Safety and Efficacy Study of IPX159 in Restless Legs Syndrome (RLS)

Study Overview
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Brief Summary
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The purpose of this study is to determine whether IPX159 is safe and effective in treating symptoms of RLS in subjects with Restless Legs Syndrome.

Detailed Description
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IPX159 was developed as an extended release formulation to reduce the fluctuation in nefopam concentration compared to IR and to reduce the incidence of peak or rate related side effects.

Official Title
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A Randomized, Double-Blind, Placebo-Controlled Safety and Efficacy Study of IPX159 in the Treatment of Moderate to Severe Restless Legs Syndrome (RLS)

Conditions
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Restless Legs Syndrome

Intervention / Treatment
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* Drug: IPX159
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Able to understand and willing to sign an informed consent form (ICF) and Health Insurance Portability and Accountability Act (HIPAA) authorization Males and females aged 18-70 with a history of primary RLS for ≥6 months prior to screening Symptoms of RLS by medical history on at least 15 nights during the month prior to Screening BMI 18.5-32 Negative alcohol and drug abuse screen Negative serum pregnancy test Agrees to use a medically acceptable method of contraception throughout the study and for 2 months after completing the study. Able and willing to comply with the protocol, including availability for all scheduled clinic visits and telephone calls. Exclusion Criteria: Subjects who use or intend to use post screening the following medications or medication categories: Sedative hypnotics, trazodone Dopamine agonists, gabapentin, gabapentin enacarbil, pregabalin Narcotic analgesics, other opioids, tramadol, cyclobenzaprine Iron supplementation therapy History of HIV, hepatitis B or C Pregnant or breastfeeding. History of or clinical signs of any form of epilepsy or seizures, excluding fever-related seizures in childhood. History or presence of glaucoma Planning to take herbal medications (eg, hypericum perforatum [St John's Wort], licorice, ephedra, ginkgo, ginseng) during the study. Use of any investigational drug within the last 30 days or within a period of 5 times the drug's half-life, whichever is longer Subjects who, in the opinion of the Investigator, should not participate in the study or are not capable of following the study schedule for any reason Employees or family members of the Investigator, study site, the Sponsor, or Contract Research Organization (if any)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IPX159<br>IPX159 90 mg daily at week 1 with titration to 180 mg daily at week 2 with possible titration to 270 mg daily at week 3. | Drug: IPX159<br> <br> |
| Placebo Comparator: Sugar Pill<br>IPX159 90 mg matching placebo daily at week 1 with titration to 180 mg matching placebo daily at week 2. | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| International Restless Legs Syndrome Study Group (IRLSSG) Rating Scale |  | Assessed at each study visit (visits 1-7), an expected average of 11 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Moderate to severe idiopathic RLS