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

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ClinicalTrials.gov Identifier: NCT02296346
Recruitment Status : Terminated (Low enrollment/PI relocated. New site couldn't reach agreement with manufacturer)
First Posted : November 20, 2014
Results First Posted : August 14, 2019
Last Update Posted : August 14, 2019
Sponsor:
Collaborator:
Mallinckrodt
Information provided by (Responsible Party):
Daniel Couriel, University of Utah

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Secondary Progressive Multiple Sclerosis
Interventions Drug: SoluMedrol
Device: Extracorporeal Photopheresis
Enrollment 13
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Corticosteriod Arm Extracorporeal Photopheresis
Hide Arm/Group Description

Patients will receive 1 gram of IV SoluMedrol over 1 hour, once every month for 12 months.

SoluMedrol: Infusion of drug subcutaneously, once a month.

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

Extracorporeal Photopheresis: 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.

Period Title: Overall Study
Started 7 6
Completed 2 0
Not Completed 5 6
Arm/Group Title Corticosteriod Arm Extracorporeal Photopheresis Total
Hide Arm/Group Description

Patients will receive 1 gram of IV SoluMedrol over 1 hour, once every month for 12 months.

SoluMedrol: Infusion of drug subcutaneously, once a month.

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

Extracorporeal Photopheresis: 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.

Total of all reporting groups
Overall Number of Baseline Participants 7 6 13
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 6 participants 13 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
6
  85.7%
5
  83.3%
11
  84.6%
>=65 years
1
  14.3%
1
  16.7%
2
  15.4%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 6 participants 13 participants
Female
4
  57.1%
2
  33.3%
6
  46.2%
Male
3
  42.9%
4
  66.7%
7
  53.8%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 6 participants 13 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
7
 100.0%
6
 100.0%
13
 100.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 6 participants 13 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
  14.3%
0
   0.0%
1
   7.7%
White
6
  85.7%
6
 100.0%
12
  92.3%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Multiple Sclerosis Functional Composite (MSFC)   [1] 
Mean (Full Range)
Unit of measure:  MSFC z-score
Number Analyzed 7 participants 6 participants 13 participants
0.2410
(-0.361 to 0.6419)
-0.2335
(-0.842 to 0.7335)
0.0022
(-0.842 to 0.7335)
[1]
Measure Description: 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.
Expanded Disability Status Scale (EDSS)   [1] 
Mean (Full Range)
Unit of measure:  EDSS Score
Number Analyzed 7 participants 6 participants 13 participants
6
(4.5 to 6.5)
5.92
(4.0 to 6.5)
5.96
(4.0 to 6.5)
[1]
Measure Description: 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.Primary Outcome
Title Multiple Sclerosis Functional Composite (MSFC) Z-score and Expanded Disability Status Scale (EDSS)
Hide Description

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.

Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title ECP Arm Corticosteroid Arm
Hide Arm/Group Description:
Study participants assigned to ECP treatment
Study participants assigned to corticosteroid treatment
Overall Number of Participants Analyzed 1 4
Mean (Full Range)
Unit of Measure: score on a scale
EDSS Score Number Analyzed 1 participants 4 participants
6
(6 to 6)
6.25
(6 to 6.5)
MSFC Z-Score Number Analyzed 1 participants 3 participants
1.1031
(1.1031 to 1.1031)
0.6751
(0.4914 to 0.9504)
2.Secondary Outcome
Title Immunological Parameters in Relation to SPMS
Hide Description Changes in immunological parameters that occur following initiation of ECP or corticosteroids and any relevant correlation with clinical outcomes
Time Frame 2 year
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Corticosteriod Arm Extracorporeal Photopheresis
Hide Arm/Group Description:

Patients will receive 1 gram of IV SoluMedrol over 1 hour, once every month for 12 months.

SoluMedrol: Infusion of drug subcutaneously, once a month.

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

Extracorporeal Photopheresis: 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.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Adverse event data were collected on study participants from baseline visit to study completion, approximately 2 years.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Corticosteriod Arm Extracorporeal Photopheresis
Hide Arm/Group Description

Patients will receive 1 gram of IV SoluMedrol over 1 hour, once every month for 12 months.

SoluMedrol: Infusion of drug subcutaneously, once a month.

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

Extracorporeal Photopheresis: 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.

