Status:
COMPLETED
Safety Study of an Immunomodulating Microparticle to Treat Progressive Multiple Sclerosis
Lead Sponsor:
Innate Immunotherapeutics
Collaborating Sponsors:
Primorus Clinical Trials
National Multiple Sclerosis Society
Conditions:
Secondary Progressive Multiple Sclerosis
Primary Progressive Multiple Sclerosis
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of the study is to determine the safety and tolerability, dose-limiting toxicities, maximum tolerated dose, and recommended therapeutic dose of intravenously administered MIS416 weekly in ...
Detailed Description
This is a single center, open-label, non-randomized, dose-escalation study, to be conducted in two phases: * a dose-escalation (DE) phase, to evaluate the safety, tolerability, MTD, and PD of MIS416 ...
Eligibility Criteria
Inclusion
- At least 18 years of age.
- Diagnosis of MS, by the McDonald criteria.
- Chronic progressive MS (CPMS), defined as either primary progressive MS (PPMS) or secondary progressive MS (SPMS), per the criteria of the National Multiple Sclerosis Society (USA) Advisory Committee on Clinical Trials of New Agents in Multiple Sclerosis. \[NOTE: In the dose-confirmation phase, only subjects with SPMS may be enrolled\].
- MS is clinically active with worsening clinical status within the past 2 years, defined as an increase in EDSS by 1 point or more, sustained for at least 6 months.
- Expanded Disability Status Scale (EDSS) of 2.5 to 7.0 at Screening.
- The following laboratory values must be documented within 3 days prior to initiation of study drug:
- Absolute neutrophil count (ANC) \>= 1 x 109/L
- Platelet count \>= 100 x 109/L
- Serum creatinine =\< 1.5 mg/dL
- AST (SGOT) and ALT (SGPT) =\< 2 × upper limit of normal.
- Provide written informed consent to participate.
Exclusion
- Relapsing-remitting MS or progressive-relapsing MS
- Any immunomodulatory drug therapy or immunosuppressive therapy within the previous six months, or vaccine or systemic corticosteroids within the previous 60 days, prior to initiation of study drug.
- Exposure to other experimental treatments currently under investigation in MS clinical trials, including alemtuzamab, rituximab, fingolimod, and clabribine.
- A diagnosis or history of collagen vascular disease (including Sjögren's syndrome and systemic lupus erythematosus), anticardiolipin antibody syndrome, cerebral autosomal dominant arteriopathy with subcortical infarcts and leukoencephalopathy (CADASIL), sarcoidosis, vasculitis, Bechet's syndrome and/or Lyme disease.
- History of alcohol or drug abuse (with the exception of cannabinoids) within 2 years prior to initiation of study drug.
- Previous exposure to MIS416.
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT01191996
Start Date
August 1 2010
End Date
November 1 2012
Last Update
December 7 2012
Active Locations (1)
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1
Primorus Clinical Trials, 40 Stewart Street
Christchurch, Canterbury, New Zealand, 8011