Use of cabergoline in the treatment of restless legs syndrome
Patent 6114326 Issued on September 5, 2000. Estimated Expiration Date: March 24, 2019. Estimated Expiration Date is calculated based on simple USPTO term provisions. It does not account for terminal disclaimers, term adjustments, failure to pay maintenance fees, or other factors which might affect the term of a patent.
514/220, Tricyclo ring system having the seven-membered hetero ring as one of the cyclos514/221, Bicyclo ring system having the seven-membered hetero ring as one of the cyclos514/284, Tetracyclo ring system having the six-membered hetero ring as one of the cyclos514/285, Plural hetero atoms in the tetracyclo ring system (e.g., acronycines, etc.)514/288, Ring carbon is shared by three of the cyclos514/289, Two of the cyclos share at least three ring members (i.e., bridged) (e.g., morphinans, etc.)514/323, Ring nitrogen in the polycyclo ring system514/923SLEEP AID (INSOMNIA)
The present invention provides for the use of cabergoline and other agents for the treatment of restless legs syndrome (RLS).
Other References
JE Ahlskog, et al., "Adjunctive Cabergoline Therapy of Parkinson's Disease: Comparison with Placebo and Assessment of Dose Response and Duration of Effect," Clin. Neuropharmacol, 1996; 19:202-212
S Akpinar, "Restless Legs Syndrome Treatment with Dopaminergic Drugs," Clinical Neuropharmacology, 1987; 10:69-79
RP Allen, "Augmentation of the Restless Legs Syndrome with Carbidopa/Levodopa," Sleep, 1996; 19(3):205-13
Anonymous, " Carbergolin: Neue Horizonte in der Therapie des Morbus Parkinson," Nervenarzt (1998 Sep.) 69 (Suppl Neue Horiz) 1-8, XP002116346
Anonymous, "Cabergoline: New Horizons in Parkinson's Disease Treatment,"--Translated version of XP0021116346, pp. 1-17 (1998)
Atlas Task Force of the American Sleep Disorders Association, Recording and Scoring Leg Movements, Sleep, 1993; 16:748-759
PM Becker, AO Jamieson, WD Brown, "Dopaminergic Agents in Restless Legs Syndrome and Periodic Limb Movements in Sleep: Response and Complications of Extended Treatment in 49 Cases," Sleep, 1993; 16:713-716
D Boghen, et al., "The Treatment of Restless legs Syndrome with Clonazepam: A Prospective Controlled Study," Can J Neurol Sci, 1986; 13:245-247
DB Boivin, D Lorrain, J Montplaisir, "Effects of Bromocriptine on Periodic Limb Movements in Human Narcolepsy," Neurology 1993; 43:2134-2136
B Bornstein, "Restless Legs," Psychiat Neurol, 1961; 141:165-201.1
C Brodeur, J Montplaisir, R Marinier, "Treatment of RLS and PMS with L-dopa: A Double-Blind Controlled Study," Neurology; 35:1845-1848. (1988)
V Collado-Seidel, et al., A Controlled Study of Additional sr-L-dopa in L-dopa-Responsive Restless Legs Syndrome with Late-Night Symptoms,Neurology, 1999, 52:285-290
N Callaghan, "Restless Legs Syndrome in Uremic Neuropathy," Neurology, 1966, 16:359-361
RM Coleman, "Periodic Movements in Sleep (Nocturnal Myoclonus) and Restless Legs Syndrome." In: Guilleminault C, (ed) Sleeping and Walking Disorders: Indications and Techniques, 1982, Menlo Park: Addison Wesley; 265-295
CJ Earley, RP Allen, "Pergolide and Carbidopa/Levodopa Treatment of the Restless Legs Syndrome and Periodic Leg Movements in Sleep in a Consecutive Series of Patients," Sleep, 1996; 19(10):801-10
KA Ekbom, "Restless Legs Syndrome," Neurology, 1960; 10:868-873
RG Fariello, "Pharmacodynamic and Pharmacokinetic Features of Carbergoline," Drugs, 1997, 55:S2, 10-16
A Feigen, "Restless Legs Syndrome," JAMA, 1995; 274 (15) 1191-2
B Frankel, "Restless Legs Syndrome," JAMA, 1974; 230:1302-1303
C Gorman, et al., "Symptoms of Restless Legs," Arch Intern Med, 1965; 115:155-60
C Guilleminault, M Cetel, P Philip, "Dopaminergic Treatment of Restless Legs and Rebound Phenomenon," Neurology, 1993; 43(2):445
D Harriman, et al., "Ekbom's Syndrome and Burning Paraesthesiae," Brain, 1970; 93:393-406
EM Heiman, et al., "Lithium-Aggravated Nocturnal Myoclonus and Restless Legs Syndrome [letter]," American Journal of Psychiatry, 1986; 143:1191-1192
F Heinze, et al., "Restless Legs and Orthostatic Hypotension in Primary Amyloidosis," Arch Neurol, 1967; 16:497-500
W Hening, et al., "The Cortical Premovement Potentials of RLS Jerks," Sleep Res, 1991; 20:255
WA Hening, et. al., "Dyskinesias While Awake and Periodic Movements in Sleep in Restless Legs Syndrome: Treatment with Opioids," Neurology; 1986; 36:1363-1366
S Iannaccone, et al., "Evidence of Peripheral Axonal Neuropathy in Primary Restless Legs Syndrome," Movement Disorders, 1995; 10:2-9
PW Kaplan, RP Allen, DW Suchholz, JK Walters, "A Double-Blind, Placebo Controlled Study of the Treatment of Periodic Limb Movements in Sleep Using Carbidopa/Levodopa and Propoxyphene," Sleep, 1993; 16:717-723
