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A Phase IV Trial of Neuroprotection With ACTH in Acute Optic Neuritis (ACTHAR)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by University of Texas Southwestern Medical Center
Sponsor:
Collaborators:
University of Colorado, Denver
Questcor Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Elliot Frohman, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT01838174
First received: April 18, 2013
Last updated: March 27, 2014
Last verified: March 2014
  Purpose

We hypothesize that the novel melanocortin-mediated anti-inflammatory effects of Adrenocorticotropic hormone (ACTH) will reduce axonal loss following ON by limiting inflammatory optic nerve injury. We will compare the effect of ACTH and intravenous methylprednisolone therapy on axonal injury following ON using ocular coherence tomography (OCT), a sensitive, reproducible and noninvasive tool to measure retinal nerve fiber layer (RNFL) thickness.

The primary outcome will be the average RNFL thickness at 6 months. Additional pre-specified statistical analyses will compare the difference in the mean RNFL thickness at 6 months in the affected eye between the IV methylprednisolone- and Acthar-treated groups, and the mean 6-month affected eye RNFL thicknesses adjusted for the baseline unaffected eye RNFL. The secondary outcome measure will examine the frequency of optic nerves with RNFL swelling between the IV methylprednisolone- and Acthar-treated groups at 1 and 3 months. The tertiary outcome will be changes in mfVEP amplitude and latency, ONHP detection, and pupillary diameter (UTSW only). A predefined exploratory outcome will compare the ganglion cell plus inner plexiform layer (GC+IPL) thickness at 6 months between treatment groups


Condition Intervention Phase
Multiple Sclerosis
Drug: ACTHAR Gel (ACTH)
Drug: IV steroids with oral taper
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase IV Trial of Neuroprotection With ACTH in Acute Optic Neuritis

Resource links provided by NLM:


Further study details as provided by University of Texas Southwestern Medical Center:

Primary Outcome Measures:
  • Retinal Nerve Fiber Layer (RNFL) thickness [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    The primary outcome will be the average RNFL thickness at 6 months.


Secondary Outcome Measures:
  • Frequency of RNFL swelling [ Time Frame: 1 and 3 months ] [ Designated as safety issue: Yes ]
    The secondary outcome measure will examine the frequency of optic nerves with RNFL swelling between the IV methylprednisolone- and Acthar-treated groups at 1 and 3 months.


Other Outcome Measures:
  • Multifocal Visual Evoked potentials (mfVEP) and Optic Nerve Head Component (ONHP) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    The tertiary outcome will be changes in mfVEP amplitude and latency, ONHP detection, and pupillary diameter (UTSW only). A predefined exploratory outcome will compare the ganglion cell plus inner plexiform layer (GC+IPL) thickness at 6 months between treatment groups.


Estimated Enrollment: 60
Study Start Date: May 2013
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Acthar Gel (ACTH)
15 days of intramuscular (IM) or sub-cutaneous corticotropin (SQ) Acthar (ACTH).
Drug: ACTHAR Gel (ACTH)
15 days of daily injections
Active Comparator: IV methylprednisolone (steroids) with oral taper
3 days of IV methylprednisolone followed by 11 days of oral prednisone
Drug: IV steroids with oral taper
3 days of intravenous methylprednisolone followed by 11 days of oral taper

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Written informed consent must be obtained before any assessment is performed.
  2. Male and female patients aged between 18 and 55 years, inclusive.
  3. Diagnosis of clinically unilateral acute demyelinating optic neuritis (ADON)
  4. Clinical signs and symptoms of ADON starting within the 14 day prior to intended randomization (loss of vision, pain on movement, impairment of color vision).
  5. The qualifying episode of optic neuritis must be the first clinical episode of optic neuritis in the affected eye.
  6. Able to undergo treatment with intravenous methylprednisolone or Acthar gel.

Exclusion Criteria:

  1. Functionally or clinically relevant comorbidity of the affected eye (e.g., glaucoma, amblyopia, optic nerve hypoplasia, macular hole, macular edema, vitreomacular traction, uveitis, diabetes, optic neuritis, or other diseases of the optic nerve or a history thereof).
  2. Bilateral optic neuritis.
  3. Concurrent functionally or clinically relevant disturbances of the eye not affected by ADON.
  4. High clinical likelihood of a form of optic neuritis other than ADON (e.g., no pain on movement, no light perception, severe optic disk edema, atrophic optic disk, retinal exudates, or hemorrhages).
  5. Non-assessable OCT at screening.
  6. Refractive error greater than ±5 diopters or (pre-surgical value to be used for patients having undergone refractive surgery).
  7. Patients with an immune system disorder other than MS or ADON (e.g. rheumatoid arthritis, scleroderma, Sjogren's syndrome, Crohn's disease, ulcerative colitis, etc.) or with a known immunodeficiency syndrome (AIDS, hereditary immune deficiency, drug-induced immune deficiency). Diagnosis of neuromyelitis optica will not exclude a patient from the study but will be accounted for in the data analysis.
  8. Prior treatment with IV methylprednisolone (IVMP) or Acthar gel within the past 30 days.
  9. Treatment with rituximab, mitoxantrone, cyclophosphamide, mycophenolate, azathioprine, alemtuzumab, ocrelizumab, or other non-approved agents for the treatment of relapsing forms of MS.
  10. Concurrent use of 4-aminopyridine.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01838174

Contacts
Contact: Gina Remington, RN, BSN 214-645-0560 gina.remington@utsouthwestern.edu

Locations
United States, Colorado
University of Colorado Denver Recruiting
Aurora, Colorado, United States, 80045
Contact: Jeffrey Bennett, MD, PhD    303-724-6450      
Principal Investigator: Jeffrey Bennett, MD, PhD         
United States, Texas
UT Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390
Contact: Gina Remington, RN, BSN    214-645-0560    gina.remington@utsouthwestern.edu   
Contact: Elliot Frohman, MD, PhD    214-645-0555    elliot.frohman@utsouthwestern.edu   
Principal Investigator: Elliot Frohman, MD, PhD         
Sponsors and Collaborators
Elliot Frohman
University of Colorado, Denver
Questcor Pharmaceuticals, Inc.
Investigators
Principal Investigator: Elliot Frohman, MD, PhD UT Southwestern Medical Center
Principal Investigator: Jeffrey Bennett, MD, PhD University of Colorado, Denver
  More Information

No publications provided

Responsible Party: Elliot Frohman, Professor, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT01838174     History of Changes
Other Study ID Numbers: 06APR2012
Study First Received: April 18, 2013
Last Updated: March 27, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Texas Southwestern Medical Center:
Optic Neuritis

Additional relevant MeSH terms:
Multiple Sclerosis
Neuritis
Optic Neuritis
Autoimmune Diseases
Autoimmune Diseases of the Nervous System
Cranial Nerve Diseases
Demyelinating Autoimmune Diseases, CNS
Demyelinating Diseases
Eye Diseases
Immune System Diseases
Nervous System Diseases
Neuromuscular Diseases
Optic Nerve Diseases
Peripheral Nervous System Diseases
Adrenocorticotropic Hormone
Methylprednisolone
Methylprednisolone Hemisuccinate
Methylprednisolone acetate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Antiemetics
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Autonomic Agents
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids

ClinicalTrials.gov processed this record on November 20, 2014