PIPE-307 for Multiple Sclerosis (VISTA Trial)
Palo Alto (17 mi)Age: 18 - 65
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Pipeline Therapeutics, Inc.
Prior Safety Data
Trial Summary
What is the purpose of this trial?This trial is testing a new drug called PIPE-307 to see if it can help people with relapsing-remitting multiple sclerosis. The drug likely works by calming the immune system to prevent nerve damage. The study will compare two different doses of PIPE-307 over several months.
What safety data is available for PIPE-307 in treating Multiple Sclerosis?The provided research does not specifically mention PIPE-307 or its safety data. However, it discusses the importance of pharmacovigilance and registry-based studies in assessing the safety of multiple sclerosis treatments. Studies like REGIMS, Optimise:MS, and FASM focus on monitoring adverse effects and safety profiles of disease-modifying therapies for MS, highlighting the need for continuous safety evaluation of new treatments.68101113
Is the drug PIPE-307 a promising treatment for Multiple Sclerosis?The information provided does not mention PIPE-307, so we can't determine if it's a promising treatment for Multiple Sclerosis based on this data.134712
What data supports the idea that PIPE-307 for Multiple Sclerosis is an effective drug?The available research does not provide specific data on the effectiveness of PIPE-307 for Multiple Sclerosis. The articles focus on other treatments and general aspects of managing the condition, such as patient satisfaction with support programs and outcomes of other therapies. Without direct evidence or comparisons involving PIPE-307, we cannot conclude its effectiveness from the provided information.2591415
Do I need to stop my current medications to join the trial?The trial requires stopping certain medications. You cannot use dalfampridine, 4-aminopyridine drugs, anticholinergic medications, or drugs affecting CYP3A4 enzyme activity within 30 days before or during the study. Check with the trial team for specifics on your current medications.
Eligibility Criteria
This trial is for English-speaking adults aged 18 to 50 with relapsing-remitting multiple sclerosis, as per the Revised McDonald Criteria. Participants must have been on a stable dose of one MS drug for the past six months and agree to use effective contraception. They should be in good health aside from MS.Inclusion Criteria
I am between 18 and 50 years old.
I have been diagnosed with relapsing-remitting MS according to the latest criteria.
Treatment Details
The study tests PIPE-307 at two different doses against a placebo in people with relapsing-remitting multiple sclerosis. It's randomized and double-blind, meaning neither participants nor researchers know who gets which treatment, divided into three groups equally over about 30 weeks.
3Treatment groups
Experimental Treatment
Placebo Group
Group I: PIPE-307 Dose BExperimental Treatment1 Intervention
Group II: PIPE-307 Dose AExperimental Treatment1 Intervention
Group III: PlaceboPlacebo Group1 Intervention
Find a clinic near you
Research locations nearbySelect from list below to view details:
Indiana University Health Neuroscience Center, Adult Neurology CenterIndianapolis, IN
University of New Mexico/Health Science Center/MIND Imaging Center/MS Specialty ClinicAlbuquerque, NM
Accel Research Sites Network - Brain & Spine InstitutePort Orange, FL
University of Kansas Medical CenterKansas City, KS
More Trial Locations
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Who is running the clinical trial?
Pipeline Therapeutics, Inc.Lead Sponsor
Contineum TherapeuticsLead Sponsor
References
Oral fingolimod (FTY720) for relapsing multiple sclerosis. [2022]Fingolimod (FTY720) is a new oral immunomodulating agent under evaluation for the treatment of relapsing multiple sclerosis.
Reconsidering clinical outcomes in Multiple Sclerosis: relapses, impairment, disability and beyond. [2019]There is an increasing number of clinical trials testing new compounds which act at different stages of Multiple Sclerosis (MS). To prove their effectiveness several clinical outcome measures are used. The overall quality of clinical trials is increasing steadily due to the growing experience in this area, the increasing awareness of quality standards in the MS community and the more stringent requirements of regulatory authorities for approval of new treatments. Each successful clinical trial provided additional information that could be incorporated into the design of subsequent studies to improve their quality. However, the choice of appropriate outcome measures still presents major challenges. For an individual patient improvement or stability of their disability and to a lesser extent the relapse rate, are the main targets of treatment. As there is yet no scale or assessment, which objectively covers all major issues, it is recommended to use multiple instruments and endpoints as secondary outcome measures.
A randomized, controlled trial of fingolimod (FTY720) in Japanese patients with multiple sclerosis. [2022]Fingolimod (FTY720) has previously shown clinical efficacy in phase II/III studies of predominantly Caucasian populations with multiple sclerosis (MS).
[Infections and fingolimod]. [2017]Fingolimod is the first approved drug with oral availability for the treatment of relapsing multiple sclerosis.
The impact of a patient support program for multiple sclerosis on patient satisfaction and subjective health status. [2022]Leading multiple sclerosis (MS) therapies have patient support programs (PSPs) aimed at improving patients' lives. There is limited knowledge about what drives patient satisfaction with PSPs and little evidence about its impact on patient-reported health status or health-related quality of life.
