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The funding source discontinued financial support for the study.
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| Name | Class |
|---|---|
| Mallinckrodt | INDUSTRY |
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This is a phase II, randomized, double-blind, placebo-controlled, multi-center study to evaluate the safety, tolerability, and efficacy of adrenocorticotropic hormone (ACTH, Acthar gel) administered as a pulsed regimen consisting of injections on three consecutive days per month in patients with progressive forms of Multiple Sclerosis (MS). Patients will be randomly assigned to either an ACTH arm or a placebo arm. The main hypotheses are that 1) pulsed ACTH will be safe and well-tolerated, and 2) pulsed ACTH will slow progression of clinical and paraclinical measures of MS progression compared to placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ACTH | Experimental | ACTH administered subcutaneously as a pulsed regimen of 3 consecutive days per month |
|
| Placebo | Placebo Comparator | Placebo subcutaneous injections administered on 3 consecutive days per month |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ACTH | Drug | Acthar gel |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Patients Exhibiting a 20% Worsening in T25FW at 36 Months | Month 36 |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability of ACTH: Menstrual Changes [Female] | Count of participants self reporting at any time throuhgout the study noticing any changes in menstrual cycle or period. | Month 36 |
| Safety and Tolerability of ACTH: DEXA Scans |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Adam F Carpenter, MD | University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Neuroscience Research Unit, University of Minnesota | Minneapolis | Minnesota | 55414 | United States | ||
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| ID | Title | Description |
|---|---|---|
| FG000 | ACTH | ACTH administered subcutaneously as a pulsed regimen of 3 consecutive days per month ACTH: Acthar gel |
| FG001 | Placebo | Placebo subcutaneous injections administered on 3 consecutive days per month Placebo: Placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | ACTH | ACTH administered subcutaneously as a pulsed regimen of 3 consecutive days per month ACTH: Acthar gel |
| BG001 | Placebo | Placebo subcutaneous injections administered on 3 consecutive days per month Placebo: Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Proportion of Patients Exhibiting a 20% Worsening in T25FW at 36 Months | Posted | Count of Participants | Participants | Month 36 |
|
|
36 Months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ACTH | ACTH administered subcutaneously as a pulsed regimen of 3 consecutive days per month ACTH: Acthar gel |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastrointestinal | Gastrointestinal disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Alopecia | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sarah Hikbert | University of Minnesota | 612-624-7745 | hilbe010@umn.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 26, 2021 | Jul 26, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 22, 2019 | Jul 26, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D020528 | Multiple Sclerosis, Chronic Progressive |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000324 | Adrenocorticotropic Hormone |
| ID | Term |
|---|---|
| D053486 | Melanocortins |
| D011333 | Pro-Opiomelanocortin |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
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| Placebo |
| Drug |
Placebo |
|
The number is a T-score. There is no maximum or minimum value. Mean change in average of 5 DEXA scan values dual-energy x-ray absorptiometry; measures bone mineral density. Higher numbers are better.
A DEXA T-score has a mean of 0 and standard deviation of 1, meaning that a T-score represents how many standard deviations a person's bone density is away from the average bone density of a healthy young adult, with a score of 0 indicating average bone density. Higher scores are better, indicating better bone density. A T-score of -1 to +1 is considered normal bone density, a score between -1 and -2.5 indicates osteopenia (low bone mass), and a score of -2.5 or lower indicates osteoporosis.
