Trial Information

Summary: A study to assess the safety, efficacy and tolerability of an investigational drug for the treatment of Restless Leg Syndrome (RLS) on as needed basis.

Inclusion Criteria:

• Male or female patient of 18 to 80 years of age.
• Patient is diagnosed with RLS.
• Symptoms must occur no earlier than 5 pm, and prior to bedtime.
• Patient must experience sleep disturbance when RLS symptoms are present.
• Patient should meet the required frequency of RLS symptoms, or stop any medication they are currently receiving for RLS treatment. This discontinuation of medication period is generally 14 consecutive nights.
• Female of non-childbearing potential, or of childbearing potential who has negative pregnancy test at screening and using an acceptable method of birth control.

Exclusion Criteria:

• Patient who has RLS symptoms occurring more than 3 days a week.
• Who has RLS due to other diseases or causes, such as excessive caffeine and/or alcohol, and unable to quit.
• Patient whose symptoms got worse after receiving and completing treatment for RLS, and whose symptoms got worse during the treatment of RLS.
• Patient who has other primary sleep and/or movement disorder.
• Patient who has extreme levels of blood pressure.
• Patient who has an abnormal sleep pattern or habit.
• Patient who has a positive pregnancy test or who are lactating at screening.
• Some restrictions for patients on Hormone Replacement Therapy (HRT) or on certain medications.
• Patient who is enrolled in any other study within 3 months of enrollment.

If you would like to learn more about participating in this study, please send an e-mail message using the form below.