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Secondary Progressive Multiple SclerosisPhase 2NCT01950234

ACTH in Progressive Forms of MS

A Phase 2 study testing ACTH in people with Secondary Progressive Multiple Sclerosis and Primary Progressive Multiple Sclerosis, run by University of Minnesota at 3 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
ACTH
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
59 participants
Where
3 sitesUnited States
Study dates
17 Apr 2014to 31 Dec 2022
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • 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.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Sanford Clinic Neuroscience

    Fargo, North Dakota, 58103

  • Wheaton Franciscan Healthcare - St Francis Center for Neurological Disorders

    Milwaukee, Wisconsin, 53215

  • Clinical Neuroscience Research Unit, University of Minnesota

    Minneapolis, Minnesota, 55414

Other trials in United States

About this study

Official title: Treatment of Progressive Forms of Multiple Sclerosis With Pulsed ACTH (Acthar Gel)

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.

Being tested
ACTH, Placebo
Medical subject headings
Multiple Sclerosis, Chronic Progressive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ACTHDrug

    Also called Acthar gel

    Acthar gel

  • PlaceboDrug

    Placebo

Study groups in NCT01950234
Study groupRoleWhat they receive
ACTHExperimentalACTH administered subcutaneously as a pulsed regimen of 3 consecutive days per month
Receives: Drug: ACTH
PlaceboPlacebo comparatorPlacebo subcutaneous injections administered on 3 consecutive days per month
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Month 36

Secondary outcomes (21)

  1. 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.

    Measured: Month 36

  2. 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.

    Measured: Month 36

  3. Safety and Tolerability of ACTH: Bruising

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

    Measured: Month 36

  4. 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

    Measured: Month 36

  5. Safety and Tolerability of ACTH: Hair Loss

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

    Measured: Month 36

  6. Safety and Tolerability of ACTH: Acne

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

    Measured: Month 36

  7. Safety and Tolerability of ACTH: Insomnia

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

    Measured: Month 36

  8. 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

    Measured: Month 36

  9. 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

    Measured: Month 36

  10. Safety and Tolerability of ACTH: Fatigue

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

    Measured: Month 36

  11. 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

    Measured: Month 36

  12. Safety and Tolerability of ACTH: Blurred Vision

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

    Measured: Month 36

  13. Safety and Tolerability of ACTH: Moon Facies

    New physician assessed moon facies over study duration

    Measured: Month 36

  14. Safety and Tolerability of ACTH: Skin Thinning

    New physician assessed skin thinning over study duration

    Measured: Month 36

  15. Safety and Tolerability of ACTH: Hirsuitism

    New physician assessed hirsuitism over study duration

    Measured: Month 36

  16. Safety and Tolerability of ACTH: Bruising

    New physician assessed bruising over study duration

    Measured: Month 36

  17. Safety and Tolerability of ACTH: Ankle Swelling

    New physician assessed ankle swelling over study duration

    Measured: Month 36

  18. Safety and Tolerability of ACTH: Hair Loss

    Any new physician assessed hair loss over study duration

    Measured: Month 36

  19. Safety and Tolerability of ACTH: Cataracts

    New physician assessed cataracts over study duration

    Measured: Month 36

  20. Safety and Tolerability of ACTH: Myopathy

    New physician assessed myopathy over study duration

    Measured: Month 36

  21. Safety and Tolerability of ACTH: Change in Hemoglobin A1c

    Change in hemoglobin A1c

    Measured: Month 36

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Sep 2013 (estimated)
  2. Study start17 Apr 2014
  3. Primary completion31 Dec 2022
  4. Study completion31 Dec 2022

Why it stopped: The funding source discontinued financial support for the study.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
59 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01950234
Sponsor's protocol ID
110271
Status last verified
Feb 2025
First submitted
30 Aug 2013
Last updated
11 Feb 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ACTH in people with Secondary Progressive Multiple Sclerosis and Primary Progressive Multiple Sclerosis, run by University of Minnesota at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 11 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of Patients Exhibiting a 20% Worsening in T25FW at 36 Months (time frame: Month 36). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01950234.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2025.

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ACTH in Progressive Forms of MS (NCT01950234) | AzTrials