Acute Exacerbation of Remitting Relapsing Multiple SclerosisPhase 2NCT01039103
Nanocort in Acute Exacerbation of Relapsing-Remitting Multiple Sclerosis (MS)
A Phase 2 study testing PEG-liposomal prednisolone sodium phosphate and Methylprednisolone in people with Acute Exacerbation of Remitting Relapsing Multiple Sclerosis and Clinically Isolated Syndrome, run by Lakefront Biotherapeutics NV at 8 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Acute Exacerbation of Remitting Relapsing Multiple Sclerosis, Clinically Isolated Syndrome
- What is being tested?
- PEG-liposomal prednisolone sodium phosphate and Methylprednisolone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 8 sitesin 3 countries
- Study dates
- Dec 2009to Nov 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
8 sites in 3 countries.
8 sites in 3 countries
Belgium3 sites
Departement Neurologie AZ St Jan AV
Bruges, 8000
Nationaal MS Centrum
Melsbroek, 1820
Revalidatie & MS-centrum Overpelt
Overpelt, B-3900
Germany3 sites
Krankenhaus Hohe Warte, Neurologische Klinik
Bayreuth, 95445
St. Josef Hospital der Ruhr
Bochum, 44791
Klinikum Rechts der Isar der technischen Universitaet Muenchen, Neurologische Klinik und Poliklinik
München, 81675
Poland2 sites
Uniwersytecki Szpital Kliniczny w Białymstoku
Bialystok, 15-276
Diagnomed-Clinical Research Sp. z o.o.
Katowice, 40-594
About this study
Official title: 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)
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.
- Conditions
- Acute Exacerbation of Remitting Relapsing Multiple Sclerosis, Clinically Isolated Syndrome
- Being tested
- PEG-liposomal prednisolone sodium phosphate, Methylprednisolone
- Keywords
- PEG-liposomal prednisolone sodium phosphate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEG-liposomal prednisolone sodium phosphateDrug
Also called Nanocort
PEG-liposomal prednisolone sodium phosphate 300 mg intravenous (IV), single dose 500 ml infusion over at least 2 hours on day 1
Also called Solu-Medrol
Methylprednisolone 1 g, IV, infusion over 2 hours on days 1, 2 and 3
| Study group | Role | What they receive |
|---|---|---|
| Nanocort | Experimental | PEG-liposomal prednisolone sodium phosphate (Nanocort) 300 mg intravenous (IV), single dose 500 ml infusion over at least 2 hours on day 1 Receives: Drug: PEG-liposomal prednisolone sodium phosphate |
| Solu-Medrol | Active comparator | Methylprednisolone (Solu-Medrol) 1 g, IV, infusion over 2 hours on days 1, 2 and 3 Receives: Drug: Methylprednisolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in gadolinium-enhanced T1-weighted lesions according to the McDonald criteria (2005) from Day 8 to Week 8.
Measured: 8 weeks
Secondary outcomes (5)
Change in gadolinium-enhanced T1-weighted lesions according to the McDonald criteria (2005) from Day 8 to Week 4.
Measured: 4 weeks
Quality of life measured by changes in MSIS-29
Measured: 12 weeks
Clinical response measured by changes in MSFC
Measured: 12 weeks
Plasma levels of free prednisolone and prednisolone phosphate
Measured: 12 weeks
Occurrence of adverse events
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2009 (estimated)
- Study startDec 2009
- Primary completionNov 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Exacerbation of Remitting Relapsing Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lakefront Biotherapeutics NV
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Johan Beetens, PhD, Study director, Lakefront Biotherapeutics NV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01039103
- Sponsor's protocol ID
- GLPG0303-CL-204
- Other IDs
- 2009-013884-21, 2009
- Status last verified
- Oct 2016
- First submitted
- 20 Dec 2009
- Last updated
- 6 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT01039103
- Acronym / sponsor ID
- GLPG0303-CL-204
- Conditions
- Acute Exacerbation of Remitting Relapsing Multiple Sclerosis, Clinically Isolated Syndrome
- Keywords
- PEG-liposomal prednisolone sodium phosphate
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Lakefront Biotherapeutics NVIndustry (pharma, biotech, devices)
- Study start
- Dec 2009
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 24 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nanocort | Experimental | Drug: PEG-liposomal prednisolone sodium phosphatePEG-liposomal prednisolone sodium phosphate (Nanocort) 300 mg intravenous (IV), single dose 500 ml infusion over at least 2 hours on day 1 |
| Solu-Medrol | Active comparator | Drug: MethylprednisoloneMethylprednisolone (Solu-Medrol) 1 g, IV, infusion over 2 hours on days 1, 2 and 3 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PEG-liposomal prednisolone sodium phosphateAlso: NanocortPEG-liposomal prednisolone sodium phosphate 300 mg intravenous (IV), single dose 500 ml infusion over at least 2 hours on day 1 | Drug | Nanocort |
| MethylprednisoloneAlso: Solu-MedrolMethylprednisolone 1 g, IV, infusion over 2 hours on days 1, 2 and 3 | Drug | Solu-Medrol |
Primary outcome
Change in gadolinium-enhanced T1-weighted lesions according to the McDonald criteria (2005) from Day 8 to Week 8.
Time frame: 8 weeks
5 secondary outcomes
Change in gadolinium-enhanced T1-weighted lesions according to the McDonald criteria (2005) from Day 8 to Week 4.
Time frame: 4 weeks
Quality of life measured by changes in MSIS-29
Time frame: 12 weeks
Clinical response measured by changes in MSFC
Time frame: 12 weeks
Plasma levels of free prednisolone and prednisolone phosphate
Time frame: 12 weeks
Occurrence of adverse events
Time frame: 12 weeks
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2016.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Johan Beetens, PhD study director
Lakefront Biotherapeutics NV
8 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PEG-liposomal prednisolone sodium phosphate and Methylprednisolone in people with Acute Exacerbation of Remitting Relapsing Multiple Sclerosis and Clinically Isolated Syndrome, run by Lakefront Biotherapeutics NV at 8 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Belgium, Germany, Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in gadolinium-enhanced T1-weighted lesions according to the McDonald criteria (2005) from Day 8 to Week 8. (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2016.