Multiple Sclerosis Trials

Purpose of the Study: 

To determine the efficacy of SAR442168 compared to placebo in delaying disability progression in primary progressive multiple sclerosis (PPMS).

Eligibility Criteria:

• 18 to 55 years of age inclusive
• Diagnosis of PPMS according to the 2017 McDonald criteria
• Expanded disability status scale (EDSS) between 2.0 to 6.5 points, inclusive at screening
• Disease duration from the onset of MS symptoms of <15 years if screening EDSS score of >5.0 OR <10 years if screening EDSS score of ≤5.0.
• Positive cerebrospinal fluid oligoclonal bands and/or elevated Immunoglobulin G (IgG) index either during screening or documented previous history.
• Contraceptive use consistent with local regulations for individuals participating in clinical studies
• Participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: Is not a woman of child bearing potential (WOCBP) OR Is a WOCBP and agrees to use an acceptable contraceptive method

Exclusion Criteria

• Participant has conditions that would adversely affect study participation such as short life expectancy.
• History of organ transplant.
• Evidence of infection with human immunodeficiency virus (HIV), progressive multifocal leukoencephalopathy (PML), active hepatitis B or C, active or latent tuberculosis or other
• active infection that would adversely affect study participation.
• History of malignancy within 5 years prior to screening.
• History of alcohol or drug abuse within 1 year prior to Screening.
• Hospitalized for psychiatric disease within 2 years prior to Screening.
• Clinically significant laboratory abnormalities (including evidence of liver injury) or electrocardiogram abnormalities at Screening.
• Bleeding disorder, known platelet dysfunction or platelet count <150 000/μL at Screening.
• Lymphocyte count below the lower limit of normal at Screening.
• Recent live (attenuated) vaccine within 2 months before the first treatment visit.
• Recent major surgery (within 4 weeks of Screening) or planned major surgery during the study.
• The participant has received medications/treatments for MS within a specified time frame.
• Receiving strong inducers or inhibitors of cytochrome P450 3A (CYP3A) or CYP2C8 hepatic enzymes.
• Receiving anticoagulant or antiplatelet therapy (such as aspirin, clopidogrel, warfarin).
• Contraindications to magnetic resonance imaging (MRI).

Link:

https://clinicaltrials.gov/ct2/show/NCT04458051

Sponsor:

Sanofi

Contact:

Kasturi Ganesh Barki: Kasturi.GaneshBarki@osumc.edu

Purpose of the Study: 

To assess efficacy of daily SAR442168 compared to a daily dose of 14 mg teriflunomide (Aubagio) measured by annualized adjudicated relapse rate (ARR) in participants with relapsing forms of MS.

Eligibility Criteria:

• The participant must be 18 to 55 years of age, inclusive, at the time of signing the informed consent
• The participant must have been diagnosed with RMS according to the 2017 revision of the McDonald diagnostic criteria
• The participant has an expanded disability status scale (EDSS) score ≤5.5 at the first Screening Visit
• The participant must have at least 1 of the following prior to screening:
  ≥1 documented relapse within the previous year OR
  ≥2 documented relapses within the previous 2 years, OR
  ≥1 documented Gd enhancing brain lesion on an MRI scan within the previous year
• Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
• Male participants are eligible to participate if they agree to the following during the intervention period and until accelerated elimination procedure:
  Refrain from donating sperm
• Plus either:
• Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent OR
• Must agree to use contraception/barrier as detailed below:
• Agree to use a male condom and should also be advised of the benefit for a female partner to use a highly effective method of contraception as a condom may break or leak when having sexual intercourse with a woman of childbearing potential (WOCBP) who is not currently pregnant
• A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions apply:
  Is not a WOCBP OR
  Is a WOCBP and agrees to use a contraceptive method that is highly effective (with a failure rate of <1% per year), preferably with low user dependency, during the intervention period and until accelerated elimination procedure is completed (or for at least 10 days after the last dose of SAR442168, if the case was unblinded) and agrees not to donate eggs (ova, oocytes) for the purpose of reproduction during the study and for the same period of time.
• A WOCBP must have a negative highly sensitive pregnancy test urine or serum, as required by local regulations) within the screening period before the first dose of study intervention.
• If a urine test cannot be confirmed as negative (eg, an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive.
• The Investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy.
• The participant must have given written informed consent prior to undertaking any study related procedure. This includes consent to comply with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. In countries where the legal age of maturity is greater than 18 years, a specific ICF for such legally minor participants must also be signed by the participant's legally authorized representative

