Back to resultsDose 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)
Primary Purpose
Secondary Progressive Multiple Sclerosis
Status
Withdrawn
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Placebo
Baminercept
Sponsored by
About this trial
This is an interventional treatment trial for Secondary Progressive Multiple Sclerosis
Eligibility Criteria
Inclusion Criteria:
- A diagnosis of Secondary Progressive Multiple Sclerosis
- Aged 18 to 57 years old, at the time of informed consent
Exclusion Criteria:
- History of clinically important (as determined by the investigator) cardiac, endocrinologic, pulmonary, neurologic, immune, psychiatric, hepatic, renal or hematologic insufficiency or any other major disease other than MS ( Multiple Sclerosis)
- Inability in the opinion of the Investigator to comply with study requirements
- Other protocol-defined criteria may apply
Sites / Locations
Outcomes
Primary Outcome Measures
Measure: Change in cerebrospinal fluid levels of secondary lymphoid organs chemokines from baseline with baminercept relative to placebo
Secondary Outcome Measures
Number of subjects experiencing Serious Adverse Event (SAE) and Adverse Event (AE) with baminercept relative to placebo
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01181089
Brief Title
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)
Official Title
A Multicenter, Randomized, Blinded, Placebo-Controlled, 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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2012
Overall Recruitment Status
Withdrawn
Study Start Date
September 2010 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biogen
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is a prospective, randomized, multicenter, dose escalation study to determine subject safety, pharmacokinetic, and pharmacodynamic responses in patients with SPMS
Detailed Description
This study is a prospective, randomized, placebo-controlled, blinded, dose escalation study of 3 to 4 cohorts with defined number of patients per cohort receiving active drug or placebo for a period of 4 months followed by safety monitoring for an additional 4 months after the last dose
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Secondary Progressive Multiple Sclerosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Type
Biological
Intervention Name(s)
Baminercept
Primary Outcome Measure Information:
Title
Measure: Change in cerebrospinal fluid levels of secondary lymphoid organs chemokines from baseline with baminercept relative to placebo
Time Frame
after 4 months of treatment
Secondary Outcome Measure Information:
Title
Number of subjects experiencing Serious Adverse Event (SAE) and Adverse Event (AE) with baminercept relative to placebo
Time Frame
8 months (4 months on drug, 4 months post-drug)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
57 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
A diagnosis of Secondary Progressive Multiple Sclerosis
Aged 18 to 57 years old, at the time of informed consent
Exclusion Criteria:
History of clinically important (as determined by the investigator) cardiac, endocrinologic, pulmonary, neurologic, immune, psychiatric, hepatic, renal or hematologic insufficiency or any other major disease other than MS ( Multiple Sclerosis)
Inability in the opinion of the Investigator to comply with study requirements
Other protocol-defined criteria may apply
12. IPD Sharing Statement
Learn more about this trial
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)
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