Information summary on research studies

Approximately 24 participants are required in a 2 period placebo-controlled crossover study being conducted in 4 research centres. Suitable participants with a diagnosis of moderate to severe Restless Legs Syndrome, will receive medication identified as IPX159 or placebo for 3 weeks, and take dose 3 times a day. After a one week "washout" they will receive the alternate treatment for another 3 weeks.

RLS Australia supports this research and urges those interested to contact one of the following centres to register expressions of interest and enquire further.

Melbourne

The Monash Medical Centre 
Department of Respiratory and Sleep Medicine.
Contact: Karen Grant
Tel: (03) 9594 5249

Brisbane

Peninsula Clinical Research
Contact: Maryanne Ryan
Tel: (07) 3889-5019

Rivercity Hospital Research Centre
Contact: Patricia Hume
Tel: (07) 3327-7888


Sydney

The Sydney centre has not yet finalised its study. Notification will be added here when ready. You may send expressions of interest to info@rls.org.au and an email can be sent when study commences.

FURTHER INFORMATION ON THE TRIAL:

1. Who is eligible to participate?

Male and Female participants of at least 18 years age (inclusive).

A diagnosis of moderate to severe idiopathic (primary) RLS 

2. How long is the commitment?

Participants will attend weekly clinical visits for 7 weeks if they qualify for the study.

3. How often will participants be required to attend?

Participants are seen at the study center at screening, at Baseline, and on Days 7, 14, 21, 28, 35, 42, and 49. These visits are one week apart.  Study participants undergo an overnight sleep lab evaluation at Baseline, and on Days 21 and 49.  In addition, participants complete the following assessments:

*  International Restless Legs Syndrome Study Group
(IRLSSG) rating scale at screening, Baseline, Days 7,
14, 21, 28, 35, 42, and 49

*  Visual Analog Scale (VAS) for measurement of limb
pain at Baseline, Days 7, 14, 21, 28, 35, 42, and 49

*  Suggested Immobilization Test (SIT) at Baseline,
Days 21 and 49

*  Actigraphy at Baseline, and prior to visits on Days 7,
14, 21, 35, 42 and 49.

4. How long will each appointment be?

Screening, Days 7, 14, 28, 35, 42 and 49 will last no
more than a couple of hours.

Baseline, Days 21 and Days 49 will be overnight visits
in the sleep laboratory.

5. Will participants be compensated for
travel expenses?

Participants will be reimbursed  for the cost of travelling to and from study visits.  

6. Do participants need to be drug free
before participating and if so for how
long?

Participants need to washout out of any prescription and/or over the counter therapy for RLS for 1 week prior to Baseline.

Participants also need to discontinue all medications they take for psychiatric conditions 1 week prior to Baseline.