Clinical trials: System Sclerosis
Relapsing Remitting Multiple Sclerosis
Treatment Interruption of Natalizumab
This is a randomized, rater blinded trial in patients who interrupt treatment with natalizumab with or without being treated with other immunomodulatory drugs, or continue treatment with natalizumab.
- Trial name
- RESTORE (NCT01071083)
- Testing
- natalizumab, interferon beta 1-a, methylprednisolone
- Where
- 33 sites in United States, Germany and 1 more
- Volunteers
- 175 people
- Sponsor
- Biogen
Multiple Sclerosis
A 12 Week Randomized Open Label Parallel Group Multicenter Study to Evaluate Bioequivalence of 20 mg Subcutaneous Ofatumumab Injected by Pre-filled Syringe or Autoinjector in Adult RMS Patients
The primary purpose of this study is to demonstrate pharmacokinetic bioequivalence of ofatumumab injected by Pre-filled Syringe (PFS) versus Auto-Injector (AI) devices and thereby establish a bridge between the ongoing Phase 3…
- Trial name
- NCT03560739
- Testing
- ofatumumab with PRF, ofatumumab with AI
- Where
- 41 sites in United States, Austria and 7 more
- Volunteers
- 284 people
- Sponsor
- Novartis Pharmaceuticals
Multiple Sclerosis
Safety of Avonex Treatment in Multiple Sclerosis Patients With Neutralizing Antibodies to Interferon Beta Therapy
This study is to find out the safety and effectiveness of Avonex (interferon-beta-1a) Therapy in patients who have developed neutralizing antibodies during previous interferon-beta treatment
- Trial name
- SAFE (NCT00493077)
- Testing
- low immunogenic interferon-beta-1a
- Where
- 5 sites in Sweden
- Volunteers
- 3 people
- Sponsor
- Biogen
Sleep Problems
Assessment of the Pharmacokinetics of Circadin® in Children With Neurodevelopmental Disorders and Sleep Disturbances
There is increasing evidence that chronic sleep disorders in children with autism spectrum disorder (ASD), Angelman Syndrome (AS) and Smith-Magenis syndrome (SMS) are associated with disturbed melatonin secretion and melatonin…
- Trial name
- NCT01903681
- Testing
- Circadin 2 mg, Circadin 10 mg
- Where
- Netherlands
- Volunteers
- 16 people
- Sponsor
- Neurim Pharmaceuticals Ltd.
Relapsing Forms of Multiple Sclerosis
Long-term Safety and Tolerability of 0.5 mg Fingolimod in Patients With Relapsing Forms of Multiple Sclerosis
The purpose of this study was to collect long-term safety and tolerability, long-term efficacy, and health outcome data in all patients currently ongoing in the fingolimod multiple sclerosis clinical development program.
- Trial name
- NCT01201356
- Testing
- Fingolimod
- Where
- 458 sites in United States, Argentina and 36 more
- Volunteers
- 4,125 people
- Sponsor
- Novartis Pharmaceuticals
Multiple Sclerosis, NMO Spectrum Disorder
Clinical Impact Through AI-assisted MS Care - A Retrospective Multi-center Observational Study.
The RECLAIM study aims to gather a centralized and harmonized dataset, enabling the secondary use of data for building AI-based models that will support diagnosis and prognosis of individual Multiple Sclerosis patient's disease…
- Conditions
- Multiple Sclerosis, NMO Spectrum Disorder, Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease, Radiologically Isolated Syndrome
- Trial name
- RECLAIM (NCT06280755)
- Where
- 3 sites in Czechia, Germany
- Volunteers
- 7,000 people, healthy volunteers welcome
- Sponsor
- icometrix
Scleroderma, Systemic
A Study to Test Whether Nintedanib Influences the Components of Birth-control Pills in Women With Systemic Sclerosis Associated Interstitial Lung Disease (SSc-ILD)
The main objective is to assess the potential influence of continuous intake of nintedanib on the systemic exposure of ethinylestradiol and levonorgestrel when administered in combination.
- Trial name
- NCT03675581
- Testing
- Microgynon, Nintedanib
- Where
- 10 sites in Belgium, France and 4 more
- Volunteers
- 17 people
- Sponsor
- Boehringer Ingelheim
Amyotrophic Lateral Sclerosis
Human Spinal Cord Derived Neural Stem Cell Transplantation for the Treatment of Amyotrophic Lateral Sclerosis
This is a first-in-human trial of spinal derived stem cells transplanted into the spinal cord of patients with Amyotrophic Lateral Sclerosis (ALS).
- Trial name
- ALS (NCT01348451)
- Testing
- surgical implantation
- Where
- United States
- Volunteers
- 18 people
- Sponsor
- Neuralstem Inc.
Relapsing Remitting Multiple Sclerosis
Evaluate Safety/Tolerability in Portuguese Participants With RRMS Transitioning From Current Therapy
The primary objective of the study is to evaluate safety and tolerability as defined by the frequency of the adverse events (AEs) of flu-like symptoms (FLS) [chills, pyrexia, myalgia, and asthenia], injection site reactions…
- Trial name
- PLENO (NCT03177083)
- Testing
- peginterferon beta-1a, interferon beta-1a, interferon beta-1b
- Where
- 15 sites in Portugal
- Volunteers
- 80 people
- Sponsor
- Biogen
Multiple Sclerosis
A Study to Investigate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Pharmacodynamics of a New Subcutaneous Formulation of Ocrelizumab in Participants With Multiple Sclerosis
The main purpose of this study is to evaluate the safety and tolerability of the ocrelizumab subcutaneous (SC) test formulation in participants with multiple sclerosis (MS).
