Safety and Efficacy of Extracorporeal Photopheresis (ECP) in the Treatment of Multiple Sclerosis (NCT05168384) | Clinical Trial Compass
CompletedPhase 1/2
Safety and Efficacy of Extracorporeal Photopheresis (ECP) in the Treatment of Multiple Sclerosis
United Arab Emirates15 participantsStarted 2022-03-26
Plain-language summary
PHOMS Study is a randomized, controlled, open-label, prospective, and multicentric clinical trial involving outpatients diagnosed with Secondary Progressive Multiple Sclerosis (SPMS) or Relapsing-Remitting Multiple Sclerosis (RRMS). The primary objective is the safety profile assessment of the investigational intervention (Extracorporeal Photopheresis -ECP) and its preliminary efficacy evaluation, while the secondary objective is the assessment of the immune response profile in MS patients.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Demonstrate Expanded Disability Status Scale (EDSS) scores between 3 to 6.5 at screening.
✓. Documented EDSS progression in the 2 years prior to screening of 1 point or greater for patients with an EDSS score less than 6 at baseline, and greater than or equal to 0.5 for patients with an EDSS score greater than or equal to 6.0 at baseline \*.
✓. Documented initial onset characterized by a relapsing-remitting course as described in the Diagnostic Criteria.
✓. Age ≥ 18 ≤ 75 years.
✓. Weight \> 40 kg.
✓. Hematocrit ≥ 28 % (with or without transfusion support).
✓. Platelet count \> 100,000 per μL (with or without transfusion support).
✓. Willingness to use at least 1 reliable method of birth control (e.g., abstinence, oral contraceptives, intrauterine devices, barrier method with spermicide, or surgical sterilization) throughout the study for all men and women of childbearing potential.
Exclusion criteria
What they're measuring
1
Tolerability to ECP procedures (Group A patients)
Timeframe: Weeks 0-24
2
Incidence of treatment-emergent adverse events (TEAEs), adverse events of special interest (AESIs), and serious adverse events (SAEs)
. Absolute medical contraindication to receive ECP.
✕. Laboratory evidence of any of the following:
✕. Concurrent diagnosis of a neurological condition that would interfere with the assessment of MS, or an autoimmune disease or inflammatory condition that is chronically treated with immunosuppressive agents.
✕. Evidence of known infection with human immunodeficiency virus (HIV) or active (not including latent) Hepatitis B.
✕. Uncontrolled infection requiring treatment at study entry.
✕. Hypersensitivity or allergy to psoralen (methoxalen).
✕. Hypersensitivity or allergy to both heparin and citrate products (If hypersensitive or allergic to only one of these products, exclusion does not apply).
✕. Inability to tolerate fluid changes associated with ECP (e.g., inadequate renal, hepatic, pulmonary and cardiac function leading to enable patient to tolerate extracorporeal volume shifts associated with ECP).
9
Occurrence of clinical relapse at any point in the study