Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 5:04 AM
Ignite Modification Date:
2025-12-25 @ 5:04 AM
NCT ID:
NCT01332318
Eligibility Criteria:
Inclusion Criteria:
* Men or women who were 21 through 65 years of age and fluent in English;
* Subjects with RLS, based on the IRLSSG Diagnostic Criteria;
* Currently a licensed and experienced driver who has driven an average of 3 or more times/week for the past 3 years;
* Able to successfully complete the 5 minute practice simulated driving test at Screening;
* History of RLS symptoms at least 15 nights in the prior month or, if on treatment, this frequency of symptoms before treatment was started;
* Total RLS severity score of 15 or greater on the IRLS Rating Scale;
* Documented RLS symptoms for at least 4 of the 7 consecutive evenings/nights Discontinuation of treatments for RLS (e.g., opioids, benzodiazepines, dopamine agonists and/or gabapentin) at least 2 weeks prior to Screening; -
* Body Mass Index of 34 or below;
* Estimated creatinine clearance of at least 60 mL/min;
* Agreed to maintain abstinence from alcohol and smoking throughout the entire study period;
* Agreed to maintain abstinence from caffeine from midnight of the day prior to and until the end of each Visit (Visits 2 to 4).
Exclusion Criteria:
* A sleep disorder (e.g., sleep apnea) other than RLS that may significantly affect the assessment of RLS;
* Current use of a sleeping medication or sedating medication;
* Current use of CNS stimulants;
* Neurologic disease or movement disorder;
* Other medical conditions which could affect RLS assessments;
* Significant medical history that may impair psychomotor coordination;
* Subjects who had clinically significant or unstable medical conditions;
* Serum ferritin level below 20 ng/mL;
* Subjects currently suffering from moderate or severe depression using the Diagnostic and Statistical Manual of Mental Disorders and Treatment IV (DSM IV TR);
* Subjects with a history of substance abuse (alcohol or drugs) or substance dependence within 12 months prior to enrollment;
* Shift workers or subjects who were not on normal day/night sleep cycles;
* Subjects who had smoked an average of greater than one half pack of cigarettes (or nicotine equivalent) per day within 30 days of the Screening Visit;
* Subjects who had consumed an average of \>5 cups (i.e., 40 ounces) of caffeinated beverages per day within 20 days of the Screening Visit;
* Subjects with a history of allergy to gabapentin, diphenhydramine, or XP13512 excipients
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
65 Years
Study:
NCT01332318
Study Brief:
Protocol Section:
NCT01332318