Study to Evaluate the Efficacy, Safety and Tolerability of PXT002331 (Foliglurax) in Reducing Motor Complications of Levodopa Therapy in Parkinson Disease's Patients

Parkinson Disease Clinical Trial

— AMBLED  

Official 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03162874
• Other study ID #: PXT-CL17-001
• Secondary ID: 18023A
• Status: Completed
• Phase: Phase 2
• Start date: July 4, 2017
• Est. completion date: March 2, 2020

Study information

• Verified date: March 2020
• Source: Prexton Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This will be a double-blind, randomised, placebo-controlled parallel-arm phase II proof of concept in subjects with PD treated with a stable dose of levodopa who are experiencing both end-of-dose wearing off and Levodopa-Induced Dyskinesia (LID)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 157
• Est. completion date: March 2, 2020
• Est. primary completion date: February 19, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 85 Years

Eligibility

Inclusion Criteria:

• Males or females diagnosed after the age of 30 years with idiopathic PD for at least 3 years

• Disease severity of 2 to 4 on the modified Hoehn and Yahr scale when in the OFF state

• Been treated with a stable regimen of levodopa-containing therapy

• Subjects who are on a long-acting formulation of levodopa-containing therapy, including Apodespan PR (or equivalent), must be on a stable dose for at least 6 weeks prior to the first screening visit

• Experienced motor fluctuations with wearing off over a period of at least 3 months prior to randomisation

• Experienced LID over a period of at least 3 months prior to randomisation

• Female subjects will be women of non-childbearing potential

• Subjects must pass a Hauser diary concordance test

• Subjects are able, with or without the help of a caregiver, to understand the purpose and risks of the study and provide signed and dated informed consent and authorisation to use confidential health information in accordance with national and local subject privacy regulations

Exclusion Criteria:

• Subjects with atypical, secondary or drug-induced Parkinsonism

• Subjects with a Mini-Mental State Examination (MMSE) score <25

• Any known contraindication to the use of levodopa, including a history of malignant melanoma or a history of narrow-angle glaucoma.

• Subjects who have had a clinically significant illness within 4 weeks of first dose, as determined by the Investigator.

• Any advanced, severe or unstable disease (other than PD) that may interfere with the primary and secondary study outcome evaluations

• Subjects who have undergone prior neurosurgical operation for PD or transcranial magnetic stimulation.

• Subjects who are participating in another clinical study (eg, attending follow-up visits) or who have participated in a clinical study involving administration of an investigational drug (new chemical entity) in the past 3 months prior to the baseline visit.

• Female subjects of childbearing potential

• Subjects who are pregnant (as determined by positive serum pregnancy test at screening and/or baseline), breastfeeding or lactating.

• Subjects who, in the opinion of the Investigator, should not participate in this study.

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Drug:
• Placebo oral capsule
BID
• PXT002331 - dose 1
Oral
• PXT002331 - dose 2
Oral

Locations

Country	Name	City	State
Austria	Universitätsklinik für Innere Medizin VI Innsbruck, Neurologisches Studienzentrum	Innsbruck
France	Centre Hospitalier Universitaire d'Amiens	Amiens
France	Centre Hospitalier de la Côte Basque	Bayonne
France	Hôpital Avicenne APHP	Bobigny
France	Hôpital Pierre Wertheimer	Bron
France	CHU Gabriel-Montpied	Clermont-Ferrand
France	CHU Grenoble - Pôle Psychiatrie et Neurologie	Grenoble
France	CHRU - Hôpital Roger Salengro	Lille
France	CHU de Nice - Hôpital Pasteur	Nice
France	Hopital Pitie-Salpetriere	Paris
France	CHU de Poitiers	Poitiers
France	Hôpital Universitaire	Rouen
France	CHU de Nantes - Hôpital Nord Laennec	Saint-Herblain
France	Hôpitaux Universitaires de Strasbourg - Hôpital de Hautepierre	Strasbourg
France	Centre Hospitalier Universitaire de Toulouse - Hôpital Purpan	Toulouse
Germany	Practice for Neurology, Psychiatry & Psychotherapy Dr. med. I. Schoell & colleagues	Bad Homburg
Germany	St. Joseph-Krankenhaus Berlin-Weissensee	Berlin
Germany	University Hospital Erlangen - Abteilung fur Molekulare Neurologie	Erlangen
Germany	Neurological Praxis	Gera
Germany	Am Klinikum 1 Jena	Jena
Germany	Paracelsus-Elena-Klinik Kassel	Kassel
Germany	MVZ Kliniken Mühldorf a. Inn	Mühldorf
Italy	Villa Margherita	Arcugnano
Italy	Fondazione Universita G. D'Annunzio Centro Studi sull'invecchiamento Centro di Ricerca Clinica	Chieti
Italy	Universita degli Studi di Salerno	Fisciano
Italy	IRCCS Centro Neurolesi Bonino Pulejo	Messina
Italy	Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta	Milano
Italy	Azienda Ospedaliero Universitaria Pisana - Stabilimento Ospedaliero di Santa Chiara	Pisa
Italy	IRCCS San Raffaele Pisana	Roma
Italy	Policlinico Tor Vergata	Roma
Italy	Università degli Studi di Roma "La Sapienza"	Roma
Italy	Humanitas Research Hospital	Rozzano
Italy	IRCCS Fondazione Ospedale San Camillo (SC)	Venezia
Spain	Hospital Clínic de Barcelona	Barcelona
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona
Spain	Hospital Universitario Vall d'Hebron	Barcelona
Spain	Hospital General Universitario de Elche	Elche
Spain	Hospital Universitari General de Catalunya	Sant Cugat del Vallès
Spain	Hospital Universitario Virgen del Rocío	Sevilla
Spain	Hospital Universitari i Politècnic La Fe	Valencia
United Kingdom	Fairfield General Hospital	Bury
United Kingdom	Imperial College Healthcare NHS Trust - Charing Cross Hospital	London
United Kingdom	Clinical Ageing Research Unit, Campus for Ageing and Vitality	Newcastle upon Tyne
United Kingdom	North Tyneside General Hospital	North Shields
United Kingdom	Plymouth Hospitals NHS Trust - Derriford Hospital	Plymouth

Sponsors (1)

Lead Sponsor	Collaborator
Prexton Therapeutics

Countries where clinical trial is conducted

Austria,  France,  Germany,  Italy,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline to end of Treatment Period in the daily awake OFF time based on subject Hauser diary entries		28 days