Trial Outcomes & Findings for ACTH for Fatigue in Multiple Sclerosis Patients (NCT NCT02315872)
NCT ID: NCT02315872
Last Updated: 2019-09-09
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
8 participants
Primary outcome timeframe
28 weeks
Results posted on
2019-09-09
Participant Flow
Participant milestones
| Measure |
ACTH
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: ACTH injections twice weekly for 28 weeks.
|
Placebo
Placebo will be given subcutaneously twice weekly for 28 weeks.
Placebo: Placebo injections twice weekly for 28 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
4
|
|
Overall Study
COMPLETED
|
1
|
3
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
ACTH for Fatigue in Multiple Sclerosis Patients
Baseline characteristics by cohort
| Measure |
ACTH
n=4 Participants
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: ACTH injections twice weekly for 28 weeks.
|
Placebo
n=4 Participants
Placebo will be given subcutaneously twice weekly for 28 weeks.
Placebo: Placebo injections twice weekly for 28 weeks.
|
Total
n=8 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
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Continuous
|
54.5 years
n=5 Participants
|
52 years
n=7 Participants
|
53.25 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 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
|
|
Region of Enrollment
United States
|
4 participants
n=5 Participants
|
4 participants
n=7 Participants
|
8 participants
n=5 Participants
|
|
Modified Fatigue Impact Scale (MFIS)
|
47.75 units on a scale
n=5 Participants
|
48.5 units on a scale
n=7 Participants
|
48.125 units on a scale
n=5 Participants
|
|
Fatigue Severity Scale
|
53.25 units on a scale
n=5 Participants
|
44.5 units on a scale
n=7 Participants
|
48.875 units on a scale
n=5 Participants
|
|
Beck Depression Inventory-II (BDI-II)
|
13 units on a scale
n=5 Participants
|
9.75 units on a scale
n=7 Participants
|
11.375 units on a scale
n=5 Participants
|
|
The Epworth Sleepiness Scale (ESS)
|
7 units on a scale
n=5 Participants
|
10.75 units on a scale
n=7 Participants
|
8.875 units on a scale
n=5 Participants
|
|
Short Form (36) Health Survey (SF-36) Mental Score
|
43 units on a scale
n=5 Participants
|
47.5 units on a scale
n=7 Participants
|
45.25 units on a scale
n=5 Participants
|
|
SF-36 Physical Score
|
37.75 units on a scale
n=5 Participants
|
45 units on a scale
n=7 Participants
|
41.25 units on a scale
n=5 Participants
|
PRIMARY outcome
Timeframe: 28 weeksPatient-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.
Outcome measures
| Measure |
ACTH
n=4 Participants
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: ACTH injections twice weekly for 28 weeks.
|
Placebo
n=4 Participants
Placebo will be given subcutaneously twice weekly for 28 weeks.
Placebo: Placebo injections twice weekly for 28 weeks.
|
|---|---|---|
|
Fatigue at 28 Weeks
MFIS
|
56.50 score on a scale
Interval 21.0 to 74.0
|
29.00 score on a scale
Interval 5.0 to 74.0
|
|
Fatigue at 28 Weeks
FSS
|
55.00 score on a scale
Interval 25.0 to 63.0
|
40.00 score on a scale
Interval 25.0 to 57.0
|
SECONDARY outcome
Timeframe: 28 weeksPatient-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.
Outcome measures
| Measure |
ACTH
n=4 Participants
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: ACTH injections twice weekly for 28 weeks.
|
Placebo
n=4 Participants
Placebo will be given subcutaneously twice weekly for 28 weeks.
Placebo: Placebo injections twice weekly for 28 weeks.
|
|---|---|---|
|
Depression at 28 Weeks
|
16.50 score on a scale
Interval 0.0 to 22.0
|
40.00 score on a scale
Interval 25.0 to 57.0
|
SECONDARY outcome
Timeframe: 28 weeksPatient-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'.
Outcome measures
| Measure |
ACTH
n=4 Participants
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: ACTH injections twice weekly for 28 weeks.
|
Placebo
n=4 Participants
Placebo will be given subcutaneously twice weekly for 28 weeks.
Placebo: Placebo injections twice weekly for 28 weeks.
|
|---|---|---|
|
Sleepiness at 28 Weeks
|
11.00 score on a scale
Interval 2.0 to 16.0
|
7.00 score on a scale
Interval 1.0 to 19.0
|
SECONDARY outcome
Timeframe: 28 weeksPatient-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.