- Trial name
- OCARINA 3 (NCT07667322)
- Testing
- Ocrelizumab Co-formulated With rHuPH20
- Where
- 12 sites in United States, Brazil and 2 more
- Volunteers
- 75 people
- Sponsor
- Hoffmann-La Roche
Multiple Sclerosis
Comparative Study of the Efficacy and Safety of BCD-132 With Teriflunomide and Placebo in Multiple Sclerosis
International multicenter, randomized, double-blind, double-masked, placebo-controlled study of efficacy and safety of BCD-132 (JSC BIOСAD, Russia) using an active reference drug (teriflunomide) for the treatment of patients with…
- Trial name
- NCT04056897
- Testing
- BCD-132, 125 mg, Teriflunomide, BCD-132, 500 mg
- Where
- Russia
- Volunteers
- 271 people
- Sponsor
- Biocad
Multiple Sclerosis
Phase I Study Evaluating Safety and Tolerability of Escalating Single and Multiple Doses of of PIPE-307 and Food Effect in Healthy Volunteers
This is a randomized, double-blind study of PIPE-307 or placebo in normal healthy subjects. The study will be conducted in three parts: Part 1 will be a Single Ascending Dose (SAD) study enrolling approximately 48 subjects for a…
- Trial name
- NCT04725175
- Testing
- PIPE-307
- Where
- Australia
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- Contineum Therapeutics
Tuberous Sclerosis, Subependymal Giant Cell Astrocytoma
Efficacy and Safety of Everolimus (RAD001) in Patients of All Ages With Subependymal Giant Cell Astrocytoma Associated With Tuberous Sclerosis Complex (TSC)(EXIST-1)
This study evaluated the efficacy and safety of Everolimus in treating patients with Subependymal Giant Cell Astrocytomas associated with Tuberous Sclerosis Complex.
- Trial name
- EXIST-1 (NCT00789828)
- Testing
- Everolimus
- Where
- 24 sites in United States, Australia and 8 more
- Volunteers
- 117 people
- Sponsor
- Novartis Pharmaceuticals
ALS - Amyotrophic Lateral Sclerosis
Controlling Amyotrophic Lateral Sclerosis Motor Neuron Excitability Study
Following completion of the ALS Early Feasibility Study of the MyoRegulator® device for treatment of ALS (NCT06165172), the CALM study will further assess the feasibility of the MyoRegulator® device to treat ALS in an expanded…
- Trial name
- CALM (NCT06649955)
- Testing
- Multi-site direct current stimulation (DCS)
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- PathMaker Neurosystems Inc.
Amyotrophic Lateral Sclerosis
Dexpramipexole Japanese PK Study
This is a single and multiple dose, open-label study to evaluate the pharmacokinetics (PK), safety, and tolerability of dexpramipexole administered orally to adult Japanese and Caucasian healthy subjects.
- Trial name
- NCT01424163
- Testing
- Single dose reduced, Single dose standard, Multiple Dose
- Where
- United Kingdom
- Volunteers
- 57 people, healthy volunteers welcome
- Sponsor
- Knopp Biosciences
Diffuse Cutaneous Systemic Sclerosis
Safety, Tolerability, Efficacy, and Pharmacokinetics of JBT-101 in Systemic Sclerosis
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and efficacy of JBT-101 in adult subjects with diffuse cutaneous systemic sclerosis.
- Trial name
- NCT02465437
- Testing
- JBT-101, Part B Open-Label Extension
- Where
- 9 sites in United States
- Volunteers
- 42 people
- Sponsor
- Corbus Pharmaceuticals Inc.
Relapsing Multiple Sclerosis, Secondary Progressive Multiple Sclerosis
A Study to Investigate Long-term Safety and Tolerability of Tolebrutinib in Participants With 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…
- Conditions
- Relapsing Multiple Sclerosis, Secondary Progressive Multiple Sclerosis, Progressive Relapsing Multiple Sclerosis
- Trial name
- NCT06372145
- Testing
- Tolebrutinib, Teriflunomide
- Where
- 352 sites in United States, Argentina and 45 more
- Volunteers
- 2,500 people
- Sponsor
- Sanofi
Amyotrophic Lateral Sclerosis
Early Feasibility Study of the MyoRegulator® for Treatment of ALS
This is a single-center, single-arm, open-label study aiming to assess the safety and feasibility of the MyoRegulator® device when used to treat individuals with amyotrophic lateral sclerosis (ALS).
- Trial name
- ALSEFS (NCT06165172)
- Testing
- MyoRegulator®
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- PathMaker Neurosystems Inc.
Multiple Sclerosis
A Non-interventional Study Evaluating Clinical Utility and Implications on Improved Patient Management of Serum Neurofilament as a Prognostic Marker for Disease Activity in Patients With Relapsing Multiple Sclerosis
This is a prospective, multicenter, observational, non-interventional study (NIS) in patients with Multiple Sclerosis (MS) and routinely assessed serum neurofilament light (sNfL) values in Germany
- Trial name
- FILAXOS (NCT06551519)
- Testing
- ofatumumab, DMT category 1
- Where
- 82 sites in Germany
- Volunteers
- 519 people
- Sponsor
- Novartis Pharmaceuticals
Relapsing Remitting Multiple Sclerosis
Observational Study of Persistence on Bafiertam Treatment in Routine Clinical Practice
This is an open-label, multicenter, observational study of the adherence of patients with relapsing-remitting multiple sclerosis (RRMS) prescribed Bafiertam (monomethyl fumarate) as their treatment.
- Trial name
- SIMPLE (NCT05978531)
- Testing
- Monomethyl Fumarate
- Where
- 10 sites in United States, Puerto Rico
- Volunteers
- 25 people
- Sponsor
- Banner Life Sciences LLC