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Намерени 53 изпитвания за "Multiple sclerosis" Стр. 3 от 3

Active (not recruiting) Phase 3

A randomized, double-blind, placebo-controlled Phase III study to evaluate the efficacy and safety of remibrutinib in patients with secondary progressive multiple sclerosis

Secondary progressive multiple sclerosis

Trial status: Authorised Time to 3-month confirmed disability progression (3mCDP) on EDSS (key secondary), Time to 6-month confirmed disability improvement (6mCDI) on EDSS (key secondary), Time to 3-month worsening by at least 20% in Timed 25-Foot Walk (T25FW) (key secondary), Time to 3-month worsening by at least 20% in 9-Hole Peg Test (9-HPT) (key secondary), Annualized rate of new or enlarging T2 lesions (key secondary), Percentage of participants with annualized rate of brain atrophy > XX (key secondary), Time to 6-month worsening by at least 4 points in Symbol Digit Modalities Test (SDMT), Adverse events, laboratory data, vital signs, electrocardiogram (ECG), Columbia Suicide Severity Rating Scale (C-SSRS) Time to 6-month confirmed disability progression (6mCDP) on Expanded Disability Status Scale (EDSS)

Начало: 03.03.2026 Възраст: от 18 г.

Austria, Belgium, Bulgaria +20 Novartis Pharma AG 2025-521546-23-00

Active (not recruiting) Phase 2

A Multi-Center, Double-Blind, Placebo-Controlled, Phase II Study Evaluating the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of RO7268489, A Monoacylglycerol Lipase Inhibitor, as Add-On Therapy to Ocrelizumab, in Participants with Progressive Forms of Multiple Sclerosis

Progressive Forms of Multiple Sclerosis (PMS)

Trial status: Authorised Time from randomization to the first occurrence of 24-week confirmed ≥ 4-point decrease (worsening) in Symbol Digit Modalities Test (SDMT), Plasma 2-arachidonoylglycreol (2-AG) levels, Change from baseline in plasma 2-AG levels, Incidence, severity, and causal relationship of adverse events (AEs), Incidence of treatment discontinuations due to AEs, Changes in vital signs and ECG parameters, Incidence of abnormal laboratory findings, Proportion of participants with suicidal ideation or behavior, as assessed by Columbia-Suicide Severity Rating Scale (C-SSRS), Plasma concentrations of RO7268489 and its metabolite(s) as appropriate Time from randomization to the first occurrence of composite confirmed disability progression confirmed for at least 12 weeks (cCDP12) according to at least one of the following three criteria: o 12-week confirmed disability progression (CDP12) o 12-week confirmed increase in Timed 25-Foot Walk Test (T25FWT) or o 12-week confirmed increase in 9-Hole Peg Test (9-HPT)

Начало: 28.01.2026 Възраст: 18–64 г.

France, Germany, Hungary +4 F. Hoffmann-La Roche AG 2025-521636-10-00

Active (not recruiting) Phase 2

An open-label, multi-center, phase I/II study to assess safety, disease progression, and cellular kinetics following YTB323 administration in participants with non-active Progressive Multiple Sclerosis (PMS)

Non-active Progressive Multiple Sclerosis (PMS)

Trial status: Authorised Change from baseline for clinical measures of disability (includes EDSS, T25FW, 9HPT, SDMT)., YTB323 transgene expression levels by qPCR over time in blood; cellular kinetics parameters (Cmax, AUC, Tmax, Clast, Tlast)., Safety data from each dose level., Pre-existing and treatment-induced immunogenicity (humoral, anti-YTB323 antibody; and cellular, presence of CAR19 specific CD4 and CD8 T cells measuring interferon gamma production). Occurrence, severity and frequency of dose limiting toxicities (DLTs), Adverse Events (AEs) and change from baseline over 2 years in safety parameters including, but not limited to vital signs, laboratory, ECG, neurological status, and safety measures from brain and spinal cord MRIs.

Начало: 22.04.2025 Възраст: 18–64 г.

