A Pilot Efficacy and Safety Study of IPX159 for the Treament of Restless Legs Syndrome.
IMPAX Pharmaceuticals
28 participants
Feb 12, 2009
Interventional
Conditions
Summary
The primary purpose of this Study is to find out if a new medication can help people that suffer from Restless Leg Syndrome. Over the course of 7 weeks, several assessments will be made to see how a person with restless leg syndrome sleeps and whether or not this medication can reduce their discomfort and therefore improve their quality of life.
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
This is a crossover study with 2 treatment: A. placebo taken orally 3 times a day. B. 30 escalating to 60mg IPX159 taken orally 3 times a day. Patients will be randomised and will have each treatment for 3 weeks. Patients will be exposed to treatment for 3 weeks over a 7-week period. The wash-out period between the 2 treatment arms is 1 week. During the treatment period, Patients will take 1 tablet 3 times a day for the first 2 days, then at day 3, the dose is increased to 2 tablets 3 times a day. If patients can not tolerate the dose increase, they can decrease the dose back down to 1 tablet 3 times a day.
Locations(1)
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ACTRN12608000558325