[Current immunotherapy of multiple sclerosis]. [2018]Following the introduction of interferon beta 1b as the first immunomodulatory therapy for multiple sclerosis (MS) in 1993, there are currently nine substances or substance classes approved for the treatment of MS (i.e. alemtuzumab, azathioprine, dimethyl fumarate, fingolimod, glatiramer acetate, interferon beta, mitoxantrone, natalizumab and teriflunomide). Major developments during the last 5 years include the approval of orally administered medications (i.e. fingolimod, teriflunomide and dimethyl fumarate), a monoclonal antibody (alemtuzumab), as well as glatiramer acetate with an administration frequency three times a week and a pegylated formulation of interferon beta 1a. The broadened therapeutic options enable a more differentiated and individualized therapy of MS; however, evidence-based data for therapeutic decision-making relevant in clinical practice are not always available. Rare but potentially severe and even life-threatening side effects of immunotherapies for MS require continuous pharmacovigilance and adherence to risk management plans.
A randomized trial of teriflunomide added to glatiramer acetate in relapsing multiple sclerosis. [2020]Teriflunomide is a once-daily oral immunomodulator for the treatment of relapsing-remitting MS.
Managing Risks with Immune Therapies in Multiple Sclerosis. [2020]Since the introduction of the interferons in the 1990s, a multitude of different immunomodulatory and immunosuppressant disease-modifying therapies for multiple sclerosis (MS) have been developed. They have all shown positive effects on clinical endpoints such as relapse rate and disease progression and are a heterogeneous group of therapeutics comprising recombinant pegylated and non-pegylated interferon-β variants, peptide combinations, monoclonal antibodies, and small molecules. However, they have relevant side effect profiles, which necessitate thorough monitoring and straightforward patient education. In individual cases, side effects can be severe and potentially life-threatening, which is why knowledge about (neurological and non-neurological) adverse drug reactions is essential for prescribing neurologists as well as general practitioners. This paper aims to provide an overview of currently available MS therapies, their modes of action and safety profiles, and the necessary therapy monitoring.
Real-Life Outcome in Multiple Sclerosis in the Czech Republic. [2022]Cohort studies and registries provide opportunities to estimate long-term outcome in multiple sclerosis.
Chances and Challenges of Registry-Based Pharmacovigilance in Multiple Sclerosis: Lessons Learnt from the Implementation of the Multicenter REGIMS Registry. [2022]The long-term and potential rare side effects of new immunomodulating drugs for the treatment of multiple sclerosis (MS) are often not well known. Spontaneous case report systems of adverse drug effects are a valuable source in pharmacovigilance, but have several limitations. Primary data collections within registries allow a comprehensive analysis of potential side effects, but face several challenges. This article will outline the chances and challenges of registry-based adverse event reporting, using the example of the German immunotherapeutic registry REGIMS. REGIMS is an observational, clinical multicenter registry that aims to assess the incidence, type, and consequences of side effects of MS immunotherapies. Patients treated with an approved MS medication are recruited by their physicians during routine visits in hospitals, outpatient clinics, and MS-specialized practices. REGIMS incorporates an electronic physician-based documentation in each center and a paper-based patient documentation, both at baseline and regular follow-up visits. By the end of 2019, 43 REGIMS centers were actively recruiting patients and performing follow-up documentations. The majority of the first 1000 REGIMS patients were female (69.3%), had relapse-remitting MS (89.8%), and were treated with a second-line therapy. During the implementation of REGIMS, several logistic and procedural challenges had to be overcome, which are outlined in this paper. Pharmacovigilance registries such as REGIMS provide high-quality primary data from a specific patient population in a real-world care setting and enable pharmacovigilance research that cannot be carried out using secondary data. Despite the logistic and procedural challenges in establishing a multicenter pharmacovigilance registry in Germany, the advantages outweigh the drawbacks.
Preliminary Results of the FASM Study, an On-Going Italian Active Pharmacovigilance Project. [2020]Disease-modifying therapies (DMTs) used in multiple sclerosis (MS) have distinct safety profiles. In this paper, we report preliminary results of an on-going pharmacovigilance project (the FASM study).
Increased Remyelination and Proregenerative Microglia Under Siponimod Therapy in Mechanistic Models. [2022]Siponimod is an oral, selective sphingosine-1-phosphate receptor-1/5 modulator approved for treatment of multiple sclerosis.
Challenges and Opportunities of Real-World Data: Statistical Analysis Plan for the Optimise:MS Multicenter Prospective Cohort Pharmacovigilance Study. [2022]Optimise:MS is an observational pharmacovigilance study aimed at characterizing the safety profile of disease-modifying therapies (DMTs) for multiple sclerosis (MS) in a real world population. The study will categorize and quantify the occurrence of serious adverse events (SAEs) in a cohort of MS patients recruited from clinical sites around the UK. The study was motivated particularly by a need to establish the safety profile of newer DMTs, but will also gather data on outcomes among treatment-eligible but untreated patients and those receiving established DMTs (interferons and glatiramer acetate). It will also explore the impact of treatment switching.
Patient reported outcomes in a secondary progressive MS cohort related to cognition, MRI and physical outcomes. [2023]Patient-reported outcomes (PROs) are increasingly being used as outcomes in secondary progressive multiple sclerosis (SPMS) trials. We examined how PROs reflect disease burden in SPMS.
Assessment of the treating physicians' first-hand experience with handling and satisfaction of ofatumumab therapy: findings from the PERITIA survey conducted in Europe. [2023]Real-world evidence on experience and satisfaction of ofatumumab as a treatment option for relapsing multiple sclerosis (RMS) is limited.