Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:27 PM
Ignite Modification Date:
2025-12-24 @ 3:27 PM
NCT ID:
NCT00753792
Eligibility Criteria:
Inclusion Criteria:
1. To have been diagnosed MS Remittent Recurrent according to Mc Donald 20052 criteria.
2. To have an EDSS between 0 and 5 before the relapse.
3. The symptoms have begun after at least one month of previous stability.
4. The symptoms have started maximum 15 days before the inclusion.
5. The patient is capable of having an adequate communication with the investigator and to carry out with the clinical trial requisites.
6. To be or not to be with allowed immunomodulatory therapy (IFN-B /AG).
7. To be capable and to be willing to ingest the medication.
Exclusion Criteria:
1. First inflammatory neurological episode (relapse).
2. Multiple sclerosis secondary progressive or primary progressive.
3. The symptoms have gone on for less than 24 hours.
4. To be in treatment or have been treated with corticoids during the three months before.
5. Patients in treatment with immunosuppressors (azathioprine, mitoxantrone, ciclofosfamide...)
6. Pregnancy or breastfeeding or women in fertile age who don't use contraceptives measurements.
7. Illnesses with contraindication treatment with corticoids.
8. Antecedents of serious adverse effects or hypersensitive to related study medication.
9. Patients who wouldn´t be able to perform periodic RMN explorations, patients who are not collaborative or who need anesthesia.
10. Patients with intolerance to lactose.
11. Patients with allergy to contrast used in RMN.
12. Patients with chronic kidney disease.
13. Patients in treatment with natalizumab.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
59 Years
Study:
NCT00753792
Study Brief:
Protocol Section:
NCT00753792