Open-Label Study to Evaluate the Efficacy of ECP in Secondary Progress
A Randomized, Controlled, Open-Label Study to Evaluate the Efficacy of Extracorporeal Photopheresis (ECP) Versus Corticosteroids in the Treatment of Patients With Secondary Progressive Multiple Sclerosis (SPMS)
What it found
The trial ended early for another reason (see below).
Reason given: Low enrollment/PI relocated. New site couldn't reach agreement with manufacturer
What was tested
Treatment tested
- Extracorporeal Photopheresis
Compared with
- SoluMedrol
Results by group
Multiple Sclerosis Functional Composite (MSFC) Z-score and Expanded Disability Status Scale (EDSS)
1 year
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| ECP Arm | 6 score on a scale | 6–6 | 1 |
| Corticosteroid Arm | 6.25 score on a scale | 6–6.5 | 4 |
| ECP Arm | 1.1031 score on a scale | 1.1031–1.1031 | 1 |
| Corticosteroid Arm | 0.6751 score on a scale | 0.4914–0.9504 | 4 |
ECP Arm
Corticosteroid Arm
ECP Arm
Corticosteroid Arm
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| Corticosteriod Arm | 7 | 0 (0.0%) | 0 |
| Extracorporeal Photopheresis | 6 | 1 (16.7%) | 1 |
As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.
What it measured
Main measures
Multiple Sclerosis Functional Composite (MSFC) Z-score and Expanded Disability Status Scale (EDSS)
1 year
Disability progressionThinking and memoryWalking and mobilityArm and hand function
Other measures (1)
Immunological Parameters in Relation to SPMS
2 year
Who could take part
Progressive MS · 18 to 75 · EDSS 3 to 6.5
Show the full criteria
Inclusion criteria
* Patients with SPMS based on the Recommended Diagnostic Criteria for MS and clinical course. * Demonstrate 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 * Documented absence of clinical relapse within 2 years of screening * Age ≥ 18 ≤ 75 years * Weight > 40≤ 150 kg. * Absolute Neutrophil count ≥ 2,000 per μL * Hematocrit ≥ 28 % and 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 * Willingness to participate in all study visits and procedures, as outlined in the informed consent * Patients able to give informed consent. * Patients must have adequate peripheral venous access to initiate ECP therapy.
Exclusion criteria
* Absolute medical contraindication to corticosteroid treatment * Absolute medical contraindication to receive ECP * Clinical relapse within 2 years of screening * Laboratory evidence of any of the following: * WBC \< 2,000 cells per uL * Serum transaminase levels > x 2 UNL * HgbA1C > 6% * Concurrent diagnosis of a neurological condition or autoimmune disease other than MS * Evidence of known infection with human immunodeficiency virus (HIV) or active (not including latent) Hepatitis B (laboratory testing is not required if virus status is already known) * Uncontrolled infection requiring treatment at study entry * Hypersensitivity or allergy to psoralen (methoxsalen) * 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) * Presence of aphakia or photosensitive disease (systemic lupus erythematosis, porphyrias, albinism, etc.) * Women who are pregnant and/or lactating. * Use of any investigational drug/treatment at the time of enrollment or within the previous 60 days, or five elimination half-lives, or until the expected pharmacodynamic effect has returned to baseline, whichever is longer. * Initiation of dalfampridine or change in the dose of dalfampridine within 6 months prior to randomization * Treatment with any of the medications or procedures listed below: * Glatiramer acetate, interferon-beta, fingolimod, teriflunomide or dimethylfumarate within 3 months prior to randomization * Natalizumab within 6 months prior to randomization * Cyclophosphamide within 1year prior to randomization * Mitoxantrone within 2 years prior to randomization * Rituximab, ofatumumab, ocrelizumab, cladribine, daclizumab within 2 years prior * Intravenous immunoglobulin within 6 months prior to randomization * Plasmapheresis within 1 year prior to randomization * Corticosteroids within 3 months prior to screening * Inability to undergo MRI scans * Contraindication to gadolinium due to past allergic, hypersensitive or adverse reaction or impaired renal function * Any other disease or condition which, in the opinion of the investigator, could interfere with participation in the study according to the study protocol, or with the ability of the patients to cooperate and comply with study procedures. * Poor venous access * Previous history of skin cancer, leukemia/lymphoma/myeloma or bone marrow transplant. * History of cataracts * Patients taking Coumadin who are unable to switch from oral anticoagulants to enoxaparin.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
In this research study, the investigators will determine whether a procedure called Extracorporeal Photopheresis (ECP) is helpful in preventing progression of disability in people with SPMS when compared to monthly corticosteroid infusions. This study will determine whether ECP has an effect on inflammatory cells in people with SPMS and whether it has a beneficial therapeutic effect.
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History
Started
Oct 2014
Main results due
Jun 2017
Finished
May 2018
Results posted
Aug 2019