All-Cause Mortality
Corticosteriod Arm Extracorporeal Photopheresis
Affected / at Risk (%) Affected / at Risk (%)
Total   0/7 (0.00%)      1/6 (16.67%)    
Hide Serious Adverse Events
Corticosteriod Arm Extracorporeal Photopheresis
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/7 (0.00%)      1/6 (16.67%)    
Psychiatric disorders     
Suicide * [1]  0/7 (0.00%)  0 1/6 (16.67%)  1
*
Indicates events were collected by non-systematic assessment
[1]
Subject committed suicide shortly after withdrawing from the trial and experiencing disease progression/worsening of MS symptoms.
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Corticosteriod Arm Extracorporeal Photopheresis
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/7 (85.71%)      3/6 (50.00%)    
Blood and lymphatic system disorders     
Iron Deficiency  [1]  0/7 (0.00%)  0 1/6 (16.67%)  1
Low Hematocrit Requiring Transfusion of 1 unit PRBC  [2]  0/7 (0.00%)  0 1/6 (16.67%)  1
Acute blood loss not requiring transfusion  [2]  0/7 (0.00%)  0 1/6 (16.67%)  1
Low Hemoglobin  [3]  0/7 (0.00%)  0 1/6 (16.67%)  1
Ear and labyrinth disorders     
Ear Congestion  [4]  1/7 (14.29%)  1 0/6 (0.00%)  0
General disorders     
"Jittery" Sensation during treatment  [5]  1/7 (14.29%)  1 0/6 (0.00%)  0
Dizziness  [6]  0/7 (0.00%)  0 1/6 (16.67%)  1
Mild Hives  [7]  0/7 (0.00%)  0 1/6 (16.67%)  1
Chest pain  [8]  1/7 (14.29%)  1 0/6 (0.00%)  0
Infusion Reaction  [9]  1/7 (14.29%)  1 0/6 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Knee Pain and Swelling  [10]  1/7 (14.29%)  1 0/6 (0.00%)  0
Spinal Vertebral Lesions  [11]  1/7 (14.29%)  1 0/6 (0.00%)  0
Swelling  [12]  1/7 (14.29%)  1 0/6 (0.00%)  0
Nervous system disorders     
Mild Concussion  [8]  1/7 (14.29%)  1 0/6 (0.00%)  0
Psychiatric disorders     
Anxiety Attacks  [13]  0/7 (0.00%)  0 1/6 (16.67%)  1
Renal and urinary disorders     
Urinary tract infection  [14]  3/7 (42.86%)  5 0/6 (0.00%)  0
Acute Cystitis without Hematuria  [10]  1/7 (14.29%)  1 0/6 (0.00%)  0
Hematuria  [15]  1/7 (14.29%)  1 0/6 (0.00%)  0
Reproductive system and breast disorders     
Groin Pain  [16]  1/7 (14.29%)  1 0/6 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Pneumonia  [17]  0/7 (0.00%)  0 1/6 (16.67%)  5
Nocturnal Hypoxia (on PSG)  [10]  0/7 (0.00%)  0 1/6 (16.67%)  1
Obstructive Sleep Apnea  [18]  2/7 (28.57%)  2 0/6 (0.00%)  0
Upper Respiratory Infection  [19]  2/7 (28.57%)  2 0/6 (0.00%)  0
Skin and subcutaneous tissue disorders     
Petechial Rash  [20]  1/7 (14.29%)  1 0/6 (0.00%)  0
Pressure Ulcer  [21]  1/7 (14.29%)  1 0/6 (0.00%)  0
Vascular disorders     
Poor Venous Access  [22]  0/7 (0.00%)  0 1/6 (16.67%)  1
Catheter Line Crack  [22]  0/7 (0.00%)  0 1/6 (16.67%)  1
Infiltrated IV with treatment  [23]  1/7 (14.29%)  1 0/6 (0.00%)  0
Indicates events were collected by systematic assessment
[1]
Ruled expected and probably related.
[2]
Ruled unexpected and probably related.
[3]
Ruled expected and probably related to trial.
[4]
Ruled unexpected and unlikely to be related to trial
[5]
Subject reported sensation during infusion treatment; Ruled expected and related.
[6]
Ruled expected and probably related to treatment.
[7]
Subject experienced mild hives during an MRI; Ruled unexpected and probably related.
[8]
Ruled unexpected and unlikely to be related to trial.
[9]
Subject experienced reaction while receiving infusion of Rituximab. AE ruled expected and unlikely to be related to trial.
[10]
Ruled unexpected and unlikely to be related.
[11]
Subject noted to have 3 new spinal vertebral lesions on MRI. AE ruled expected and unlikely to be related.
[12]
Subject experienced swelling in left calf. AE ruled unexpected and unlikely to be related.
[13]
Subject experienced intermittent anxiety attacks; Ruled unexpected and unlikely to be related to trial.
[14]
Multiple subjects experienced urinary tract infections throughout the trial. All ruled expected and unlikely to be related.
[15]
AE ruled expected and unlikely to be related.
[16]
AE ruled unexpected and unlikely to be related.
[17]
Subject experienced pneumonia on 4 separate occasions; Ruled expected and unlikely to be attributed to trial.
[18]
Ruled unexpected and unlikely to be related in both subjects.
[19]
In both subjects, infections were ruled expected and unlikely to be related.
[20]
Subject experienced petechial rash on left chin; Ruled unexpected and unlikely to be related.
[21]
Stage 1 Pressure Ulcer in right foot. Ruled unexpected and unlikely to be related to trial
[22]
Ruled Unexpected and Related.
[23]
AE ruled expected and probably related.
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.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Daniel Couriel
Organization: Huntsman Cancer Institute, University of Utah
Phone: 801-213-3082
EMail: dan.couriel@hci.utah.edu
Layout table for additonal information
Responsible Party: Daniel Couriel, University of Utah
ClinicalTrials.gov Identifier: NCT02296346    
Other Study ID Numbers: HUM00083301
First Submitted: November 18, 2014
First Posted: November 20, 2014
Results First Submitted: May 20, 2019
Results First Posted: August 14, 2019
Last Update Posted: August 14, 2019