Dyskinesia, Foliglurax (AMBLED)

NOTICE – Trial completed

Lundbeck has announced that the AMBLED study did not show a statistically significant reduction in OFF time (primary endpoint) nor an improvement of dyskinesia (secondary endpoint).  The development programme of foliglurax will be terminated.

To whom is this relevant?

Anyone with Parkinson’s experiencing end-of-dose wearing-off AND levodopa-induced dyskinesia. Principal inclusion criteria are age 35 – 85, diagnosis of PD for at least 3 years,  Broad age range, off-time and dykinesia thresholds noting a minimum off 2 hours Off time and 2 hours dyskinesia per day.  Participation is also subject to a medical examination.

What is being trialled and where?

This research at Derriford Hospital in Plymouth is part of a European study of the ability the oral drug Foligliurax to reduce the motor complications of levodopa therapy. This is a double-blind randomised placebo-controlled Trial, meaning that neither you nor anyone in Derriford know whether you have been assigned the drug or the placebo.

What is involved?

The Trial schedule over 6 weeks requires nine visits to Derriford. Visits 1 to 3 are for screening and preparation. Visits 4, 5, 6, 7 and 8 must take place on diarised dates in the 28-day drug trial cycle. Visit 9 is for follow-up . More information is given in the  Patient Information Sheet. Travel expenses are paid and free parking can be arranged at the Trial Unit’s premises.

Interested in taking part?

Please contact Dr Camille Carroll’s research team on 01752 432048 or email abigail.patrick1@nhs.net.

Further Information

Recruitment for this Trial was expected to close late last year but remains open. This is a Phase 2 trial. Unblinding, which means the record seals are broken by the Trial organisers, takes place after the closure of all participation. You will not be told until then whether you were taking the placebo or the drug. There are no arrangements for availablity of the drug beyond the 28-day trial.

The international AMBLED Trial registration is by Prexton Therapeutics, purchased since registration by the The Lundberg Group.