| Month 36 |
| Safety and Tolerability of ACTH: Bruising | Count of participants self reporting at any time throuhgout the study that they bruise more easily | Month 36 |
| Safety and Tolerability of ACTH: Swelling Ankles | Count of participants self reporting at any time throuhgout the study that have noticed swelling in their ankles | Month 36 |
| Safety and Tolerability of ACTH: Hair Loss | Count of participants self reporting at any time throuhgout the study that have noticed losing more hair | Month 36 |
| Safety and Tolerability of ACTH: Acne | Count of participants self reporting at any time throuhgout the study that have noticed in increase in acne | Month 36 |
| Safety and Tolerability of ACTH: Insomnia | Count of participants self reporting at any time throuhgout the study that they have been having trouble sleeping | Month 36 |
| Safety and Tolerability of ACTH: Mood Change | Count of participants self reporting at any time throuhgout the study that they have noticed changes in mood | Month 36 |
| Safety and Tolerability of ACTH: GI Upset | Count of participants self reporting at any time throuhgout the study that they have had upset stomach, indigestion, diarrhea, or bloating | Month 36 |
| Safety and Tolerability of ACTH: Fatigue | Count of participants self reporting at any time throuhgout the study that noticed feeling tired or worn out | Month 36 |
| Safety and Tolerability of ACTH: Unpleasant Taste | Count of participants self reporting at any time throuhgout the study noticing a metallic taste in their mouth | Month 36 |
| Safety and Tolerability of ACTH: Blurred Vision | Count of participants self reporting at any time throuhgout the study noticing any blurred vision | Month 36 |
| Safety and Tolerability of ACTH: Moon Facies | New physician assessed moon facies over study duration | Month 36 |
| Safety and Tolerability of ACTH: Skin Thinning | New physician assessed skin thinning over study duration | Month 36 |
| Safety and Tolerability of ACTH: Hirsuitism | New physician assessed hirsuitism over study duration | Month 36 |
| Safety and Tolerability of ACTH: Bruising | New physician assessed bruising over study duration | Month 36 |
| Safety and Tolerability of ACTH: Ankle Swelling | New physician assessed ankle swelling over study duration | Month 36 |
| Safety and Tolerability of ACTH: Hair Loss | Any new physician assessed hair loss over study duration | Month 36 |
| Safety and Tolerability of ACTH: Cataracts | New physician assessed cataracts over study duration | Month 36 |
| Safety and Tolerability of ACTH: Myopathy | New physician assessed myopathy over study duration | Month 36 |
| Safety and Tolerability of ACTH: Change in Hemoglobin A1c | Change in hemoglobin A1c | Month 36 |
| Sanford Clinic Neuroscience |
| Fargo |
| North Dakota |
| 58103 |
| United States |
| Wheaton Franciscan Healthcare - St Francis Center for Neurological Disorders | Milwaukee | Wisconsin | 53215 | United States |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
|
| Secondary | Safety and Tolerability of ACTH: Menstrual Changes [Female] | Count of participants self reporting at any time throuhgout the study noticing any changes in menstrual cycle or period. | Posted | Count of Participants | Participants | Month 36 |
|
|
|
| Secondary | Safety and Tolerability of ACTH: DEXA Scans | The number is a T-score. There is no maximum or minimum value. Mean change in average of 5 DEXA scan values dual-energy x-ray absorptiometry; measures bone mineral density. Higher numbers are better. A DEXA T-score has a mean of 0 and standard deviation of 1, meaning that a T-score represents how many standard deviations a person's bone density is away from the average bone density of a healthy young adult, with a score of 0 indicating average bone density. Higher scores are better, indicating better bone density. A T-score of -1 to +1 is considered normal bone density, a score between -1 and -2.5 indicates osteopenia (low bone mass), and a score of -2.5 or lower indicates osteoporosis. | Posted | Mean | Standard Deviation | units on a scale | Month 36 |
|
|
|
| Secondary | Safety and Tolerability of ACTH: Bruising | Count of participants self reporting at any time throuhgout the study that they bruise more easily | Posted | Count of Participants | Participants | Month 36 |
|
|
|
| Secondary | Safety and Tolerability of ACTH: Swelling Ankles | Count of participants self reporting at any time throuhgout the study that have noticed swelling in their ankles | Posted | Count of Participants | Participants | Month 36 |
|
|
|
| Secondary | Safety and Tolerability of ACTH: Hair Loss | Count of participants self reporting at any time throuhgout the study that have noticed losing more hair | Posted | Count of Participants | Participants | Month 36 |
|
|
|
| Secondary | Safety and Tolerability of ACTH: Acne | Count of participants self reporting at any time throuhgout the study that have noticed in increase in acne | Posted | Count of Participants | Participants | Month 36 |
|
|
|
