Trial Outcomes & Findings for Effects of Acthar on Recovery From Cognitive Relapses in MS (NCT NCT02290444)
NCT ID: NCT02290444
Last Updated: 2020-04-06
Results Overview
A measure of visual processing speed and working memory. Minimum score of 0, Maximum score of 120. Higher scores indicate better performance. The difference in total correct responses on the SDMT from Day 0 to Day 90 were analyzed to address change in this outcome.
COMPLETED
PHASE3
64 participants
Day 0 and Day 90
2020-04-06
Participant Flow
Participant milestones
| Measure |
Cognitively Relapsing Patients
For individuals experiencing cognitive relapses/exacerbations, 5ml/80 IU of Adrenocorticotropic Hormone will be administered through either subcutaneous or intramuscular self-injection (selected by the patient) for 5-days.
Adrenocorticotropic Hormone: Acthar Gel will be administered in accordance with the recommendations set forth in the package insert. The dosage may be individualized according to the medical condition of each patient. Frequency and dose of the drug may be determined by considering the severity of the disease and the initial response of the patient.
|
Stable Multiple Sclerosis Patients
Individuals whose Multiple Sclerosis is currently in a stable state (not currently or recently exacerbating) are age-matched with relapsing MS patients. There is no intervention for individuals with MS whose are currently in a stable state.
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
34
|
|
Overall Study
COMPLETED
|
29
|
32
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effects of Acthar on Recovery From Cognitive Relapses in MS
Baseline characteristics by cohort
| Measure |
Cognitively Relapsing Patients
n=25 Participants
For individuals experiencing cognitive relapses/exacerbations, 5ml/80 IU of Adrenocorticotropic Hormone will be administered through either subcutaneous or intramuscular self-injection (selected by the patient) for 5-days.
Adrenocorticotropic Hormone: Acthar Gel will be administered in accordance with the recommendations set forth in the package insert. The dosage may be individualized according to the medical condition of each patient. Frequency and dose of the drug may be determined by considering the severity of the disease and the initial response of the patient.
|
Stable Multiple Sclerosis Patients
n=25 Participants
Individuals whose Multiple Sclerosis is currently in a stable state (not currently or recently exacerbating) are age-matched with relapsing MS patients. There is no intervention for individuals with MS whose are currently in a stable state.
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
25 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
42.4 years
STANDARD_DEVIATION 10.7 • n=5 Participants
|
43.8 years
STANDARD_DEVIATION 10.5 • n=7 Participants
|
43.1 years
STANDARD_DEVIATION 10.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
22 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Symbol Digit Modalities Test
|
55.2 Total Correct
STANDARD_DEVIATION 13.5 • n=5 Participants
|
55.9 Total Correct
STANDARD_DEVIATION 12.4 • n=7 Participants
|
55.6 Total Correct
STANDARD_DEVIATION 13.0 • n=5 Participants
|
|
California Verbal Learning Test, 2nd Edition
|
51.4 Total Learning Score
STANDARD_DEVIATION 12.6 • n=5 Participants
|
49.1 Total Learning Score
STANDARD_DEVIATION 11.1 • n=7 Participants
|
50.3 Total Learning Score
STANDARD_DEVIATION 11.9 • n=5 Participants
|
|
Brief Visuospatial Memory Test Revised (BVMTR)
|
23.1 Total Learning Score
STANDARD_DEVIATION 7.1 • n=5 Participants
|
23.9 Total Learning Score
STANDARD_DEVIATION 7.0 • n=7 Participants
|
23.5 Total Learning Score
STANDARD_DEVIATION 7.1 • n=5 Participants
|
|
Timed 25-foot Walk
|
5.4 Seconds
STANDARD_DEVIATION 1.9 • n=5 Participants
|
5.0 Seconds
STANDARD_DEVIATION 1.2 • n=7 Participants
|
5.2 Seconds
STANDARD_DEVIATION 1.6 • n=5 Participants
|
|
Multiple Sclerosis Neuropsychological Screening Questionnaire (MSNQ)
|
30.1 Total Score
STANDARD_DEVIATION 12.6 • n=5 Participants
|
18.0 Total Score
STANDARD_DEVIATION 8.9 • n=7 Participants
|
24.1 Total Score
STANDARD_DEVIATION 10.8 • n=5 Participants
|
|
Expanded Disability Status Scale (EDSS)
|
2.5 Total Score
n=5 Participants
|
2.5 Total Score
n=7 Participants
|
2.5 Total Score
n=5 Participants
|
|
Fatigue Severity Scale (FSS)
|
4.9 Total Score
STANDARD_DEVIATION 1.6 • n=5 Participants
|
4.2 Total Score
STANDARD_DEVIATION 1.5 • n=7 Participants
|
4.6 Total Score
STANDARD_DEVIATION 1.6 • n=5 Participants
|
PRIMARY outcome
Timeframe: Day 0 and Day 90Population: The sample used for final analysis was smaller than the total enrolled (see Participant Flow) because participants were excluded from the final analysis due to (1) withdrawal prior to follow-up, (2) occasional missing data from one or more timepoints, and (3) to optimize matching of the groups based on demographic characteristics.
