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

Sponsor

Boston Scientific Corporation (Industry)

Overall Status

Terminated

CT.gov ID

NCT01037907

Collaborator

(none)

173

Enrollment

Locations

Arms

Duration (Months)

4.9

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Relapsing Remitting Multiple Sclerosis	Drug: Pleneva TM BGC20-0134 Drug: Placebo	Phase 2

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

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

Study Design

Study Type:

Interventional

Actual Enrollment :

173 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, 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

Study Start Date :

Nov 1, 2009

Actual Primary Completion Date :

Dec 1, 2011

Actual Study Completion Date :

Dec 1, 2011

Arms and Interventions

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

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

Outcome Measures

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). [24 weeks]

Secondary Outcome Measures

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]
Brain atrophy [24 weeks]
Cumulative number of new T1 hypointense lesions (black holes) [24 weeks]
Disease burden, T1 and T2 lesion activity at week 48. [48 weeks]
Number of clinical relapses from baseline during the first 24 weeks. [24 weeks]
Change on the Expanded Disability Status Scale (EDSS) during the first 24 weeks [48 weeks]
Number of patients receiving methylprednisolone treatment for a relapse during the first 24 weeks. [48 weeks]
Serum levels of cytokines during the first 24 weeks. [24 weeks]
Quality of life (MSQOL-54) assessment [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. [24 weeks]
Overall safety of BGC20-0134 [48 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

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