France, Germany, Italy +1 Novartis Pharma AG 2024-514006-31-00

Active (not recruiting) Phase 3

Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of a New Maintenance Dosing Regimen of Ofatumumab

Relapsing Multiple Sclerosis (RMS)

This study will evaluate the pharmacokinetics, pharmacodynamics, safety and tolerability of a new dosage of ofatumumab compared to the approved dosage of ofatumumab followed by extended treatment in participants with relapsing multiple sclerosis.

Начало: 13.03.2025 Край: 23.03.2030 Възраст: 18–100 г.

Puerto Rico, United States Novartis Pharmaceuticals NCT06869785

Active (not recruiting) Phase 2

P2-IMU-838-PMS - Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate Efficacy, Safety, and Tolerability of IMU-838 in Patients with Progressive Multiple Sclerosis (Calliper)

Progressive forms of Multiple Sclerosis

Trial status: Authorised Time to 24-week confirmed disability worsening as assessed on a composite of EDSS, 9-Hole Peg Test (9-HPT), or Timed 25-foot Walk (T25-FW) (24wCDW-Comp) during the MT period Annualized rate of percent brain volume change (PBVC) during MT period.

Начало: 12.09.2024 Възраст: 18–64 г.

Bulgaria, Czech Republic, Germany +3 Immunic AG 2024-514617-35-00

Active (not recruiting) Phase 3

A Study to Investigate Long-term Safety and Tolerability of Tolebrutinib in Participants With Multiple Sclerosis.

Relapsing Multiple Sclerosis Secondary Progressive Multiple Sclerosis Progressive Relapsing Multiple Sclerosis

This is a Phase 3 extension, global, multicenter study to assess the long-term safety and tolerability of tolebrutinib in adult participants (aged ≥18 years) with RMS, PPMS, or NRSPMS who were previously enrolled in the Phase 2b LTS (LTS16004) or 1 of the 4 Phase 3 tolebrutinib pivotal trials (GEMINI 1 \[EFC16033\], GEMINI 2 \[EFC16034\], HERCULES \[EFC16645\], or PERSEUS \[EFC16035\]). SUBSTUDY: ToleDYNAMIC substudy

Начало: 16.04.2024 Край: 30.04.2029 Възраст: от 18 г. Treatment

Argentina, Australia, Belgium +40 Sanofi NCT06372145

Active (not recruiting)

Remote Therapeutic Monitoring Exercise Tracking

Parkinson Disease Multiple Sclerosis

The purpose of this study is to examine physical activity and exercise behaviors in people with Parkinson's Disease and Multiple Sclerosis over the course of 1-year using a cloud-based remote monitoring platform.

Начало: 01.04.2024 Край: 01.03.2028 Възраст: 18–89 г.

United States Shirley Ryan AbilityLab NCT06306768

Active (not recruiting) Phase 2

A Randomized Controlled Trial With Rituximab for Psychotic Disorder in Adults

Schizophrenia Spectrum and Other Psychotic Disorders

Immunological factors are assumed to be determinants for some psychiatric disorders, thus anti-inflammatory drugs may be helpful. However, studies on such treatments are scarce. An inflammatory modulating drug rituximab, cluster of differentiation antigen 20 antibodies (anti-CD20 antibodies), is a standard treatment for e.g. multiple sclerosis. The investigators aim to test rituximab in a randomised placebo-controlled double-blinded, add-on treatment trial in 120 participants (18-55 years) with schizophrenia spectrum disorder. Sampling from blood for analyses of inflammatory mediators are investigated at gene and protein levels and resting state functional magnetic resonance imaging (rsfMRI) and lumbar puncture are optional. Biomarkers will be investigated in relation to treatment response. Family member(s) to the patient and the patient (separate) will be asked to participate in a qualitative interview by an independent researcher after 3 months.

Начало: 21.03.2023 Край: 31.12.2026 Възраст: 18–55 г.

