A Study for Patients With Secondary Progressive Multiple Sclerosis (MAESTRO-01)
This study has been completed.
Sponsor:
Eli Lilly and Company
Collaborator:
BioMS Technology Corp.
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00869726
First received: March 24, 2009
Last updated: May 27, 2010
Last verified: May 2010
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Secondary Progressive Multiple Sclerosis |
Drug: dirucotide Drug: Placebo |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Double-Blind, Placebo Controlled Multicentre Study To Evaluate The Efficacy And Safety Of MBP8298 In Subjects With Secondary Progressive Multiple Sclerosis |
Resource links provided by NLM:
Genetics Home Reference related topics:
multiple sclerosis
MedlinePlus related topics:
Multiple Sclerosis
U.S. FDA Resources
Further study details as provided by Eli Lilly and Company:
Primary Outcome Measures:
- Increase in the time to worsening of disability by Kurtzke Expended Disability Status (EDSS). [ Time Frame: baseline, 3mos, 6mos, 9mos, 12mos, 15mos,18mos, 21mos, 24mos ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- degree of change in EDSS [ Time Frame: baseline, 24mos ] [ Designated as safety issue: No ]
- Brain Atrophy by MRI [ Time Frame: baseline, 12mos, 24mos ] [ Designated as safety issue: No ]
- Activity analysis of T2 and Gadolinium enhancing lesions [ Time Frame: 12mos and 24mos ] [ Designated as safety issue: No ]
- Lesion burden [ Time Frame: 12mos and 24mos ] [ Designated as safety issue: No ]
- Degree of change in MS Functional Composite Index (MSFC) [ Time Frame: baseline, 3mos, 6mos, 9mos, 12mos, 15mos, 18mos, 21mos, 24mos ] [ Designated as safety issue: No ]
- Relapse rates [ Time Frame: baseline, 3mos, 6mos, 9mos, 12mos, 15mos,18mos, 21mos, 24mos ] [ Designated as safety issue: No ]
- Quality of life as measured by Short Form 36 (SF-36) or MSQoL54 [ Time Frame: baseline, 6mos, 12mos, 18mos, 24mos ] [ Designated as safety issue: No ]
| Enrollment: | 596 |
| Study Start Date: | December 2004 |
| Study Completion Date: | May 2009 |
| Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Dirucotide |
Drug: dirucotide
500mg, intravenous, dosed once every six months for 18 months
Other Names:
|
| Placebo Comparator: Placebo |
Drug: Placebo
intravenous, once every six months for 18 months
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00869726
Locations
| Canada, Ontario | |
| St. Michaels Hospital | |
| Toronto, Ontario, Canada, M5B 1W8 | |
| Denmark | |
| Copenhagen University Hospital | |
| Kobenhavn, Denmark, 2100 | |
| Estonia | |
| West Tallinn Central Hospital | |
| Tallinn, Estonia, 10617 | |
| Finland | |
| Terveystalo Turku Kuvantaminen | |
| Turku, Finland, 20101 | |
| Germany | |
| Heinrich Heine Universitaets | |
| Duesseldorf, Germany, 40225 | |
| Latvia | |
| Vecmilgravis Hospital | |
| Riga, Latvia, 1015 | |
| Netherlands | |
| Maaslandziekenhuis | |
| Sittard, Netherlands, 6131 BK | |
| Spain | |
| Hospital Duran I Reynals | |
| Barcelona, Spain, 08907 | |
| Sweden | |
| Karolinska Universitetssjukhus | |
| Stockholm, Sweden, 14186 | |
| United Kingdom | |
| Walton Hospital | |
| Liverpool, United Kingdom, L97LJ | |
Sponsors and Collaborators
Eli Lilly and Company
BioMS Technology Corp.
Investigators
| Study Director: | Call 1-877-CTLILLY (1-877-285-4559) or 317-615-4559 Mon-Fri 9am-5pm Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company |
More Information
No publications provided
| Responsible Party: | Chief Medical Officer, Eli Lilly |
| ClinicalTrials.gov Identifier: | NCT00869726 History of Changes |
| Other Study ID Numbers: | 12788, I3E-BM-MSAB, MBP8298-01 |
| Study First Received: | March 24, 2009 |
| Last Updated: | May 27, 2010 |
| Health Authority: | Canada: Health Canada United States: Food and Drug Administration Denmark: Danish Medicines Agency Estonia: The State Agency of Medicine Finland: Finnish Medicines Agency Germany: Federal Institute for Drugs and Medical Devices Latvia: State Agency of Medicines Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) Spain: Spanish Agency of Medicines Sweden: Medical Products Agency United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Additional relevant MeSH terms:
|
Multiple Sclerosis Sclerosis Multiple Sclerosis, Chronic Progressive Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System |
Nervous System Diseases Demyelinating Diseases Autoimmune Diseases Immune System Diseases Pathologic Processes |
ClinicalTrials.gov processed this record on May 16, 2013