NCT01524250

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Mar 2012

Typical duration for phase_2

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 30, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 1, 2012

Completed
29 days until next milestone

Study Start

First participant enrolled

March 1, 2012

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

September 2, 2015

Status Verified

September 1, 2015

Enrollment Period

3.2 years

First QC Date

January 30, 2012

Last Update Submit

September 1, 2015

Conditions

Optic Neuritis

Keywords

Multiple Sclerosisrelapsedemyelinationtreatmentcorticosteroids

Outcome Measures

Primary Outcomes (1)

  • P100 latency of the Visual Evoked Potential in the affected eye

    6 months

Secondary Outcomes (3)

  • High contrast visual acuity

    one and six months

  • contrast sensitivity

    one and six months

  • P100 latency of the Visual Evoked Potential in the affected eye

    one month

Study Arms (2)

oral prednisone

EXPERIMENTAL

1250mg oral prednisone daily for 3 days

Drug: corticosteroids

IV methylprednisolone

ACTIVE COMPARATOR

1000mg IV methylprednisolone daily for 3 days

Drug: corticosteroids

Interventions

corticosteroidsDRUG

1250mg of oral prednisone daily for 3 days

oral prednisone

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Males/Females who are ≥ 18 years old and \< 65 years old and are capable of understanding and complying with the protocol
  • Have a diagnosis of unilateral acute demyelinating optic neuritis and will be treated with high dose corticosteroids
  • Are within 14 days of symptom onset
  • Have a visual acuity in the affected of eye of ≥ 20/40
  • Have not received corticosteroids in the last thirty (30) days
  • 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:
  • Carbamazepine or other anticonvulsants (45)
  • Benzodiazepines
  • Opioid and opiates
  • Barbiturates
  • Sleep aids such as zopiclone or trazadone
  • Tricyclic antidepressants
  • 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

You may not qualify if:

  • 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
  • Have had optic neuritis in the same eye previously

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

London Health Sciences Center

London, Ontario, N6A 5A5, Canada

Location

London Health Sciences Center

London, Ontario, N6G1W8, Canada

Location

Related Publications (1)

  • Morrow SA, Fraser JA, Day C, Bowman D, Rosehart H, Kremenchutzky M, Nicolle M. Effect of Treating Acute Optic Neuritis With Bioequivalent Oral vs Intravenous Corticosteroids: A Randomized Clinical Trial. JAMA Neurol. 2018 Jun 1;75(6):690-696. doi: 10.1001/jamaneurol.2018.0024.

    PMID: 29507942DERIVED

MeSH Terms

Conditions

Optic NeuritisMultiple SclerosisRecurrenceDemyelinating Diseases

Interventions

Adrenal Cortex Hormones

Condition Hierarchy (Ancestors)

Optic Nerve DiseasesCranial Nerve DiseasesNervous System DiseasesEye DiseasesDemyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemAutoimmune DiseasesImmune System DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

HormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Neurology

Study Record Dates

First Submitted

January 30, 2012

First Posted

February 1, 2012

Study Start

March 1, 2012

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

September 2, 2015

Record last verified: 2015-09

Locations

CA(2)