S Kotagal, et al., "Nocturnal Myoclonus--A Sleep Disturbance in Children with Leukemia," Annals of Neurology, 1984; 16:392
C Kramer, M Kerkjarto, B Leplow, EO Krasemann, "LebensqualitatsmeSsungen im wochentlich erhobenen Verlauf bei Herzinfarktpatienten," Psychother Psychosom Med Psychol, 1990; 40:409-416
E Lugaresi, et al., "Nocturnal Myoclonus and Restless Legs Syndrome," In: S Fahn et al. (eds), Advances in Neurology, 1986, vol. 43: Myoclonus, New York: Raven Press; 295-307
P Martinelli, et al., "Nocturnal Myoclonus, Restless Legs Syndrome, and Abnormal Electrophysiological Findings," Ann Neurol, 1987; 21:515
WB Matthews, "Iron Deficiency and Restless Legs," Br Med J, 1976; 1-898
M Miyagi, et al., "Dopamine Receptor Affinities in vitro and Stereotypic Activities in Vivo of Cabergoline in Rats," Biol. Pharm. Bull., 1996; 19L 1210-1213
H Moldofsky, et al., "Sleep-Related Myoclonus in Rheumatic Pain Modulation Disorder (Fibrositis Syndrome) and in Excessive Daytime Somnolence," Psychosomatic Medicine, 1984; 46:145-151
J Montplaisir, et al., "Familial Restless Legs with Periodic Movements in Sleep:Electrophysiologic, Biochemical, and Pharmacological Study," Neurology, 1985; 35:130-134
J Montplaisir, et. al., "Restless Legs Syndrome and Periodic Movements in Sleep: Physiopathology and Treatment with L-dopa," Clinical Neuropharmacology, 1986; 9:456-463
SS Mosko, et al., "Somatosensory and Brainstem Auditory Evoked Responses in Sleep-related Periodic Leg Movements," Sleep, 1986; 9:399-404
W Ondo, "Ropinirole for Restless Legs Syndrome," Movement Disorder; 14:138-140 (1999)
G Reynolds, et al., "Restless Leg Syndrome and Rheumatoid Arthritis," British medical Journal, 1986; 292:659-660
UK Rinne, et al: "Cabergoline in the Treatment of Early Parkinson's Disease: Results of the First Year of Treatment in a Double-Blind Comparison of Cabergoline and Levodopa," Neurology, 1997, 48/2 (363-368). XP002116347
E Ruiz-Primo, Is Nocturnal Myoclonus a Common Sleep Disturbance in Children with Leukaemia, Dev Med Child Neurol, 1987; 29:833
F Salvi, et al., "Restless Legs Syndrome and Nocturnal Myoclonus: Initial Clinical Manifestation of Familial Amyloid Polyneuropathy," J Neurol Neurosurg Psychiatry, 1990; 53:522-525
R Sandyk, et al., "L-Dopa in Uremic Patients with the Restless Legs Syndrome," Int J Neurosci, 1987; 35:233-235
MH Silber, JW Shepard, Jr., JA Wisbey, "Pergolide in the Management of Restless Legs Syndrome: An Extended Study," Sleep, 1997; 20(10): 878-82
JD Spillane, "Restless Legs Syndrome in Chronic Pulmonary Diseases," Br Med J, 1970; 4:796-798
K Stiasny, et al., "Treatment of Restless Leg Syndrome (RLS)with Cabergoline" ENS, Nice Abstract, 1988
MJ Thorpy, Chairman, Diagnostic Classification Steering Committee in International Classification of Sleep Disorders: Diagnostic and Coding Manual, 1990, American Sleep Disorders Association
C Trenkwalder, et al., "L-Dopa in Uremic and Idiopathic Restless Legs Syndrome:A Double-Blind, Crossover Trial," Sleep, 1995; 18:681-688
PT Trzepacz, et. al., "Response to Opioids in Three Patients with Restless Legs Syndrome," Ann J Psychiatry, 1984; 141:993-995
C Von Scheele, "Levodopa in Restless Legs," Lancet, 1986; 2:426-427
C Von Scheele, V Kempi, Long-Term Effect of Dopaminergic Drugs in Restless Legs. A 2-Year Follow-up, Arch Neurol, 1990; 47:1223-1224
SL Walker, A Fine, MH Kryger, "L-Dopa/Carbidopa for Nocturnal Movement in Uremia," Sleep, 1996; 19:213-218
AS Walters, et al., "A Double-Blind Randomized Crossover Trial of Bromocriptine and Placebo in Restless Leg Syndrome," Ann Neurol, 1988; 24:455-458
AS Walters, "Toward a Better Definition of the Restless Legs Syndrome," The International Restless Legs Syndrome Study Group., Mov Disord, 1995; 10(5):634-42
JC Ware, et al., "Nocturnal Myoclonus and Tricyclic Antidepressants," Sleep Research, 1984; 13:72
S Watanabe, et al., "Periodic Legs Movements During Either Epidural or Spinal Anesthesia in an Elderly Man without Sleep-related (Nocturnal) Myoclonus," Sleep, 1990; 13:262-266
LR Wechsler, et al., "Periodic Leg Movements of Sleep (Nocturnal Myoclonus): An Electrophysiological Study," Annals of Neurology ,1986; 19:168-173
TC Wetter, K Stiasny, J Winkelmann, A Buhlinger, U Brandenburg, T Penzel, et al. A Polysomnographic, Controlled Study of Pergolide in the Treatment of Restless Legs Syndrome, Neurology, 1998; 50(4):A69
J Winkelman, TC Wetter, K Stiasny, WH Oertel, C Trenkwalder, Treatment of Restless Leg Syndrome with Pergolide--An Open Clinical Trial, Mov. Disord 1998; 13 (3):566-