Study to Compare the Clinical and Radiological Efficacy of 625 mg Versus 1250 mg of Oral Methylprednisolone in Patients With Multiple Sclerosis in Relapse
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|ClinicalTrials.gov Identifier: NCT01986998|
Recruitment Status : Completed
First Posted : November 19, 2013
Last Update Posted : June 3, 2016
|Condition or disease||Intervention/treatment||Phase|
|Multiple Sclerosis||Drug: Methylprednisolone 1250 mg/24h x3 days Drug: Oral Methylprednisolone 625 mg/24h x3 days||Phase 4|
DESIGN: Phase IV clinical trial, multicentre, randomized and double blind, active drug controlled and parallel groups. Patients will be randomised to a high dose of oMP vs a lower-high dose of oral Methylprednisolone (oMP).
SETTING: 9 MS Units from 9 hospitals of the public health system with extensive experience in treating patients with MS and design and participation in clinical trials.
After signing the informed consent, the inclusion and exclusion criteria specific to the study will be checked. The diagnostic test will take place prior to administration of study medication and will include medical history, neurological examination (EDSS measurement) taking of vital signs (blood pressure, heart rate and body temperature) and MRI. Concomitant medication will be checked. Patients will be instructed about the requirements during the study.
The trial medication will be provided to the patient in the medical office (day 1 of the study), where the patient will remain until the intake. This action will be repeated the following 2 days. The latency period from the beginning of the relapse until the start of treatment will be registered. The questionnaires of tolerance will be completed.
Day 1 will be defined as the first day on which first dose of oMP is administered.
Once given the treatment under study, the adverse events reported spontaneously or after question will be collected.
There will be follow-up visits at 7 and 28 days, and 3 months after initiation of treatment. At baseline, prior to drug administration, and on days 7 and 28 after initiation of treatment, a brain MRI with and without contrast will be performed. In case of adverse events or laboratory abnormalities, the patients could have an accessory follow-up visits until resolution.
Randomization will be performed on the day of administration (day 1)
The treatments are:
Group A: Methylprednisolone 1250 mg / day orally for 3 days Group B: Methylprednisolone 625 mg / day orally for 3 days
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||49 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Multicenter, Randomized, Double-blind Clinical Trial to Compare the Clinical and Radiological Efficacy of 625 mg Versus 1250 mg of Oral Methylprednisolone in Patients With Multiple Sclerosis in Relapse.|
|Study Start Date :||October 2013|
|Actual Primary Completion Date :||February 2016|
|Actual Study Completion Date :||March 2016|
Active Comparator: oMP 1250 mg: Group A
Methylprednisolone 1250 mg/24h x3 days
Drug: Methylprednisolone 1250 mg/24h x3 days
Oral Methylprednisolone 1.250 mg daily, over 1 hour and during 3 consecutive days. 13 capsules will be administered (12 capsules of 100 mg and 1 capsule of 50 mg)
Other Name: Group A
Active Comparator: oMP 625 mg: Group B
Methylprednisolone oral 625 mg/24h x3 days
Drug: Oral Methylprednisolone 625 mg/24h x3 days
Oral Methylprednisolone 625 mg daily, over 1 hour and during 3 consecutive days. 13 capsules will be administered (6 capsules of 100 mg, 1 capsule of 25 mg and 6 capsules of placebo with the same appearance of capsules of 100 mg)
Other Name: Group B
- Disability scale of Kurtzke EDSS score [ Time Frame: up to day 91 ]
- Adverse events / tolerability [ Time Frame: Baseline and day 29 ]
- Disability scale of Kurtzke EDSS score [ Time Frame: Baseline and day 8 ]
- The number and volume of active lesions (measured by the T2 or gadolinium enhancement), the number of new active lesions and the percentage of active lesions at baseline that becomes black holes [ Time Frame: day -1 and day 29 ]
- Adverse events / tolerability [ Time Frame: Baseline and day 8 ]
- Questionnaire MSQOL-54 [ Time Frame: Baseline and day 8 ]
- Questionnaire MSQOL-54 [ Time Frame: Baseline and day 29 ]
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): NCT01986998
|Hospital Universitari Germans Trias I Pujol de|
|Badalona, Barcelona, Spain, 08916|
|Hospital Del Mar|
|Barcelona, Spain, 08003|
|Hospital de Mataró|
|Barcelona, Spain, 08034|
|Hospital Clinic I Provincial de Barcelona|
|Barcelona, Spain, 08036|
|Hospital de Sant Joan Despí Moisés Broggi|
|Hospital Universitari de Girona Dr. Josep Trueta|
|Girona, Spain, 17007|
|Hospital Universitari Arnau de Vilanova de Lleida|
|Lleida, Spain, 25198|
|Hospital de Sant Pau I Santa Tecla|
|Principal Investigator:||Cristina Ramo, MD||Germans Trias i Pujol Hospital|