Outcome measures
| Measure |
ACTH
n=4 Participants
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: ACTH injections twice weekly for 28 weeks.
|
Placebo
n=4 Participants
Placebo will be given subcutaneously twice weekly for 28 weeks.
Placebo: Placebo injections twice weekly for 28 weeks.
|
|---|---|---|
|
Quality of Life at 28 Weeks
SF-36 Mental
|
39.50 score on a scale
Interval 25.0 to 57.0
|
49.00 score on a scale
Interval 34.0 to 68.0
|
|
Quality of Life at 28 Weeks
SF-36 Physical
|
37.50 score on a scale
Interval 30.0 to 57.0
|
45.00 score on a scale
Interval 30.0 to 57.0
|
Adverse Events
ACTH
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
ACTH
n=4 participants at risk
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: ACTH injections twice weekly for 28 weeks.
|
Placebo
n=4 participants at risk
Placebo will be given subcutaneously twice weekly for 28 weeks.
Placebo: Placebo injections twice weekly for 28 weeks.
|
|---|---|---|
|
Infections and infestations
bronchitis
|
25.0%
1/4 • Number of events 1 • Data was collected over 28 weeks.
|
25.0%
1/4 • Number of events 1 • Data was collected over 28 weeks.
|
|
Infections and infestations
Sinus infection
|
25.0%
1/4 • Number of events 1 • Data was collected over 28 weeks.
|
25.0%
1/4 • Number of events 1 • Data was collected over 28 weeks.
|
|
Infections and infestations
Flu
|
50.0%
2/4 • Number of events 2 • Data was collected over 28 weeks.
|
0.00%
0/4 • Data was collected over 28 weeks.
|
|
Gastrointestinal disorders
incontinence
|
0.00%
0/4 • Data was collected over 28 weeks.
|
25.0%
1/4 • Number of events 1 • Data was collected over 28 weeks.
|
|
Gastrointestinal disorders
heartburn
|
0.00%
0/4 • Data was collected over 28 weeks.
|
25.0%
1/4 • Number of events 1 • Data was collected over 28 weeks.
|
|
General disorders
insomnia
|
25.0%
1/4 • Number of events 1 • Data was collected over 28 weeks.
|
25.0%
1/4 • Number of events 1 • Data was collected over 28 weeks.
|
|
General disorders
agitation
|
25.0%
1/4 • Number of events 1 • Data was collected over 28 weeks.
|
0.00%
0/4 • Data was collected over 28 weeks.
|
|
General disorders
anxiety
|
25.0%
1/4 • Number of events 1 • Data was collected over 28 weeks.
|
0.00%
0/4 • Data was collected over 28 weeks.
|
|
General disorders
depression
|
25.0%
1/4 • Number of events 1 • Data was collected over 28 weeks.
|
25.0%
1/4 • Number of events 1 • Data was collected over 28 weeks.
|
|
General disorders
fatigue
|
25.0%
1/4 • Number of events 1 • Data was collected over 28 weeks.
|
0.00%
0/4 • Data was collected over 28 weeks.
|
|
General disorders
confusion
|
25.0%
1/4 • Number of events 1 • Data was collected over 28 weeks.
|
0.00%
0/4 • Data was collected over 28 weeks.
|
|
General disorders
memory loss
|
25.0%
1/4 • Number of events 1 • Data was collected over 28 weeks.
|
0.00%
0/4 • Data was collected over 28 weeks.
|
|
General disorders
irritability
|
25.0%
1/4 • Number of events 1 • Data was collected over 28 weeks.
|
0.00%
0/4 • Data was collected over 28 weeks.
|
|
Skin and subcutaneous tissue disorders
injection site reaction
|
25.0%
1/4 • Number of events 2 • Data was collected over 28 weeks.
|
50.0%
2/4 • Number of events 3 • Data was collected over 28 weeks.
|
|
Infections and infestations
Herpes simplex
|
25.0%
1/4 • Number of events 1 • Data was collected over 28 weeks.
|
0.00%
0/4 • Data was collected over 28 weeks.
|
|
Infections and infestations
Yeast infection
|
0.00%
0/4 • Data was collected over 28 weeks.
