A Study of Orally Administered BGC20-0134 (Structured Lipid) in Patients With Relapsing Remitting Multiple Sclerosis (RRMS)
- Conditions
- Relapsing Remitting Multiple Sclerosis
- Interventions
- Drug: Pleneva TM BGC20-0134Drug: Placebo
- Registration Number
- NCT01037907
- Lead Sponsor
- Boston Scientific Corporation
- Brief Summary
To determine the efficacy and safety of an oral drug (BGC20-0134) in patients with relapsing remitting multiple sclerosis. Specifically, the cumulative number of new gadolinium enhancing lesions after 24 weeks of treatment with BGC20-0134.
- Detailed Description
Primary outcome measure:
The cumulative number of new GdE T1 lesions developing while on treatment.
Secondary outcome measures:
* MRI:
* Cumulative number of total GdE T1 lesions developing while on treatment
* Cumulative number of new T2 lesions
* Patients free of GdE (T1-weighted) lesions at week 24
* Change in volume of GdE T1
* Brain atrophy
* Cumulative number of new T1 hypointense lesions (black holes)
* Disease burden, T1 and T2 lesion activity at week 48.
* Number of clinical relapses from baseline to the end of treatment. • Change on the Expanded Disability Status Scale (EDSS)
* Number of patients requiring methylprednisolone treatment for a relapse.
* Serum levels of pro- and anti-inflammatory cytokines.
* Quality of life (MSQOL-54)
Eligibility Criteria
MS-Related inclusion criteria
1. Diagnosis of relapsing MS according to the revised 2005 McDonald criteria.
2. Has shown disease activity defined by 1 or more MS attack within the last year which has been documented in prior medical notes and or the presence of active lesions on historical scans being either (based on radiology report or investigator review of MRI):
1. Gd-enhancing on any scan obtained in the last year, or
2. new T2 lesions between two scans both obtained within the last year.
3. A minimum total of 9 T2 lesions reported on a recent MRI obtained within 1 month prior to the screening visit.
3. Baseline EDSS score 0 - 5.5.
4. Has refused to be treated with approved disease modifying therapies available for MS, for any reason and once the investigator has fully informed the patient about the related benefits and potential adverse events associated with such treatments. Also, patients for whom such treatments have proved to be intolerable.
Exclusion Criteria:
1. Has experienced an MS relapse or received systemic corticosteroids or adrenocorticotropic hormone (ACTH) in the previous 1 month.
2. Has a secondary progressive (SPMS), progressive relapsing (PRMS), or primary progressive MS (PPMS).
3. Has received any of the following agents to treat MS (approved or unapproved):
* Within the previous 3 months: interferon beta, glatiramer acetate, intravenous immunoglobulin or plasmapheresis.
* Within the previous 12 months: natalizumab, daclizumab, cytapheresis, azathioprine, cladribine, cyclophosphamide, methotrexate, mitoxantrone, mycophenolate, pixantrone, sirolimus, tacrolimus, or other agents typically used to prevent transplant rejection or as cancer chemotherapy, excluding hormonal treatments.
* Ever having received: stem cell or bone marrow transplant, total lymphoid irradiation, vaccine therapy for MS, or monoclonal antibodies whose effects may be longer than 1 year (such as alemtuzumab or rituximab).
* Within the previous 3 months: any other agents given for the non-symptomatic treatment of MS which are not included above, including over-the-counter, herbal and nutritional supplements. However, if the agent is being taken primarily to treat another medical condition, then it is allowed as long as the dose is unchanged within the previous 3 months and is unlikely to change before week
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 173
- Diagnosis of relapsing MS according to the revised 2005 McDonald criteria
- Has shown disease activity defined by 1 or more MS attack within the last year which has been documented in prior medical notes and or the presence of active lesions on historical scans being either (based on radiology report or investigator review of MRI):
- Gd-enhancing on any scan obtained in the last year, or
- new T2 lesions between two scans both obtained within the last year
- A minimum total of 9 T2 lesions reported on a recent MRI obtained within 1 month prior to the screening visit
- Baseline EDSS score 0 - 5.5
- Has refused to be treated with approved disease modifying therapies available for MS, for any reason and once the investigator has fully informed the patient about the related benefits and potential adverse events associated with such treatments. Also, patients for whom such treatments have proved to be intolerable
- Has experienced an MS relapse or received systemic corticosteroids or adrenocorticotropic hormone (ACTH) in the previous 1 month
- Has a secondary progressive (SPMS), progressive relapsing (PRMS), or primary progressive MS (PPMS).
