Towards the Improvement of the Treatment of Acute Relapses in Multiple Sclerosis: A Randomized Double-blind, Non-inferiority Controlled Trial Comparing Intranasal Versus Intravenous Methylprednisolone
试验速览
- 阶段
- 2 期
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Patients' score on the Expanded Disability Status Scale (EDSS) before and after treatment to assess clinical efficacy of treatments
研究概览
简要总结
This Clinical Trial evaluates the nasal administration of Methylprednisolone as a treatment strategy for Acute Relapses in Multiple Sclerosis
详细描述
This is a prospective, comparative, randomized, double-blind study adhered to the principles established by the Helsinki Declaration, including informed consent. Patients with a diagnosis of Relapsing-Remitting Multiple Sclerosis (RRMS) from the National Institute of Neurology and Neurosurgery (INNN) that are coursing with acute recurrency will be included. The recruited patients will be organized into two paired groups of 40 patients each, of which group 1 will receive 1g IV methylprednisolone, and group 2 will receive the intranasal dose equivalent to 1g of IV methylprednisolone. Clinical symptoms will be measured with the Expanded Disability Status Scale (EDSS) and data will be complemented with results of clinical tests, general laboratories and serum concentration of MP and inflammatory markers. Adverse effects in each group will also be identified and quantified. Statistical analysis: descriptive, assumption of normality, bivariate comparison of means and multivariate, in addition to intention to treat.
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 (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 65 years.
- •Diagnosis of RRMS with an evolution from diagnosis of 3 months to 10 years.
- •Kurtzke Expanded Disability Status Scale (EDSS) from 1 to 6 (grade 6 includes patients with unilateral aid to ambulate)
- •No contraindication for the administration of MP.
- •Agree to participate in the study by means of a signed informed consent
排除标准
- •Intake of anti-inflammatory steroids in the last 3 days.
- •Patients with active bacterial, viral or fungal infections or undergoing treatment.
- •Patients with hypertension.
- •Patients with diabetes mellitus.
- •Patients with hypo or hyperthyroidism.
- •Patients with glaucoma.
- •Patients with neoplasms.
- •Diagnosis of systemic diseases such as: cardiovascular, pulmonary, hepatic, endocrine, gastrointestinal, etc.
- •Patients with suspected or confirmed pregnancy by means of serum or urinary laboratory tests.
- •Breastfeeding patients.
- •Patients with a history of resistance to glucocorticoids.
- •Patients with a history of severe adverse reactions to glucocorticoids.
- •Patients with a history of hyposmia or anosmia.
- •Patients diagnosed with active sinusitis.
- •Patients with allergic rhinitis.
- •Patients with upper respiratory tract infections.
- •deviated septum
- •History of nasal surgery.
研究组 & 干预措施
Standard Intravenous Methylprednisolone treatment in relapsing-remittent multiple sclerosis
Intravenous methylprednisolone is the standard treatment for a multiple sclerosis relapse. Thus, 40 randomly enrolled patients aged 18-65 years with relapsing-remitting multiple sclerosis that assist to the hospital and confirmed with a relapse, will be treated with intravenous methylprednisolone, 1000 mg, once a day for 3 days for moderate relapses or 5 days for severe ones.
A written informed consent will be obtained from each participant or a legal representative whenever the participant could not provide consent.
干预措施: IV Methylprednisolone administration (Other)
Intranasal Methylprednisolone administration in relapsing-remittent multiple sclerosis
Nasal Methylprednisolone Administration For this group, 40 randomly enrolled patients aged 18-65 years with relapsing-remitting multiple sclerosis that assist to the hospital and confirmed with a relapse, will be treated with intranasal methylprednisolone administration (1000 mg once a day for 3 days for moderate relapses or 5 days for severe ones) using a Mucosal Atomization Device (MAD Nasal).
A written informed consent will be obtained from each participant or a legal representative whenever the participant could not provide consent
干预措施: Nasal Methylprednisolone (MT) (Drug)
结局指标
主要结局
Patients' score on the Expanded Disability Status Scale (EDSS) before and after treatment to assess clinical efficacy of treatments
时间窗: Days 0 and 30 after treatment
* The Expanded Disability Status Scale has a minimum score of 0, when the patient has no MS-related disability or abnormalities, and a maximum score of 10, when death is caused by MS. * Patients will be assessed with the EDSS prior to treatment and 30 days after the treatment ends
次要结局
- Concentration of inflammatory cytokines and chemokines in peripheral blood before, during, and after treatment(Days 0, 5 and 30 after treatment)
研究者
Edda Sciutto Conde
Principal Investigator
Universidad Nacional Autonoma de Mexico