SPIDOL study protocol for the assessment of intrathecal ziconotide antalgic efficacy for ... - Trials
The study involves a 45-month trial with 8 centers, recruiting patients over 24 months for ziconotide or placebo treatment phases, each lasting 6 months, with a 1-month wash-out period. Patients undergo LP or continuous infusion tests to determine response, with responders implanted with continuous infusion pumps. The study includes detailed visit schedules, randomization procedures, and statistical analysis plans to evaluate pain reduction and patient satisfaction.
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The study involves a 45-month trial with 8 centers, recruiting patients over 24 months for ziconotide or placebo treatment phases, each lasting 6 months, with a 1-month wash-out period. Patients undergo LP or continuous infusion tests to determine response, with responders implanted with continuous infusion pumps. The study includes detailed visit schedules, randomization procedures, and statistical analysis plans to evaluate pain reduction and patient satisfaction.