- Has received any of the following agents to treat MS (approved or unapproved):
- Within the previous 3 months: interferon beta, glatiramer acetate, intravenous immunoglobulin or plasmapheresis
- Within the previous 12 months: natalizumab, daclizumab, cytapheresis, azathioprine, cladribine, cyclophosphamide, methotrexate, mitoxantrone, mycophenolate, pixantrone, sirolimus, tacrolimus, or other agents typically used to prevent transplant rejection or as cancer chemotherapy, excluding hormonal treatments
- Ever having received: stem cell or bone marrow transplant, total lymphoid irradiation, vaccine therapy for MS, or monoclonal antibodies whose effects may be longer than 1 year (such as alemtuzumab or rituximab)
- Within the previous 3 months: any other agents given for the non-symptomatic treatment of MS which are not included above, including over-the-counter, herbal and nutritional supplements. However, if the agent is being taken primarily to treat another medical condition, then it is allowed as long as the dose is unchanged within the previous 3 months and is unlikely to change before week 24.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BGC20-0134 (Pleneva TM) Pleneva TM BGC20-0134 Structured lipid Placebo control Placebo Placebo - dummy pill
- Primary Outcome Measures
Name Time Method The cumulative number of new gadolinium-enhanced (GdE) T1 weighted lesions developing while on treatment (specifically the sum of new GdE T1 lesions seen on MRI at weeks 12, 16, 20 and 24). 24 weeks
- Secondary Outcome Measures
Name Time Method Cumulative number of new T1 hypointense lesions (black holes) 24 weeks Cumulative number of new T2 weighted lesions 24 weeks Change in volume of T2 lesions 24 weeks Number of clinical relapses from baseline during the first 24 weeks. 24 weeks Cumulative number of total GdE T1 weighted lesions developing while on treatment 24 weeks Patients free of GdE (T1-weighted) lesions 24 weeks Change in volume of GdE T1 weighted lesions 24 weeks Brain atrophy 24 weeks Disease burden, T1 and T2 lesion activity at week 48. 48 weeks Change on the Expanded Disability Status Scale (EDSS) during the first 24 weeks 48 weeks Number of patients receiving methylprednisolone treatment for a relapse during the first 24 weeks. 48 weeks Serum levels of cytokines during the first 24 weeks. 24 weeks Quality of life (MSQOL-54) assessment 48 weeks PK for determination of circulating levels of BGC20-0134 and plasma concentrations of dihomo-gamma linolenic acid (DHGLA) during the first 24 weeks. 24 weeks Overall safety of BGC20-0134 48 weeks
Trial Locations
- Locations (35)
Upper Silezian Medical Center SAM Ul Ziolowa 45/47
🇵🇱Katowice, Poland
Medical University of Lodz
🇵🇱Lodz, Poland
Universitätsklinikum Essen
🇩🇪Essen, Germany
Universitätsklinikum Magdeburg A.ö.R
🇩🇪Magdeburg, Germany
Jüdisches Krankenhaus Berlin
🇩🇪Berlin, Germany
Samodzielny Publiczny Szpital Kliniczny
🇵🇱Lublin, Poland
University Hospital Gent
🇧🇪Gent, Belgium
AZ St. Jan Brugge Oostende AV.
🇧🇪Ruddershove, Belgium
City hospital # 11 Str. Dvintcev 6
🇷🇺Moscow, Russian Federation
Klinikum Osnabrück Klinik für Neurologie
🇩🇪Osnabrück, Germany
AZ ALMA
🇧🇪Sijsele, Belgium
Universitätsklinikum Rostock AöR
🇩🇪Rostock, Germany
Hospital Universitari Germans Trias i Pujol
🇪🇸Badalona, Spain
Hospital Clinic de Barcelona
🇪🇸Barcelona, Spain
Universitätsklinikum Ulm
🇩🇪Ulm, Germany
CHRU Strasbourg- Hôpital Civil-1 place de l'hôpital
🇫🇷Strasbourg, France
CHU Amiens-Hôpital Nord-
🇫🇷Amiens, France
Vall'd Hebron
🇪🇸Barcelona, Spain
Universitätsklinikum Charité, Campus Mitte
🇩🇪Berlin, Germany
Hospital Universitari de Girona
🇪🇸Girona, Avda.De Franca, S/n, Spain
Klinikum der Ruhr-Universität Bochum
🇩🇪Bochum, Germany
Klnik Hohe Warte
🇩🇪Bayreuth, Germany
Universitätsklinikum der Heinrich-Heine-Universität Düsseldorf
🇩🇪Dusseldorf, Germany
Medical University of Gdansk Ul. Nowe Ogrody 1-6
🇵🇱Gdansk, Poland
Hospital Universitario Ramón y Cajal
🇪🇸Madrid, Spain
Hospital Universitario Ntra Sra de la Candelaria
🇪🇸Santa Cruz de Tenerife, Spain
Neurologische und psychiatrische Praxis
🇩🇪Stuttgart, Germany
CHU Toulouse-Hôpital Purpan
🇫🇷Toulouse, France
CHU Clermont Ferrand-Hôpital Gabriel Montpied-
🇫🇷Clermont, France
State Medical University named after I.P. Pavlov
🇷🇺St. Petersburg, Str. L. Tolstogo 6/8, Russian Federation
hospital # 33 pr. Lenina 54, Nizniy Novgorod
🇷🇺Novgorod, Russian Federation
Institute of Human Brain, str. Acad. Pavlov, St-Petersburg
🇷🇺St Petersburg, Russian Federation
City hospital # 9 Str. B. Gornaya 43, Saratov
🇷🇺Saratov, Russian Federation
Hospital General Universitario Gregorio Marañón
🇪🇸Madrid, Spain
Moscow regional institute of clinical research named after M.F. Vladimirsky
🇷🇺Moscow, Russian Federation