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NCT01181089 Clinical 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)

Secondary Progressive Multiple Sclerosis Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT01181089
Other study ID # 104MS101
Secondary ID
Status Withdrawn
Phase Phase 1/Phase 2
First received August 5, 2010
Last updated September 12, 2013
Start date September 2010

Study information
Verified date January 2012
Source Biogen
Contact n/a
Is FDA regulated No
Health authority United Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited Kingdom: Research Ethics Committee
Study type Interventional

Clinical Trial Summary

This is a prospective, randomized, multicenter, dose escalation study to determine subject safety, pharmacokinetic, and pharmacodynamic responses in patients with SPMS

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

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 57 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Biological:
• Placebo

• Baminercept

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Biogen

Outcome
Type Measure Description Time frame Safety issue
Primary Measure: Change in cerebrospinal fluid levels of secondary lymphoid organs chemokines from baseline with baminercept relative to placebo after 4 months of treatment No
Secondary Number of subjects experiencing Serious Adverse Event (SAE) and Adverse Event (AE) with baminercept relative to placebo 8 months (4 months on drug, 4 months post-drug) Yes
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