Restless Legs Syndrome (RLS) MedDRA version: 7.1 Level: LLT Classification code 10038741
Conditions
Interventions
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
Concentratio
Sponsors
Sepracor, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
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 (RLS) with a score of >15, as determined by the IRLSSG questionnaire, at Visit 1. 5. Subjects must have a self-reported sleep disturbance of 3 or more nights per week with RLS symptoms for greater than 3 months. 6. Subjects must be medication naïve for their RLS or must have discontinued medication for their RLS within 30 days of screening (Visit 1). 7. Subject must be in general good health (defined as the absence of any clinically relevant abnormalities), based on screening physical examination, medical history, 12-lead ECG, and clinical laboratory tests (hematology, serum chemistry and urinalysis). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Subjects who are currently receiving treatment for their RLS or who have taken medication for their RLS within the past 30 days of screening (Visit 1). 2. Subjects who have any clinically significant unstable medical abnormality, chronic disease, or a history of a clinically significant abnormality of the cardiovascular, gastrointestinal, respiratory, hepatic, or renal systems. 3. Subjects who have a history of significant psychiatric illness, such as depression, schizophrenia, anxiety disorders, and eating disorders. 4. Subjects who have a history of cancer within the past 5 years, or current malignancy except for non melanomatous skin cancer. 5. Subjects who test positive at screening (Visit 1) for hepatitis B surface antigen, hepatitis C antibody or have a history of a positive result. 6. Subjects who have a clinically significant clinical laboratory finding (including a positive urine drug screen) or ECG abnormalities during screening. 7. Subjects whose screening serum ferritin level is below 18 ng/mL. 8. Subjects who are known to be seropositive for HIV. 9. Female subjects who are pregnant, lactating or within 6 months post partum. 10. Subjects who have a disorder or history of a condition (e.g., malabsorption, gastrointestinal surgery) that may interfere with drug absorption, distribution, metabolism, or excretion. 11. Subjects who have used any drugs known or suspected to affect hepatic or renal clearance capacity within a period of 30 days prior to screening. 12. Subjects who self-reported consumption of 14 or more alcoholic beverages weekly or five or more alcoholic beverages on any given day. 13. Subjects who have taken any psychotropic medications or other medications known to affect sleep within the 30 days prior to screening visit (Visit 1) or are anticipated to need any of these types of medications during double-blind treatment. 14. Subjects who have participated in any investigational drug or device study within 30 days prior to screening (Visit 1). 15. Subjects who have taken herbal supplements, purported to have central nervous system effects, (tablets, powders, extracts or tinctures) or combination products with herbs or melatonin within 14 days prior to screening (Visit 1) or St. John’s Wort within 30 days prior to screening (Visit 1). 16. Subjects who are currently taking any disallowed mediations for chronic treatment. 17. Subjects who are rotating or (second or third) shift workers. 18. Subjects who are staff members or relatives of a staff members.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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.;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. ;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. | — |
Countries
Iceland
Outcome results
None listed