Amyotrophic Lateral Sclerosis Clinical Trial
Official title:
A Phase 2, Randomised, Double-Blind, Placebo-Controlled Study of IC14 for Treatment of Patients With Rapidly Progressive Motor Neuron Disease
Fifty patients with amyotrophic lateral sclerosis that is progressing rapidly will be randomized to receive either the monoclonal antibody IC14 or placebo to be given intravenously over two hours twice weekly for 12 weeks. Blood and urine tests will be done to measure biomarkers in order to evaluate clinical response and to monitor for safety. Other evaluations include patient questionnaires about function, quality of life and mental function; pulmonary function test; and sniff nasal pressure.
This will be a placebo-controlled, double-blind, parallel-group comparison.
Fifty patients with rapidly progressive ALS will be randomised to receive one of the
following regimens:
- IC14 4 mg/kg given intravenously twice weekly for 12 weeks; or
- Identical-appearing placebo given intravenously twice weekly for 12 weeks. There will be
an interim safety review by an independent Data Safety Monitoring Board after the
initial 20 subjects have completed 4 weeks and 8 weeks of treatment. Study observation
will continue until 12 weeks after the last dose of study drug.
The primary endpoint is:
• Treatment-related change in disease biomarker profiles [e.g., neurofilaments (Nf), urinary
p75 neurotrophin receptor (p75NTR), cytokines, and soluble CD14].
The secondary endpoints are:
- Safety, tolerability and lack of immunogenicity of IC14.
- Treatment-related change in the Revised Amyotrophic Lateral Sclerosis Functional Rating
Scale (ALSFRS-R).
- Treatment-related change in respiratory function by seated forced vital capacity (FVC)
parameters.
- Treatment-related change in inspiratory muscle strength by sniff nasal pressure (SNP)
test.
- Treatment-related change in quality of life by the ALS Specific Quality of Life-Revised
(ALSSQOL-R) score.
- Treatment-related change in cognitive function by Edinburgh Cognitive and Behavioural
Assessment (ECAS) score.
- Treatment-related changes stratified by disease severity and prognostic indicators.
- Peak serum IC14 concentration following administration of the initial dose and peak
serum concentration following a course of treatment.
- Area under the serum IC14 concentration versus time curve (AUC) following administration
of the initial dose and following a course of treatment.
;
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