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AFQ056 treatment of levodopa-induced dyskinesias: Results of 2 randomized controlled trials
Movement disorders, 2011-06, Vol.26 (7), p.1243-1250
Berg, Daniela
Godau, Jana
Trenkwalder, Claudia
Eggert, Karla
Csoti, IIona
Storch, Alexander
Huber, Heiko
Morelli-Canelo, Monica
Stamelou, Maria
Ries, Vincent
Wolz, Martin
Schneider, Christine
Di Paolo, Thérèse
Gasparini, Fabrizio
Hariry, Sam
Vandemeulebroecke, Marc
Abi-Saab, Walid
Cooke, Katy
Johns, Donald
Gomez-Mancilla, Baltazar
2011
Details
Autor(en) / Beteiligte
Berg, Daniela
Godau, Jana
Trenkwalder, Claudia
Eggert, Karla
Csoti, IIona
Storch, Alexander
Huber, Heiko
Morelli-Canelo, Monica
Stamelou, Maria
Ries, Vincent
Wolz, Martin
Schneider, Christine
Di Paolo, Thérèse
Gasparini, Fabrizio
Hariry, Sam
Vandemeulebroecke, Marc
Abi-Saab, Walid
Cooke, Katy
Johns, Donald
Gomez-Mancilla, Baltazar
Titel
AFQ056 treatment of levodopa-induced dyskinesias: Results of 2 randomized controlled trials
Ist Teil von
Movement disorders, 2011-06, Vol.26 (7), p.1243-1250
Ort / Verlag
Hoboken: Wiley Subscription Services, Inc., A Wiley Company
Erscheinungsjahr
2011
Link zum Volltext
Quelle
MEDLINE
Beschreibungen/Notizen
Study objectives were to assess the efficacy, safety, and tolerability of AFQ056 in Parkinson's disease patients with levodopa‐induced dyskinesia. Two randomized, double‐blind, placebo‐controlled, parallel‐group, in‐patient studies for Parkinson's disease patients with moderate to severe levodopa‐induced dyskinesia (study 1) and severe levodopa‐induced dyskinesia (study 2) on stable dopaminergic therapy were performed. Patients received 25–150 mg AFQ056 or placebo twice daily for 16 days (both studies). Study 2 included a 4‐day down‐titration. Primary outcomes were the Lang‐Fahn Activities of Daily Living Dyskinesia Scale (study 1), the modified Abnormal Involuntary Movement Scale (study 2), and the Unified Parkinson's Disease Rating Scale–part III (both studies). Secondary outcomes included the Unified Parkinson's Disease Rating Scale–part IV items 32–33. The primary analysis was change from baseline to day 16 on all outcomes. Treatment differences were assessed. Fifteen patients were randomized to AFQ056 and 16 to placebo in study 1; 14 patients were randomized to each group in study 2. AFQ056‐treated patients showed significant improvements in dyskinesias on day 16 versus placebo (eg, Lang‐Fahn Activities of Daily Living Dyskinesia Scale, P = .021 [study 1]; modified Abnormal Involuntary Movement Scale, P = .032 [study 2]). No significant changes were seen from baseline on day 16 on the Unified Parkinson's Disease Rating Scale‐part III in either study. Adverse events were reported in both studies, including dizziness. Serious adverse events (most commonly worsening of dyskinesias, apparently associated with stopping treatment) were reported by 4 AFQ056‐treated patients in study 1, and 3 patients (2 AFQ056‐treated patient and 1 in the placebo group) in study 2. AFQ056 showed a clinically relevant and significant antidyskinetic effect without changing the antiparkinsonian effects of dopaminergic therapy. © 2011 Movement Disorder Society
Sprache
Englisch
Identifikatoren
ISSN: 0885-3185
eISSN: 1531-8257
DOI: 10.1002/mds.23616
Titel-ID: cdi_proquest_miscellaneous_873316328
Format
–
Schlagworte
Adult
,
Aged
,
Aged, 80 and over
,
Antiparkinson Agents - adverse effects
,
Biological and medical sciences
,
Drug Interactions
,
Drug toxicity and drugs side effects treatment
,
Dyskinesia, Drug-Induced - drug therapy
,
dyskinesias
,
Excitatory Amino Acid Antagonists - administration & dosage
,
Excitatory Amino Acid Antagonists - adverse effects
,
Female
,
Follow-Up Studies
,
glutamate antagonists
,
Humans
,
levodopa
,
Levodopa - adverse effects
,
Male
,
Medical sciences
,
Middle Aged
,
Neurology
,
Parkinson Disease - drug therapy
,
parkinsonism
,
Pharmacology. Drug treatments
,
Receptor, Metabotropic Glutamate 5
,
Receptors, Metabotropic Glutamate - antagonists & inhibitors
,
Toxicity: nervous system and muscle
,
Treatment Outcome
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