A measure of visual processing speed and working memory. Minimum score of 0, Maximum score of 120. Higher scores indicate better performance. The difference in total correct responses on the SDMT from Day 0 to Day 90 were analyzed to address change in this outcome.
Outcome measures
| Measure |
Cognitively Relapsing Patients
n=25 Participants
For individuals experiencing cognitive relapses/exacerbations, 5ml/80 IU of Adrenocorticotropic Hormone will be administered through either subcutaneous or intramuscular self-injection (selected by the patient) for 5-days.
Adrenocorticotropic Hormone: Acthar Gel will be administered in accordance with the recommendations set forth in the package insert. The dosage may be individualized according to the medical condition of each patient. Frequency and dose of the drug may be determined by considering the severity of the disease and the initial response of the patient.
|
Stable Multiple Sclerosis Patients
n=25 Participants
Individuals whose Multiple Sclerosis is currently in a stable state (not currently or recently exacerbating) are age-matched with relapsing MS patients. There is no intervention for individuals with MS whose are currently in a stable state.
|
|---|---|---|
|
Change From Baseline on the Symbol Digit Modalities Test (SDMT)
|
44.6 Total Correct
Standard Deviation 13.9
|
58.5 Total Correct
Standard Deviation 13.9
|
PRIMARY outcome
Timeframe: Day 0 and Day 90Population: The sample used for final analysis was smaller than the total enrolled (see Participant Flow) because participants were excluded from the final analysis due to (1) withdrawal prior to follow-up, (2) occasional missing data from one or more timepoints, and (3) to optimize matching of the groups based on demographic characteristics.
An MS-specific measure of functional status walking speed. How many seconds does it take to walk 25 feet. Ceiling value of 300 seconds.
Outcome measures
| Measure |
Cognitively Relapsing Patients
n=25 Participants
For individuals experiencing cognitive relapses/exacerbations, 5ml/80 IU of Adrenocorticotropic Hormone will be administered through either subcutaneous or intramuscular self-injection (selected by the patient) for 5-days.
Adrenocorticotropic Hormone: Acthar Gel will be administered in accordance with the recommendations set forth in the package insert. The dosage may be individualized according to the medical condition of each patient. Frequency and dose of the drug may be determined by considering the severity of the disease and the initial response of the patient.
|
Stable Multiple Sclerosis Patients
n=25 Participants
Individuals whose Multiple Sclerosis is currently in a stable state (not currently or recently exacerbating) are age-matched with relapsing MS patients. There is no intervention for individuals with MS whose are currently in a stable state.
|
|---|---|---|
|
Timed 25-foot Walk
|
6.7 Seconds
Standard Deviation 3.2
|
5.3 Seconds
Standard Deviation 1.2
|
PRIMARY outcome
Timeframe: Day 0 and Day 90Population: The sample used for final analysis was smaller than the total enrolled (see Participant Flow) because participants were excluded from the final analysis due to (1) withdrawal prior to follow-up, (2) occasional missing data from one or more timepoints, and (3) to optimize matching of the groups based on demographic characteristics.
A measure of auditory processing speed and working memory. Minimum value of 0, maximum value of 60. Higher score indicates better performance. The difference in total correct on the PASAT from Day 0 to Day 90 were analyzed to address change in this outcome.
Outcome measures
| Measure |
Cognitively Relapsing Patients
n=25 Participants
For individuals experiencing cognitive relapses/exacerbations, 5ml/80 IU of Adrenocorticotropic Hormone will be administered through either subcutaneous or intramuscular self-injection (selected by the patient) for 5-days.
Adrenocorticotropic Hormone: Acthar Gel will be administered in accordance with the recommendations set forth in the package insert. The dosage may be individualized according to the medical condition of each patient. Frequency and dose of the drug may be determined by considering the severity of the disease and the initial response of the patient.
|
Stable Multiple Sclerosis Patients
n=25 Participants
Individuals whose Multiple Sclerosis is currently in a stable state (not currently or recently exacerbating) are age-matched with relapsing MS patients. There is no intervention for individuals with MS whose are currently in a stable state.
|
|---|---|---|
|
Change From Baseline on the Paced Auditory Serial Addition Test (PASAT)
|
40.1 Total Correct
Standard Deviation 12.2
|
47.0 Total Correct
Standard Deviation 14.3
|
PRIMARY outcome
Timeframe: Day 0 and Day 90Population: The sample used for final analysis was smaller than the total enrolled (see Participant Flow) because participants were excluded from the final analysis due to (1) withdrawal prior to follow-up, (2) occasional missing data from one or more timepoints, and (3) to optimize matching of the groups based on demographic characteristics.
