Trial Information

Summary: A study to assess the efficacy and safety of an investigational drug for the treatment of patients who has Restless Leg Syndrome (RLS) requiring extended treatment coverage.

Inclusion Criteria:

• Patient has been diagnosed with RLS.
• Patient has had a minimum of 15 nights of RLS symptoms during the previous month. This condition can be waived for those who are currently on RLS treatment, but the patient needs to discontinue that treatment for at least 10 consecutive nights before he/she can enter into the study.
• During the screening period, the patient must have RLS symptoms for 4 of the last 7 nights immediately prior to enrollment.
• Patient must be experiencing RLS symptoms no earlier than 5 pm, and prior to bedtime.
• Patient is a male or female between 18 to 80 years of age.

Exclusion Criteria:

• Patient who has other primary sleep and/or movement disorder.
• Patient who has RLS due to other diseases or causes.
• Patient who would not benefit from extended dosing of the trial drug.
• Patient who has medical condition that might affect assessment of efficacy of the trial drug difficult.
• Patient whose symptoms got worse after receiving and completing treatment for RLS, and whose symptoms got worse during the treatment of RLS.
• Alcohol or substance abuse within the past year.
• Patient on certain medications known to induce drowsiness, affect RLS or sleep. These patients will need to discontinue these medications for a period, with some exceptions.
• Patient who has extreme levels of blood pressure.
• Women of childbearing potential who are not practicing a clinically accepted method of contraception.
• Patient who has an abnormal sleep pattern or habit.
• Participation in another clinical trial within one month prior to enrollment.
• Patient who is on Hormone Replacement Therapy (HRT), but is not on a stable dose within 10 days prior to enrollment. They have to fulfill a stabilization period.

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