National Institute of Allergy and Infectious Diseases (NIAID) — Biomedical Watch V2

Traitements8programmes

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Traitements

8

Molécule	Indication / population	Phase	Objectif	Pays	Résultat
CilostazolIn a double blind placebo-controlled cross-over study the effect of cilostazol on aura induction and endothelial response is tested in patient with migraine with aura.	Migraine, SEP	Phase 1/2	À vérifier	United States	À vérifier
Comprehensive Multimodal Analysis of Neuroimmunological Diseases of the Central Nervous SystemInflammatory or degenerative diseases of the brain and spinal cord, such as multiple sclerosis, may be related to problems with an individual s immune system. However, more information is needed on the ways in which the cells of the immune system interact with the central nervous system (CNS). This study will compare tests performed on both healthy volunteers and individuals who have signs or symptoms of immune-related damage to their CNS. This study will include two groups of subjects at least 12 years old. Subjects will either have symptoms of immune-related CNS damage, or will be healthy volunteers selected for comparison purposes. Study participants will visit the NIH Clinical Center on an outpatient basis for an initial evaluation visit. During the visit, patients will provide a comprehensive medical history and undergo a neurological examination, and will provide blood samples for research purposes. The healthy volunteers will be asked to schedule a return visit for a magnetic resonance imaging (MRI) procedure, and may be asked to undergo other tests requested by the study researchers on an as-needed basis. The group of patients with symptoms of immune-related CNS damage will be asked to undergo a series of tests, including the following: * MRI procedures, with a minimum of three brain MRIs and one spinal cord MRI taken approximately 4 weeks apart * A diagnostic lumbar puncture, performed on an outpatient basis * Tests of brain and vision activity * Additional blood and tissue samples Patients with symptoms of immune-related CNS damage may be offered the opportunity to participate in additional followup tests with NIH researchers.	SEP	À vérifier	Immunomodulation + Traitement symptomatique	United States	À vérifier
DantroleneBackground: In people with multiple sclerosis (MS), brain and cerebrospinal fluid (CSF) biomarkers indicate inflammation or disease. Researchers want to see if 4 drugs given alone or combined affect MS biomarkers. They want to see if a change in biomarker levels can predict which drugs a person with MS might respond to. Objective: To see if signs of inflammation in CSF help predict a person s response to different drugs. Eligibility: People ages 18 and older who: * Are in protocol 09-I-0032 * Have progressive MS * Can stand and walk a few steps * Take an MS drug Design: Participants will be screened in protocol 09-I-0032. Participants will take 1 of the 4 study drugs. Researchers will call after 1 month to see how they are doing. Some will start a second drug. They may take each drug or combination for up to 18 months. Participants will have 2 visits a year for up to 6 years. Visits include: * Medical history * Physical exam * Blood and heart tests * X-rays and scans * Eye exam and tear collection * Lumbar puncture: A needle inserted between back bones removes some CSF. * Lymphocytapheresis: Blood is removed through a needle in one arm and run through a machine. The blood is returned through a needle in the other arm. * A sensor on the forehead records blood flow and oxygen use. * Participants may get a device for testing at home. Participants will stop taking the drugs if they have taken 2 drugs together for 18 months or if they do not do well on the drugs. Participants will be called 3 months later to see how they are doing....	SEP	Phase 1/2	Immunomodulation	United States	À vérifier
PioglitazoneBackground: In people with multiple sclerosis (MS), brain and cerebrospinal fluid (CSF) biomarkers indicate inflammation or disease. Researchers want to see if 4 drugs given alone or combined affect MS biomarkers. They want to see if a change in biomarker levels can predict which drugs a person with MS might respond to. Objective: To see if signs of inflammation in CSF help predict a person s response to different drugs. Eligibility: People ages 18 and older who: * Are in protocol 09-I-0032 * Have progressive MS * Can stand and walk a few steps * Take an MS drug Design: Participants will be screened in protocol 09-I-0032. Participants will take 1 of the 4 study drugs. Researchers will call after 1 month to see how they are doing. Some will start a second drug. They may take each drug or combination for up to 18 months. Participants will have 2 visits a year for up to 6 years. Visits include: * Medical history * Physical exam * Blood and heart tests * X-rays and scans * Eye exam and tear collection * Lumbar puncture: A needle inserted between back bones removes some CSF. * Lymphocytapheresis: Blood is removed through a needle in one arm and run through a machine. The blood is returned through a needle in the other arm. * A sensor on the forehead records blood flow and oxygen use. * Participants may get a device for testing at home. Participants will stop taking the drugs if they have taken 2 drugs together for 18 months or if they do not do well on the drugs. Participants will be called 3 months later to see how they are doing....	SEP	Phase 1/2	Immunomodulation	United States	À vérifier
PirfenidoneBackground: In people with multiple sclerosis (MS), brain and cerebrospinal fluid (CSF) biomarkers indicate inflammation or disease. Researchers want to see if 4 drugs given alone or combined affect MS biomarkers. They want to see if a change in biomarker levels can predict which drugs a person with MS might respond to. Objective: To see if signs of inflammation in CSF help predict a person s response to different drugs. Eligibility: People ages 18 and older who: * Are in protocol 09-I-0032 * Have progressive MS * Can stand and walk a few steps * Take an MS drug Design: Participants will be screened in protocol 09-I-0032. Participants will take 1 of the 4 study drugs. Researchers will call after 1 month to see how they are doing. Some will start a second drug. They may take each drug or combination for up to 18 months. Participants will have 2 visits a year for up to 6 years. Visits include: * Medical history * Physical exam * Blood and heart tests * X-rays and scans * Eye exam and tear collection * Lumbar puncture: A needle inserted between back bones removes some CSF. * Lymphocytapheresis: Blood is removed through a needle in one arm and run through a machine. The blood is returned through a needle in the other arm. * A sensor on the forehead records blood flow and oxygen use. * Participants may get a device for testing at home. Participants will stop taking the drugs if they have taken 2 drugs together for 18 months or if they do not do well on the drugs. Participants will be called 3 months later to see how they are doing....	SEP	Phase 1/2	Immunomodulation	United States	À vérifier
CilostazolIn a double blind placebo-controlled cross-over study the effect of cilostazol on aura induction and endothelial response is tested in patient with migraine with aura.	Migraine	Phase 1	À vérifier	Denmark	À vérifier
Comprehensive Multimodal Analysis of Neuroimmunological Diseases of the Central Nervous SystemInflammatory or degenerative diseases of the brain and spinal cord, such as multiple sclerosis, may be related to problems with an individual s immune system. However, more information is needed on the ways in which the cells of the immune system interact with the central nervous system (CNS). This study will compare tests performed on both healthy volunteers and individuals who have signs or symptoms of immune-related damage to their CNS. This study will include two groups of subjects at least 12 years old. Subjects will either have symptoms of immune-related CNS damage, or will be healthy volunteers selected for comparison purposes. Study participants will visit the NIH Clinical Center on an outpatient basis for an initial evaluation visit. During the visit, patients will provide a comprehensive medical history and undergo a neurological examination, and will provide blood samples for research purposes. The healthy volunteers will be asked to schedule a return visit for a magnetic resonance imaging (MRI) procedure, and may be asked to undergo other tests requested by the study researchers on an as-needed basis. The group of patients with symptoms of immune-related CNS damage will be asked to undergo a series of tests, including the following: * MRI procedures, with a minimum of three brain MRIs and one spinal cord MRI taken approximately 4 weeks apart * A diagnostic lumbar puncture, performed on an outpatient basis * Tests of brain and vision activity * Additional blood and tissue samples Patients with symptoms of immune-related CNS damage may be offered the opportunity to participate in additional followup tests with NIH researchers.	SEP	À vérifier	Immunomodulation + Traitement symptomatique	United States	À vérifier
CilostazolIn a double blind placebo-controlled cross-over study the effect of cilostazol on aura induction and endothelial response is tested in patient with migraine with aura.	SEP	Phase 1/2	À vérifier	United States	À vérifier

