Nanocort in Acute Exacerbation of Relapsing-Remitting Multiple Sclerosis (MS)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Study Completion Date

2011-11-30

Brief Summary

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Patients with an acute exacerbation of Relapsing-Remitting Multiple Sclerosis or with Clinically Isolated Syndrome receive either one single infusion of Nanocort or three daily infusions of SoluMedrol. Main objective is to assess the occurrence of new gadolinium-enhanced T1-weighted lesions at week 8 vs week 1 after treatment.

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Detailed Description

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Conditions

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Acute Exacerbation of Remitting Relapsing Multiple Sclerosis Clinically Isolated Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

SINGLE

Investigators

Study Groups

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Nanocort

PEG-liposomal prednisolone sodium phosphate (Nanocort) 300 mg intravenous (IV), single dose 500 ml infusion over at least 2 hours on day 1

Group Type EXPERIMENTAL

PEG-liposomal prednisolone sodium phosphate

Intervention Type DRUG

PEG-liposomal prednisolone sodium phosphate 300 mg intravenous (IV), single dose 500 ml infusion over at least 2 hours on day 1

Solu-Medrol

Methylprednisolone (Solu-Medrol) 1 g, IV, infusion over 2 hours on days 1, 2 and 3

Group Type ACTIVE_COMPARATOR

Methylprednisolone

Intervention Type DRUG

Methylprednisolone 1 g, IV, infusion over 2 hours on days 1, 2 and 3

Interventions

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PEG-liposomal prednisolone sodium phosphate

PEG-liposomal prednisolone sodium phosphate 300 mg intravenous (IV), single dose 500 ml infusion over at least 2 hours on day 1

Intervention Type DRUG

Methylprednisolone

Methylprednisolone 1 g, IV, infusion over 2 hours on days 1, 2 and 3

Intervention Type DRUG

Other Intervention Names

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Nanocort Solu-Medrol

Eligibility Criteria

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Inclusion Criteria

* 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
* New neurological symptoms or exacerbation of prior neurological symptoms of over 24 hours duration but \<7 days duration, verified by neurological examination

Exclusion Criteria

* Primary progressive MS.
* Secondary progressive MS without superimposed relapses.
* Received systemic corticosteroids within 4 weeks of screening for treatment of MS or other conditions.
* any contraindication for treatment with (systemic) corticosteroids

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No