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Optic Neuritis Recovery After Oral or IV Corticosteroids

This study is currently recruiting participants.
Verified August 2012 by London Health Sciences Centre
Sponsor:
Collaborator:
The Physicians' Services Incorporated Foundation
Information provided by (Responsible Party):
Sarah Morrow, London Health Sciences Centre
ClinicalTrials.gov Identifier:
NCT01524250
First received: January 30, 2012
Last updated: August 13, 2012
Last verified: August 2012
History of Changes
  Purpose

Patients aged 18-65 with acute demyelinating optic neuritis where treatment with high dose corticosteroids are already been chosen by the patient and the diagnosing physician will be contacted for screening and enrollment. Patients will then be randomized to receive equivalent doses of either intravenous (IV) or oral corticosteroid treatment. Optic nerve function assessments will be compared at baseline, prior to treatment, one and six months post corticosteroid treatment. This will allow for a comparison on whether the route of medication plays a role in the effectiveness of treatment with high dose corticosteroids.


Condition Intervention Phase
Optic Neuritis
 Drug: corticosteroids
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Recovery of Demyelinating Optic Neuritis After Treatment With Equivalent High Doses of Oral vs. Intravenous Corticosteroids: a Randomized Single Blinded Clinical Trial

Resource links provided by NLM:

MedlinePlus related topics: Steroids
U.S. FDA Resources

Further study details as provided by London Health Sciences Centre:

Primary Outcome Measures:
  • P100 latency of the Visual Evoked Potential in the affected eye [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • High contrast visual acuity [ Time Frame: one and six months ] [ Designated as safety issue: No ]
  • contrast sensitivity [ Time Frame: one and six months ] [ Designated as safety issue: No ]
  • P100 latency of the Visual Evoked Potential in the affected eye [ Time Frame: one month ] [ Designated as safety issue: No ]

Estimated Enrollment: 46
Study Start Date: March 2012
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: oral prednisone
1250mg oral prednisone daily for 3 days
 Drug: corticosteroids
1250mg of oral prednisone daily for 3 days
Active Comparator: IV methylprednisolone
1000mg IV methylprednisolone daily for 3 days
 Drug: corticosteroids
1000mg IV methylprednisolone daily for 3 days

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Males/Females who are ≥ 18 years old and < 65 years old and are capable of understanding and complying with the protocol
  2. Have a diagnosis of unilateral acute demyelinating optic neuritis and will be treated with high dose corticosteroids
  3. Are within 14 days of symptom onset
  4. Have a visual acuity in the affected of eye of ≥ 20/40
  5. Have not received corticosteroids in the last thirty (30) days

  6. Medications that could potentially affect the VEP P100 amplitude or may cause drowsiness/difficulty with visual fixation are allowed if there has been no change in dose within 30 days of study enrollment or anytime during the study. These medications include:

    1. Carbamazepine or other anticonvulsants (45)
    2. Benzodiazepines
    3. Opioid and opiates
    4. Barbiturates
    5. Sleep aids such as zopiclone or trazadone
    6. Tricyclic antidepressants
  7. Have given written informed consent prior to any study related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to his/her future medical care

Exclusion Criteria:

  1. Have another medical condition that could affect the visual outcomes, such as, but not limited to, diabetes retinopathy, glaucoma, cataracts and optic neuropathy not due to a demyelinating lesion
  2. Have had optic neuritis in the same eye previously
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01524250

Contacts
Contact: Sarah A Morrow, MD, FRCPC, MSc 519 663 2993 smorrow8@uwo.ca

Locations
Canada, Ontario
London Health Sciences Center Not yet recruiting
London, Ontario, Canada, N6A 5A5
Principal Investigator: Sarah A Morrow, MD, FRCPC, MSc            
Sub-Investigator: Marcelo Kremenchutzky, MD            
Sub-Investigator: J. Alexander Fraser, MD, FRCPC            
Sub-Investigator: Michael Nicolle, MD, FRCPC, DPhil            
London Health Sciences Center Recruiting
London, Ontario, Canada, N6G1W8
Contact: Heather Rosehart, BScH     519 6858500 ext 18152     heather.rosehart@lhsc.on.ca    
Sponsors and Collaborators
London Health Sciences Centre
The Physicians' Services Incorporated Foundation
  More Information

No publications provided

Responsible Party: Sarah Morrow, Assistant Professor of Neurology, London Health Sciences Centre
ClinicalTrials.gov Identifier: NCT01524250     History of Changes
Other Study ID Numbers: REB 18804
Study First Received: January 30, 2012
Last Updated: August 13, 2012
Health Authority: Ethics Review Committee:

Keywords provided by London Health Sciences Centre:
Multiple Sclerosis
relapse
demyelination
treatment
corticosteroids

Additional relevant MeSH terms:
Neuritis
Optic Neuritis
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Optic Nerve Diseases
Cranial Nerve Diseases
Eye Diseases
Methylprednisolone acetate
Prednisolone acetate
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone
Prednisone
Prednisolone hemisuccinate
 Prednisolone phosphate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents
Protective Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on May 23, 2013