Study to Evaluate the Efficacy, Safety and Tolerability of PXT002331 (Foliglurax) in Reducing Motor Complications of Levodopa Therapy in Parkinson Disease's Patients
NCT ID: NCT03162874
Last Updated: 2020-03-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
157 participants
INTERVENTIONAL
2017-07-04
2020-03-02
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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PLACEBO
Placebo oral capsule
BID
PXT002331 - 10mg
PXT002331 - dose 1
Oral
PXT002331 - 30mg
PXT002331 - dose 2
Oral
Interventions
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Placebo oral capsule
BID
PXT002331 - dose 1
Oral
PXT002331 - dose 2
Oral
Eligibility Criteria
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Inclusion Criteria
* 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 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.
35 Years
85 Years
ALL
No
Sponsors
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Prexton Therapeutics
INDUSTRY
Responsible Party
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Locations
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Universitätsklinik für Innere Medizin VI Innsbruck, Neurologisches Studienzentrum
Innsbruck, , Austria
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, , France
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, , Germany
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
Milan, , Italy
Azienda Ospedaliero Universitaria Pisana - Stabilimento Ospedaliero di Santa Chiara
Pisa, , Italy
Policlinico Tor Vergata
Roma, , Italy
IRCCS San Raffaele Pisana
Roma, , Italy
Università degli Studi di Roma "La Sapienza"
Roma, , Italy
Humanitas Research Hospital
Rozzano, , Italy
IRCCS Fondazione Ospedale San Camillo (SC)
Venezia, , Italy
Hospital de la Santa Creu i Sant Pau
Barcelona, , Spain
Hospital Universitario Vall d'Hebron
Barcelona, , Spain
Hospital Clínic de Barcelona
Barcelona, , Spain
Hospital General Universitario de Elche
Elche, , Spain
Hospital Universitari General de Catalunya
Sant Cugat del Vallès, , Spain
Hospital Universitario Virgen del Rocío
Seville, , Spain
Hospital Universitari i Politècnic La Fe
Valencia, , Spain
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, , United Kingdom
Countries
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Other Identifiers
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18023A
Identifier Type: OTHER
Identifier Source: secondary_id
PXT-CL17-001
Identifier Type: -
Identifier Source: org_study_id
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