A measure of visual/spatial memory. Minimum of 0, maximum of 36. Higher score indicates better performance. The difference in total learning score on the BVMT-R from Day 0 to Day 90 were analyzed to address change in this outcome.
Outcome measures
| Measure |
Cognitively Relapsing Patients
n=25 Participants
For individuals experiencing cognitive relapses/exacerbations, 5ml/80 IU of Adrenocorticotropic Hormone will be administered through either subcutaneous or intramuscular self-injection (selected by the patient) for 5-days.
Adrenocorticotropic Hormone: Acthar Gel will be administered in accordance with the recommendations set forth in the package insert. The dosage may be individualized according to the medical condition of each patient. Frequency and dose of the drug may be determined by considering the severity of the disease and the initial response of the patient.
|
Stable Multiple Sclerosis Patients
n=25 Participants
Individuals whose Multiple Sclerosis is currently in a stable state (not currently or recently exacerbating) are age-matched with relapsing MS patients. There is no intervention for individuals with MS whose are currently in a stable state.
|
|---|---|---|
|
Change From Baseline on the Brief Visuospatial Memory Test-Revised (BVMT-R)
|
22.0 Total Learning Score
Standard Deviation 8.9
|
22.5 Total Learning Score
Standard Deviation 7.9
|
PRIMARY outcome
Timeframe: Day 0 and Day 90Population: The sample used for final analysis was smaller than the total enrolled (see Participant Flow) because participants were excluded from the final analysis due to (1) withdrawal prior to follow-up, (2) occasional missing data from one or more timepoints, and (3) to optimize matching of the groups based on demographic characteristics.
A measure of auditory/verbal episodic memory. Minimum of 0, maximum of 80. Higher score indicates better performance. The difference in total learning score on the CVLT-II from Day 0 to Day 90 were analyzed to address change in this outcome.
Outcome measures
| Measure |
Cognitively Relapsing Patients
n=25 Participants
For individuals experiencing cognitive relapses/exacerbations, 5ml/80 IU of Adrenocorticotropic Hormone will be administered through either subcutaneous or intramuscular self-injection (selected by the patient) for 5-days.
Adrenocorticotropic Hormone: Acthar Gel will be administered in accordance with the recommendations set forth in the package insert. The dosage may be individualized according to the medical condition of each patient. Frequency and dose of the drug may be determined by considering the severity of the disease and the initial response of the patient.
|
Stable Multiple Sclerosis Patients
n=25 Participants
Individuals whose Multiple Sclerosis is currently in a stable state (not currently or recently exacerbating) are age-matched with relapsing MS patients. There is no intervention for individuals with MS whose are currently in a stable state.
|
|---|---|---|
|
Change From Baseline on the California Verbal Learning Test, Second Edition (CVLT-II)
|
46.6 Total Learning Score
Standard Deviation 14.1
|
51.2 Total Learning Score
Standard Deviation 11.8
|
SECONDARY outcome
Timeframe: Day 0 and Day 90Population: The sample used for final analysis was smaller than the total enrolled (see Participant Flow) because participants were excluded from the final analysis due to (1) withdrawal prior to follow-up, (2) occasional missing data from one or more timepoints, and (3) to optimize matching of the groups based on demographic characteristics.
A clinician assigned measure of disability specific to MS. Minimum of 0 (no disability), maximum of 10 (death due to MS). Higher scores indicate greater disability. The difference in total score on the EDSS from Day 0 to Day 90 were analyzed to address change in this outcome.
Outcome measures
| Measure |
Cognitively Relapsing Patients
n=25 Participants
For individuals experiencing cognitive relapses/exacerbations, 5ml/80 IU of Adrenocorticotropic Hormone will be administered through either subcutaneous or intramuscular self-injection (selected by the patient) for 5-days.
Adrenocorticotropic Hormone: Acthar Gel will be administered in accordance with the recommendations set forth in the package insert. The dosage may be individualized according to the medical condition of each patient. Frequency and dose of the drug may be determined by considering the severity of the disease and the initial response of the patient.
|
Stable Multiple Sclerosis Patients
n=25 Participants
Individuals whose Multiple Sclerosis is currently in a stable state (not currently or recently exacerbating) are age-matched with relapsing MS patients. There is no intervention for individuals with MS whose are currently in a stable state.
|
|---|---|---|
|
Change From Baseline on the Expanded Disability Status Scale (EDSS).
|
3.0 Total Score
Interval 2.0 to 3.5
|
2.0 Total Score
Interval 1.5 to 3.25
|
SECONDARY outcome
Timeframe: Day 0 and Day 90Population: The sample used for final analysis was smaller than the total enrolled (see Participant Flow) because participants were excluded from the final analysis due to (1) withdrawal prior to follow-up, (2) occasional missing data from one or more timepoints, and (3) to optimize matching of the groups based on demographic characteristics.
