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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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8 October 2021 |
Main ID: |
EUCTR2009-017182-38-ES |
Date of registration:
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25/05/2010 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Estudio abierto de extensión para evaluar la seguridad y la eficacia de IPX066 en la enfermedad de Parkinson.
An Open Label Extension Study of the Safety and Clinical Utility of IPX066 in Subjects with Parkinson?s Disease.
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Scientific title:
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Estudio abierto de extensión para evaluar la seguridad y la eficacia de IPX066 en la enfermedad de Parkinson.
An Open Label Extension Study of the Safety and Clinical Utility of IPX066 in Subjects with Parkinson?s Disease. |
Date of first enrolment:
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26/07/2010 |
Target sample size:
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500 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-017182-38 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: no Randomised: Open: Single blind: Double blind: Parallel group: Cross over: Other: If controlled, specify comparator, Other Medicinial Product: Placebo: Other:
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
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Countries of recruitment
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Estonia
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Germany
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Latvia
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Lithuania
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Poland
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Spain
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Contacts
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Haber llegado al final de los estudios IPX066-B08-05, IPX066-B08-11 o IPX066-B09-02. 2. A juicio del investigador, diagnóstico de enfermedad de Parkinson todavía válido e idoneidad para recibir tratamiento con LD.
1. Successful completion of studies IPX066 B08-05, IPX066 B08 11, or IPX066 B09 02. 2. In the opinion of the Investigator, the Parkinson´s disease diagnosis is still valid and the subject remains eligible for LD therapy. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria: 1. Tratamiento con un fármaco en fase de investigación distinto de los administrados en un ensayo del IPX066 en las 4 semanas previas al inicio previsto del tratamiento. 2. Previsión de tratamiento neuroquirúrgico funcional de la EP (p.ej. ablación o estimulación cerebral profunda) durante la participación en el estudio. 3. Administración en las 4 semanas previas a la visita basal o previsión de administración durante el estudio de inhibidores no selectivos de la monoaminooxidasa (IMAO), a excepción de la rasagilina. 4. A juicio del investigador, inadecuación de la participación en el estudio.
1. Received an investigational medication other than those from an IPX066 trial within 4 weeks prior to the planned start of treatment. 2. Anticipates functional neurosurgical treatment for PD (e.g., ablation or deep brain stimulation) during study participation. 3. Received within 4 weeks prior to Baseline Visit or planning to take during study participation: nonselective monoamine oxidase (MAO) inhibitors (with the exception of rasagiline). 4. In the opinion of the Investigator, should not participate in the study.
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Enfermedad de Parkinson idiopática (parálisis agitante) MedDRA version: 12.1
Level: LLT
Classification code 10061536
Term: Parkinson's disease
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Intervention(s)
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Product Name: IPX066 Product Code: IPX066-95 Pharmaceutical Form: Capsule* INN or Proposed INN: CARBIDOPA CAS Number: 38821-49-7 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 23.75- INN or Proposed INN: LEVODOPA CAS Number: 59-92-7 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 95-
Product Name: IPX066 Product Code: IPX066-145 Pharmaceutical Form: Capsule* INN or Proposed INN: CARBIDOPA CAS Number: 38821-49-7 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 36.25- INN or Proposed INN: LEVODOPA CAS Number: 59-92-7 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 145-
Product Name: IPX066 Product Code: IPX066-195 Pharmaceutical Form: Capsule* INN or Proposed INN: CARBIDOPA CAS Number: 38821-49-7 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 48.75- INN or Proposed INN: LEVODOPA CAS Number: 59-92-7 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 195-
Product Name: IPX066 Product Code: IPX066-245 Pharmaceutical Form: Capsule* INN or Proposed INN: CARBIDOPA CAS Number: 38821-49-7 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 61.25- INN or Proposed INN: LEVODOPA CAS Number: 59-92-7 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 245-
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Primary Outcome(s)
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Primary end point(s): Seguridad (evaluada mediante constantes vitales, análisis clínicos, electrocardiogramas, acontecimientos adversos); utilidad clínica (evaluada mediante puntuación de UPDRS, Cuestionario de la enfermedad de Parkinson-39 (PDQ-39), Impresión Global del Paciente (PGI)); Resultados de salud (evaluados mediante los cuestionarios EQ-5D y SF-36) Safety (assessed by vital signs, laboratory results, ECG, adverse events); clinical utility (assessed by UPDRS, PDG-39, PGI); health outcomes (assessed by EG-5D, SF-36).
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Secondary Objective: Ninguno None.
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Main Objective: Evaluar la seguridad a largo plazo y la utilidad clínica de IPX066 en pacientes con enfermedad de Parkinson. To evaluate the long-term safety and clinical utility of IPX066 in subjects with Parkinson´s disease (PD).
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Secondary ID(s)
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2009-017182-38-EE
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IPX066-B09-03
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date: 14/07/2010
Contact:
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