“Off” Episodes, Apomorphine (APL-130277)

What’s it about?

To compare a new form of apomorphine (wafer under the tongue) with the existing injectable version.

To whom is this relevant?

Those with Parkinson’s disease who have a good response to Levodopa therapy, are taking it at least three times a day and nevertheless experience motor complications as “Off” periods.

What is being trialled and where?

Research at Derriford Hospital in Plymouth is investigating oral Apomorphine. This is a new chemical formulation named APL-130277 and developed by Sunovion, which is taken by placing a thin film under the tongue.

The aim of this research is to see how movement may be improved by taking oral Apomorphine,  and compare this with the existing method of injected Apomorphine.

This is a An Open-Label (you know what you are taking) Randomized Crossover (you are randomly assigned to either drug to start with) Trial, utilizing a Single Blinded Rater (who doesn’t know what you are taking at the time of the observations made in the Trials Unit or at home).

What is involved?

The  duration of the Trial is 12 weeks.  Several visits to the Trials Unit are necessary.  The first visit to the Trials Unit at Derriford will assess your suitability to take part.  A range of assessments will be performed and you will have the opportunity to ask questions. If you are suitable for the Trial you will be invited to give your consent.   You will be required to take both oral Apomorphine and subcutaneous Apomorphine injections during the course of the study. The study is of long duration because you will be taking increasing quantities of each drug (“titration”).

More information is given in the Participant Information Sheet and the Study Drug Flow Chart.

Interested in taking part?

Please contact Dr Camille Carroll’s research team on 01752 432048 or email plh-tr.integrityresearchteam@nhs.net

Further Information

Go the international  CTH-302 Drug Trial Protocol