| Secondary | Safety and Tolerability of ACTH: Insomnia | Count of participants self reporting at any time throuhgout the study that they have been having trouble sleeping | Posted | Count of Participants | Participants | Month 36 |
|
|
|
| Secondary | Safety and Tolerability of ACTH: Mood Change | Count of participants self reporting at any time throuhgout the study that they have noticed changes in mood | Posted | Count of Participants | Participants | Month 36 |
|
|
|
| Secondary | Safety and Tolerability of ACTH: GI Upset | Count of participants self reporting at any time throuhgout the study that they have had upset stomach, indigestion, diarrhea, or bloating | Posted | Count of Participants | Participants | Month 36 |
|
|
|
| Secondary | Safety and Tolerability of ACTH: Fatigue | Count of participants self reporting at any time throuhgout the study that noticed feeling tired or worn out | Posted | Count of Participants | Participants | Month 36 |
|
|
|
| Secondary | Safety and Tolerability of ACTH: Unpleasant Taste | Count of participants self reporting at any time throuhgout the study noticing a metallic taste in their mouth | Posted | Count of Participants | Participants | Month 36 |
|
|
|
| Secondary | Safety and Tolerability of ACTH: Blurred Vision | Count of participants self reporting at any time throuhgout the study noticing any blurred vision | Posted | Count of Participants | Participants | Month 36 |
|
|
|
| Secondary | Safety and Tolerability of ACTH: Moon Facies | New physician assessed moon facies over study duration | Posted | Count of Participants | Participants | Month 36 |
|
|
|
| Secondary | Safety and Tolerability of ACTH: Skin Thinning | New physician assessed skin thinning over study duration | Posted | Count of Participants | Participants | Month 36 |
|
|
|
| Secondary | Safety and Tolerability of ACTH: Hirsuitism | New physician assessed hirsuitism over study duration | Posted | Count of Participants | Participants | Month 36 |
|
|
|
| Secondary | Safety and Tolerability of ACTH: Bruising | New physician assessed bruising over study duration | Posted | Count of Participants | Participants | Month 36 |
|
|
|
| Secondary | Safety and Tolerability of ACTH: Ankle Swelling | New physician assessed ankle swelling over study duration | Posted | Count of Participants | Participants | Month 36 |
|
|
|
| Secondary | Safety and Tolerability of ACTH: Hair Loss | Any new physician assessed hair loss over study duration | Posted | Count of Participants | Participants | Month 36 |
|
|
|
| Secondary | Safety and Tolerability of ACTH: Cataracts | New physician assessed cataracts over study duration | Posted | Count of Participants | Participants | Month 36 |
|
|
|
| Secondary | Safety and Tolerability of ACTH: Myopathy | New physician assessed myopathy over study duration | Posted | Count of Participants | Participants | Month 36 |
|
|
|
| Secondary | Safety and Tolerability of ACTH: Change in Hemoglobin A1c | Change in hemoglobin A1c | Posted | Mean | Standard Deviation | percent | Month 36 |
|
|
|
| 0 |
| 29 |
| 8 |
| 29 |
| 29 |
| 29 |
| EG001 | Placebo | Placebo subcutaneous injections administered on 3 consecutive days per month Placebo: Placebo | 0 | 30 | 7 | 30 | 29 | 30 |
| infection | General disorders | Systematic Assessment |
|
| Musculoskeletal | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| respiratory | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Bladder function | Renal and urinary disorders | Systematic Assessment |
|
| Bruising | General disorders | Systematic Assessment |
|
| cardiovascular | Cardiac disorders | Systematic Assessment |
|
| dermatologic | General disorders | Systematic Assessment |
|
| Dysgeusia | General disorders | Systematic Assessment |
|
| Edema | General disorders | Systematic Assessment |
|
| Fatigue | General disorders | Systematic Assessment |
|
| Gastrointestinal | Gastrointestinal disorders | Systematic Assessment |
|
| genitourinary | General disorders | Systematic Assessment |
|
| Infection | General disorders | Systematic Assessment |
|
| Injection site reaction | General disorders | Systematic Assessment |
|
| Metabolic | General disorders | Systematic Assessment |
|
| Metabolic/endocrine | General disorders | Systematic Assessment |
|
| Mood | General disorders | Systematic Assessment |
|
| Musculoskeletal | General disorders | Systematic Assessment |
|
| Neoplasm | General disorders | Systematic Assessment |
|
| Neurologic | Nervous system disorders | Systematic Assessment |
|
| other | General disorders | Systematic Assessment |
|
| renal | Renal and urinary disorders | Systematic Assessment |
|
| respiratory | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| sleep | General disorders | Systematic Assessment |
|
| visual | General disorders | Systematic Assessment |
|
| weight gain | General disorders | Systematic Assessment |
|
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| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010908 | Pituitary Hormones, Anterior |
| D010907 | Pituitary Hormones |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |