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Nanocort in Acute Exacerbation of Relapsing-Remitting Multiple Sclerosis (MS) | Clinical Trials | Clareo Health

TERMINATEDPHASE2

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

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)

NCT01039103•Galapagos NV

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

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

Locations (8)

Departement Neurologie AZ St Jan AV

Bruges, Belgium

Nationaal MS Centrum

Melsbroek, Belgium

Revalidatie & MS-centrum Overpelt

Overpelt, Belgium

Krankenhaus Hohe Warte, Neurologische Klinik

Bayreuth, Germany

St. Josef Hospital der Ruhr

Bochum, Germany

Klinikum Rechts der Isar der technischen Universitaet Muenchen, Neurologische Klinik und Poliklinik

München, Germany

Uniwersytecki Szpital Kliniczny w Białymstoku

Bialystok, Poland

Diagnomed-Clinical Research Sp. z o.o.

Katowice, Poland

Key Dates

Start Date

December 1, 2009

Primary Completion Date

November 1, 2011

Completion Date

November 1, 2011

Last Updated

October 6, 2016

Enrollment

ACTUAL participants

Conditions

Acute Exacerbation of Remitting Relapsing Multiple SclerosisClinically Isolated Syndrome

Interventions

PEG-liposomal prednisolone sodium phosphate

DRUG

Methylprednisolone

DRUG

Natalizumab for the Treatment of People With Inflammatory Demyelination Suggestive of Multiple Sclerosis, or Definite Multiple Sclerosis, at First Presentation (AttackMS)

NCT05418010

Multiple SclerosisClinically Isolated Syndrome of Demyelination

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RECRUITINGNA

Predictive Value of the Optic Nerve Involvement in Clinically Isolated Syndrome

NCT06455332

Clinically Isolated SyndromeMultiple Sclerosis

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 6, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Natalizumab for the Treatment of People With Inflammatory Demyelination Suggestive of Multiple Sclerosis, or Definite Multiple Sclerosis, at First Presentation (AttackMS)

Predictive Value of the Optic Nerve Involvement in Clinically Isolated Syndrome

Pregnancy Cohort in Multiple Sclerosis (MS)

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A Study Evaluating B Cell Levels In Infants Of Lactating Women With CIS Or MS Receiving Ocrelizumab

A Study Evaluating B Cell Levels In Infants Potentially Exposed To Ocrelizumab During Pregnancy