Working... Menu

A Study of Orally Administered BGC20-0134 (Structured Lipid) in Patients With Relapsing Remitting Multiple Sclerosis (RRMS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01037907
Recruitment Status : Terminated (Lack of efficacy)
First Posted : December 23, 2009
Last Update Posted : July 29, 2013
Information provided by:
BTG International Inc.

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.

Condition or disease Intervention/treatment Phase
Relapsing Remitting Multiple Sclerosis Drug: Pleneva TM BGC20-0134 Drug: Placebo Phase 2

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 173 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Placebo-controlled Phase IIa Study of Orally Administered BGC20-0134/Pleneva TM (Structured Lipid) in Patients With RRMS
Study Start Date : November 2009
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: BGC20-0134 (Pleneva TM)
Structured lipid
Drug: Pleneva TM BGC20-0134
Placebo or 5 g dose

Placebo Comparator: Placebo control
Placebo - dummy pill
Drug: Placebo
Placebo or 5 g dose

Primary Outcome Measures :
  1. 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). [ Time Frame: 24 weeks ]

Secondary Outcome Measures :
  1. Cumulative number of total GdE T1 weighted lesions developing while on treatment [ Time Frame: 24 weeks ]
  2. Cumulative number of new T2 weighted lesions [ Time Frame: 24 weeks ]
  3. Patients free of GdE (T1-weighted) lesions [ Time Frame: 24 weeks ]
  4. Change in volume of GdE T1 weighted lesions [ Time Frame: 24 weeks ]
  5. Change in volume of T2 lesions [ Time Frame: 24 weeks ]
  6. Brain atrophy [ Time Frame: 24 weeks ]
  7. Cumulative number of new T1 hypointense lesions (black holes) [ Time Frame: 24 weeks ]
  8. Disease burden, T1 and T2 lesion activity at week 48. [ Time Frame: 48 weeks ]
  9. Number of clinical relapses from baseline during the first 24 weeks. [ Time Frame: 24 weeks ]
  10. Change on the Expanded Disability Status Scale (EDSS) during the first 24 weeks [ Time Frame: 48 weeks ]
  11. Number of patients receiving methylprednisolone treatment for a relapse during the first 24 weeks. [ Time Frame: 48 weeks ]
  12. Serum levels of cytokines during the first 24 weeks. [ Time Frame: 24 weeks ]
  13. Quality of life (MSQOL-54) assessment [ Time Frame: 48 weeks ]
  14. PK for determination of circulating levels of BGC20-0134 and plasma concentrations of dihomo-gamma linolenic acid (DHGLA) during the first 24 weeks. [ Time Frame: 24 weeks ]
  15. Overall safety of BGC20-0134 [ Time Frame: 48 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01037907

Layout table for location information
University Hospital Gent
Gent, Belgium
AZ St. Jan Brugge Oostende AV.
Ruddershove, Belgium
Sijsele, Belgium
CHU Amiens-Hôpital Nord-
Amiens, France
CHU Clermont Ferrand-Hôpital Gabriel Montpied-
Clermont, France
CHRU Strasbourg- Hôpital Civil-1 place de l'hôpital
Strasbourg, France
CHU Toulouse-Hôpital Purpan
Toulouse, France
Klnik Hohe Warte
Bayreuth, Germany, D-95445
Jüdisches Krankenhaus Berlin
Berlin, Germany
Universitätsklinikum Charité, Campus Mitte
Berlin, Germany
Klinikum der Ruhr-Universität Bochum
Bochum, Germany
Universitätsklinikum der Heinrich-Heine-Universität Düsseldorf
Dusseldorf, Germany
Universitätsklinikum Essen
Essen, Germany
Universitätsklinikum Magdeburg A.ö.R
Magdeburg, Germany, 39120
Klinikum Osnabrück Klinik für Neurologie
Osnabrück, Germany, 49076
Universitätsklinikum Rostock AöR
Rostock, Germany, 18147
Neurologische und psychiatrische Praxis
Stuttgart, Germany, 70191
Universitätsklinikum Ulm
Ulm, Germany
Medical University of Gdansk Ul. Nowe Ogrody 1-6
Gdansk, Poland
Upper Silezian Medical Center SAM Ul Ziolowa 45/47
Katowice, Poland
Medical University of Lodz
Lodz, Poland
Samodzielny Publiczny Szpital Kliniczny
Lublin, Poland, 20-954
Russian Federation
State Medical University named after I.P. Pavlov
St. Petersburg, Str. L. Tolstogo 6/8, Russian Federation, 197022
City hospital # 11 Str. Dvintcev 6
Moscow, Russian Federation
Moscow regional institute of clinical research named after M.F. Vladimirsky
Moscow, Russian Federation
hospital # 33 pr. Lenina 54, Nizniy Novgorod
Novgorod, Russian Federation
City hospital # 9 Str. B. Gornaya 43, Saratov
Saratov, Russian Federation
Institute of Human Brain, str. Acad. Pavlov, St-Petersburg
St Petersburg, Russian Federation
Hospital Universitari de Girona
Girona, Avda.De Franca, s/n, Spain, 17007
Hospital Universitari Germans Trias i Pujol
Badalona, Spain
Hospital Clinic de Barcelona
Barcelona, Spain
Vall'd Hebron
Barcelona, Spain
Hospital General Universitario Gregorio Marañón
Madrid, Spain, 28007
Hospital Universitario Ramón y Cajal
Madrid, Spain, 28034
Hospital Universitario Ntra Sra de la Candelaria
Santa Cruz de Tenerife, Spain, 38010
Sponsors and Collaborators
BTG International Inc.
Layout table for investigator information
Study Director: Fayaz Master BTG International Inc.

Additional Information:
Layout table for additonal information
Responsible Party: Professor Xavier Montalban, Vall d'Hebron University Hospital Barcelona Identifier: NCT01037907     History of Changes
Other Study ID Numbers: BGC20-0134-02
First Posted: December 23, 2009    Key Record Dates
Last Update Posted: July 29, 2013
Last Verified: July 2013

Keywords provided by BTG International Inc.:
Gamma Linolenic Acid
Fatty acid
Polyunsaturated fatty acid
Oral treatment for MS
Oral drug for multiple sclerosis
Oral relapsing remitting multiple sclerosis
Structured lipid
Magnetic resonance imaging
gadolinium enhancing lesions
expanded disability status scale
Transforming growth factor beta 1
disease modifying therapy
Anti inflammatory
Pro inflammatory
TNF alpha
interleukin 1 beta
interferon gamma
Fayaz Master
Omega 6
Cytokine balance

Additional relevant MeSH terms:
Layout table for MeSH terms
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases