The results of a Phase III study have provided evidence that the drug apomorphine, first produced in 1865, could be effective in the management of advanced Parkinson’s disease. The study will be presented at the American Academy of Neurology’s 69th Annual Meeting in Boston (MA, USA), April 22–28, 2017.
The oral drug levodopa is the current drug of choice for the treatment of Parkinson’s disease. However, over time the effectiveness of the medication decreases, leading sufferers to experience “off time” when periods of immobility occur. Apomorphine has been used since the 1950s to treat advanced Parkinson’s disease. In the 1990s, physicians in Europe began using subcutaneous infusions of the drug to treat fluctuations in mobility that could not be controlled by the pills. Despite this, there is a lack of high-level evidence from randomized, blinded studies of the effectiveness and safety of apomorphine.
Regina Katzenschlager (Danube Hospital, Vienna, Austria), one of the study authors, explained: “If a person with Parkinson’s disease can reduce their “off” times that can have a great impact on their everyday life. In some patients in the trial, the insecurity of unpredictable periods of incapacity was completely alleviated.”
In the study, the researchers recruited 107 participants with advanced Parkinson’s disease from 23 centers in seven countries. The participants were then randomized to receive either apomorphine subcutaneous infusion or a placebo saline infusion. The infusions were administered over a period of 14–18 hours each day using a small portable pump.
It was found that participants who received apomorphine had a significantly greater reduction of “off” time than those who were given the placebo infusion. On average, they experienced 2.5 hours less “off” time per day, while those who received the placebo infusion had an average 30 mins per day reduction in “off” time. In addition, for apomorphine participants, there was an increase of “on” time without the abnormal involuntary movements known as dyskinesias that are often observed with levodopa.
Study participants were also asked to evaluate how well they thought the treatment worked. At week 12, those who received apomorphine gave their treatment higher scores than those who received the placebo infusion. In the apomorphine group, 71% of patients reported improvement, compared with 18% receiving placebo. Additionally, only 19% of participants worsened on apomorphine compared to 45% on placebo. Importantly, apomorphine was generally well tolerated and there were no serious side effects.
Katzenschlager concluded: “It is our hope that these findings confirming the efficacy of apomorphine infusion will encourage doctors in the USA to offer this treatment to their patients and assess its efficacy in their own clinical practice.”