Trial · NCT02296346

Open-Label Study to Evaluate the Efficacy of ECP in Secondary Progressive Multiple Sclerosis

NCT02296346, Not applicable, Terminated, University of Utah; results first posted 2019-08-14

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Open-Label Study to Evaluate the Efficacy of ECP in Secondary Progressive Multiple Sclerosis. Trials, record NCT02296346. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02296346

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Open-Label Study to Evaluate the Efficacy of ECP in Secondary Progressive Multiple Sclerosis
NCT number: NCT02296346
Status: Terminated
Phases: Not applicable
Enrollment: 13 participants, actual
Lead sponsor: University of Utah
Conditions: Secondary Progressive Multiple Sclerosis
Interventions: SoluMedrol, Extracorporeal Photopheresis
First posted: 2014-11-20
Last updated: 2019-08-14
Results first posted: 2019-08-14
Limitations and caveats: Analysis of the data in this study was severely limited by the high dropout rate and low enrollment numbers. Given that only 2/13 participants completed the study, we do not have enough outcome data to complete a meaningful analysis.

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Multiple Sclerosis Functional Composite (MSFC) Z-score and Expanded Disability Status Scale (EDSS)	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.
Secondary	Immunological Parameters in Relation to SPMS	2 year	Changes in immunological parameters that occur following initiation of ECP or corticosteroids and any relevant correlation with clinical outcomes

Source ClinicalTrials.gov

Outcomes2

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Multiple Sclerosis Functional Composite (MSFC) Z-score and Expanded Disability Status Scale (EDSS)	1 year	Baseline MSFC and EDSS scores were captured for all 13 subjects, however some subjects withdrew immediately after baseline. Withdrawal of additional subjects continued from that point. Only 1 patient from the ECP arm made it to the 12 month visit. Four patients from the CS arm made it to 12 mos, however 1 of the 4 declined the MSFC tests.	score on a scale	MEAN
SECONDARY	Immunological Parameters in Relation to SPMS	2 year	Due to low enrollment numbers and a high dropout rate, there was insufficient data to analyze and correlate treatment with clinical outcomes. Only 2 subjects continued to the 24 month completion, both were corticosteroid patients. No ECP subjects made it to 24 mos. Therefore, there was no analysis performed on the 2 year data.

Source ClinicalTrials.gov

Results by group4

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Multiple Sclerosis Functional Composite (MSFC) Z-score and Expanded Disability Status Scale (EDSS)	ECP Arm	EDSS Score	6	Full Range 6 to 6	score on a scale
Multiple Sclerosis Functional Composite (MSFC) Z-score and Expanded Disability Status Scale (EDSS)	Corticosteroid Arm	EDSS Score	6.25	Full Range 6 to 6.5	score on a scale
Multiple Sclerosis Functional Composite (MSFC) Z-score and Expanded Disability Status Scale (EDSS)	ECP Arm	MSFC Z-Score	1.1031	Full Range 1.1031 to 1.1031	score on a scale
Multiple Sclerosis Functional Composite (MSFC) Z-score and Expanded Disability Status Scale (EDSS)	Corticosteroid Arm	MSFC Z-Score	0.6751	Full Range 0.4914 to 0.9504	score on a scale

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Corticosteriod Arm	7
Overall Study	STARTED	Extracorporeal Photopheresis	6
Overall Study	COMPLETED	Corticosteriod Arm	2
Overall Study	COMPLETED	Extracorporeal Photopheresis	0
Overall Study	NOT COMPLETED	Corticosteriod Arm	5
Overall Study	NOT COMPLETED	Extracorporeal Photopheresis	6

Source ClinicalTrials.gov

Adverse events58

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Pneumonia	Respiratory, thoracic and mediastinal disorders	Corticosteriod Arm	0	7	0
other	Pneumonia	Respiratory, thoracic and mediastinal disorders	Extracorporeal Photopheresis	1	6	5
other	Poor Venous Access	Vascular disorders	Corticosteriod Arm	0	7	0
other	Poor Venous Access	Vascular disorders	Extracorporeal Photopheresis	1	6	1
other	Nocturnal Hypoxia (on PSG)	Respiratory, thoracic and mediastinal disorders	Corticosteriod Arm	0	7	0
other	Nocturnal Hypoxia (on PSG)	Respiratory, thoracic and mediastinal disorders	Extracorporeal Photopheresis	1	6	1
other	Iron Deficiency	Blood and lymphatic system disorders	Corticosteriod Arm	0	7	0
other	Iron Deficiency	Blood and lymphatic system disorders	Extracorporeal Photopheresis	1	6	1
other	Low Hematocrit Requiring Transfusion of 1 unit PRBC	Blood and lymphatic system disorders	Corticosteriod Arm	0	7	0
other	Low Hematocrit Requiring Transfusion of 1 unit PRBC	Blood and lymphatic system disorders	Extracorporeal Photopheresis	1	6	1

1 to 10 of 58Source ClinicalTrials.gov

See all 58 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Corticosteriod Arm	0	7
Total, all-cause mortality	Extracorporeal Photopheresis	1	6
Total, other adverse events	Corticosteriod Arm	6	7
Total, other adverse events	Extracorporeal Photopheresis	3	6
Total, serious adverse events	Corticosteriod Arm	0	7
Total, serious adverse events	Extracorporeal Photopheresis	1	6

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Corticosteriod Arm vs Extracorporeal Photopheresis: deaths from any cause	Trial comparisons
Corticosteriod Arm vs Extracorporeal Photopheresis: serious adverse events	Trial comparisons

Tests1

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

Test	Named as
Paced Visual Serial Addition Test	Primary outcome

Source ConductCognition

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02296346

GET https://conductscience.org/api/trials/v1/NCT02296346/events?page=2

API reference For AI assistants