Secondary Progressive Multiple SclerosisMSECPNCT02296346
Open-Label Study to Evaluate the Efficacy of ECP in Secondary Progressive Multiple Sclerosis
A study testing SoluMedrol and Extracorporeal Photopheresis in people with Secondary Progressive Multiple Sclerosis, run by University of Utah at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Secondary Progressive Multiple Sclerosis
- What is being tested?
- SoluMedrol and Extracorporeal Photopheresis
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2014to 10 May 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan Health Systems
Ann Arbor, Michigan, 48109
About this study
Official title: 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)
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.
Read the detailed description
This is a Phase II randomized, open-label study to evaluate the efficacy of extracorporeal photopheresis (ECP) versus IVMP on disability progression in subjects with SPMS. At the initial screening visit, an extensive medical history will be obtained and a detailed neurological examination will be performed to determine eligibility. Subjects who meet eligibility criteria will be enrolled in one of two study arms. Subjects will be randomized at a 1:1 ratio to receive ECP (study arm) or active treatment with intravenous methylprednisolone pulses (control arm) administered every 4 Weeks (1 gram per infusion) for 52 weeks.
ECP will be administered according to the following schedule:
Study Arm: Weeks 1-8: 3 times per week Weeks 9-16: Twice per week Weeks 17-36: Treatment on two consecutive days every 2 weeks (or optionally, one treatment per week) Weeks 37-43: Once every 2 weeks Weeks 44-52: Once every 4 Weeks
All subjects, including patients who receive corticosteroids, will be evaluated using the MSFC tool at baseline and every 3 months through 2 years. They will also be scored using the EDSS at baseline and every 3 months through 2 years. Subjects in the control arm will be evaluated by MSFC and EDSS during the week prior to their next intravenous methylprednisolone infusion and every three months from baseline through two year mark. Blood will be collected for immune function (cytokines) testing at baseline, and months 3, 6, 9 and 12. MRI will be done at baseline as well as months 6 and 12 following initiation of treatment; if the disability measurements are stable or improved at any point in time, then ECP will be continued per protocol..
Patients in the ECP arm should have all of their treatments with the CELLEX ® System. Patients randomized to the ECP arm must receive their treatment within 5 days of baseline visit.
In the ECP process, UVADEX ® (methoxsalen) Sterile Solution will be injected directly the recirculation bag of the extracorporeal circuit after completion of the buffy coat collection. The dose of UVADEX® (methoxsalen) Sterile Solution will be calculated based on the standard treatment volume formula.
- Conditions
- Secondary Progressive Multiple Sclerosis
- Being tested
- SoluMedrol, Extracorporeal Photopheresis
- Medical subject headings
- Multiple Sclerosis, Chronic Progressive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SoluMedrolDrug
Also called Corticosteroids
Infusion of drug subcutaneously, once a month.
Extracorporeal PhotopheresisDevice
Also called ECP, Cellex machine, Therakos
This intervention is the placement of up to two IV's to extract your blood as a set volume, separate out the white cells and return the red cells to your body. Then the white cells are treated with a drug called UVADEX (methoxsalen), excited by a UV light and returned to your body. Once IV is to withdraw your blood and the other is to return your blood to your body.
| Study group | Role | What they receive |
|---|---|---|
| Corticosteroid arm | Active comparator | Patients will receive 1 gram of IV SoluMedrol over 1 hour, once every month for 12 months. Receives: Drug: SoluMedrol |
| Extracorporeal Photopheresis | Experimental | Patient will receive an Extracorporeal Photopheresis treatment at a set frequency over the course of 1 year. The treatment takes about 2-3 hours per session to complete. The treatment schedule is as follows:
ECP will be administered according to the following schedule:
Study Arm: Weeks 1-8: 3 times per week Weeks 9-16: Twice per week Weeks 17-36: Treatment on two consecutive days every 2 weeks (or optionally, one treatment per week) Weeks 37-43: Once every 2 weeks Weeks 44-52: Once every 4 Weeks Receives: Device: Extracorporeal Photopheresis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Multiple Sclerosis Functional Composite (MSFC) Z-score and Expanded Disability Status Scale (EDSS)
MSFC score is a composite score calculated from 3 tests: 1) Timed 25-Foot walk (leg function); 2) 9-Hole Peg Test (arm function); and 3) Paced Auditory Serial Addition Test (cognitive function). The results are combined to create a single score (the MSFC Z-Score) to measure performance and change over time in subjects with MS. MSFC Z-score = {Z arm + Z leg + Z cognitive} / 3.0. A positive score indicates that, on average, an individual performed better than the reference population and a negative score indicates that, on average, an individual performed worse than the reference population.
The Expanded Disability Status Scale (EDSS) is used to quantify disability due to symptoms of MS and to track changes in disability status over time. Scores range from 0 (normal neurological exam) to 10 (death due to multiple sclerosis). Scores are determined by performing a neurological exam and given in increments of 0.5.
