Study to Evaluate the Efficacy, Safety and Tolerability of PXT002331 (Foliglurax) in Reducing Motor Complications of Levodopa Therapy in Parkinson Disease's Patients
AMBLED
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)
2 other identifiers
interventional
157
6 countries
45
Brief 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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 parkinson-disease
Started Jul 2017
Typical duration for phase_2 parkinson-disease
45 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 19, 2017
CompletedFirst Posted
Study publicly available on registry
May 22, 2017
CompletedStudy Start
First participant enrolled
July 4, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 19, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 2, 2020
CompletedMarch 17, 2020
March 1, 2020
2.6 years
May 19, 2017
March 16, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline to end of Treatment Period in the daily awake OFF time based on subject Hauser diary entries
28 days
Study Arms (3)
PLACEBO
PLACEBO COMPARATORPXT002331 - 10mg
EXPERIMENTALPXT002331 - 30mg
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (45)
Universitätsklinik für Innere Medizin VI Innsbruck, Neurologisches Studienzentrum
Innsbruck, 6020, Austria
Centre Hospitalier Universitaire d'Amiens
Amiens, 80054, France
Centre Hospitalier de la Côte Basque
Bayonne, 64100, France
Hôpital Avicenne APHP
Bobigny, 93009, France
Hôpital Pierre Wertheimer
Bron, 69500, France
CHU Gabriel-Montpied
Clermont-Ferrand, 63003, France
CHU Grenoble - Pôle Psychiatrie et Neurologie
Grenoble, 38043, France
CHRU - Hôpital Roger Salengro
Lille, 59037, France
CHU de Nice - Hôpital Pasteur
Nice, 06002, France
Hopital Pitie-Salpetriere
Paris, 75013, France
CHU de Poitiers
Poitiers, 86000, France
Hôpital Universitaire
Rouen, 76031, France
CHU de Nantes - Hôpital Nord Laennec
Saint-Herblain, 44805, France
Hôpitaux Universitaires de Strasbourg - Hôpital de Hautepierre
Strasbourg, France
Centre Hospitalier Universitaire de Toulouse - Hôpital Purpan
Toulouse, 31059, France
Practice for Neurology, Psychiatry & Psychotherapy Dr. med. I. Schoell & colleagues
Bad Homburg, 61348, Germany
St. Joseph-Krankenhaus Berlin-Weissensee
Berlin, 13088, Germany
University Hospital Erlangen - Abteilung fur Molekulare Neurologie
Erlangen, 91054, Germany
Neurological Praxis
Gera, 07551, Germany
Am Klinikum 1 Jena
Jena, 07747, Germany
Paracelsus-Elena-Klinik Kassel
Kassel, 34128, Germany
MVZ Kliniken Mühldorf a. Inn
Mühldorf, Germany
Villa Margherita
Arcugnano, 36057, Italy
Fondazione Universita G. D'Annunzio Centro Studi sull'invecchiamento Centro di Ricerca Clinica
Chieti, 66100, Italy
Universita degli Studi di Salerno
Fisciano, 84084, Italy
IRCCS Centro Neurolesi Bonino Pulejo
Messina, 98123, Italy
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Milan, 20133, Italy
Azienda Ospedaliero Universitaria Pisana - Stabilimento Ospedaliero di Santa Chiara
Pisa, 56126, Italy
Policlinico Tor Vergata
Roma, 00133, Italy
IRCCS San Raffaele Pisana
Roma, 163, Italy
Università degli Studi di Roma "La Sapienza"
Roma, 185, Italy
Humanitas Research Hospital
Rozzano, 20089, Italy
IRCCS Fondazione Ospedale San Camillo (SC)
Venezia, 30126, Italy
Hospital de la Santa Creu i Sant Pau
Barcelona, 8025, Spain
Hospital Universitario Vall d'Hebron
Barcelona, 8035, Spain
Hospital Clínic de Barcelona
Barcelona, 8036, Spain
Hospital General Universitario de Elche
Elche, 3203, Spain
Hospital Universitari General de Catalunya
Sant Cugat del Vallès, 8195, Spain
Hospital Universitario Virgen del Rocío
Seville, 41013, Spain
Hospital Universitari i Politècnic La Fe
Valencia, 46010, Spain
Fairfield General Hospital
Bury, BL9 7TD, United Kingdom
Imperial College Healthcare NHS Trust - Charing Cross Hospital
London, W6 8RF, United Kingdom
Clinical Ageing Research Unit, Campus for Ageing and Vitality
Newcastle upon Tyne, NE4 5PL, United Kingdom
North Tyneside General Hospital
North Shields, NE29 8NH, United Kingdom
Plymouth Hospitals NHS Trust - Derriford Hospital
Plymouth, PL6 8DH, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 19, 2017
First Posted
May 22, 2017
Study Start
July 4, 2017
Primary Completion
February 19, 2020
Study Completion
March 2, 2020
Last Updated
March 17, 2020
Record last verified: 2020-03