Clinical trial NCT01037907: A Study of Orally Administered BGC20-0134 (Structured Lipid) in Patients With Relapsing Remitting Multiple Sclerosis (RRMS)
Official title: A Placebo-controlled Phase IIa Study of Orally Administered BGC20-0134/Pleneva TM (Structured Lipid) in Patients With RRMS
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
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
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2009-12-23
Enrollment: 173
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Primary outcomes:
measure: 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).
timeFrame: 24 weeks
Secondary outcomes:
measure: Cumulative number of total GdE T1 weighted lesions developing while on treatment
timeFrame: 24 weeks
measure: Cumulative number of new T2 weighted lesions
timeFrame: 24 weeks
measure: Patients free of GdE (T1-weighted) lesions
timeFrame: 24 weeks
measure: Change in volume of GdE T1 weighted lesions
timeFrame: 24 weeks
measure: Change in volume of T2 lesions
timeFrame: 24 weeks
measure: Brain atrophy
timeFrame: 24 weeks
measure: Cumulative number of new T1 hypointense lesions (black holes)
timeFrame: 24 weeks
measure: Disease burden, T1 and T2 lesion activity at week 48.
timeFrame: 48 weeks
measure: Number of clinical relapses from baseline during the first 24 weeks.
timeFrame: 24 weeks
measure: Change on the Expanded Disability Status Scale (EDSS) during the first 24 weeks
timeFrame: 48 weeks
measure: Number of patients receiving methylprednisolone treatment for a relapse during the first 24 weeks.
timeFrame: 48 weeks
measure: Serum levels of cytokines during the first 24 weeks.
timeFrame: 24 weeks
measure: Quality of life (MSQOL-54) assessment
timeFrame: 48 weeks
measure: PK for determination of circulating levels of BGC20-0134 and plasma concentrations of dihomo-gamma linolenic acid (DHGLA) during the first 24 weeks.
timeFrame: 24 weeks
measure: Overall safety of BGC20-0134
timeFrame: 48 weeks
Other outcomes:
Locations:
city: Gent
country: Belgium
facility: University Hospital Gent
city: Ruddershove
country: Belgium
facility: AZ St. Jan Brugge Oostende AV.
city: Sijsele
country: Belgium
facility: AZ ALMA
city: Amiens
country: France
facility: CHU Amiens-Hôpital Nord-
city: Clermont
country: France
facility: CHU Clermont Ferrand-Hôpital Gabriel Montpied-
city: Strasbourg
country: France
facility: CHRU Strasbourg- Hôpital Civil-1 place de l'hôpital
city: Toulouse
country: France
facility: CHU Toulouse-Hôpital Purpan
city: Bayreuth
country: Germany
facility: Klnik Hohe Warte
city: Berlin
country: Germany
facility: Jüdisches Krankenhaus Berlin
city: Berlin
country: Germany
facility: Universitätsklinikum Charité, Campus Mitte
city: Bochum
country: Germany
facility: Klinikum der Ruhr-Universität Bochum
city: Dusseldorf
country: Germany
facility: Universitätsklinikum der Heinrich-Heine-Universität Düsseldorf
city: Essen
country: Germany
facility: Universitätsklinikum Essen
city: Magdeburg
country: Germany
facility: Universitätsklinikum Magdeburg A.ö.R
city: Osnabrück
country: Germany
facility: Klinikum Osnabrück Klinik für Neurologie
city: Rostock
country: Germany
facility: Universitätsklinikum Rostock AöR
city: Stuttgart
country: Germany
facility: Neurologische und psychiatrische Praxis
city: Ulm
country: Germany
facility: Universitätsklinikum Ulm
city: Gdansk
country: Poland
facility: Medical University of Gdansk Ul. Nowe Ogrody 1-6
city: Katowice
country: Poland
facility: Upper Silezian Medical Center SAM Ul Ziolowa 45/47
city: Lodz
country: Poland
facility: Medical University of Lodz
city: Lublin
country: Poland
facility: Samodzielny Publiczny Szpital Kliniczny
city: St. Petersburg
country: Russian Federation
facility: State Medical University named after I.P. Pavlov
state: Str. L. Tolstogo 6/8
city: Moscow
country: Russian Federation
facility: City hospital # 11 Str. Dvintcev 6
city: Moscow
country: Russian Federation
facility: Moscow regional institute of clinical research named after M.F. Vladimirsky
city: Novgorod
country: Russian Federation
facility: hospital # 33 pr. Lenina 54, Nizniy Novgorod
city: Saratov
country: Russian Federation
facility: City hospital # 9 Str. B. Gornaya 43, Saratov
city: St Petersburg
country: Russian Federation
facility: Institute of Human Brain, str. Acad. Pavlov, St-Petersburg
city: Girona
country: Spain
facility: Hospital Universitari de Girona
state: Avda.De Franca, S/n
city: Badalona
country: Spain
facility: Hospital Universitari Germans Trias i Pujol
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
city: Barcelona
country: Spain
facility: Vall'd Hebron
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañón
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal
city: Santa Cruz de Tenerife
country: Spain
facility: Hospital Universitario Ntra Sra de la Candelaria
Study officials:
References: