of 0.5 Mg FTY720 Administered Orally Once Daily Versus Placebo in Patients With Primary Progressive Multiple Sclerosis

Purpose of the Study: To assess the long-term safety and tolerability of fingolimod 0.5 mg/day in patients with PPMS and to assess the long-term efficacy of fingolimod 0.5 mg/day in patients with PPMS as measured by clinical and MRI parameters of disease activity.


Study Status: Closed enrollment


Principal Investigator: Kisanuki


Contact:
Misty Green
Phone: 614-293-6486


Funding: Novartis

Efficacy and Safety of Ocrelizumab

Purpose of the Study: To investigate the efficacy of ocrelizumab compared with placebo in patients with primary progressive multiple sclerosis, as measured by the time to onset of confirmed disability progression over the treatment period, defined as an increase in EDSS that is sustained for at least 12 weeks, based on regularly scheduled visits.


Study Status: Closed enrollment


Principal Investigator: Michael Racke, MD


Contact:
Stephanie Scarberry
Phone: 614-688-4678


Funding: Roche

A Randomized, Double-Blind, Double-Dummy, Parallel-Group Study to Evaluate the Efficacy and Safety of Ocrelizumab in Comparison to Interferon

Purpose of the Study: The primary objective of this study is to assess whether the efficacy of ocrelizumab 600 mg (given as dual infusions of 300 mg on Days 1 and 15 of the first 24-week treatment cycle and as a single infusion of 600 mg on Day 1 of each 24-week treatment cycle thereafter) intravenously every 24 weeks is superior to Rebif® as measured by the annualized protocol-defined relapse rate by two years (96 weeks) in patients with relapsing multiple sclerosis.


Study Status: Closed enrollment


Principal Investigator: Michael Racke, MD


Contact:
Stephanie Scarberry, RN, CCRC
Phone: 614-688-4678


Funding: Roche

More +

A Clinical Evaluation of the Safety of Baclofen ER Capsules (GRS) When Administered Once Daily to Subjects with Spasticity Due to Multiple Sclerosis (MS): An Open Label, Long-Term, Safety Trial

Purpose of the Study: The objective of this study is to investigate the long-term safety of Baclofen ER Capsules (GRS) when administered once daily to subjects aged 18 years and older.


Study Status: Enrolling


Principal Investigator: Michael Racke, MD


Contact:
Misty Green
Phone: 614-293-6486


Funding: Sun Pharma

A Phase II Study of High-Dose Immunosuppressive Therapy (HDIT) Using Carmustine, Etoposide, Cytarabine and Melphalan (BEAM) + Thymoglobulin, and Autologous CD34+ Hematopoietic Stem Cell Transplant (HCT) for the Treatment of Poor-Prognosis Multiple Sclerosis

Purpose of the Study:

  1. The primary objective is to determine the 5-year durability of disease stabilization in MS subjects after HDIT and autologous HCT
  2. The secondary objective of this study is to evaluate the safety and efficacy of autologous HCT
  3. The tertiary objective of the study is to evaluate myelin content and axonal integrity using magnetic resonance imaging approaches in MS subjects undergoing autologous HCT. Immune reconstitution and mechanisms of disease following autologous HCT for MS will also be explored through a number of specific endpoints.

Principal Investigator: Michael Racke, MD


Contact:
Misty Green
Phone: 614-293-6486


Funding: NIH

A Multicenter, Open-Label, Phase IV Study to Evaluate Whether a Medication Event Monitoring System (MEMS®) Can Improve Adherence to Tecfidera® (delayed-release dimethyl fumarate) Treatment in Multiple Sclerosis Patients

Purpose of the Study: The primary objective of the study is to determine whether a MEMS® cap with an LCD reader (a “smart” cap”) and MEMS® reader along with additional patient counseling intervention (Arm 3) can improve adherence to DMF treatment in MS patients as compared to a MEMS® cap without an LCD reader (a “standard” cap) and no patient counseling intervention (standard of care, Arm 1) at month 12.


Study Status: Enrolling


Principal Investigator: Michael Racke, MD


Contact:
Misty Green
Phone: 614-293-06486


Funding: Biogen

Long-Term, Prospective, Multinational, Parallel-Cohort Study Monitoring Safety in Patients With MS Newly Started on Fingolimod Once Daily or Treated With Another Approved Disease-Modifying Therapy

Purpose of the Study: The purpose of this prospective parallel-cohort study in patients with relapsing forms of MS, either newly treated with fingolimod or receiving another disease-modifying therapy, is to further monitor the overall safety profile of fingolimod under conditions of routine medical practice and to explore the incidence of selected safety-related outcomes.


The study is also meant to address other specific questions via several sub-studies. This includes a PRO sub-study, a pulmonary sub-study, a cardiac sub-study (for fingolimod-treated patients only) and a resource utilization sub-study in Canadian patients.


Study Status: Enrolling


Principal Investigator: Michael Racke, MD


Contact:
Stephanie Scarberry, RN, CCRC
Phone: 614-688-4678


Funding: Novartis

JCV Antibody Program in Patients With Relapsing Multiple Sclerosis Receiving or Considering Treatment With Tysabri®: STRATIFY-2

Purpose of the Study: Demonstrate that the incidence of PML in Tysabri-treated patients who do not have detectable antibodies to JC virus (JCV) (antibody negative) is lower than in patients who have detectable antibodies to JCV (antibody positive).


