Pregabalin in subjects with Restless Legs Syndrome (v1)

• Research type

  Research Study

• Full title

  Randomized, double-blind, 12-month study of pregabalin in subjects with Restless Legs Syndrome

• IRAS ID

  21289

• Contact name

  John Robinson

• Sponsor organisation

  Pfizer Inc

• Eudract number

  2008-005889-32

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  Restless Legs Syndrome (RLS - also known as Ekbom's syndrome) is a neurological disorder affecting about 10-15% of the population in western countries. RLS is characterised by unusual, unpleasant and sometimes painful sensations in the legs (sometimes other parts of the body) with an overwhelming urge to move them to relieve the sensations. Symptoms occur primarily in the evening or at night and are worst whilst at rest, trying to relax or sleep. When non-drug therapies are insufficient, dopaminergic drugs (which affect dopamine receptors in the nervous system) are the current approved treatment of choice, although some other, therapies are also used to manage patients. One limitation of these dopaminergic drugs is that they can actually cause a worsening of the condition after a few months or even weeks use in some patients ǽ?ª?? a phenomenon known as 'augmentation'. Not all patients with RLS respond well to dopaminergic drugs and some cannot tolerate the adverse (side) effects. These drugs may also lose their efficacy over time. Thus there are some unmet needs in the treatment of RLS. Clinical evidence suggests a new class of compound for RLS, called 'alpha-2-delta calcium channel ligands', currently licensed and used to treat epilepsy and pain may be more helpful than dopaminergic agents in treating RLS. One such drug in this new class being researched for RLS is pregabalin. The current study will evaluate the prevalence of augmentation during long-term treatment of pregabalin as compared to two different doses of pramipexole, an approved dopaminergic agent for RLS. Also, during the first 12 weeks of the study, the efficacy of pregabalin in treating RLS will be compared to placebo ('dummy medication'). This will be a fixed-dose, randomised, 12-week placebo-controlled, one-year comparator (pramipexole) controlled, double-blind study in subjects with moderate to severe RLS of unknown origin.

• REC name

  East Midlands - Nottingham 2 Research Ethics Committee

• REC reference

  09/H0408/91

• Date of REC Opinion

  26 Nov 2009

• REC opinion

  Further Information Favourable Opinion