A self and informant rating measure of perceived cognitive problems. Minimum of 0, maximum of 60. Higher scores indicates greater self-reported neuropsychological impairment. The difference in total score on the MSNQ from Day 0 to Day 90 were analyzed to address change in this outcome.
Outcome measures
| Measure |
Cognitively Relapsing Patients
n=25 Participants
For individuals experiencing cognitive relapses/exacerbations, 5ml/80 IU of Adrenocorticotropic Hormone will be administered through either subcutaneous or intramuscular self-injection (selected by the patient) for 5-days.
Adrenocorticotropic Hormone: Acthar Gel will be administered in accordance with the recommendations set forth in the package insert. The dosage may be individualized according to the medical condition of each patient. Frequency and dose of the drug may be determined by considering the severity of the disease and the initial response of the patient.
|
Stable Multiple Sclerosis Patients
n=25 Participants
Individuals whose Multiple Sclerosis is currently in a stable state (not currently or recently exacerbating) are age-matched with relapsing MS patients. There is no intervention for individuals with MS whose are currently in a stable state.
|
|---|---|---|
|
Change From Baseline on the Multiple Sclerosis Neuropsychological Questionnaire (MSNQ)
|
34.5 Total Score
Standard Deviation 9.4
|
20.0 Total Score
Standard Deviation 12.3
|
SECONDARY outcome
Timeframe: Day 0 and Day 90A self-report, multiple choice inventory of depression. Minimum of 0, maximum of 21. Higher score indicates higher levels of depression. The difference in total score on the BDI-FS from Day 0 to Day 90 were analyzed to address change in this outcome.
Outcome measures
| Measure |
Cognitively Relapsing Patients
n=25 Participants
For individuals experiencing cognitive relapses/exacerbations, 5ml/80 IU of Adrenocorticotropic Hormone will be administered through either subcutaneous or intramuscular self-injection (selected by the patient) for 5-days.
Adrenocorticotropic Hormone: Acthar Gel will be administered in accordance with the recommendations set forth in the package insert. The dosage may be individualized according to the medical condition of each patient. Frequency and dose of the drug may be determined by considering the severity of the disease and the initial response of the patient.
|
Stable Multiple Sclerosis Patients
n=25 Participants
Individuals whose Multiple Sclerosis is currently in a stable state (not currently or recently exacerbating) are age-matched with relapsing MS patients. There is no intervention for individuals with MS whose are currently in a stable state.
|
|---|---|---|
|
Change From Baseline on the Beck Depression Inventory-Fast Screen (BDI-FS)
|
5.0 Total Score
Standard Deviation 4.0
|
1.6 Total Score
Standard Deviation 2.8
|
SECONDARY outcome
Timeframe: Day 0 and Day 90Population: The sample used for final analysis was smaller than the total enrolled (see Participant Flow) because participants were excluded from the final analysis due to (1) withdrawal prior to follow-up, (2) occasional missing data from one or more timepoints, and (3) to optimize matching of the groups based on demographic characteristics.
A self-report measure of fatigue. 1 (no fatigue) to 9 (severe fatigue). The difference in total score on FSS from Day 0 to Day 90 were analyzed to address change in this outcome.
Outcome measures
| Measure |
Cognitively Relapsing Patients
n=25 Participants
For individuals experiencing cognitive relapses/exacerbations, 5ml/80 IU of Adrenocorticotropic Hormone will be administered through either subcutaneous or intramuscular self-injection (selected by the patient) for 5-days.
Adrenocorticotropic Hormone: Acthar Gel will be administered in accordance with the recommendations set forth in the package insert. The dosage may be individualized according to the medical condition of each patient. Frequency and dose of the drug may be determined by considering the severity of the disease and the initial response of the patient.
|
Stable Multiple Sclerosis Patients
n=25 Participants
Individuals whose Multiple Sclerosis is currently in a stable state (not currently or recently exacerbating) are age-matched with relapsing MS patients. There is no intervention for individuals with MS whose are currently in a stable state.
|
|---|---|---|
|
Change From Baseline on the Fatigue Severity Scale (FSS)
|
5.4 Total Score
Standard Deviation 1.4
|
3.8 Total Score
Standard Deviation 1.7
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 3 monthsThe number of patients reporting adverse events over the course of the study
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 3 monthsInitiation or discontinuation of any medications occurring over the course of the study; monitored by clinician and study personnel.
Outcome measures
Outcome data not reported
Adverse Events
Cognitively Relapsing Patients
Stable Multiple Sclerosis Patients
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place