Study Status: Closed enrollment


Principal Investigator: Michael Racke, MD


Contact:
Stephanie Scarberry, RN CCRC
Phone: 614-688-4678


Funding: Biogen

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Activity of Ibudilast (MN-166) in Subjects with Progressive Multiple Sclerosis #NN102

Purpose of the Study:

  • To evaluate the activity of ibudilast (MN-166) (100 mg/d) versus placebo at 96 weeks as measured by quantitative magnetic resonance imaging (MRI) analysis for whole brain atrophy using brain parenchymal fraction (BPF)
  • To evaluate the safety and tolerability of ibudilast (MN-166) (100 mg/d) versus placebo administered orally in subjects with primary progressive multiple sclerosis (PPMS) and secondary progressive multiple sclerosis (SPMS)

Study Status: Closed enrollment


Principal Investigator: Michael Racke, MD


Contact: Amy


Funding: Cleveland Clinic- Fox

Multicenter, Randomized, Double-Blind, Parallel-Group Extension to Study AC 058B201 to Investigate the Long-Term Safety, Tolerability, and Efficacy of 10, 20 and 40 Mg/Day ACT-128800, an Oral S1P1 Receptor Agonist, in Patients With Relapsing-Remitting Multiple Sclerosis

Purpose of the Study: The objective of this study is to investigate the long-term effects of ponesimod, orally administered once daily at doses of 10, 20 or 40 mg, on safety, tolerability and efficacy.


Study Status: Closed enrollment


Principal Investigator: Michael Racke, MD


Contact:
Misty Green
Phone: 614-293-6486


Funding: Actelion

A Multicenter, Retrospective, Observational Study Evaluating Real World Clinical Outcomes in Relapsing-Remitting Multiple Sclerosis Patients Who Transition From Tysabri® (Natalizumab) to Tecfidera® (Dimethyl Fumarate)

Purpose of the Study: The primary objective of the study is to evaluate relapse activity, as measured by the proportion of patients relapsed at 12 months, in patients with RRMS who transition from Tysabri to Tecfidera in the real-world setting.


Study Status: Closed enrollment


Principal Investigator: Michael Racke, MD


Contact:
Misty Green
Phone: 614-293-6486
Stephanie Scarberry
Phone: 614-688-4678


Funding: Biogen

Multiple Sclerosis Hand/Arm Neurorehabilitation Study: In-home Virtual Reality Gaming

Purpose of the Study: The purpose of this study is to determine whether an intensive, in-home, video game-based intervention improves hand and arm function in individuals with progressive multiple sclerosis (MS). The video game is easy to operate and game play is driven entirely by movements of the weaker hand and arm.


Eligibility Criteria: Adults (18+) diagnosed with of primary progressive or secondary progressive MS, experiencing arm weakness and who have not already received CI movement therapy


Study Status: Recruiting


Principal Investigator: Dr. Lynne Gauthier


Contact:
Dr. Lynne Gauthier
Phone: 614-293-6287
Email: lynne.gauthier@osumc.edu


Funding/Study Sponsor: National Multiple Sclerosis Society, Rudi Schulte Foundation

Other Conditions

Other Conditions

A Longitudinal Study to Identify and Validate Biomarkers From Serum and Cerebrospinal Fluid in Patients Evaluated by Neurologist

Purpose of the Study: The objective of this study is to create an electronic database for patient information and a repository of biological materials including blood, spinal fluid and other samples from people being evaluated or treated for central nervous system (CNS) diseases such as multiple sclerosis (MS), transverse myelitis (TM), acute disseminated encephalomyelitis (ADEM), neuromyelitis optica (NMO), optic neuritis (ON), autoimmune conditions, headaches, dementia, infections of the nervous system, or those who have abnormal nervous system MRIs.


Study Status: Closed enrollment


Principal Investigator: Michael Racke, MD


Contact:
Misty Green
Phone: 614-293-6486


Funding: Diogenix

A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Trial to Evaluate the Safety and Efficacy of Eculizumab in Patients With Relapsing Neuromyelitis Optica (NMO)

Purpose of the Study: To assess the efficacy of eculizumab treatment as compared with placebo in relapsing NMO patients based on the time to first relapse and relapse-risk reduction.


Inclusion:

  1. Diagnosis of NMO
  2. NMO-IgG seropositive at screening visit
  3. Historical relapse of at least 2 relapses in the past 12 months or 3 relapses in the past 24 months, with at least 1 relapse in the 12 months
  4. EDSS score ≤7
  5. If a patient enters the trial receiving an IST, the patient must have been on a stable maintenance dose of IST(s), as defined by the treating physician, prior to the screening and must remain on that dose for the duration of the study

Exclusion:

  1. Use of rituximab or mitoxantrone within 3 months prior to screening
  2. Use of intravenous immunoglobulin (IVIg) within 3 weeks prior to screening
  3. The daily corticosteroid dose must be no more than prednisone 20 mg/day prior to the screening, and the patient must remain on that dose for the duration of the study
  4. Any systemic bacterial or other infection that is clinically significant in the opinion of the investigator and has not been treated with appropriate antibiotics

Study Status: Enrolling


Principal Investigator: Michael Racke, MD


Contact:
Stephanie Scarberry, RN, CCRC
Phone: 614-688-4678


Funding: Alexion

Study to Assess the Safety of 3 Mg/Ml Gablofen (Baclofen Injection) Delivered by Intrathecal Administration Using the Synchromed II Programmable Infusion System

Purpose of the Study: The primary objective of this safety and post-approval surveillance study is to obtain data on the rate of inflammatory granulomas in patients given Gablofen® (baclofen injection) 3mg/mL by the intrathecal route of administration.


Study Status: Closed enrollment


Principal Investigator: Imitola


Contact:
Misty Green
Phone: 614-293-6486


Funding: CNS

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