Dose Escalation Study to Evaluate the Penetration and Pharmacodynamic
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
What it found
The trial ended early for another reason (see below).
What was tested
Treatment tested
- Baminercept
Heterotrimeric lymphotoxin LTa1b2 inhibitor|Tumor necrosis factor ligand superfamily member 14 inhibitor
Placebo
- Placebo
What it measured
Main measures
Measure: Change in cerebrospinal fluid levels of secondary lymphoid organs chemokines from baseline with baminercept relative to placebo
after 4 months of treatment
Blood or spinal fluid markers
Other 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)
Safety
Who could take part
Progressive MS · 18 to 57
Show the full 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
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
This is a prospective, randomized, multicenter, dose escalation study to determine subject safety, pharmacokinetic, and pharmacodynamic responses in patients with SPMS
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History
Started
Sept 2010