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

June 2, 2022 updated by: Boston Scientific Corporation

A Placebo-controlled Phase IIa Study of Orally Administered BGC20-0134/Pleneva TM (Structured Lipid) in Patients With RRMS

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

173

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
24 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Cumulative number of total GdE T1 weighted lesions developing while on treatment
Time Frame: 24 weeks
24 weeks
Cumulative number of new T2 weighted lesions
Time Frame: 24 weeks
24 weeks
Patients free of GdE (T1-weighted) lesions
Time Frame: 24 weeks
24 weeks
Change in volume of GdE T1 weighted lesions
Time Frame: 24 weeks
24 weeks
Change in volume of T2 lesions
Time Frame: 24 weeks
24 weeks
Brain atrophy
Time Frame: 24 weeks
24 weeks
Cumulative number of new T1 hypointense lesions (black holes)
Time Frame: 24 weeks
24 weeks
Disease burden, T1 and T2 lesion activity at week 48.
Time Frame: 48 weeks
48 weeks
Number of clinical relapses from baseline during the first 24 weeks.
Time Frame: 24 weeks
24 weeks
Change on the Expanded Disability Status Scale (EDSS) during the first 24 weeks
Time Frame: 48 weeks
48 weeks
Number of patients receiving methylprednisolone treatment for a relapse during the first 24 weeks.
Time Frame: 48 weeks
48 weeks
Serum levels of cytokines during the first 24 weeks.
Time Frame: 24 weeks
24 weeks
Quality of life (MSQOL-54) assessment
Time Frame: 48 weeks
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.
Time Frame: 24 weeks
24 weeks
Overall safety of BGC20-0134
Time Frame: 48 weeks
48 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston Scientific Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (ACTUAL)

December 1, 2011

Study Completion (ACTUAL)

December 1, 2011

Study Registration Dates

First Submitted

December 21, 2009

First Submitted That Met QC Criteria

December 22, 2009

First Posted (ESTIMATE)

December 23, 2009

Study Record Updates

Last Update Posted (ACTUAL)

June 3, 2022

Last Update Submitted That Met QC Criteria

June 2, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BGC20-0134-02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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