A randomized, international, multi centre study to assess the efficacy and safety of intravenous PEG-liposomal prednisolone sodium phosphate (Nanocort®) vs intravenous methylprednisolone (Solu-Medrol®) treatment in patients with acute exacerbation of relapsing-remitting Multiple Sclerosis or in patients with clinically isolated syndrome (CIS)

Enceladus Pharmaceuticals BV0 sites90 target enrollmentSeptember 10, 2009

DrugsSolu-Medrol

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Not specified
Sponsor: Enceladus Pharmaceuticals BV
Enrollment: 90
Status: Active, not recruiting
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

September 10, 2009

End Date

TBD

Last Updated

5 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Enceladus Pharmaceuticals BV

Eligibility Criteria

Inclusion Criteria

•Patients who are eligible for inclusion will be female or male patients, 18 to 65 years of age (inclusive), who have a diagnosis of RRMS (per McDonald criteria, 2005\) with dissemination in time and space or a diagnosis of CIS confirmed by MRI. Patients with CIS who only have optic neuritis will be excluded from this study, a maximum Expanded Disability Status Scale (EDSS) score of \= 6\.0, who have new neurological symptoms or exacerbation of prior neurological symptoms of over 24 hours duration but \<7 days duration, verified by neurological examination and who have signed an informed consent.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) yes
•F.1\.2\.1 Number of subjects for this age range 90
•F.1\.3 Elderly (\>\=65 years) no
•F.1\.3\.1 Number of subjects for this age range

Exclusion Criteria

•Patients will be excluded from participation in the study who have
•\-Primary progressive MS.
•\-Secondary progressive MS without superimposed relapses.
•\-Received systemic corticosteroids within 4 weeks of screening for treatment of MS or other conditions. If non\-systemic steroids (topical, inhalation, ocular) are being used for other chronic inflammatory conditions, patients may be included at the discretion of the investigator after discussion with the medical monitor.
•\-Known contraindications or hypersensitivity to parenteral steroids e.g. systemic infection such as mycoses or parasitoses, acute viral infections (herpes zoster, herpes simplex, varicella), hepatitis B surface antigen (HBsAg) positive chronic active hepatitis, immunisations within recent weeks, lymphadenitis after Bacille Calmette\-Guérin (BCG) vaccination, history of psychiatric problems including prior steroid psychosis, gastroduodenal or \-intestinal ulcer, uncontrolled hypertension, severe osteoporosis and narrow\- and wide\-angle glaucoma
•\-Previous treatment with azathioprine, mitoxantrone, natalizumab, intravenous immunoglobulin or plasmapheresis in the last 6 months.
•\-Women who are lactating, pregnant (positive pregnancy test at Screening), or planning to become pregnant during the course of the study.
•\-Unwillingness to use reliable and acceptable contraceptive methods (e.g. implants, injectables, combined oral contraceptives, intrauterine devices \[IUDs], sexual abstinence or vasectomised partner) throughout the study and till 3 months after last study medication administration except for female patients who are surgically sterile (post hysterectomy or at least 1 year post tubal ligation) or at least 2 years postmenopausal.
•\-Any concurrent illness, disability or clinically significant abnormality that may affect the interpretation of clinical efficacy or safety data or prevent the subject from safely completing the assessments required by the protocol.
•\- History of malignancy within the last 5 years with exception of basal cell skin carcinoma