Secondary Progressive Multiple Sclerosis Clinical Trial
— MAESTRO-01Official title:
A Double-Blind, Placebo Controlled Multicentre Study To Evaluate The Efficacy And Safety Of MBP8298 In Subjects With Secondary Progressive Multiple Sclerosis
The purpose of this study is to determine whether MBP8298 is effective and safe in the
treatment secondary progressive multiple sclerosis.
Dirucotide is generic name for MBP8298.
Status | Completed |
Enrollment | 596 |
Est. completion date | May 2009 |
Est. primary completion date | May 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Documented history of SPMS - Absence of relapse in the 3mos prior to baseline - EDSS of 3.5 - 6.5 - Pyramidal or Cerebellar FSS greater than or equal to 3 - A cohort of 100 HLA DR2/4 negative patients is required. Once enrollment to this cohort is complete, all further patients are required to be HLA DR2/4 positive. - Informed consent - Subject reliability and compliance Exclusion Criteria: - Diagnosis of Primary Progressive MS - Subjects have previously received MBP8298 - Recent history of malignancy, with the exclusion on basal cell carcinoma. - Steroid therapy within 30 days prior to first study specific procedure or any other treatment known to be used for putative or experimental MS treatment - Therapy with beta-interferon, glatiramer acetate within 3 mos or mitoxantrone, cyclophosphamide, methotrexate, azathioprine, or any other immuno-modulating or immunosuppressive drugs including recombinant or non-recombinant cytokines or plasma exchange within 6 mos prior to performance of the first study-specific test, with the exception of corticosteroids or ACTH for relapse treatment. - Initiation or discontinuation of therapy with 4-AP or 3,4-DAP at any time during the study period. - History of anaphylactic/anaphlactoid reactions to glatiramer acetate - Abnormal lab values at the Screening Visit deemed by the Investigator to be clinically significant - Known allergy to Gadolinium-DTPA - Treatment at any time with Cladribine, total lymphoid irradiation, monoclonal antibody treatment - Treatment at any time wtih an altered peptide ligand - Any conditions that could interfere with the performance of study specific procedures e.g.MRI - Previous randomization to this study - Known positivity for HIV, Hepatitis B, or Hepatitis C - Participation in any other non-MS clinical trial within 30 days prior to performance of the first study specific test or any investigational therapy in the past 6 mos. - Females who are breast feeding, pregnant or not using a medically approved method of contraception regularly - Known or suspected current or past alcohol or drug abuse (within the last year) - Any medical, psychiatric or other condition that could result in a subject not being able to give fully informed consent, or to comply with the protocol requirements - Any other condition that, in the investigator's opinion, makes the subject unsuitable for participation in the study |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | St. Michaels Hospital | Toronto | Ontario |
Denmark | Copenhagen University Hospital | Kobenhavn | |
Estonia | West Tallinn Central Hospital | Tallinn | |
Finland | Terveystalo Turku Kuvantaminen | Turku | |
Germany | Heinrich Heine Universitaets | Duesseldorf | |
Latvia | Vecmilgravis Hospital | Riga | |
Netherlands | Maaslandziekenhuis | Sittard | |
Spain | Hospital Duran I Reynals | Barcelona | |
Sweden | Karolinska Universitetssjukhus | Stockholm | |
United Kingdom | Walton Hospital | Liverpool |
Lead Sponsor | Collaborator |
---|---|
Eli Lilly and Company | BioMS Technology Corp. |