Sweden Region Örebro County NCT05622201

Active (not recruiting) Phase 3

A Study to Evaluate Safety and Efficacy of Ocrelizumab in Comparison With Fingolimod in Children and Adolescents With Relapsing-Remitting Multiple Sclerosis (RRMS)

Relapsing-Remitting Multiple Sclerosis

This double-blind, double-dummy study will evaluate the safety and efficacy of ocrelizumab compared with fingolimod in children and adolescents with RRMS aged between 10 and \< 18 years over a flexible duration. The double-blind period will last until after the last participant randomized has completed 24 weeks.

Начало: 19.05.2022 Край: 17.09.2029 Възраст: 10–17 г. Treatment

Argentina, Australia, Belgium +20 Hoffmann-La Roche NCT05123703

Active (not recruiting) Phase 3

A Rollover Study to Evaluate the Long-Term Safety and Efficacy of Ocrelizumab In Patients With Multiple Sclerosis

Multiple Sclerosis

This is a Phase IIIb, single-arm, multicenter, OLE study. Participants receiving ocrelizumab as an investigational medicinal product (IMP) in a Roche sponsored Parent study who continue to receive ocrelizumab or are in safety follow-up at the time of the closure of their respective Parent study (WA21092, WA21093 or WA25046) are eligible for enrollment in this extension study. Participants who will continue ocrelizumab treatment will receive IMP based on the dosage and administration received at the time of rollover from the Parent study.

Начало: 03.05.2022 Край: 31.12.2027 Възраст: от 18 г. Treatment

Argentina, Australia, Belarus +29 Hoffmann-La Roche NCT05269004

Active (not recruiting) Phase 3

A Study to Evaluate the Efficacy, Safety and Pharmacokinetics (PK) of a Higher Dose of Ocrelizumab in Adults With Relapsing Multiple Sclerosis (RMS)

Multiple Sclerosis

This is a randomized, double-blind, controlled, parallel group, multicenter study to evaluate efficacy, safety and PK of a higher dose of ocrelizumab per intravenous (IV) infusion every 24 weeks (Q24W) in participants with RMS, in comparison to the approved 600 milligrams (mg) dose of ocrelizumab.

Начало: 26.11.2020 Край: 31.08.2028 Възраст: 18–55 г. Treatment

Argentina, Australia, Belgium +16 Hoffmann-La Roche NCT04544436

Active (not recruiting) Phase 3

Long-term Safety, Tolerability and Effectiveness Study of Ofatumumab in Patients With Relapsing MS

Relapsing Multiple Sclerosis

The purpose of this study is to collect long-term safety, tolerability, effectiveness and health outcomes data in eligible subjects who have participated in a Novartis ofatumumab clinical MS study. Vaccination sub-study The purpose of this research sub-study is to find out the effects of ofatumumab on the development of antibody responses to selected vaccines and keyhole limpet hemocyanin (KLH) neo-antigen in subjects with relapsing multiple sclerosis (RMS). COVID-19 sub-study: The purpose of this research sub-study is to explore the immune response following Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) vaccination in a subset of subjects on long-term ofatumumab 20 mg sc. Note: Novartis is not supplying the SARS-CoV-2 vaccine.

Начало: 28.12.2018 Край: 30.09.2028 Възраст: 18–100 г. Treatment

Argentina, Australia, Belgium +30 Novartis Pharmaceuticals NCT03650114

By invitation only

Relationship Between Oral DMT Burden and Adherence in MS

Multiple Sclerosis Adherence, Medication

STATURE is a prospective observational six-arm translation multi-site study that will run for approx. 4.5 years. The primary aim is to measure treatment burden and its relationship to medication adherence across six self-administered oral disease-modifying therapies (cladribine, dimethyl fumarate, fingolimod, teriflunomide, ozanimod, and diroximel fumarate) in multiple sclerosis (MS). The information gained will assist prescribing decision-making; accounting for medication burden at a patient level and potential implications on medication adherence and persistence, thus minimising primary and secondary healthcare costs. Three-hundred and twenty-three individuals with MS will be recruited into the study. Patient-reported outcome measures will be administered via Qualtrics, a secure online data collection tool. Medicare and pharmaceutical benefits scheme (PBS) data will also be collected.

Начало: 25.09.2020 Край: 11.07.2026 Възраст: 18–99 г.

Australia Monash University NCT04676204

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