AMBLED Study
Research type
Research Study
Full title
A Multi-centre, Double-blind, Randomised, Placebo-controlled, Parallel-arm Phase IIa Trial to Evaluate the Efficacy, Safety and Tolerability of 28-Day Oral Treatment with PXT002331 (foliglurax) in Reducing Motor Complications of Levodopa Therapy in Subjects with Parkinson’s Disease Experiencing End-of-dose Wearing Off and Levodopa-Induced Dyskinesia (AMBLED)
IRAS ID
222912
Contact name
Camille Carroll
Contact email
Sponsor organisation
Prexton Therapeutics B.V.
Eudract number
2017-000135-14
Duration of Study in the UK
1 years, 4 months, 19 days
Research summary
Parkinson's disease (PD) is the second most common neurodegenerative disease which causes the gradual death of dopamine-producing cells of the central nervous system. This depletion of dopamine from the basal ganglia causes the occurrence of PD. Current therapies are primarily based on a dopamine “replacement” strategy using the dopamine precursor levodopa. However, it has been noted that over time the majority of patients suffer from motor complications (“wearing off” and dyskinesia).
Scientists noticed that when targeting a receptor called metabotropic glutamate receptor 4 (mGluR4), it assisted in reversing motor symptoms. Using this knowledge Prexton Therapeutics has developing a drug called PXT002331 which allows the natural protein found in the body to bind to this mGLuR4 receptor. This makes the reversing of the motor symptoms last longer and with greater effect whilst maintaining low doses of levodopa and still having the same anti-Parkinsonian benefit in patients (levodopa sparing potential).This will be a double-blind (neither the site or the patients will know what drug is being administered), randomised, placebo-controlled parallel-arm study with 2 doses of PXT002331 as add-on therapy in PD patients treated with a stable dose of levodopa who are experiencing both end-of-dose wearing off and Levodopa-induced dyskinesia.
Approximately 165 patients with PD with motor complications of wearing off and dyskinesia will be recruited at approximately 46 study sites in Europe. Considering the potential for patients to drop out during the course of the study, it is estimated that approximately 135 patients will complete the study. Each patient will undergo a Screening Period of at least 28 days that starts with 2 screening visits and a baseline visit, followed by a 28-day, double-blind, placebo-controlled Treatment Period and a safety follow-up visit approximately 14 days after completion of the investigational treatment. Patients will be randomised 1:1:1 to 1 of 3 treatment groups: 10 mg PXT002331, 30 mg PXT002331 and placebo. Doses will be administered twice daily (in the morning and evening) on Days 1 through to 28 (morning dose only on Day 28).
REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
17/EM/0154
Date of REC Opinion
15 Jun 2017
REC opinion
Further Information Favourable Opinion