Study to Evaluate the Efficacy, Safety and Tolerability of PXT002331 (Foliglurax) in Reducing Motor Complications of Levodopa Therapy in Parkinson Disease's Patients
- Conditions
- Parkinson Disease
- Interventions
- Drug: Placebo oral capsuleDrug: PXT002331 - dose 1Drug: PXT002331 - dose 2
- Registration Number
- NCT03162874
- Lead Sponsor
- Prexton Therapeutics
- 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)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 157
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PLACEBO Placebo oral capsule - PXT002331 - 10mg PXT002331 - dose 1 - PXT002331 - 30mg PXT002331 - dose 2 -
- Primary Outcome Measures
Name Time Method Change from baseline to end of Treatment Period in the daily awake OFF time based on subject Hauser diary entries 28 days
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (45)
H么pital Avicenne APHP
馃嚝馃嚪Bobigny, France
Centre Hospitalier Universitaire d'Amiens
馃嚝馃嚪Amiens, France
Universit盲tsklinik f眉r Innere Medizin VI Innsbruck, Neurologisches Studienzentrum
馃嚘馃嚬Innsbruck, Austria
St. Joseph-Krankenhaus Berlin-Weissensee
馃嚛馃嚜Berlin, Germany
Paracelsus-Elena-Klinik Kassel
馃嚛馃嚜Kassel, Germany
Hospital Universitari General de Catalunya
馃嚜馃嚫Sant Cugat del Vall猫s, Spain
Universit脿 degli Studi di Roma "La Sapienza"
馃嚠馃嚬Roma, Italy
IRCCS Fondazione Ospedale San Camillo (SC)
馃嚠馃嚬Venezia, Italy
CHRU - H么pital Roger Salengro
馃嚝馃嚪Lille, France
CHU Grenoble - P么le Psychiatrie et Neurologie
馃嚝馃嚪Grenoble, France
CHU de Nice - H么pital Pasteur
馃嚝馃嚪Nice, France
CHU de Poitiers
馃嚝馃嚪Poitiers, France
H么pital Universitaire
馃嚝馃嚪Rouen, France
CHU de Nantes - H么pital Nord Laennec
馃嚝馃嚪Saint-Herblain, France
H么pitaux Universitaires de Strasbourg - H么pital de Hautepierre
馃嚝馃嚪Strasbourg, France
Centre Hospitalier de la C么te Basque
馃嚝馃嚪Bayonne, France
CHU Gabriel-Montpied
馃嚝馃嚪Clermont-Ferrand, France
H么pital Pierre Wertheimer
馃嚝馃嚪Bron, France
Hopital Pitie-Salpetriere
馃嚝馃嚪Paris, France
Centre Hospitalier Universitaire de Toulouse - H么pital Purpan
馃嚝馃嚪Toulouse, France
Practice for Neurology, Psychiatry & Psychotherapy Dr. med. I. Schoell & colleagues
馃嚛馃嚜Bad Homburg, Germany
University Hospital Erlangen - Abteilung fur Molekulare Neurologie
馃嚛馃嚜Erlangen, Germany
Neurological Praxis
馃嚛馃嚜Gera, Germany
MVZ Kliniken M眉hldorf a. Inn
馃嚛馃嚜M眉hldorf, Germany
Am Klinikum 1 Jena
馃嚛馃嚜Jena, Germany
Villa Margherita
馃嚠馃嚬Arcugnano, Italy
Fondazione Universita G. D'Annunzio Centro Studi sull'invecchiamento Centro di Ricerca Clinica
馃嚠馃嚬Chieti, Italy
Universita degli Studi di Salerno
馃嚠馃嚬Fisciano, Italy
IRCCS Centro Neurolesi Bonino Pulejo
馃嚠馃嚬Messina, Italy
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
馃嚠馃嚬Milano, Italy
Azienda Ospedaliero Universitaria Pisana - Stabilimento Ospedaliero di Santa Chiara
馃嚠馃嚬Pisa, Italy
Fairfield General Hospital
馃嚞馃嚙Bury, United Kingdom
Policlinico Tor Vergata
馃嚠馃嚬Roma, Italy
Humanitas Research Hospital
馃嚠馃嚬Rozzano, Italy
IRCCS San Raffaele Pisana
馃嚠馃嚬Roma, Italy
Hospital Cl铆nic de Barcelona
馃嚜馃嚫Barcelona, Spain
Hospital Universitario Vall d'Hebron
馃嚜馃嚫Barcelona, Spain
Hospital de la Santa Creu i Sant Pau
馃嚜馃嚫Barcelona, Spain
Hospital Universitario Virgen del Roc铆o
馃嚜馃嚫Sevilla, Spain
Hospital General Universitario de Elche
馃嚜馃嚫Elche, Spain
Hospital Universitari i Polit猫cnic La Fe
馃嚜馃嚫Valencia, Spain
North Tyneside General Hospital
馃嚞馃嚙North Shields, United Kingdom
Imperial College Healthcare NHS Trust - Charing Cross Hospital
馃嚞馃嚙London, United Kingdom
Clinical Ageing Research Unit, Campus for Ageing and Vitality
馃嚞馃嚙Newcastle upon Tyne, United Kingdom
Plymouth Hospitals NHS Trust - Derriford Hospital
馃嚞馃嚙Plymouth, United Kingdom