New clinical trial investigates APOKYN for treating debilitating morning akinesia in Parkinson’s disease patients

LOUISVILLE, Ky.--(BUSINESS WIRE)--

US WorldMeds today announced the launch of a new clinical trial investigating APOKYN (apomorphine hydrochloride injection) as a rapid and reliable treatment for morning akinesia in Parkinsons disease. AM IMPAKT, short for Apokyn for Motor IMProvement of Morning AKinesia Trial, is a Phase IV, multi-center, open-label study that will enroll approximately 100 subjects at 12 study sites across the US.

Stuart H. Isaacson, M.D., Associate Professor at Florida International University Herbert Wertheim College of Medicine, Director of the Parkinsons Disease and Movement Disorders Center of Boca Raton and Research Director of the Marcus Neuroscience Institute at Boca Raton Regional Hospital, is the lead investigator on the study.

We are very excited to have commenced this important study, said Dr. Isaacson. We hope to show that APOKYN will provide a valuable treatment option for Parkinsons disease patients with morning akinesia due to delayed onset of levodopa by rapidly and reliably restoring their motor function and enabling them to get on with their day. We plan to have initial results available in August.

Patients with morning akinesia can experience hand tremor, muscle stiffness, and difficulty in moving and walking in the morning because their first daily dose of oral levodopa fails to provide dependable relief. Oral levodopa is the most frequently used Parkinsons disease medication, and it typically provides robust dependable relief of symptoms when it is first started. However, after taking the medicine for many months or years, most Parkinsons patients begin to develop a fluctuating response to levodopa.

Fluctuating responses are divided into ON time, when the medication is working well and controlling Parkinsons symptoms, and OFF time when the medication fails or is delayed in working and Parkinsons disease symptoms are poorly controlled. Morning akinesia is one form of OFF episodes. Its symptoms include tremor, slowness, stiffness, freezing and falls which can significantly hinder the patients ability to carry out their normal daily morning activities.

Because the effects of Parkinsons disease on the gastrointestinal (GI) tract may contribute to morning akinesia, a subset of study patients will have GI tests prior to, and after, APOKYN.

GI tract problems are a common underlying part of Parkinsons disease patients. This includes a condition known as gastroparesis, in which the stomach takes longer than normal to empty. A survey of Parkinsons disease patients found that 24% reported nausea and 45% reported bloating, both symptoms of gastroparesis.1 Despite its frequency, gastroparesis in Parkinsons disease often goes unrecognized and, therefore, untreated. It is thought that gastroparesis contributes to poor unpredictable absorption of oral levodopa dosing resulting in OFF episodes and delayed-ON episodes such as morning akinesia.

There are few therapeutic options for people with Parkinsons disease who suffer from morning akinesia and gastroparesis, said P. Breckinridge Breck Jones, CEO of US WorldMeds. APOKYN, which has offered great benefit to patients experiencing OFF episodes, has shown initial promise in helping to alleviate symptoms associated with these conditions. US WorldMeds is committed to working with researchers and healthcare providers to advance the application and delivery of this medication.

APOKYN is a medication that provides levodopa-like effects. It is given as injection under the skin much like an insulin injection and so, unlike levodopa, its onset of action is quick and reliable because it does not depend on absorption in the GI tract. In addition to measuring the benefits of APOKYN in treating morning akinesia, the potential benefits of APOKYN in improving gastroparesis will be explored in the AM IMPAKT study.

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New clinical trial investigates APOKYN for treating debilitating morning akinesia in Parkinson’s disease patients