None listed
Conditions
Brief summary
The primary purpose of this Study is to find out if a new medication can help people that suffer from Restless Leg Syndrome. Over the course of 7 weeks, several assessments will be made to see how a person with restless leg syndrome sleeps and whether or not this medication can reduce their discomfort and therefore improve their quality of life.
Interventions
This is a crossover study with 2 treatment:
A. placebo taken orally 3 times a day.
B. 30 escalating to 60mg IPX159 taken orally 3 times a day.
Patients will be randomised and will have each treatment for 3 weeks. Patients will be exposed to treatment for 3 weeks over a 7-week period. The wash-out period between the 2 treatment arms is 1 week. During the treatment period, Patients will take 1 tablet 3 times a day for the first 2 days, then at day 3, the dose is increased to 2 tablets 3 times a da
This is a crossover study with 2 treatment: A. placebo taken orally 3 times a day. B. 30 escalating to 60mg IPX159 taken orally 3 times a day. Patients will be randomised and will have each treatment for 3 weeks. Patients will be exposed to treatment for 3 weeks over a 7-week period. The wash-out period between the 2 treatment arms is 1 week. During the treatment period, Patients will take 1 tablet 3 times a day for the first 2 days, then at day 3, the dose is increased to 2 tablets 3 times a day. If patients can not tolerate the dose increase, they can decrease the dose back down to 1 tablet 3 times a day.
Sponsors
IMPAX Pharmaceuticals
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subjects aged at least 18 years (inclusive). 2. A diagnosis of moderate to severe idiopathic (primary) Restless Leg Syndrome (RLS) based on the following guidelines: a. A score of at least 15 on the IRLSSG rating scale at baseline b. Symptoms of RLS documented by medical history on at least 10 nights during the month prior to screening or, if currently on treatment for RLS, this frequency of symptoms must have been present before current RLS treatment started, based on subject report. c. RSL symptoms documented by patient diary for at least 4 of 7 evenings / nights during the screening period. d. Periodic limb index movement (PLMI) of more than 5 per hour of total sleep time (TST) as determined by PSG, following washout of any medications. 3. Negative urine screen for drugs of abuse at baseline. 4. Subjects must agree to use a medically acceptable method of contraception throughout the study, including the washout period, and for 3 months after completing the study.
Exclusion criteria
1. Secondary Restless Leg Syndrome (RLS)associated with end-stage renal disease, post-pregnancy, or iron-deficiency anemia. 2. A sleep disorder (e.g. sleep apnea, narcolepsy, parasomnia or circadian rhythm disorder) that may significantly affect the assessment of RLS. 3. Schizophrenia, psychotic or mental disorders. 4. Diabetes, glaucoma, presence of urinary retention or at risk of urinary retention, significant renal, hepatic, gastrointestinal, pulmonary, endocrine, cardiovascular, or neurologic disorder. 5. Received any investigational medications over the 30 days prior to baseline. 6. Prescription therapy or over-the-counter (OTC) medications for RLS as well as any other psychotrophic medications (including monoamine oxidase inhibitors) during the week prior to baseline. 7. Supine (after 5 minutes) Blood Pressure > 140/90mmHg at screening. 8. QTc (Wave point measures of atrial and ventricular acitivity) (Fridericia) interval in the resting electrocardiogram (ECG) >450 msec in males and >470 msec in females. 9. History of seizures or serious head injury within the previous 10 years. 10. Currently working evenings or nights. 11. Inability or unwillingness to discontinue medications currently being taken for RLS. 12. History of known allergy or intolerance to IPX159. 13. Pregnant or breastfeeding. 14. History of alcohol use greater than 14 units per week (a unit is defined as 360mL of beer, 120mL of wine or 30mL of hard liquor). 15. History or or current abuse of substances as described by the DMS-IV Criteria for Alcohol or Substance Abuse and Dependence within 6 months prior to Screening, other than nicotine or caffeine dependence. 16. Unable to comply with study procedures. 17. Employees or family members of the investigator, study site or the sponsor.
Outcome results
None listed