|
25.0%
1/4 • Number of events 1 • Data was collected over 28 weeks.
|
|
Eye disorders
worsening vision
|
0.00%
0/4 • Data was collected over 28 weeks.
|
25.0%
1/4 • Number of events 1 • Data was collected over 28 weeks.
|
|
General disorders
pain
|
0.00%
0/4 • Data was collected over 28 weeks.
|
25.0%
1/4 • Number of events 5 • Data was collected over 28 weeks.
|
|
General disorders
weight gain
|
50.0%
2/4 • Number of events 2 • Data was collected over 28 weeks.
|
0.00%
0/4 • Data was collected over 28 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
worsening asthma
|
0.00%
0/4 • Data was collected over 28 weeks.
|
25.0%
1/4 • Number of events 2 • Data was collected over 28 weeks.
|
|
General disorders
weakness
|
25.0%
1/4 • Number of events 1 • Data was collected over 28 weeks.
|
25.0%
1/4 • Number of events 1 • Data was collected over 28 weeks.
|
|
General disorders
loss of coordination
|
0.00%
0/4 • Data was collected over 28 weeks.
|
25.0%
1/4 • Number of events 1 • Data was collected over 28 weeks.
|
|
Musculoskeletal and connective tissue disorders
Worsening muscle spasticity
|
0.00%
0/4 • Data was collected over 28 weeks.
|
25.0%
1/4 • Number of events 1 • Data was collected over 28 weeks.
|
|
Musculoskeletal and connective tissue disorders
Broken toe
|
25.0%
1/4 • Number of events 1 • Data was collected over 28 weeks.
|
0.00%
0/4 • Data was collected over 28 weeks.
|
|
Skin and subcutaneous tissue disorders
decreased cutaneous sensation
|
25.0%
1/4 • Number of events 1 • Data was collected over 28 weeks.
|
0.00%
0/4 • Data was collected over 28 weeks.
|
|
Gastrointestinal disorders
dysphagia
|
25.0%
1/4 • Number of events 1 • Data was collected over 28 weeks.
|
0.00%
0/4 • Data was collected over 28 weeks.
|
|
Skin and subcutaneous tissue disorders
plantar dysthesia
|
25.0%
1/4 • Number of events 1 • Data was collected over 28 weeks.
|
0.00%
0/4 • Data was collected over 28 weeks.
|
|
Cardiac disorders
systolic aortic murmur
|
25.0%
1/4 • Number of events 1 • Data was collected over 28 weeks.
|
0.00%
0/4 • Data was collected over 28 weeks.
|
|
General disorders
Headache
|
25.0%
1/4 • Number of events 1 • Data was collected over 28 weeks.
|
0.00%
0/4 • Data was collected over 28 weeks.
|
|
General disorders
edema
|
25.0%
1/4 • Number of events 1 • Data was collected over 28 weeks.
|
0.00%
0/4 • Data was collected over 28 weeks.
|
|
General disorders
diaphoresis
|
25.0%
1/4 • Number of events 1 • Data was collected over 28 weeks.
|
0.00%
0/4 • Data was collected over 28 weeks.
|
|
General disorders
syncope
|
25.0%
1/4 • Number of events 1 • Data was collected over 28 weeks.
|
0.00%
0/4 • Data was collected over 28 weeks.
|
|
Cardiac disorders
hypertension
|
25.0%
1/4 • Number of events 1 • Data was collected over 28 weeks.
|
0.00%
0/4 • Data was collected over 28 weeks.
|
|
General disorders
pain and numbness
|
0.00%
0/4 • Data was collected over 28 weeks.
|
25.0%
1/4 • Number of events 1 • Data was collected over 28 weeks.
|
|
Renal and urinary disorders
enlarged prostate
|
25.0%
1/4 • Number of events 1 • Data was collected over 28 weeks.
|
0.00%
0/4 • Data was collected over 28 weeks.
|
|
Gastrointestinal disorders
appendicitis
|
25.0%
1/4 • Number of events 1 • Data was collected over 28 weeks.
|
0.00%
0/4 • Data was collected over 28 weeks.
|
|
Gastrointestinal disorders
colonic diverticula
|
25.0%
1/4 • Number of events 1 • Data was collected over 28 weeks.
|
0.00%
0/4 • Data was collected over 28 weeks.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place