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

NCT ID: NCT01037907

Last Updated: 2022-06-03

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 173 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-11-30
• Study Completion Date: 2011-12-31

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

Conditions

Relapsing Remitting Multiple Sclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

BGC20-0134 (Pleneva TM)

Structured lipid

Group Type: EXPERIMENTAL

Pleneva TM BGC20-0134

Intervention Type: DRUG

Placebo or 5 g dose

Placebo control

Placebo - dummy pill

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo or 5 g dose

Interventions

Pleneva TM BGC20-0134

Placebo or 5 g dose

Intervention Type: DRUG

Placebo

Placebo or 5 g dose

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston Scientific Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University Hospital Gent

Ghent, , Belgium

AZ St. Jan Brugge Oostende AV.

Ruddershove, , Belgium

AZ ALMA

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

Jüdisches Krankenhaus Berlin

Berlin, , Germany

Universitätsklinikum Charité, Campus Mitte

Berlin, , Germany

Klinikum der Ruhr-Universität Bochum

Bochum, , Germany

Universitätsklinikum der Heinrich-Heine-Universität Düsseldorf

Düsseldorf, , Germany

Universitätsklinikum Essen

Essen, , Germany

Universitätsklinikum Magdeburg A.ö.R

Magdeburg, , Germany

Klinikum Osnabrück Klinik für Neurologie

Osnabrück, , Germany

Universitätsklinikum Rostock AöR

Rostock, , Germany

Neurologische und psychiatrische Praxis

Stuttgart, , Germany

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

State Medical University named after I.P. Pavlov

Saint Petersburg, Str. L. Tolstogo 6/8, Russia

City hospital # 11 Str. Dvintcev 6

Moscow, , Russia

Moscow regional institute of clinical research named after M.F. Vladimirsky

Moscow, , Russia

Institute of Human Brain, str. Acad. Pavlov, St-Petersburg

Saint Petersburg, , Russia

City hospital # 9 Str. B. Gornaya 43, Saratov

Saratov, , Russia

hospital # 33 pr. Lenina 54, Nizniy Novgorod

Veliky Novgorod, , Russia

Hospital Universitari de Girona

Girona, Avda.De Franca, S/n, Spain

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

Hospital Universitario Ramón y Cajal

Madrid, , Spain

Hospital Universitario Ntra Sra de la Candelaria

Santa Cruz de Tenerife, , Spain

Countries

Belgium; France; Germany; Poland; Russia; Spain

Related Links

http://www.btgplc.com

Sponsor's website

Other Identifiers

BGC20-0134-02

Identifier Type: -

Identifier Source: org_study_id