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

Phase 2

Terminated

• Conditions: Clinically Isolated Syndrome; Acute Exacerbation of Remitting Relapsing Multiple Sclerosis
• Interventions: Drug: PEG-liposomal prednisolone sodium phosphate; Drug: Methylprednisolone

• Registration Number: NCT01039103
• Lead Sponsor: Galapagos NV

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-12
• Study First Submitted: 2009-12-20
• Study First Submitted QC: 2009-12-22
• Study First Posted: 2009-12-24
• Primary Completion: 2011-11
• Study Completion: 2011-11
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-05
• Last Update Posted: 2016-10-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nanocort	PEG-liposomal prednisolone sodium phosphate	PEG-liposomal prednisolone sodium phosphate (Nanocort) 300 mg intravenous (IV), single dose 500 ml infusion over at least 2 hours on day 1
Solu-Medrol	Methylprednisolone	Methylprednisolone (Solu-Medrol) 1 g, IV, infusion over 2 hours on days 1, 2 and 3

Primary Outcome Measures

Name	Time	Method
Change in gadolinium-enhanced T1-weighted lesions according to the McDonald criteria (2005) from Day 8 to Week 8.	8 weeks

Secondary Outcome Measures

Name	Time	Method
Change in gadolinium-enhanced T1-weighted lesions according to the McDonald criteria (2005) from Day 8 to Week 4.	4 weeks
Clinical response measured by changes in MSFC	12 weeks
Plasma levels of free prednisolone and prednisolone phosphate	12 weeks
Occurrence of adverse events	12 weeks
Quality of life measured by changes in MSIS-29	12 weeks

Trial Locations

Locations (8)

Diagnomed-Clinical Research Sp. z o.o.; 🇵🇱 Katowice, Poland

St. Josef Hospital der Ruhr; 🇩🇪 Bochum, Germany

Klinikum Rechts der Isar der technischen Universitaet Muenchen, Neurologische Klinik und Poliklinik; 🇩🇪 Muenchen, Germany

Revalidatie & MS-centrum Overpelt; 🇧🇪 Overpelt, Belgium

Krankenhaus Hohe Warte, Neurologische Klinik; 🇩🇪 Bayreuth, Germany

Departement Neurologie AZ St Jan AV; 🇧🇪 Brugge, Belgium

Uniwersytecki Szpital Kliniczny w Białymstoku; 🇵🇱 Białystok, Poland

Nationaal MS Centrum; 🇧🇪 Melsbroek, Belgium