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)

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01181089
• Date of registration: 05/08/2010
• Primary sponsor: Biogen Idec
• Public 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)
• Scientific 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
• Date of first enrolment: September 2010
• Target sample size: 0
• Recruitment status: Withdrawn
• URL: http://clinicaltrials.gov/show/NCT01181089
• 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

Countries of recruitment

Canada, United Kingdom

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 57 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Secondary Progressive Multiple Sclerosis

Intervention(s)

Biological: Baminercept

Biological: Placebo

Primary Outcome(s)

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(s)

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)]

Secondary ID(s)

104MS101

Source(s) of Monetary Support

Please refer to primary and secondary sponsors