A Pilot Study of the Safety and Efficacy of SEP-226330 in Subjects with Restless Legs Syndrome

INTERVENTION: Product Name: SEP‐226330 Product Code: (S)‐DDMS Pharmaceutical Form: Capsule* INN or Proposed INN: N/A CAS Number: 259729‐85‐8 Current Sponsor code: SEP‐226330 Other descriptive name: N/A Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10 mg‐ Pharmaceutical form of the placebo: Capsule* Route of administration of the placebo: Oral use Product Name: SEP‐226330 Product Code: (S)‐DDMS Pharmaceutical Form: Capsule* INN or Proposed INN: N/A CAS Number: 259729‐85‐8 Current Sponsor code: SEP‐226330 Other descriptive name: N/A Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 40 mg‐ Pharmaceutical form of the placebo: Capsule* Route of administration of the placebo: Oral use CONDITION: Restless Legs Syndrome (RLS) ; MedDRA version: 7.1 Level: LLT Classification code 10038741 PRIMARY OUTCOME: Main Objective: The primary objective is to compare the efficacy of SEP‐226330 in subjects with Restless Legs Syndrome (RLS) to placebo, as measured by the change from baseline to the end of treatment in the International Restless Legs Syndrome Study Group (IRLSSG) score. Primary end point(s): The primary endpoint will be the change from baseline to the end of the treatment in the IRLSSG score.; ; The key secondary endpoints will include:; · The change from baseline to the end of the treatment in the weekly average of RLS symptom severity during night, measured by the RLS‐6 scale; · The change from baseline to the end of the treatment in the weekly average of CGI score. Secondary Objective: The secondary objectives are:; · To determine the efficacy of SEP‐226330 on hourly periodic limb movement during sleep index (PLMi), as measured by actigraphy; · To determine the effect of SEP‐226330 on quality of life measures; · To assess the safety of SEP‐226330 in doses up to 80 mg taken orally once daily for 14 days.; INCLUSION CRITERIA: 1. Subjects are capable of understanding and complying with the protocol and have signed the informed consent document. Female subjects of childbearing potential must sign the Women of Childbearing Potential Addendum to the informed consent form. 2. Male and female subjects must be between 18 and 64 years of age, inclusive, at the time of consent. 3. All female subjects must have a negative serum pregnancy at Visit 1 and a negative urine pregnancy test prior to Randomization at Visit 3. Female subjects of childbearing potential must be using double barrier contraception and must sign the Women of Childbearing Potential Addendum. Women not of childbearing potential are defined as women who are either surgically sterile or postmenopausal. Postmenopausal women are defined as women with menstruation cessation for 12 consecutive months prior to signing of the informed consent form. 4. Subjects must have a clinical diagnosis of Restless Legs Syndrome