Apomorphine sublingual film for off episodes in Parkinson's disease: a randomised, double-blind, placebo-controlled phase 3 study

In this study, we assessed the safety and efficacy of apomorphine sublingual film as an on-demand therapy for off episodes in patients with Parkinson's disease.MethodsThis randomised, double-blind, placebo-controlled study was done by movement disorder specialists at 32 sites in the USA and one in Canada. Patients with Parkinson's disease who had 2 h or more of off time per day with predictable morning off periods, were responsive to levodopa, and were on stable doses of anti-parkinsonian medication were eligible. In an open-label titration phase, increasing doses of apomorphine sublingual film (10–35 mg) were administered until a tolerable full on response was achieved. Patients were then randomly assigned (1:1) with an interactive web-response system to receive the effective dose of apomorphine sublingual film or matching placebo in a 12-week, double-blind maintenance phase. Randomisation was not stratified, and the block size was four. All patients and study personnel were masked to treatment assignments. The primary endpoint was the in-clinic change from predose to 30 min post-dose in the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part 3 (motor) score at week 12, analysed on a modified intention-to-treat population by use of a mixed-effect model for repeated measures. Safety analyses were done on all enrolled patients who received at least one dose of study medication. This trial is registered with ClinicalTrials.gov, NCT02469090....
Source: The Lancet Neurology - Category: Neurology Source Type: research

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Levodopa is a dopamine precursor and a mainstay treatment in the management of Parkinson's disease. Its side effects induce dyskinesia, nausea, vomiting, and orthostatic hypotension. Acute levodopa acute poisoning is uncommon, with only a few reported case...
Source: SafetyLit - Category: International Medicine & Public Health Tags: Age: Infants and Children Source Type: news
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Source: Drugs and Aging - Category: Geriatrics Source Type: research
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Source: Neurological Sciences - Category: Neurology Source Type: research
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Source: European Journal of Pharmacology - Category: Drugs & Pharmacology Authors: Tags: Eur J Pharmacol Source Type: research
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Source: Trials - Category: General Medicine Authors: Tags: Study protocol Source Type: research
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Source: Frontiers in Neurology - Category: Neurology Source Type: research
Although the administration of dopamine precursor levodopa remains as the mainstay for the treatment of Parkinson's disease, long-term exposure to levodopa often causes a disabling complication, referred to as levodopa-induced dyskinesias. Therefore, the development of new therapeutic interventions to dampen levodopa-induced dyskinesias and parkinsonian motor deficits is needed in the treatment of Parkinson's disease. Intracerebral brain infusion has the merit of being able to specifically deliver any drug into any brain part. By using an intracerebral infusion system equipped with implantable, programmable, and refillable...
Source: Frontiers in Neurology - Category: Neurology Source Type: research
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Source: Frontiers in Neurology - Category: Neurology Source Type: research
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Source: World of Psychology - Category: Psychiatry & Psychology Authors: Tags: Brain and Behavior Disorders General Inside Schizophrenia Mental Health and Wellness Active psychosis Delusions Delusions Hallucinations Living with Schizoprenia Mental Disorder Mental Illness Psychology psychotic Psychotic Break Source Type: blogs
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Source: Turkish Journal of Medical Sciences - Category: General Medicine Tags: Turk J Med Sci Source Type: research
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