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Acthar Gel for Multiple Sclerosis That Keeps Getting Better and Worse (RRMS) (OPTIONS)

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ClinicalTrials.gov Identifier: NCT03126760
Recruitment Status : Terminated (Recruitment difficulties and COVID-19 logistical challenges; no safety concerns)
First Posted : April 24, 2017
Results First Posted : June 3, 2021
Last Update Posted : July 12, 2021
Sponsor:
Information provided by (Responsible Party):
Mallinckrodt ( Mallinckrodt ARD LLC )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Multiple Sclerosis, Relapsing-Remitting
Interventions Drug: Acthar Gel
Drug: Placebo
Enrollment 35
Recruitment Details The study was terminated early by sponsor decision because of recruitment difficulties and the impact of the COVID-19 pandemic.
Pre-assignment Details Approximately 66 participants were planned at 25 sites; while only 35 were randomized using 31 sites, because of recruitment difficulties and the impact of the COVID-19 pandemic.
Arm/Group Title Acthar Gel Placebo
Hide Arm/Group Description Participants receive Acthar Gel under the skin once a day for 14 consecutive days Participants receive Placebo under the skin once a day for 14 consecutive days
Period Title: Overall Study
Started 18 17
Modified Intent to Treat (mITT) [1] 18 17
Completed Treatment 17 [2] 17
Completed 18 17
Not Completed 0 0
[1]
All participants who received study treatment
[2]
One participant halted treatment for adverse event, but completed the study
Arm/Group Title Acthar Gel Placebo Total
Hide Arm/Group Description Participants receive Acthar Gel under the skin once a day for 14 consecutive days Participants receive Placebo under the skin once a day for 14 consecutive days Total of all reporting groups
Overall Number of Baseline Participants 18 17 35
Hide Baseline Analysis Population Description
All participants
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 18 participants 17 participants 35 participants
40
(21 to 62)
43
(26 to 64)
40
(21 to 64)
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Adults 21-64 Number Analyzed 18 participants 17 participants 35 participants
≤35
4
  22.2%
6
  35.3%
10
  28.6%
36-45
10
  55.6%
6
  35.3%
16
  45.7%
46-55
2
  11.1%
2
  11.8%
4
  11.4%
56-64
2
  11.1%
3
  17.6%
5
  14.3%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 17 participants 35 participants
Female
15
  83.3%
12
  70.6%
27
  77.1%
Male
3
  16.7%
5
  29.4%
8
  22.9%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 17 participants 35 participants
Hispanic or Latino
0
   0.0%
1
   5.9%
1
   2.9%
Not Hispanic or Latino
17
  94.4%
16
  94.1%
33
  94.3%
Unknown or Not Reported
1
   5.6%
0
   0.0%
1
   2.9%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 17 participants 35 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
3
  16.7%
2
  11.8%
5
  14.3%
White
15
  83.3%
15
  88.2%
30
  85.7%
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%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 18 participants 17 participants 35 participants
18 17 35
1.Primary Outcome
Title Score on the Expanded Disability Status Scale (EDSS) at Baseline and Day 42
Hide Description The EDSS is a 10-point assessment of neurological impairment/disability in multiple sclerosis (MS) patients, ranging from 0 (normal neurological examination) to 10 (death due to MS). EDSS is rated by a person who only collects outcome measures, and has no knowledge of the treatment received.
Time Frame Baseline, Day 42
Hide Outcome Measure Data
Hide Analysis Population Description
modified Intent to Treat (mITT)
Arm/Group Title Acthar Gel Placebo
Hide Arm/Group Description:
Participants receive Acthar Gel under the skin once a day for 14 consecutive days
Participants receive Placebo under the skin once a day for 14 consecutive days
Overall Number of Participants Analyzed 18 17
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline 3.86  (1.122) 3.85  (1.169)
Day 42 2.92  (0.974) 3.62  (1.485)
Time Frame 42 days
Adverse Event Reporting Description Treatment emergent serious and non-serious adverse events are recorded. Treatment emergent is defined as adverse events that started or worsened in severity on or after the first dose of study drug. Clinically significant change in vital signs, laboratory values and/or physical examinations are recorded as adverse events.
