Lecigon intestinal gel controls Parkinson’s motor symptoms: Study
Treatment is a combination of levodopa, entacapone, and carbidopa
Lecigon, an intestinal gel formulation of levodopa, entacapone, and carbidopa, provided sustained motor symptom control for people with advanced Parkinson’s disease, according to interim, one-year analyses from a real-world study in Europe.
The treatment, which is approved in several European countries and Australia, but not the U.S., was also associated with sleep improvements and gains in quality of life.
“Routine use of [Lecigon] for up to 12 months provided sustained control of motor symptoms and was well tolerated with a positive impact on [quality of life] and high patient satisfaction,” the researchers wrote. The study, “Levodopa–Entacapone–Carbidopa Intrajejunal Infusion in Advanced Parkinson’s Disease – Interim Analysis of the ELEGANCE Study,” was published in Movement Disorders Clinical Practice. It was funded by Britannia Pharmaceuticals, which markets Lecigon in Europe.
In Parkinson’s, there is the progressive loss of nerve cells that produce the brain signaling chemical dopamine. The gold standard treatment is levodopa, a precursor that can be converted to dopamine in the body. Levodopa is often combined with other compounds, namely carbidopa or entacapone, that modulate its metabolism in order to boost therapeutic exposure to the medication and reduce side effects. These combinations are usually taken orally.
Over time, however, people with Parkinson’s generally require higher and more frequent doses to control their symptoms. Motor fluctuations, or off episodes, where symptoms reemerge between doses, become more frequent.
Effects of Lecigon on motor symptoms
Lecigon is given as a continuous infusion via a tube inserted into the intestines and controlled with a wearable pump. This mode of administration helps ensure a steady supply of the medication and enables better symptom control over long periods of time where motor symptoms can’t be controlled with standard oral therapies.
An intestinal gel formulation of levodopa and carbidopa, sold as Duopa in the U.S. and Duodopa elsewhere, is used for a similar purpose, but the researchers said not all patients achieve adequate symptom control with this combination. Moreover, adding “entacapone to the [levodopa and carbidopa] formulation increases the bioavailability of levodopa … allowing a lower levodopa dose and, hence lower infusion volume, to be administered.” This also makes it possible to “reduce the size and the weight of the infusion pump,” they wrote.
The observational ELEGANCE study (NCT05043103) was designed to collect data on the real-world effects of Lecigon among advanced Parkinson’s patients in Europe who were having motor fluctuations despite an optimized therapeutic regimen, which most often involved oral treatments.
The trial was designed to follow participants for two years. The recent study covered an interim analysis of 167 participants who had available data of up to a year of treatment, with a median follow-up time of about six months.
At their assessment when starting Lecigon, or baseline, the participants exhibited significant motor fluctuations, with a mean of more than five hours of daily off time, where their symptoms weren’t adequately controlled. This daily off time was significantly reduced, by a mean of more than three hours a day, after three to six months of treatment. This was sustained between six months and a year.
Moreover, patients spent significantly less time of their waking day in an off state and had fewer daily hours having dyskinesia, or involuntary movements that can come as a side effect of long-term levodopa use, after switching to Lecigon.
Overall scores on the Movement Disorder Society-Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) Part IV, which assess motor complications, were significantly improved with Lecigon over baseline, as were scores on the MDS-UPDRS Part II, which evaluates the effects of motor symptoms on daily living. These improvements met the threshold to be considered clinically meaningful, the researchers noted.
Gains in sleep, quality of life
Improvements in sleep and life quality were also observed. Participants and clinicians generally perceived a clinical improvement with Lecigon. Participants also reported a high degree of satisfaction with the infusion pump.
The treatment was generally well tolerated with no new safety signals observed. The most common side effects were procedure- or device-related.
The findings point to “favorable clinical outcomes” with Lecigon, according to the researchers.
“As data accumulate on the real-world use of [Lecigon] and also other evolving medication therapies … it is likely that [Lecigon] will find its position in patients in whom … motor fluctuations impact quality of life and activities of daily living,” wrote the researchers, who noted that, while intestinal therapies are generally reserved for patients with advanced disease, “there are good reasons not to delay their use for too long.” If started too late, such therapies may not have the benefits observed in clinical trials, they said.
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