Pilot Clinical Trial of ACTHar Gel 14 Days Subcutaneous (SQ)Versus ACTHar Gel Five Days SQ for the Treatment of MS Exacerbations

NCT01888354 | Completed Phase 4

• 1 other identifier: HSC-MS-12-0210
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 2

Brief Summary

This pilot study is designed as a prospective cohort study to determine whether standard subcutaneous (SQ) Highly-Purified (HP) Acthar Gel 14 days is superior to SQ HP Acthar Gel 5 days in the treatment of relapses or attacks in multiple sclerosis (MS).

Conditions

Multiple Sclerosis (MS)

Keywords

MS; Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• Comparison of EDSS Mean Recovery between 5-day vs 14-day SQ 80 IU ACTHar Gel therapy groups

  To determine whether a standard 14 day course of SQ 80 IU ACTHar Gel therapy might be superior (in twice as many patients) to treatment with 5 day SQ regimen for ACTHar Gel as determined by EDSS mean recovery from Day 0 (time of steroid therapy initiation) to Day 28 (and day 90).

  28 Days (with 90 day follow-up)

Secondary Outcomes (5)

• Comparison of ambulation between the 5-day vs.14-day SQ 80 IU ACTHar Gel therapy groups

  28 Days (with 90 day follow-up)

• Comparison of upper extremity function between the 5-day vs.14-day SQ 80 IU ACTHar Gel therapy groups

  28 day (with 90 follow up)

• Comparison of subjective impressions of effectiveness between the 5-day vs 14-day SQ 80 IU ACTHar Gel therapy groups

  28 day (with 90 day follow up)

• Compare visual function between 5-day vs 14-day SQ 80 IU ACTHar Gel therapy groups

  28 day (with 90 day follow up)

• Comparison of cognitive function between the 5-day vs 14-day SQ 80 IU ACTHar Gel therapy groups

  28 day (with 90 day follow up)

Other Outcomes (2)

• Comparison of MRI brain activity before and after ACTH treatment between the two treatment groups

  28 Days (with 90 day follow-up)

• Comparison of immune changes before and after ACTH treatment between the two treatment groups

  28 Days (with 90 day follow-up)

Study Arms (2)

Acthar Gel 80 IU x 14 days

EXPERIMENTAL

Acthar Gel 80 IU SQ x 14 days

Drug: H.P. Acthar Gel (repository corticotropin injection)

Acthar Gel 80 IU x 5 days

EXPERIMENTAL

Acthar Gel 80 IU SQ x 5 days

Drug: H.P. Acthar Gel (repository corticotropin injection)

Interventions

H.P. Acthar Gel (repository corticotropin injection) DRUG

Acthar Gel 80 IU

Also known as: Acthar, Repository Corticotropin Injection, ACTH Gel

Acthar Gel 80 IU x 14 days; Acthar Gel 80 IU x 5 days

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Adult male or female subjects with MS having a relapse (attack) or exacerbation of MS. Acute symptomatic exacerbation of MS present for \> 24 hours and \< 14 days at screening with new or worsening symptoms, and with signs referable to the symptoms in the absence of a fever or active infection.
• Diagnosis of a relapsing forms of multiple sclerosis before randomization as determined by Poser or McDonald Criteria (standard MS diagnostic criteria).
• Expanded disability status scale (EDDS) between 2 and 6.5, inclusive at entry.
• Episodes include study neurologist or neuro-ophthalmologist diagnosed: acute optic neuritis, cerebellar, brainstem dysfunction, myelitis, focal cerebral, and/or definitive focal sensory dysfunction.
• New objective clinical finding other than the sensory exacerbation or the bowel/bladder signs alone. Sensory deficits alone will not qualify except for optic neuritis.
• Subjects may continue on their current immunomodulation therapy such as interferons, glatiramer acetate, gilenya or natalizumab.
• Identified patients must be between the ages of 18 and 55 years, inclusive.
• Ability to understand and the willingness to sign a written informed consent document.

You may not qualify if:

• Subjects who are pregnant, or nursing.
• Any patients treated with systemic corticosteroid use within one month of the index episode at screening.
• Prior use of immunosuppressive treatments within 90 days of index episode (mitoxantrone, azathioprine, Cellcept, IVIg) or plasmapheresis.
• Unable to perform timed 25 foot walk (ambulation Index), 9 HPT (9 hole peg test), PASAT (Paced Auditory Serial Addition Test) 3.
• Peripheral or cranial neuropathy as sole problem of acute episode.
• Subjects with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, or psychiatric illness/social situations that would limit compliance with study requirements.
• History of any significant cardiac, gastrointestinal, hepatic, pulmonary, or renal disease; immune deficiency; or other medical conditions that would preclude corticosteroid therapy.
• Subjects with clinical diagnosis of scleroderma, osteoporosis, systemic fungal infections, ocular herpes simplex, recent surgery, history of or the presence of a peptic ulcer, congestive heart failure, hypertension, or sensitivity to proteins of porcine origin.
• Primary Progressive Multiple Sclerosis (PPMS) (MS without attacks). -

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (2)

The MS Center at the Neurology Center in Southern California

Oceanside, California, 92056, United States

Location

The University of Texas-Houston Neurology Clinic

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Adrenocorticotropic Hormone

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Melanocortins; Pro-Opiomelanocortin; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pituitary Hormones, Anterior; Pituitary Hormones; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins

Study Officials

• Staley A. Brod, MD

  The Universtiy of Texas-Houston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staley A. Brod, MD

Study Record Dates

• First Submitted: May 16, 2013
• First Posted: June 27, 2013
• Study Start: April 1, 2013
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: September 16, 2014

Record last verified: 2014-09

Locations

US (2)