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)

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
Biogen Idec
ClinicalTrials.gov Identifier:
NCT01181089
First received: August 5, 2010
Last updated: September 12, 2013
Last verified: January 2012
  Purpose

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


Condition Intervention Phase
Secondary Progressive Multiple Sclerosis
Biological: Placebo
Biological: Baminercept
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Biogen Idec:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: Yes ]

Enrollment: 0
Study Start Date: September 2010
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

  Eligibility

Ages Eligible for Study:   18 Years to 57 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Biogen Idec
ClinicalTrials.gov Identifier: NCT01181089     History of Changes
Other Study ID Numbers: 104MS101
Study First Received: August 5, 2010
Last Updated: September 12, 2013
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: Research Ethics Committee

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 April 17, 2014