Canada, Denmark, Estonia, Finland, Germany, Latvia, Netherlands, Spain, Sweden, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Increase in the time to worsening of disability by Kurtzke Expended Disability Status (EDSS). | baseline, 3mos, 6mos, 9mos, 12mos, 15mos,18mos, 21mos, 24mos | No | |
Secondary | degree of change in EDSS | baseline, 24mos | No | |
Secondary | Brain Atrophy by MRI | baseline, 12mos, 24mos | No | |
Secondary | Activity analysis of T2 and Gadolinium enhancing lesions | 12mos and 24mos | No | |
Secondary | Lesion burden | 12mos and 24mos | No | |
Secondary | Degree of change in MS Functional Composite Index (MSFC) | baseline, 3mos, 6mos, 9mos, 12mos, 15mos, 18mos, 21mos, 24mos | No | |
Secondary | Relapse rates | baseline, 3mos, 6mos, 9mos, 12mos, 15mos,18mos, 21mos, 24mos | No | |
Secondary | Quality of life as measured by Short Form 36 (SF-36) or MSQoL54 | baseline, 6mos, 12mos, 18mos, 24mos | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04239664 -
Acceptance Based Telephone Support When Transitioning to SPMS
|
N/A | |
Active, not recruiting |
NCT04411641 -
Nonrelapsing Secondary Progressive Multiple Sclerosis (NRSPMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168)
|
Phase 3 | |
Completed |
NCT02549703 -
Mitochondrial Dysfunction and Disease Progression
|
||
Terminated |
NCT01416181 -
A Clinical Study of the Efficacy of Natalizumab on Reducing Disability Progression in Participants With Secondary Progressive Multiple Sclerosis
|
Phase 3 | |
Withdrawn |
NCT01181089 -
Dose Escalation Study to Evaluate the Penetration and Pharmacodynamic Effects of Baminercept in the Cerebrospinal Fluid (CSF)and Safety in Subjects With Secondary Progressive Multiple Sclerosis (SPMS)
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT03471338 -
Neuropsychological Management of Multiple Sclerosis: Benefits of a Computerised Semi-autonomous At-home Cognitive Rehabilitation Programme
|
N/A | |
Withdrawn |
NCT05029609 -
Phase 1b Multiple Ascending Dose Study of Foralumab in Primary and Secondary Progressive MS
|
Phase 1 | |
Completed |
NCT02228213 -
Safety and Efficacy Study of MIS416 to Treat Secondary Progressive Multiple Sclerosis
|
Phase 2 | |
Terminated |
NCT02296346 -
Open-Label Study to Evaluate the Efficacy of ECP in Secondary Progressive Multiple Sclerosis
|
N/A | |
Completed |
NCT00559702 -
Safety Study of Natalizumab to Treat Multiple Sclerosis (MS)
|
Phase 1 | |
Terminated |
NCT03283826 -
Phase 1/2 Study to Evaluate the Safety and Efficacy of ATA188 in Subjects With Progressive Multiple Sclerosis
|
Phase 1/Phase 2 | |
Completed |
NCT02253264 -
A Phase 1 Trial of Intrathecal Rituximab for Progressive Multiple Sclerosis Patients
|
Phase 1 | |
Completed |
NCT01737372 -
A Pilot Study to Assess microRNA Biomarkers in Early and Later Stage Multiple Sclerosis
|
N/A | |
Completed |
NCT00257855 -
A Randomised Controlled Trial of Neuroprotection With Lamotrigine in Secondary Progressive Multiple Sclerosis
|
Phase 2 | |
Recruiting |
NCT06292923 -
A Study of Nasal Foralumab in Non-Active Secondary Progressive Multiple Sclerosis Patients
|
Phase 2 | |
Active, not recruiting |
NCT01228396 -
AIMSPRO in the Treatment of Bladder Dysfunction in Secondary Progressive Multiple Sclerosis
|
Phase 2 | |
Completed |
NCT03896217 -
Simvastatin in Secondary Progressive Multiple Sclerosis
|
Phase 2 | |
Completed |
NCT02495766 -
Autologous Mesenchymal Stromal Cells for Multiple Sclerosis
|
Phase 1/Phase 2 | |
Completed |
NCT00813969 -
Autologous Mesenchymal Stem Cell (MSC) Transplantation in MS
|
Phase 1 | |
Completed |
NCT01077466 -
Natalizumab Treatment of Progressive Multiple Sclerosis
|
Phase 2 |