Exclusion Criteria

• The participant has been diagnosed with primary progressive multiple sclerosis (PPMS) according to the 2017 revision of the McDonald diagnostic criteria or with nonrelapsing secondary progressive multiple sclerosis (SPMS)
• The participant has a history of infection or may be at risk for infection including but not limited to: HIV, transplantation, live attenuated vaccines, progressive multifocal leukoencephalopathy, tuberculosis, hepatitis B or C, any persistent chronic or active recurring infection
• The participant has conditions or situations that would adversely affect participation in this study, including but not limited to:
  A short life expectancy due to pre-existing health condition(s) as determined by their treating neurologist
  Medical condition(s) or concomitant disease(s) making them nonevaluable for the primary efficacy endpoint or that would adversely affect participation in this study, as judged by the Investigator
  A requirement for concomitant treatment that could bias the primary evaluation
• The participant has a history of or currently has concomitant medical or clinical conditions that would adversely affect participation in this study
• At screening, the participant is positive for hepatitis B surface antigen and/or hepatitis B core antibody and/or is positive for hepatitis C antibody
• The participant has any of the following:
  A bleeding disorder or known platelet dysfunction at any time prior to the screening visit
  A platelet count <150 000/μL at the screening visit
• The participant has a lymphocyte count below the lower limit of normal (LLN) at the screening visit
• The presence of psychiatric disturbance or substance abuse
• Prior/concomitant therapy
• The participant is receiving strong inducers or inhibitors of cytochrome P450 (CYP) 3A or CYP2C8 hepatic enzymes as listed in Appendix 8A (Section 10.8).
• The participant is receiving anticoagulant/antiplatelet therapies
• The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Link:

https://clinicaltrials.gov/ct2/show/NCT04410978

Sponsor:

Sanofi

Contact:

Kasturi Ganesh Barki: Kasturi.GaneshBarki@osumc.edu

Purpose of the Study: 

This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study designed to evaluate the safety, tolerability and activity of ibudilast administered twice daily over a 96 week period in subjects with primary or secondary progressive multiple sclerosis who are currently untreated with long-term MS disease modifying therapy (DMT) or who are receiving either glatiramer acetate (GA) or interferon beta-1, any formulation (IFNβ-1A [Avonex, Rebif] or IFNβ-1B [Betaseron, Extavia]). Study drug or placebo will be administered to a total of 250 male and female subjects from 21 to 65 years old, inclusive, in two treatment groups. Randomization of subjects will be stratified by disease status (primary progressive multiple sclerosis or secondary progressive multiple sclerosis) and immunomodulating therapy status: current use of immunomodulating therapy or no current use of immunomodulating therapy.

Status: Closed

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

Status: Closed

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.

Status: Closed

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.

Status: Closed

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.

Status: Closed

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.

Status: Closed

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.

Status: Closed

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.

Status: Closed

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.

Status: Closed

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.

Status: Closed

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.

Status: Closed

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).

Status: Closed

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)

Status: Closed

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.

Status: Closed

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.

Status: Closed

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.

Status: Closed

Purpose of the Study: Blood sample testing prior to the COVID-19 vaccine. Blood taken once after the vaccination and again 4-6 weeks after the vaccination. 

Study Status: Enrolling

Contact: Kasturi Ganesh Barki: Kasturi.GaneshBarki@osumc.edu