Measured: 1 year
Secondary outcomes (1)
Immunological Parameters in Relation to SPMS
Changes in immunological parameters that occur following initiation of ECP or corticosteroids and any relevant correlation with clinical outcomes
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2014 (estimated)
- Study startOct 2014
- Primary completion13 Jun 2017
- Study completion10 May 2018
Why it stopped: Low enrollment/PI relocated. New site couldn't reach agreement with manufacturer
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Secondary Progressive Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- Mallinckrodt
- Responsible party
- Principal investigator, Daniel Couriel, University of Utah
- Investigators
- Benjamin Segal, MD, Principal investigator, University of Michigan, Director of Multiple Sclerosis CenterDaniel Couriel, MD, Principal investigator, University of Utah, Huntsman Cancer Institute, Internal Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02296346
- Sponsor's protocol ID
- HUM00083301
- Acronym
- MSECP
- Status last verified
- Aug 2019
- First submitted
- 18 Nov 2014
- Last updated
- 14 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT02296346
- Acronym / sponsor ID
- MSECP / HUM00083301
- Conditions
- Secondary Progressive Multiple Sclerosis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low enrollment/PI relocated. New site couldn't reach agreement with manufacturer
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- Mallinckrodt
- Study start
- Oct 2014 (actual)
- Primary completion
- 13 Jun 2017 (actual)
- Study completion
- 10 May 2018 (actual)
- First posted
- 20 Nov 2014 (estimated)
- Results
- Posted 14 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a Phase II randomized, open-label study to evaluate the efficacy of extracorporeal photopheresis (ECP) versus IVMP on disability progression in subjects with SPMS. At the initial screening visit, an extensive medical history will be obtained and a detailed neurological examination will be performed to determine eligibility. Subjects who meet eligibility criteria will be enrolled in one of two study arms. Subjects will be randomized at a 1:1 ratio to receive ECP (study arm) or active treatment with intravenous methylprednisolone pulses (control arm) administered every 4 Weeks (1 gram per infusion) for 52 weeks.
ECP will be administered according to the following schedule:
Study Arm: Weeks 1-8: 3 times per week Weeks 9-16: Twice per week Weeks 17-36: Treatment on two consecutive days every 2 weeks (or optionally, one treatment per week) Weeks 37-43: Once every 2 weeks Weeks 44-52: Once every 4 Weeks
All subjects, including patients who receive corticosteroids, will be evaluated using the MSFC tool at baseline and every 3 months through 2 years. They will also be scored using the EDSS at baseline and every 3 months through 2 years. Subjects in the control arm will be evaluated by MSFC and EDSS during the week prior to their next intravenous methylprednisolone infusion and every three months from baseline through two year mark. Blood will be collected for immune function (cytokines) testing at baseline, and months 3, 6, 9 and 12. MRI will be done at baseline as well as months 6 and 12 following initiation of treatment; if the disability measurements are stable or improved at any point in time, then ECP will be continued per protocol..
Patients in the ECP arm should have all of their treatments with the CELLEX ® System. Patients randomized to the ECP arm must receive their treatment within 5 days of baseline visit.
In the ECP process, UVADEX ® (methoxsalen) Sterile Solution will be injected directly the recirculation bag of the extracorporeal circuit after completion of the buffy coat collection. The dose of UVADEX® (methoxsalen) Sterile Solution will be calculated based on the standard treatment volume formula.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Corticosteroid arm | Active comparator | Drug: SoluMedrolPatients will receive 1 gram of IV SoluMedrol over 1 hour, once every month for 12 months. |
| Extracorporeal Photopheresis | Experimental | Device: Extracorporeal PhotopheresisPatient will receive an Extracorporeal Photopheresis treatment at a set frequency over the course of 1 year. The treatment takes about 2-3 hours per session to complete. The treatment schedule is as follows: ECP will be administered according to the following schedule: Study Arm: Weeks 1-8: 3 times per week Weeks 9-16: Twice per week Weeks 17-36: Treatment on two consecutive days every 2 weeks (or optionally, one treatment per week) Weeks 37-43: Once every 2 weeks Weeks 44-52: Once every 4 Weeks |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (33 listed)
- 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:
- Concurrent diagnosis of a neurological condition or autoimmune disease other than MS
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SoluMedrolAlso: CorticosteroidsInfusion of drug subcutaneously, once a month. | Drug | Corticosteroid arm |
| Extracorporeal PhotopheresisAlso: ECP, Cellex machine, TherakosThis intervention is the placement of up to two IV's to extract your blood as a set volume, separate out the white cells and return the red cells to your body. Then the white cells are treated with a drug called UVADEX (methoxsalen), excited by a UV light and returned to your body. Once IV is to withdraw your blood and the other is to return your blood to your body. | Device | Extracorporeal Photopheresis |
Primary outcome
Multiple Sclerosis Functional Composite (MSFC) Z-score and Expanded Disability Status Scale (EDSS)
Time frame: 1 year
MSFC score is a composite score calculated from 3 tests: 1) Timed 25-Foot walk (leg function); 2) 9-Hole Peg Test (arm function); and 3) Paced Auditory Serial Addition Test (cognitive function). The results are combined to create a single score (the MSFC Z-Score) to measure performance and change over time in subjects with MS. MSFC Z-score = {Z arm + Z leg + Z cognitive} / 3.0. A positive score indicates that, on average, an individual performed better than the reference population and a negative score indicates that, on average, an individual performed worse than the reference population. The Expanded Disability Status Scale (EDSS) is used to quantify disability due to symptoms of MS and to track changes in disability status over time. Scores range from 0 (normal neurological exam) to 10 (death due to multiple sclerosis). Scores are determined by performing a neurological exam and given in increments of 0.5.
1 secondary outcome
Immunological Parameters in Relation to SPMS
Time frame: 2 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benjamin Segal, MD principal investigator
University of Michigan, Director of Multiple Sclerosis Center
Daniel Couriel, MD principal investigator
University of Utah, Huntsman Cancer Institute, Internal Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SoluMedrol and Extracorporeal Photopheresis in people with Secondary Progressive Multiple Sclerosis, run by University of Utah at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Multiple Sclerosis Functional Composite (MSFC) Z-score and Expanded Disability Status Scale (EDSS) (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2019.