Recovery of Demyelinating Optic Neuritis After Treatment With Equivalent High Doses of Oral vs. Intravenous Corticosteroids: a Randomized Single Blinded Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- P100 latency of the Visual Evoked Potential in the affected eye
研究概览
简要总结
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.
详细描述
This will be a single-blind, randomized comparison study between 1000mg IV methylprednisolone daily for three days and 1250mg oral prednisone daily for three days of the recovery of optic nerve function in acute demyelinating optic neuritis. We will be comparing assessments at baseline, prior to corticosteroid treatment, with assessments at one and six months post corticosteroid treatment.
Patient Population
We propose to study patients with acute demyelinating optic neuritis where treatment with high dose corticosteroids is being considered. This presentation can be either the first presentation of a demyelinating event (CIS) or in a patient with a previous diagnosis of CIS or MS but must be the first presentation of ON in the affected eye.
Subjects will be recruited from out-patients assessed for acute demyelinating optic neuritis by neurology, ophthalmology, neuro-ophthalmology at London Health Sciences Center and St. Joseph's Health Care Center in London, Ontario. Subjects will be included only if the first visit takes place within 14 days of symptom onset. Only subjects where the physician who identifies/diagnoses the optic neuritis is considering corticosteroid treatment will be contacted for potential screening and enrollment. To ensure treatment is chosen based on the clinical judgement of physician diagnosing ON, the investigators will only contact potential subjects after the decision to use corticosteroids has been made by the patient's treating physician.
Primary and Secondary Endpoints
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
oral prednisone
1250mg oral prednisone daily for 3 days
干预措施: corticosteroids (Drug)
IV methylprednisolone
1000mg IV methylprednisolone daily for 3 days
干预措施: corticosteroids (Drug)
结局指标
主要结局
P100 latency of the Visual Evoked Potential in the affected eye
时间窗: 6 months
次要结局
- 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)
研究者
Sarah Morrow
Assistant Professor of Neurology
London Health Sciences Centre