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

This study has been terminated.
(Lack of efficacy)
Sponsor:
Information provided by:
BTG International Inc.
ClinicalTrials.gov Identifier:
NCT01037907
First received: December 21, 2009
Last updated: July 25, 2013
Last verified: July 2013
  Purpose

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 Intervention Phase
Relapsing Remitting Multiple Sclerosis
Drug: Pleneva TM BGC20-0134
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by BTG International Inc.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cumulative number of total GdE T1 weighted lesions developing while on treatment [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Cumulative number of new T2 weighted lesions [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Patients free of GdE (T1-weighted) lesions [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Change in volume of GdE T1 weighted lesions [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Change in volume of T2 lesions [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Brain atrophy [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Cumulative number of new T1 hypointense lesions (black holes) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Disease burden, T1 and T2 lesion activity at week 48. [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • Number of clinical relapses from baseline during the first 24 weeks. [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
  • Change on the Expanded Disability Status Scale (EDSS) during the first 24 weeks [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
  • Number of patients receiving methylprednisolone treatment for a relapse during the first 24 weeks. [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
  • Serum levels of cytokines during the first 24 weeks. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Quality of life (MSQOL-54) assessment [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Overall safety of BGC20-0134 [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 173
Study Start Date: November 2009
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01037907

Locations
Belgium
University Hospital Gent
Gent, Belgium
AZ St. Jan Brugge Oostende AV.
Ruddershove, Belgium
AZ ALMA
Sijsele, Belgium
France
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
Germany
Klnik Hohe Warte
Bayreuth, Germany, D-95445
Universitätsklinikum Charité, Campus Mitte
Berlin, Germany
Jüdisches Krankenhaus Berlin
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
Poland
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
Spain
Hospital Universitari de Girona
Girona, Avda.De Franca, s/n, Spain, 17007
Hospital Universitari Germans Trias i Pujol
Badalona, Spain
Vall'd Hebron
Barcelona, Spain
Hospital Clinic de Barcelona
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.
Investigators
Study Director: Fayaz Master BTG International Inc.
  More Information

Additional Information:
No publications provided

Responsible Party: Professor Xavier Montalban, Vall d'Hebron University Hospital Barcelona
ClinicalTrials.gov Identifier: NCT01037907     History of Changes
Other Study ID Numbers: BGC20-0134-02
Study First Received: December 21, 2009
Last Updated: July 25, 2013
Health Authority: Germany: Ethics Commission
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Spain: Comité Ético de Investigación Clínica
Belgium: Federal Agency for Medicinal Products and Health Products
Italy: Ministry of Health
Poland: Ethics Committee
Russia: Pharmacological Committee, Ministry of Health

Keywords provided by BTG International Inc.:
Oral treatment for MS
Oral drug for multiple sclerosis
Oral RRMS
Oral relapsing remitting multiple sclerosis
Gamma Linolenic Acid
GLA
Fatty acid
Triglyceride
Structured lipid
MRI
Magnetic resonance imaging
gadolinium enhancing lesions
expanded disability status scale
EDSS
Demyelination
Remyelination
TGFB1
Transforming growth factor beta 1
cytokines
disease modifying therapy
immunomodulator
Anti inflammatory
Pro inflammatory
TNF alpha
interleukin 1 beta
interferon gamma
Fayaz Master
Omega 6
Polyunsaturated fatty acid
Cytokine balance

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

ClinicalTrials.gov processed this record on July 29, 2014