2001
DOI: 10.1001/archneur.58.9.1385
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A Randomized, Double-blind, Placebo-Controlled Trial of Subcutaneously Injected Apomorphine for Parkinsonian Off-State Events

Abstract: Apomorphine by intermittent subcutaneous injection is effective and safe for outpatient use to reverse off-state events that occur despite optimized oral therapy.

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Cited by 210 publications
(121 citation statements)
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“…A single Class II study evaluated subcutaneously injected apomorphine (mean dose 5.4 mg/injection) in a double masked, parallel group, randomized study of 29 patients for 4 weeks (20 active, 9 placebo). 12 There were over 80% completers (85% active, 88% placebo). The active group experienced a 34% decrease (2 hours) in off time compared to 0% in the placebo group (p ϭ 0.02).…”
Section: R E T I R E Dmentioning
confidence: 99%
“…A single Class II study evaluated subcutaneously injected apomorphine (mean dose 5.4 mg/injection) in a double masked, parallel group, randomized study of 29 patients for 4 weeks (20 active, 9 placebo). 12 There were over 80% completers (85% active, 88% placebo). The active group experienced a 34% decrease (2 hours) in off time compared to 0% in the placebo group (p ϭ 0.02).…”
Section: R E T I R E Dmentioning
confidence: 99%
“…66 The pivotal, double-blind, placebo-controlled trial that led to FDA approval in the United States was a combined inpatient and outpatient study with 29 patients (20 patients received active drug; 9 received placebo). 67 In part one, inpatients received escalating doses of apomorphine in a blinded fashion and in a standardized schedule, up to an equivalent response to LD or 10 mg. There was a statistically significant improvement in UPDRS motor scores, compared with placebo (p Ͻ 0.001).…”
Section: Phase III Clinical Trial Results In Advanced Patientsmentioning
confidence: 99%
“…Both have been used for many years but continue to be refined [9,34]. Sublingual and nasal preparations have not been successfully developed to this point but new preparations are being tested [35][36][37]. Specific preparations have unique side effects but the drug itself has several consistent problems.…”
Section: Current and Future Delivery Methods: Tolerabilitymentioning
confidence: 99%
“…The trials all assessed the use of subcutaneous apomorphine (10 mg/ mL) as an acute treatment for ''off'' episodes in patients with idiopathic PD, and employed the Unified Parkinson's Disease Rating Scale (UPDRS) motor score from pre-dose to post-dose to assess the effect of apomorphine. They consistently found significant improvement in UPDRS scores after a mean time of 20 min versus placebo, which were generally similar in degree to L-Dopa [35,37,39,40].…”
Section: Intermittent Sub-cutaneous Injectionsmentioning
confidence: 99%