A Pilot Efficacy and Safety Study of IPX159 for the Treament of Restless Legs Syndrome.

Phase 2

Completed

• Conditions: Restless Legs Syndrome; Neurological - Other neurological disorders

• Registration Number: ACTRN12608000558325
• Lead Sponsor: IMPAX Pharmaceuticals

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-11-07
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 28

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Polysomnography will be performed to determine the reduction in periodic limb movements and the improvement in sleep quality.[This will be assessed at baseline, and study days 21 and 49, being the end of each treatment period.];Efficacy will be assessed using the International Restless Legs Syndrome Study Group Questionnaire (IRLSSG)[This will be assessed at Study days 21 and 49, being the end of each 3 week treatment period.]

Secondary Outcome Measures

Name	Time	Method
Visual Analog Scale (VAS) will be performed to measure pain in limbs due to immobility.[This will be assessed at Baseline and study days 7,14,21,28,35,42 and 49.];Actigraphy will be performed to look at limb movements. This is measured by the use of a 'actimeter' which patients will wear on each ankle at night.[This will be assessed at baseline, and study days 7, 14, 21, 35, 42 and 49.]