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)
Status and phase
Withdrawn
Phase 2
Phase 1
Conditions
Secondary Progressive Multiple Sclerosis
Treatments
Biological: Baminercept
Biological: Placebo
Details and patient eligibility
About
This is a prospective, randomized, multicenter, dose escalation study to determine subject safety, pharmacokinetic, and pharmacodynamic responses in patients with SPMS
Full 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
Sex
All
Ages
18 to 57 years old
Volunteers
No Healthy Volunteers
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
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Single Group Assignment
Masking
Triple Blind
Trial contacts and locations
0
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Data sourced from clinicaltrials.gov
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