A Study of Orally Administered BGC20-0134 (Structured Lipid) in Patien

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

Stopped earlyPhase 2Relapsing MSNCT01037907

What it found

Stopped: not working

The trial was stopped early because the treatment was not working.

Reason given: Lack of efficacy

This trial finished 14 years ago. We found no results in the registry or in any paper that cites it.

What was tested

Treatment tested

  • Pleneva TM BGC20-0134

Placebo

  • Placebo

What it measured

Main 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

    MRI lesions

Other measures (15)

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

    24 weeks

    MRI lesions

  • Cumulative number of new T2 weighted lesions

    24 weeks

    MRI lesions

  • Patients free of GdE (T1-weighted) lesions

    24 weeks

    MRI lesions

  • Change in volume of GdE T1 weighted lesions

    24 weeks

    MRI lesions

  • Change in volume of T2 lesions

    24 weeks

    MRI lesions

  • Brain atrophy

    24 weeks

    Brain volume loss

  • Cumulative number of new T1 hypointense lesions (black holes)

    24 weeks

    MRI lesions

  • Disease burden, T1 and T2 lesion activity at week 48.

    48 weeks

    MRI lesions

  • Number of clinical relapses from baseline during the first 24 weeks.

    24 weeks

    Relapses

  • Change on the Expanded Disability Status Scale (EDSS) during the first 24 weeks

    48 weeks

    Disability progression

Who could take part

Relapsing MS · 18 to 65 · EDSS 0 to 5.5

Show the full 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.

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

Papers

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    History

      1. Started

        Nov 2009

      2. Main results due

        Dec 2011

      3. Finished

        Dec 2011

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