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Trial · Interventional

TerminatedPhase 2Results postedRegistry data

ACTH in Progressive Forms of MS

NCTNCT01950234 (opens ClinicalTrials.gov in a new tab)Other id110271
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Overview

Status
Terminated
Phase
Phase 2
Enrollment
59 participants (actual)
Sponsor
University of Minnesota · Other
Design
Randomized · Quadruple masking
Countries
1 country

United States

Start
17 Apr 2014
Primary completion
31 Dec 2022
Completion
31 Dec 2022
First posted
25 Sept 2013 (estimated)
Last update posted
11 Feb 2025
Conditions
Secondary Progressive Multiple Sclerosis · Primary Progressive Multiple Sclerosis · Progressive Relapsing Multiple Sclerosis

Timeline

1 trial · 1 stopped early · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20142016201820202022
  1. Ph 2

    ACTH in Progressive Forms of MS

    NCT01950234

    17 Apr 2014 to 31 Dec 2022

    Terminated

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • ACTHDrug
  • PlaceboDrug

Arms2

  • Experimental

    ACTH

    ACTH administered subcutaneously as a pulsed regimen of 3 consecutive days per month

  • Placebo comparator

    Placebo

    Placebo subcutaneous injections administered on 3 consecutive days per month

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Proportion of Patients Exhibiting a 20% Worsening in T25FW at 36 Months

    Time frame · Month 36

Secondary outcomes(20)

  1. Safety and Tolerability of ACTH: Menstrual Changes [Female]

    Time frame · Month 36

    Registry description

    Count of participants self reporting at any time throuhgout the study noticing any changes in menstrual cycle or period.

  2. Safety and Tolerability of ACTH: DEXA Scans

    Time frame · Month 36

    Registry description

    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.

  3. Safety and Tolerability of ACTH: Bruising

    Time frame · Month 36

    Registry description

    Count of participants self reporting at any time throuhgout the study that they bruise more easily

  4. Safety and Tolerability of ACTH: Swelling Ankles

    Time frame · Month 36

    Registry description

    Count of participants self reporting at any time throuhgout the study that have noticed swelling in their ankles

  5. Safety and Tolerability of ACTH: Hair Loss

    Time frame · Month 36

    Registry description

    Count of participants self reporting at any time throuhgout the study that have noticed losing more hair

  6. Safety and Tolerability of ACTH: Acne

    Time frame · Month 36

    Registry description

    Count of participants self reporting at any time throuhgout the study that have noticed in increase in acne

  7. Safety and Tolerability of ACTH: Insomnia

    Time frame · Month 36

    Registry description

    Count of participants self reporting at any time throuhgout the study that they have been having trouble sleeping

  8. Safety and Tolerability of ACTH: Mood Change

    Time frame · Month 36

    Registry description

    Count of participants self reporting at any time throuhgout the study that they have noticed changes in mood

  9. Safety and Tolerability of ACTH: GI Upset

    Time frame · Month 36

    Registry description

    Count of participants self reporting at any time throuhgout the study that they have had upset stomach, indigestion, diarrhea, or bloating

  10. Safety and Tolerability of ACTH: Fatigue

    Time frame · Month 36

    Registry description

    Count of participants self reporting at any time throuhgout the study that noticed feeling tired or worn out

  11. Safety and Tolerability of ACTH: Unpleasant Taste

    Time frame · Month 36

    Registry description

    Count of participants self reporting at any time throuhgout the study noticing a metallic taste in their mouth

  12. Safety and Tolerability of ACTH: Blurred Vision

    Time frame · Month 36

    Registry description

    Count of participants self reporting at any time throuhgout the study noticing any blurred vision

  13. Safety and Tolerability of ACTH: Moon Facies

    Time frame · Month 36

    Registry description

    New physician assessed moon facies over study duration

  14. Safety and Tolerability of ACTH: Skin Thinning

    Time frame · Month 36

    Registry description

    New physician assessed skin thinning over study duration

  15. Safety and Tolerability of ACTH: Hirsuitism

    Time frame · Month 36

    Registry description

    New physician assessed hirsuitism over study duration

  16. Safety and Tolerability of ACTH: Bruising

    Time frame · Month 36

    Registry description

    New physician assessed bruising over study duration

  17. Safety and Tolerability of ACTH: Ankle Swelling

    Time frame · Month 36

    Registry description

    New physician assessed ankle swelling over study duration

  18. Safety and Tolerability of ACTH: Hair Loss

    Time frame · Month 36

    Registry description

    Any new physician assessed hair loss over study duration

  19. Safety and Tolerability of ACTH: Cataracts

    Time frame · Month 36

    Registry description

    New physician assessed cataracts over study duration

  20. Safety and Tolerability of ACTH: Myopathy

    Time frame · Month 36

    Registry description

    New physician assessed myopathy over study duration

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 outcomeCount of participants· Month 36

Proportion of Patients Exhibiting a 20% Worsening in T25FW at 36 Months

GroupValue (Participants)
ACTH3
Placebo4
Secondary and other outcome results(7)
Secondary outcomeCount of participants· Month 36

Safety and Tolerability of ACTH: Menstrual Changes [Female]

GroupValue (Participants)
ACTH1
Placebo1
Secondary outcomeMean· Month 36

Safety and Tolerability of ACTH: DEXA Scans

GroupValue (units on a scale)Spread
ACTH-0.410.49
Placebo00.5
Secondary outcomeCount of participants· Month 36

Safety and Tolerability of ACTH: Bruising

GroupValue (Participants)
ACTH7
Placebo8
Secondary outcomeCount of participants· Month 36

Safety and Tolerability of ACTH: Swelling Ankles

GroupValue (Participants)
ACTH15
Placebo9
Secondary outcomeCount of participants· Month 36

Safety and Tolerability of ACTH: Hair Loss

GroupValue (Participants)
ACTH7
Placebo7
Secondary outcomeCount of participants· Month 36

Safety and Tolerability of ACTH: Acne

GroupValue (Participants)
ACTH2
Placebo4
Secondary outcomeCount of participants· Month 36

Safety and Tolerability of ACTH: Insomnia

GroupValue (Participants)
ACTH12
Placebo11

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
ACTHACTH administered subcutaneously as a pulsed regimen of 3 consecutive days per month ACTH: Acthar gel0 / 298 / 2929 / 29
PlaceboPlacebo subcutaneous injections administered on 3 consecutive days per month Placebo: Placebo0 / 307 / 3029 / 30

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
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Male or female patients with a confirmed diagnosis of MS by McDonald criteria * Age \>/= 18 years * SPMS, PPMS, or PRMS phenotype, according to Lublin and Reingold criteria * EDSS 2.0 - 6.0, inclusive * Able to understand the consent process Exclusion Criteria: * Known intolerance of ACTH or corticosteroids * Diabetes mellitus, defined as pre-existing diagnosis, fasting blood glucose \> 125 mg/dl, or glycosylated hemoglobin \>/= 6.5% * Osteoporosis, defined as pre-existing diagnosis or T-score on dual-energy x-ray absorptiometry (DEXA) scan of \</= -2.5. * Current serious medical condition which may interfere with subject's ability to complete the study, or for which pulsed ACTH therapy is contraindicated or might complicate current therapy (e.g., cancer, severe psychiatric illness, chronic infections, autoimmune disorders) * Treatment with cytotoxic agents (including but not necessarily limited to mitoxantrone, cyclophosphamide, alemtuzumab, or rituximab) within 3 years prior to randomization * Treatment with non-cytotoxic immunosuppressive agents (including but not necessarily limited to corticosteroids, ACTH, azathioprine, mycophenolate mofetil, methotrexate or natalizumab) within 3 months prior to randomization * Treatment with FDA-approved first-line MS disease-modifying therapies (B-interferon, glatiramer acetate, fingolimod, teriflunomide or dimethyl fumarate) will be permitted, as long as treatment has been ongoing and stable for at least 3 months prior to randomization * Treatment with dalfampridine or compounded 4-aminopyridine (4-AP) will be permitted as long as treatment has been ongoing and stable for at least 3 months prior to randomization * Stimulant medications for fatigue (such as methylphenidate, modafinil, armodafinil, amantadine or dextroamphetamine) will be permitted, but subjects will be asked to not take these medications on study visit days until all study procedures/assessments are completed.

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