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)

• Sponsor: Biogen (Industry)
• Overall Status: Withdrawn
• CT.gov ID: NCT01181089
• Collaborator: (none)
• Enrollment: 0

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Secondary Progressive Multiple Sclerosis	Biological: Placebo; Biological: Baminercept	Phase 1/Phase 2

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 0 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• 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 Start Date: Sep 1, 2010

Outcome Measures

Primary Outcome Measures

1. Measure: Change in cerebrospinal fluid levels of secondary lymphoid organs chemokines from baseline with baminercept relative to placebo [after 4 months of treatment]

Secondary Outcome Measures

1. 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)]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 57 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Biogen

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Biogen
• ClinicalTrials.gov Identifier: NCT01181089
• Other Study ID Numbers: 104MS101
• First Posted: Aug 13, 2010
• Last Update Posted: Sep 16, 2013
• Last Verified: Jan 1, 2012

• Additional relevant MeSH terms: Neoplasm Metastasis; Multiple Sclerosis; Multiple Sclerosis, Chronic Progressive; Sclerosis

Study Results

No Results Posted as of Sep 16, 2013