A Phase IV Trial of Neuroprotection With ACTH in Acute Optic Neuritis (ACTHAR)
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|ClinicalTrials.gov Identifier: NCT01838174|
Recruitment Status : Unknown
Verified March 2014 by Elliot Frohman, University of Texas Southwestern Medical Center.
Recruitment status was: Recruiting
First Posted : April 23, 2013
Last Update Posted : March 28, 2014
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 or disease||Intervention/treatment||Phase|
|Multiple Sclerosis||Drug: ACTHAR Gel (ACTH) Drug: IV steroids with oral taper||Phase 4|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Official Title:||A Phase IV Trial of Neuroprotection With ACTH in Acute Optic Neuritis|
|Study Start Date :||May 2013|
|Estimated Primary Completion Date :||August 2014|
|Estimated Study Completion Date :||April 2015|
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
- Retinal Nerve Fiber Layer (RNFL) thickness [ Time Frame: 6 months ]The primary outcome will be the average RNFL thickness at 6 months.
- Frequency of RNFL swelling [ Time Frame: 1 and 3 months ]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.
- Multifocal Visual Evoked potentials (mfVEP) and Optic Nerve Head Component (ONHP) [ Time Frame: 6 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01838174
|Contact: Gina Remington, RN, BSNemail@example.com|
|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 firstname.lastname@example.org|
|Contact: Elliot Frohman, MD, PhD 214-645-0555 email@example.com|
|Principal Investigator: Elliot Frohman, MD, PhD|
|Principal Investigator:||Elliot Frohman, MD, PhD||UT Southwestern Medical Center|
|Principal Investigator:||Jeffrey Bennett, MD, PhD||University of Colorado, Denver|