ACTH in Progressive Forms of MS

Sponsor

University of Minnesota (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT01950234

Collaborator

Mallinckrodt (Industry)

100

Enrollment

Locations

Arms

111

Duration (Months)

33.3

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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 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.

Condition or Disease	Intervention/Treatment	Phase
Secondary Progressive Multiple Sclerosis Primary Progressive Multiple Sclerosis Progressive Relapsing Multiple Sclerosis	Drug: ACTH Drug: Placebo	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Oct 1, 2013

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ACTH ACTH administered subcutaneously as a pulsed regimen of 3 consecutive days per month	Drug: ACTH Acthar gel Other Names: Acthar gel
Placebo Comparator: Placebo Placebo subcutaneous injections administered on 3 consecutive days per month	Drug: Placebo Placebo

Arm

Intervention/Treatment

Experimental: ACTH

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

Drug: ACTH

Acthar gel

Other Names:

Acthar gel

Placebo Comparator: Placebo

Placebo subcutaneous injections administered on 3 consecutive days per month

Drug: Placebo

Placebo

Outcome Measures

Primary Outcome Measures

Proportion of patients exhibiting a 20% worsening in T25FW at 36 months [Month 36]

Secondary Outcome Measures

Safety and tolerability of ACTH [Month 36]
Safety and tolerability will be assessed via safety lab tests, skin and edema assessments, DEXA scans, symptom questionnaires and adverse event assessments.

Other Outcome Measures

Slowed progression of sustained cognitive disability [Month 36]
Brief Repeatable Battery of Neuropsychological Tests (BRB-N)
Retinal nerve fiber layer thickness [Month 36]
Decline in retinal nerve fiber layer thickness as measured by optical coherence tomography (OCT)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinical Neuroscience Research Unit, University of Minnesota	Minneapolis	Minnesota	United States	55414
2	Sanford Clinic Neuroscience	Fargo	North Dakota	United States	58103
3	Wheaton Franciscan Healthcare - St Francis Center for Neurological Disorders	Milwaukee	Wisconsin	United States	53215

Sponsors and Collaborators

University of Minnesota
Mallinckrodt

Investigators

Principal Investigator: Adam F Carpenter, MD, University of Minnesota

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Minnesota

ClinicalTrials.gov Identifier:

NCT01950234

Other Study ID Numbers:

110271

First Posted:

Sep 25, 2013

Last Update Posted:

Aug 3, 2022

Last Verified:

Aug 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Multiple Sclerosis

Multiple Sclerosis, Chronic Progressive

Sclerosis

Study Results

No Results Posted as of Aug 3, 2022