A new therapeutic strategy improves the control of motor symptoms in patients with Parkinson's disease

Vall d'Hebron has participated in a phase III clinical trial which confirmed the efficacy and safety of subcutaneous infusion of levodopa therapy.

11/04/2024

Oral levodopa is currently the most effective therapy for controlling the symptoms of Parkinson's disease. However, it is not possible for many patients to maintain stable and continuous control, with motor symptoms appearing and disappearing at different times of the day. Now, an international multicentre phase III clinical trial involving Vall d'Hebron has shown that a new levodopa-based therapy administered subcutaneously reduces these motor fluctuations. The results have been published in the journal The Lancet Neurology.

Parkinson's patients often suffer from involuntary and uncontrolled movements and fluctuations in their motor status. In patients in whom this control is more difficult with conventional therapies, there are other therapeutic options, such as deep brain stimulation, but they are not possible in all patients and are very invasive. Thus, the aim of this work is to find new, less invasive alternatives.

In this sense, Vall d'Hebron has been one of the centres that has participated with the largest number of patients in a phase III clinical trial conducted with 243 patients with Parkinson's disease from more than 100 centres around the world. The study tested the safety and efficacy of administering levodopa subcutaneously, i.e. via a small pump implanted under the skin.

The therapy tested in this study, called ND0612, was developed by the pharmaceutical company NeuroDerm and offers an alternative to oral drugs, which have limitations. "When levodopa is administered orally, the levels of drug in the blood vary and this means that symptoms are not always controlled. Subcutaneous infusion offers more stable drug levels. In this way, we expect to see significant benefits for patients", explains Dr. Jorge Hernández-Vara, associate neurologist at the Movement Disorders Unit of the Neurology Service of Vall d'Hebron University Hospital and researcher in the Neurodegenerative Diseases group at Vall d'Hebron Research Institute (VHIR).

The study compared the efficacy of the subcutaneous drug (ND0612) throughout the day compared to oral administration. In a first phase, to find the optimal dose for each participant, everyone received the oral drug separately for 4-6 weeks and the subcutaneous therapy for another 4-6 weeks. Subsequently, one group received only oral therapy while the other received ND0612 therapy.

The results showed that the subcutaneous infusion decreased motor fluctuations in patients: with ND0612 it is possible to have almost two hours longer without involuntary movements, and the periods of time when the treatment is ineffective are reduced. In addition, patients receiving ND0612 performed activities of daily living, such as eating, dressing, personal hygiene, writing, etc., better.

The researchers also highlight the fast benefits observed for the patients. While other subcutaneous infusion therapies require months of treatment to see a change, patients with ND0612 had improved symptom control within a few weeks. "With this trial we demonstrate that ND0612 therapy allows an individualised and flexible approach to optimise treatment, with a clear impact on improving the quality of life of Parkinson's patients. It is, therefore, a good alternative before considering other options with much more invasive surgery", says Dr Hernández-Vara.

In terms of safety, the trial confirmed that the adverse effects observed were mild.

The study was the result of multidisciplinary work, which is key to obtaining successful results. In device-assisted drug infusion therapies, such as the one used in this study, the role of nurses specialised in the disease is fundamental. In this sense, Vall d'Hebron is committed to the role of the Advanced Practice Nurse. In addition, it is worth mentioning the work of study coordinators, who work to ensure the quality of the data and manage all the processes associated with the development of a clinical trial.

“Subcutaneous infusion offers more stable drug levels. In this way, we expect to see significant benefits for patients”, explains Dr. Jorge Hernández-Vara.

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