Primary outcomeMean· Day 0 and Day 90
Change From Baseline on the Symbol Digit Modalities Test (SDMT)
| Group | Value (Total Correct) | Spread |
|---|---|---|
| Cognitively Relapsing Patients | 44.6 | 13.9 |
| Stable Multiple Sclerosis Patients | 58.5 | 13.9 |
Trial · Interventional
CompletedPhase 3Results postedRegistry dataEffects of Acthar on Recovery From Cognitive Relapses in MS
NCTNCT02290444 (opens ClinicalTrials.gov in a new tab)Other id465028
Overview
- Status
- Completed
- Phase
- Phase 3
- Enrollment
- 64 participants (actual)
- Sponsor
- State University of New York at Buffalo · Other
- Design
- Not randomized · Open label (no masking)
- Countries
1 country
United States
- Start
- Aug 2013
- Primary completion
- 1 Nov 2018
- Completion
- 1 Nov 2018
- First posted
- 14 Nov 2014 (estimated)
- Last update posted
- 6 Apr 2020
- Conditions
- Multiple Sclerosis
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
2013201420152016201720182019
- Ph 3
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
The purpose of this study is to evaluate the effect of a medication called Acthar on recovery from multiple sclerosis-related relapses that impact cognition.
Interventions
- Adrenocorticotropic HormoneDrug
Arms2
Experimental
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.
No intervention
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.
Primary outcomes5
Outcomes the sponsor listed as primary.
Change From Baseline on the Symbol Digit Modalities Test (SDMT)
Time frame · Day 0 and Day 90
Registry description
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.
Timed 25-foot Walk
Time frame · Day 0 and Day 90
Registry description
An MS-specific measure of functional status walking speed. How many seconds does it take to walk 25 feet. Ceiling value of 300 seconds.
Change From Baseline on the Paced Auditory Serial Addition Test (PASAT)
Time frame · Day 0 and Day 90
Registry description
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.
Change From Baseline on the Brief Visuospatial Memory Test-Revised (BVMT-R)
Time frame · Day 0 and Day 90
Registry description
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.
Change From Baseline on the California Verbal Learning Test, Second Edition (CVLT-II)
Time frame · Day 0 and Day 90
Registry description
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.
Secondary outcomes(4)
Change From Baseline on the Expanded Disability Status Scale (EDSS).
Time frame · Day 0 and Day 90
Registry description
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.
Change From Baseline on the Multiple Sclerosis Neuropsychological Questionnaire (MSNQ)
Time frame · Day 0 and Day 90
Registry description
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.
Change From Baseline on the Beck Depression Inventory-Fast Screen (BDI-FS)
Time frame · Day 0 and Day 90
Registry description
A 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.
Change From Baseline on the Fatigue Severity Scale (FSS)
Time frame · Day 0 and Day 90
Registry description
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.
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Primary outcomeMean· Day 0 and Day 90
Timed 25-foot Walk
| Group | Value (Seconds) | Spread |
|---|---|---|
| Cognitively Relapsing Patients | 6.7 | 3.2 |
| Stable Multiple Sclerosis Patients | 5.3 | 1.2 |
Primary outcomeMean· Day 0 and Day 90
Change From Baseline on the Paced Auditory Serial Addition Test (PASAT)
| Group | Value (Total Correct) | Spread |
|---|---|---|
| Cognitively Relapsing Patients | 40.1 | 12.2 |
| Stable Multiple Sclerosis Patients | 47.0 | 14.3 |
Primary outcomeMean· Day 0 and Day 90
Change From Baseline on the Brief Visuospatial Memory Test-Revised (BVMT-R)
| Group | Value (Total Learning Score) | Spread |
|---|---|---|
| Cognitively Relapsing Patients | 22.0 | 8.9 |
| Stable Multiple Sclerosis Patients | 22.5 | 7.9 |
Primary outcomeMean· Day 0 and Day 90
Change From Baseline on the California Verbal Learning Test, Second Edition (CVLT-II)
| Group | Value (Total Learning Score) | Spread |
|---|---|---|
| Cognitively Relapsing Patients | 46.6 | 14.1 |
| Stable Multiple Sclerosis Patients | 51.2 | 11.8 |
Secondary and other outcome results(3)
Secondary outcomeMedian· Day 0 and Day 90
Change From Baseline on the Expanded Disability Status Scale (EDSS).
| Group | Value (Total Score) |
|---|---|
| Cognitively Relapsing Patients | 3.0 |
| Stable Multiple Sclerosis Patients | 2.0 |
Secondary outcomeMean· Day 0 and Day 90
Change From Baseline on the Multiple Sclerosis Neuropsychological Questionnaire (MSNQ)
| Group | Value (Total Score) | Spread |
|---|---|---|
| Cognitively Relapsing Patients | 34.5 | 9.4 |
| Stable Multiple Sclerosis Patients | 20.0 | 12.3 |
Secondary outcomeMean· Day 0 and Day 90
Change From Baseline on the Beck Depression Inventory-Fast Screen (BDI-FS)
| Group | Value (Total Score) | Spread |
|---|---|---|
| Cognitively Relapsing Patients | 5.0 | 4.0 |
| Stable Multiple Sclerosis Patients | 1.6 | 2.8 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Cognitively Relapsing PatientsFor 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. | 0 / 25 | 0 / 25 | 0 / 25 |
| Stable Multiple Sclerosis PatientsIndividuals 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. | 0 / 25 | 0 / 25 | 0 / 25 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years up to 65 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria:
1. Males/Females between 18 and 65 years of age who are capable of understanding and complying with the protocol (ie. have completed at least a 9th grade education and are fluent English).
2. Have a diagnosis of Relapsing Remitting MS (RRMS) or early Secondary Progressive MS (SPMS) as per revised McDonald's Criteria.
3. Have an Expanded Disability Severity Scale (EDSS) of ≤ 7.0.
4. Have had valid neuropsychological testing (NP) within the past 4 years
5. Experiencing an acute cognitive relapse identified by a clinical care provider as a.) a cognitive symptom of recent origin developing over 48 hours, or b.) supratentorial GAD enhancing lesions on MRI with confirmed cognitive decline.
* Confirmation of cognitive decline will be obtained by administering the Symbol Digit Modalities Test (SDMT) as a screening procedure for the study and comparing it to scores obtained within 4 years (see inclusion criteria #4). Participants qualify if a raw point change on the SDMT greater than or equal to -3 points is detected.
6. Are capable of performing the requirements of neuropsychological (NP) testing, including near visual acuity 20/70 or better with correction.
7. Have given written informed consent prior to any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to his/her future medical care.
Exclusion Criteria:
1. Are found to have evidence on MRI of new lesions in the brainstem, spinal cord, or optic nerve.
2. Have clear new physical signs or symptoms that are referable to the cord, brainstem or optic nerve.
3. Have cognitive deficits/impairment caused by concomitant medication usage, or are attributable to another medical condition or significant neurological/psychological disease.
4. Have evidence of current major depression as determined by a positive Beck Depression Inventory-Fast Screen (BDI-FS) and clinician interview.
5. Patients with changes to medications known to influence cognition (narcotics, stimulants, etc.) or disease modifying therapy within one month of study initiation (or within a time frame deemed high risk by treating physician) will be excluded.
6. Are taking any medication, or have any medical condition contraindicated with Acthar.
7. Presence of current infections as determined by clinician interview.
8. Are currently nursing, intentionally seeking pregnancy, or deemed at-risk for unplanned pregnancy.
PepBank is a research reference. Talk to a doctor before you use any peptide.