ACTH for Fatigue in Multiple Sclerosis Patients (ACTH)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02315872|
Recruitment Status : Completed
First Posted : December 12, 2014
Results First Posted : August 13, 2019
Last Update Posted : September 9, 2019
|Condition or disease||Intervention/treatment||Phase|
|Multiple Sclerosis, Relapsing-Remitting||Drug: ACTH Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||8 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||The Effect of ACTH (Acthar) on Measures of Chronic Fatigue in Patients With Relapsing Multiple Sclerosis.|
|Actual Study Start Date :||May 22, 2015|
|Actual Primary Completion Date :||June 20, 2017|
|Actual Study Completion Date :||December 13, 2018|
The study drug (ACTH 40 units) will be given subcutaneously twice weekly for 2 weeks. If the patient tolerates this dosage regimen, the dose will be increased to 80 units twice weekly. If the 80 unit dosage is not tolerated, the dosage will be reduced to 40 units twice weekly for the remainder of the 24 week participation. The weekly doses will be given 3 days apart, for example, on every Monday and Thursday or every Tuesday and Friday.
ACTH injections twice weekly for 28 weeks.
Placebo Comparator: Placebo
Placebo will be given subcutaneously twice weekly for 28 weeks.
Placebo injections twice weekly for 28 weeks.
Other Name: Control
- Fatigue at 28 Weeks [ Time Frame: 28 weeks ]Patient-reported levels of fatigue as measured by score on the Modified Fatigue Impact Scale (MFIS) and the Fatigue Severity Scale (FSS) at 28 weeks. The full-length MFIS consists of 21 items. A higher score on the MFIS indicates a greater impact of fatigue on a patient's activities. The FSS is a 9-item scale which measures the severity of fatigue and its effect on a person's activities and lifestyle in patients with a variety of disorders. Higher scores on each scale indicate a greater severity of fatigue.
- Depression at 28 Weeks [ Time Frame: 28 weeks ]Patient-reported depression as measured by the Beck Depression Inventory-II (BDI-II) at 28 weeks. The BDI-II is a 21-item self-report multiple-choice inventory used as an indicator of the severity of depression. A higher score indicates a greater severity of depression.
- Sleepiness at 28 Weeks [ Time Frame: 28 weeks ]Patient-reported daytime sleepiness as measure by the Epworth Sleepiness Scale (ESS) at 28 weeks. The ESS is a self-administered questionnaire with 8 questions. Respondents are asked to rate, on a 4-point scale (0-3), their usual chances of dozing off or falling asleep while engaged in eight different activities. The ESS score (the sum of 8 item scores, 0-3) can range from 0 to 24. The higher the ESS score, the higher that person's average sleep propensity in daily life, or their 'daytime sleepiness'.
- Quality of Life at 28 Weeks [ Time Frame: 28 weeks ]Patient-reported quality of life as measured by the 36-Item Short Form Health Survey (SF-36) at 28 weeks. The SF-36 is a 36-item, patient-reported survey of patient mental and physical health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02315872
|United States, Alabama|
|North Central Neurology Associates, PC|
|Cullman, Alabama, United States, 35058|
|United States, Oregon|
|Providence Medical Group - Medford Neurology|
|Medford, Oregon, United States, 97504|
|Providence St. Vincent Medical Center|
|Portland, Oregon, United States, 97225|
|United States, Washington|
|Swedish Medical Center|
|Seattle, Washington, United States, 98122|
|MultiCare Health System -- Institute for Research and Innovation|
|Tacoma, Washington, United States, 98405|
|Principal Investigator:||Stanely Cohan, MD, PhD||Providence Health & Services|