Member
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Join Date: Mar 2013
Location: New Jersey
Posts: 832
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Member
Join Date: Mar 2013
Location: New Jersey
Posts: 832
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Summary od Phase II safety trials
Keeping in mind that this was primarily a safety study and only looked at efficacy as a secondary outcome, here is a summary of the Phase II trials:
FINAL OUTCOME
STEADY-PD successfully completed enrollment of 99 subjects at 21 sites over 13 months. The tolerability of isradipine was dose-dependent. Isradipine 10 mg daily dose was the maximally tolerable dosage. The most common adverse events were dosage-dependent peripheral edema and dizziness. While there was no difference in efficacy between treatment arms, the effect size compared to placebo did not rule out possible meaningful clinical benefit. Isradipine had no PD symptomatic effect based on the wash-in or washout analyses. The data supports the use of 10 mg dosage for the future efficacy trial.
There was no symptomatic benefit. However, as I previously posted, you wouldn't necessarily expect anything different if the drug does have neuroprotective potential.
Last edited by Tupelo3; 04-07-2014 at 09:46 AM.
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