Clinical Trials
Several compounds have undergone or undergoing clinical trials in RLS. The trial with Sumanirole, a dopamine agonist has been discontinued.
Robust trial data from double blind placebo controlled studies performed in a reasonable number of patients ranging from 80-350 have been published in relation to cabergoline, pergolide, ropinirole, rotigotine and pramipexole (the latter in an abstract version). All show significant superiority of dopamine agonists compared to placebo.
Rotigotine skin patch is currently undergoing field testing in the UK.
Methadone has been reported to be useful in resistant RLS recently.
Recently Published Trials:
Goldberg J, Burdick KE, Endick CJ. 2004.Preliminary randomized placebo-controlled trial of pramipexole added to mood stabilizers for treatment resistant bipolar depression. Am J Psychiatry, 161:564-6.
Happe S, Sauter C, Klosch G et al. 2003. Gabapentin versus ropinirole in the treatment of idiopathic restless legs syndrome. Neuropsychobiology, 48:82-6.
Oertel W, Stiasny-Kolster K. Effective treatment of restless legs syndrome (RLS) with pramiexole: results of a 6 week, multi-centre, double blind and placebo controlled study. Eur J Neurology 2005;12(s2):P2205 (abstract)
Ondo WG. Methadone for refarctory restless legs syndrome. 2005. Mov Disord, 20:345-8.
Partinen M, Hirvonen K, Alakuijala A, et al. 2004. Rapid relief from RLS symptoms with pramipexole: results of a large polysomnographic study. Neurology, 2004; 62(7, Suppl 5):LBS.002
Stiasny-Kolster K, Benes H, Peglau I, et al. 2004a. Effective cabergoline treatment in idiopathic restless legs syndrome. Neurology, 63:2272-9.
Stiasny-Kolster K, Kohnen R, Schollmayer E, et al. 2004b. The Rotigotine Sp 666 Study Group. Patch application of the dopamine agonist rotigotine to patients with moderate to advanced stages of restless legs syndrome: A double-blind, placebo-controlled pilot study. Mov Disord, 19:1432-8.
Trenkwalder C, Garcia-Borreguero D, Montagna P, et al. 2004a. Therapy with ropinirole; efficacy and tolerability in RLS. TREAT RLS 1 Study Group. J Neurol Neurosurg Psychiatry, 75:92-7.
Trenkwalder C, Hundemer HP, Lledo A, et al. PEARLS Study Group. 2004b. Efficacy of pergolide intreatment of restless legs syndrome: the PEARLS study. Neurology, 62:1391-7.
Walters AS, Ondo WG, Dreykluft T, et al. on behalf of the TREAT RLS 2 (Therapy with Ropinirole: Efficacy And Tolerability in RLS 2) Study Group. 2004. Ropinirole is effective in the treatment of restless legs syndrome. TREAT RLS 2: A 12-week, double-blind, randomized, parallel-group, placebo-controlled study. Mov Disord, 19:1414-23.
Books
Dr K Ray Chaudhuri has also edited the first textbook on RLS with Prof Per Odin (Germany) and Professor Warren Olanow (USA). The book is available at major book shops and is titled Restless Legs Syndrome and is published by Taylor and Francis.
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