ACTH in Progressive Forms of MS

Secondary Progressive Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01950234
• Other study ID #: 110271
• Status: Terminated
• Phase: Phase 2
• Start date: April 17, 2014
• Est. completion date: December 31, 2022

Study information

• Verified date: May 2023
• Source: University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 59
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Chronic Progressive
• Primary Progressive Multiple Sclerosis
• Progressive Relapsing Multiple Sclerosis
• Sclerosis
• Secondary Progressive Multiple Sclerosis

Intervention

Drug:
• ACTH
Acthar gel
• Placebo
Placebo

Locations

Country	Name	City	State
United States	Sanford Clinic Neuroscience	Fargo	North Dakota
United States	Wheaton Franciscan Healthcare - St Francis Center for Neurological Disorders	Milwaukee	Wisconsin
United States	Clinical Neuroscience Research Unit, University of Minnesota	Minneapolis	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
University of Minnesota	Mallinckrodt

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Slowed progression of sustained cognitive disability	Brief Repeatable Battery of Neuropsychological Tests (BRB-N)	Month 36
Other	Retinal nerve fiber layer thickness	Decline in retinal nerve fiber layer thickness as measured by optical coherence tomography (OCT)	Month 36
Primary	Proportion of patients exhibiting a 20% worsening in T25FW at 36 months		Month 36
Secondary	Safety and tolerability of ACTH	Safety and tolerability will be assessed via safety lab tests, skin and edema assessments, DEXA scans, symptom questionnaires and adverse event assessments.	Month 36