Essais cliniques

5

Molécule	Indication / population	Phase	NCT	Titre	Statut
Cilostazol	SEP	Phase 1/2	NCT03109288	Targeting Residual Activity By Precision, Biomarker-Guided Combination Therapies of Multiple Sclerosis (TRAP-MS)	RECRUITING
Comprehensive Multimodal Analysis of Neuroimmunological Diseases of the Central Nervous System	SEP	À vérifier	NCT00794352	Comprehensive Multimodal Analysis of Neuroimmunological Diseases of the Central Nervous System	RECRUITING
Ublituximab	Myopathies	Phase 2	NCT07103746	SUMMIT — Ublituximab in Autoantibody Positive Immune Mediated Necrotizing Myopathy	RECRUITING
Ocrelizumab	SEP	Phase 4	NCT05285891	AMS05 — Ocrelizumab Discontinuation in Relapsing Multiple Sclerosis	ACTIVE_NOT_RECRUITING
Cilostazol	Migraine	Phase 1	NCT02253004	Induction of Migraine Aura With Cilostazol	COMPLETED

Publications

8

Molécule	Indication / population	Titre	Journal	Date
Cilostazol		Cilostazol in a Child With Moyamoya Disease.	Journal of child neurology
Cilostazol		Secondary prevention strategies for patients with lower extremity peripheral artery disease after successful peripheral vascular intervention.	American heart journal
Cilostazol		Prognostic implications of single antiplatelet therapy in individuals developing diabetic foot disease with concurrent peripheral arterial disease.	Annals of medicine
Comprehensive Multimodal Analysis of Neuroimmunological Diseases of the Central Nervous System		Extrapolating from trials to clinic: a predictive model defining the boundaries of benefit for multiple sclerosis therapies in real-world populations based on systematic review.	BMC medicine
Cilostazol		Isosorbide Mononitrate/Cilostazol for Lacunar Cerebral Small Vessel Disease-Outcomes at 6 Months in the LACI-2 Randomized Controlled Trial.	Journal of the American Heart Association
Cilostazol		Emerging Neurovascular Interventions for the Prevention of Cerebral Vasospasm and Delayed Cerebral Ischemia After Aneurysmal Subarachnoid Hemorrhage: A Systematic Review.	Cureus
Cilostazol		Antithrombotic Drug Eruptions in Dermatology Practice: Selection Bias, Clinical Phenotypes, and Diagnostic Approaches.	Cureus
Cilostazol		Pharmacogenetic mechanism of cilostazol-induced headaches: Splicing-mediated loss of ABCC5 gene function.	British journal of pharmacology