NCT01039103

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)

Terminated Phase 2 Last updated 5 October 2016

What this trial tests

Phase 2 trial testing PEG-liposomal prednisolone sodium phosphate in Acute Exacerbation of Remitting Relapsing Multiple Sclerosis in 15 participants. Terminated before completion.

Timeline

1 December 2009

Primary endpoint
1 November 2011

1 November 2011

Quick facts

Lead sponsor	Lakefront Biotherapeutics NV
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Enrollment	15
Start date	1 December 2009
Primary completion	1 November 2011
Estimated completion	1 November 2011
Sites	8 locations across Belgium, Germany, Poland

Drugs / interventions tested

• PEG-liposomal prednisolone sodium phosphate — full drug profile →
• Methylprednisolone (methylprednisolone) — full drug profile →

Conditions studied

• Acute Exacerbation of Remitting Relapsing Multiple Sclerosis — all drugs for Acute Exacerbation of Remitting Relapsing Multiple Sclerosis →
• Clinically Isolated Syndrome — all drugs for Clinically Isolated Syndrome →

Sponsor

Lakefront Biotherapeutics NV

Who can join

Adults 18 to 65, any sex, with Acute Exacerbation of Remitting Relapsing Multiple Sclerosis or Clinically Isolated Syndrome. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

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

Sponsor's own description

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.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. Prednisolone-containing liposomes accumulate in human atherosclerotic macrophages upon intravenous administration.
   van der Valk FM, van Wijk DF, Lobatto ME, Verberne HJ, et al · · 2015 · cited 114× · PMID 25791806 · DOI 10.1016/j.nano.2015.02.021
2. Pharmacological Approaches to Delaying Disability Progression in Patients with Multiple Sclerosis.
   Wiendl H, Meuth SG. · · 2015 · cited 24× · PMID 26033077 · DOI 10.1007/s40265-015-0411-0
3. An Overview on the Physiopathology of the Blood-Brain Barrier and the Lipid-Based Nanocarriers for Central Nervous System Delivery.
   Susa F, Arpicco S, Pirri CF, Limongi T. · · 2024 · cited 15× · PMID 39065547 · DOI 10.3390/pharmaceutics16070849
4. Design strategies, advances and future perspectives of colon-targeted delivery systems for the treatment of inflammatory bowel disease.
   Zheng B, Wang L, Yi Y, Yin J, et al · · 2024 · cited 14× · PMID 39246510 · DOI 10.1016/j.ajps.2024.100943
5. Advancements in dual-targeting nanoparticle strategies for enhanced atherosclerosis therapy: Overcoming limitations of single-targeting approaches.
   Yang C, Mo L, Zhang G, Dai Y, et al · · 2026 · cited 3× · PMID 41069764 · DOI 10.1016/j.bioactmat.2025.09.023
6. Liposome-Assisted Drug Delivery in the Treatment of Multiple Sclerosis.
   Greco G, Sarpietro MG. · · 2024 · cited 1× · PMID 39407617 · DOI 10.3390/molecules29194689