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

NCT01037907 | Terminated Phase 2 DMC

• 1 other identifier: BGC20-0134-02
• Study Type: interventional
• Target: 173
• Locations: 6 countries
• Sites: 35

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.

Conditions

Relapsing Remitting Multiple Sclerosis

Keywords

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; Pleneva TM; BGC20-0134; RRMS

Outcome Measures

Primary Outcomes (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).

  24 weeks

Secondary Outcomes (15)

• Cumulative number of total GdE T1 weighted lesions developing while on treatment

  24 weeks

• Cumulative number of new T2 weighted lesions

  24 weeks

• Patients free of GdE (T1-weighted) lesions

  24 weeks

• Change in volume of GdE T1 weighted lesions

  24 weeks

• Change in volume of T2 lesions

  24 weeks

Study Arms (2)

BGC20-0134 (Pleneva TM)

EXPERIMENTAL

Structured lipid

Drug: Pleneva TM BGC20-0134

Placebo control

PLACEBO COMPARATOR

Placebo - dummy pill

Drug: Placebo

Interventions

Pleneva TM BGC20-0134 DRUG

Placebo or 5 g dose

BGC20-0134 (Pleneva TM)

Placebo DRUG

Placebo or 5 g dose

Placebo control

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (35)

University Hospital Gent

Ghent, Belgium

Location

AZ St. Jan Brugge Oostende AV.

Ruddershove, Belgium

Location

AZ ALMA

Sijsele, Belgium

Location

CHU Amiens-Hôpital Nord-

Amiens, France

Location

CHU Clermont Ferrand-Hôpital Gabriel Montpied-

Clermont, France

Location

CHRU Strasbourg- Hôpital Civil-1 place de l'hôpital

Strasbourg, France

Location

CHU Toulouse-Hôpital Purpan

Toulouse, France

Location

Klnik Hohe Warte

Bayreuth, D-95445, Germany

Location

Jüdisches Krankenhaus Berlin

Berlin, Germany

Location

Universitätsklinikum Charité, Campus Mitte

Berlin, Germany

Location

Klinikum der Ruhr-Universität Bochum

Bochum, Germany

Location

Universitätsklinikum der Heinrich-Heine-Universität Düsseldorf

Düsseldorf, Germany

Location

Universitätsklinikum Essen

Essen, Germany

Location

Universitätsklinikum Magdeburg A.ö.R

Magdeburg, 39120, Germany

Location

Klinikum Osnabrück Klinik für Neurologie

Osnabrück, 49076, Germany

Location

Universitätsklinikum Rostock AöR

Rostock, 18147, Germany

Location

Neurologische und psychiatrische Praxis

Stuttgart, 70191, Germany

Location

Universitätsklinikum Ulm

Ulm, Germany

Location

Medical University of Gdansk Ul. Nowe Ogrody 1-6

Gdansk, Poland

Location

Upper Silezian Medical Center SAM Ul Ziolowa 45/47

Katowice, Poland

Location

Medical University of Lodz

Lodz, Poland

Location

Samodzielny Publiczny Szpital Kliniczny

Lublin, 20-954, Poland

Location

State Medical University named after I.P. Pavlov

Saint Petersburg, Str. L. Tolstogo 6/8, 197022, Russia

Location

City hospital # 11 Str. Dvintcev 6

Moscow, Russia

Location

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

Moscow, Russia

Location

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

Saint Petersburg, Russia

Location

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

Saratov, Russia

Location

hospital # 33 pr. Lenina 54, Nizniy Novgorod

Veliky Novgorod, Russia

Location

Hospital Universitari de Girona

Girona, Avda.De Franca, S/n, 17007, Spain

Location

Hospital Universitari Germans Trias i Pujol

Badalona, Spain

Location

Hospital Clinic de Barcelona

Barcelona, Spain

Location

Vall'd Hebron

Barcelona, Spain

Location

Hospital General Universitario Gregorio Marañón

Madrid, 28007, Spain

Location

Hospital Universitario Ramón y Cajal

Madrid, 28034, Spain

Location

Hospital Universitario Ntra Sra de la Candelaria

Santa Cruz de Tenerife, 38010, Spain

Location

Related Links

• Sponsor's website

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting; Demyelinating Diseases; Camurati-Engelmann Syndrome

Condition Hierarchy (Ancestors)

Multiple Sclerosis; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Autoimmune Diseases; Immune System Diseases; Osteochondrodysplasias; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2009
• First Posted: December 23, 2009
• Study Start: November 1, 2009
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: June 3, 2022

Record last verified: 2022-06

Locations

PL (4); DE (11); FR (4); RU (6); BE (3); ES (7)