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Trial registered on ANZCTR


Registration number
ACTRN12608000558325
Ethics application status
Approved
Date submitted
23/10/2008
Date registered
7/11/2008
Date last updated
31/03/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
A Pilot Efficacy and Safety Study of IPX159 for the Treament of Restless Legs Syndrome.
Scientific title
A Pilot Efficacy and Safety Study of IPX159 for the Treament of Restless Legs Syndrome.
Secondary ID [1] 291595 0
IPX159-B08-01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Restless Legs Syndrome 3866 0
Condition category
Condition code
Neurological 4062 4062 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 3594 0
Other interventions
Comparator / control treatment
Placebo (sugar pill)
Control group
Placebo

Outcomes
Primary outcome [1] 4960 0
Polysomnography will be performed to determine the reduction in periodic limb movements and the improvement in sleep quality.
Timepoint [1] 4960 0
This will be assessed at baseline, and study days 21 and 49, being the end of each treatment period.
Primary outcome [2] 5034 0
Efficacy will be assessed using the International Restless Legs Syndrome Study Group Questionnaire (IRLSSG)
Timepoint [2] 5034 0
This will be assessed at Study days 21 and 49, being the end of each 3 week treatment period.
Secondary outcome [1] 8374 0
Visual Analog Scale (VAS) will be performed to measure pain in limbs due to immobility.
Timepoint [1] 8374 0
This will be assessed at Baseline and study days 7,14,21,28,35,42 and 49.
Secondary outcome [2] 8482 0
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.
Timepoint [2] 8482 0
This will be assessed at baseline, and study days 7, 14, 21, 35, 42 and 49.

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Inclusion / Exclusion criteria will be assessed by the clinical sites. Eligible participant will be enrolled according to a randomisation schedule provided to the Sites. Each participant will receive both the active and placebo treatments. The sequence of treatment will be concealed from the study investigators, and the participants. Allocation concealment will be determind by numbered containers.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Qualified personnel created a computer program to generate the randomisation schedule for sequence assignment.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/11/2008
Actual
12/02/2009
Date of last participant enrolment
Anticipated
Actual
9/07/2009
Date of last data collection
Anticipated
Actual
3/09/2009
Sample size
Target
28
Accrual to date
Final
23
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC

Funding & Sponsors
Funding source category [1] 4045 0
Commercial sector/Industry
Name [1] 4045 0
Novotech (Australia) Pty, Ltd
Country [1] 4045 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
IMPAX Pharmaceuticals
Address
1502 Crocker Avenue
Hayward
CA 94544
Country
United States of America
Secondary sponsor category [1] 3638 0
None
Name [1] 3638 0
Address [1] 3638 0
Country [1] 3638 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6126 0
Ethics committee address [1] 6126 0
Ethics committee country [1] 6126 0
Date submitted for ethics approval [1] 6126 0
Approval date [1] 6126 0
16/12/2008
Ethics approval number [1] 6126 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29066 0
Dr Michael Ho
Address 29066 0
246 Clayton Road, Clayton VIC 3168
Country 29066 0
Austria
Phone 29066 0
61 3 9594 2699
Fax 29066 0
Email 29066 0
Michael.Ho@southernhealth.org.au
Contact person for public queries
Name 12223 0
Michelle Landolfi
Address 12223 0
30831 Huntwood Ave
Country 12223 0
United States of America
Phone 12223 0
15102406000
Fax 12223 0
Email 12223 0
mlandolfi@impaxlabs.com
Contact person for scientific queries
Name 3151 0
Michelle Landolfi
Address 3151 0
30831 Huntwood Ave, Hayward CA 94544
Country 3151 0
United States of America
Phone 3151 0
15102406000
Fax 3151 0
Email 3151 0
mlandolfi@impaxlabs.com

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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