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

Relapsing Remitting Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01037907
• Other study ID #: BGC20-0134-02
• Status: Terminated
• Phase: Phase 2
• Start date: November 2009
• Est. completion date: December 2011

Study information

• Verified date: June 2022
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 173
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Relapsing Remitting Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• Pleneva TM BGC20-0134
Placebo or 5 g dose
• Placebo
Placebo or 5 g dose

Locations

Country	Name	City	State
Belgium	University Hospital Gent	Gent
Belgium	AZ St. Jan Brugge Oostende AV.	Ruddershove
Belgium	AZ ALMA	Sijsele
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
Germany	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	Dusseldorf
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
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
Russian Federation	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	State Medical University named after I.P. Pavlov	St. Petersburg	Str. L. Tolstogo 6/8
Spain	Hospital Universitari Germans Trias i Pujol	Badalona
Spain	Hospital Clinic de Barcelona	Barcelona
Spain	Vall'd Hebron	Barcelona
Spain	Hospital Universitari de Girona	Girona	Avda.De Franca, S/n
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

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Countries where clinical trial is conducted

Belgium,  France,  Germany,  Poland,  Russian Federation,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Cumulative number of total GdE T1 weighted lesions developing while on treatment		24 weeks
Secondary	Cumulative number of new T2 weighted lesions		24 weeks
Secondary	Patients free of GdE (T1-weighted) lesions		24 weeks
Secondary	Change in volume of GdE T1 weighted lesions		24 weeks
Secondary	Change in volume of T2 lesions		24 weeks
Secondary	Brain atrophy		24 weeks
Secondary	Cumulative number of new T1 hypointense lesions (black holes)		24 weeks
Secondary	Disease burden, T1 and T2 lesion activity at week 48.		48 weeks
Secondary	Number of clinical relapses from baseline during the first 24 weeks.		24 weeks
Secondary	Change on the Expanded Disability Status Scale (EDSS) during the first 24 weeks		48 weeks
Secondary	Number of patients receiving methylprednisolone treatment for a relapse during the first 24 weeks.		48 weeks
Secondary	Serum levels of cytokines during the first 24 weeks.		24 weeks
Secondary	Quality of life (MSQOL-54) assessment		48 weeks
Secondary	PK for determination of circulating levels of BGC20-0134 and plasma concentrations of dihomo-gamma linolenic acid (DHGLA) during the first 24 weeks.		24 weeks
Secondary	Overall safety of BGC20-0134		48 weeks

External Links

•   Sponsor's website