 
Arm/Group Title Acthar Gel Placebo
Hide Arm/Group Description Participants receive Acthar Gel under the skin once a day for 14 consecutive days Participants receive Placebo under the skin once a day for 14 consecutive days
All-Cause Mortality
Acthar Gel Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/18 (0.00%)   0/17 (0.00%) 
Hide Serious Adverse Events
Acthar Gel Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/18 (0.00%)   0/17 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Acthar Gel Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   14/18 (77.78%)   12/17 (70.59%) 
Endocrine disorders     
Goitre  1  0/18 (0.00%)  1/17 (5.88%) 
Eye disorders     
Corneal degeneration  1  0/18 (0.00%)  1/17 (5.88%) 
Vision blurred  1  0/18 (0.00%)  1/17 (5.88%) 
Gastrointestinal disorders     
Dyspepsia  1  0/18 (0.00%)  1/17 (5.88%) 
Gastrointestinal disorder  1  0/18 (0.00%)  1/17 (5.88%) 
General disorders     
Feeling jittery  1  1/18 (5.56%)  0/17 (0.00%) 
Generalised oedema  1  1/18 (5.56%)  0/17 (0.00%) 
Injection site bruising  1  3/18 (16.67%)  4/17 (23.53%) 
Injection site discomfort  1  0/18 (0.00%)  1/17 (5.88%) 
Injection site erythema  1  1/18 (5.56%)  2/17 (11.76%) 
Injection site haemorrhage  1  1/18 (5.56%)  0/17 (0.00%) 
Injection site inflammation  1  0/18 (0.00%)  1/17 (5.88%) 
Injection site pain  1  0/18 (0.00%)  1/17 (5.88%) 
Injection site reaction  1  1/18 (5.56%)  0/17 (0.00%) 
Oedema peripheral  1  0/18 (0.00%)  1/17 (5.88%) 
Pain  1  1/18 (5.56%)  0/17 (0.00%) 
Peripheral swelling  1  1/18 (5.56%)  1/17 (5.88%) 
Infections and infestations     
Herpes zoster  1  1/18 (5.56%)  0/17 (0.00%) 
Nasopharyngitis  1  1/18 (5.56%)  1/17 (5.88%) 
Oral candidiasis  1  1/18 (5.56%)  0/17 (0.00%) 
Pharyngitis  1  1/18 (5.56%)  0/17 (0.00%) 
Tooth abscess  1  1/18 (5.56%)  0/17 (0.00%) 
Urinary tract infection  1  1/18 (5.56%)  0/17 (0.00%) 
Injury, poisoning and procedural complications     
Contusion  1  2/18 (11.11%)  0/17 (0.00%) 
Fall  1  1/18 (5.56%)  1/17 (5.88%) 
Road traffic accident  1  0/18 (0.00%)  1/17 (5.88%) 
Investigations     
Alanine aminotransferase increased  1  1/18 (5.56%)  0/17 (0.00%) 
Heart rate increased  1  1/18 (5.56%)  0/17 (0.00%) 
Lymphocyte count decreased  1  0/18 (0.00%)  1/17 (5.88%) 
Neutrophil count decreased  1  0/18 (0.00%)  1/17 (5.88%) 
Protein total decreased  1  1/18 (5.56%)  0/17 (0.00%) 
White blood cell count decreased  1  0/18 (0.00%)  1/17 (5.88%) 
Metabolism and nutrition disorders     
Decreased appetite  1  0/18 (0.00%)  1/17 (5.88%) 
Fluid retention  1  1/18 (5.56%)  0/17 (0.00%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  1/18 (5.56%)  2/17 (11.76%) 
Back pain  1  0/18 (0.00%)  1/17 (5.88%) 
Muscle spasms  1  0/18 (0.00%)  1/17 (5.88%) 
Musculoskeletal stiffness  1  0/18 (0.00%)  1/17 (5.88%) 
Plica syndrome  1  0/18 (0.00%)  1/17 (5.88%) 
Nervous system disorders     
Dysgeusia  1  1/18 (5.56%)  0/17 (0.00%) 
Headache  1  0/18 (0.00%)  2/17 (11.76%) 
Hypoaesthesia  1  0/18 (0.00%)  1/17 (5.88%) 
Migraine  1  1/18 (5.56%)  0/17 (0.00%) 
Multiple sclerosis  1  1/18 (5.56%)  1/17 (5.88%) 
Multiple sclerosis relapse  1  0/18 (0.00%)  1/17 (5.88%) 
Psychiatric disorders     
Anxiety  1  0/18 (0.00%)  1/17 (5.88%) 
Depression  1  0/18 (0.00%)  1/17 (5.88%) 
Insomnia  1  2/18 (11.11%)  0/17 (0.00%) 
Renal and urinary disorders     
Micturition urgency  1  1/18 (5.56%)  0/17 (0.00%) 
Nephrolithiasis  1  1/18 (5.56%)  0/17 (0.00%) 
Proteinuria  1  0/18 (0.00%)  1/17 (5.88%) 
Respiratory, thoracic and mediastinal disorders     
Nasal congestion  1  1/18 (5.56%)  0/17 (0.00%) 
Respiration abnormal  1  1/18 (5.56%)  0/17 (0.00%) 
Sinus congestion  1  0/18 (0.00%)  1/17 (5.88%) 
Upper-airway cough syndrome  1  0/18 (0.00%)  1/17 (5.88%) 
Skin and subcutaneous tissue disorders     
Acne  1  1/18 (5.56%)  0/17 (0.00%) 
Pruritus  1  0/18 (0.00%)  1/17 (5.88%) 
Rash  1  1/18 (5.56%)  1/17 (5.88%) 
Rash erythematous  1  0/18 (0.00%)  1/17 (5.88%) 
1
Term from vocabulary, MedDRA (19.1)
Indicates events were collected by systematic assessment
The study was terminated early by sponsor decision because of recruitment difficulties and the impact of the COVID-19 pandemic. The planned analyses did not change except that the total sample size was reduced. Inferential statistics were not performed. Results are nominal because the sample size did not reach that specified in the protocol.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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: Medical Information Call Center
Organization: Mallinckrodt
Phone: 800-844-2830
EMail: medinfo@mnk.com
Layout table for additonal information
Responsible Party: Mallinckrodt ( Mallinckrodt ARD LLC )
ClinicalTrials.gov Identifier: NCT03126760    
Other Study ID Numbers: MNK14274069
First Submitted: April 4, 2017
First Posted: April 24, 2017
Results First Submitted: May 10, 2021
Results First Posted: June 3, 2021
Last Update Posted: July 12, 2021