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| ID | Type | Description | Link |
|---|---|---|---|
| 18023A | Other Identifier | Lundbeck |
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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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PLACEBO | Placebo Comparator |
| |
| PXT002331 - 10mg | Experimental |
| |
| PXT002331 - 30mg | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo oral capsule | Drug | BID |
| |
| PXT002331 - dose 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline to end of Treatment Period in the daily awake OFF time based on subject Hauser diary entries | 28 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitätsklinik für Innere Medizin VI Innsbruck, Neurologisches Studienzentrum | Innsbruck | 6020 | Austria | |||
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| Drug |
Oral |
|
| PXT002331 - dose 2 | Drug | Oral |
|
| 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 |
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
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