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.

• Register: EUCTR
• Last refreshed on: 8 October 2021
• Main ID: EUCTR2009-017182-38-ES
• Date of registration: 25/05/2010
• Prospective Registration: Yes
• Primary sponsor: Impax Laboratories, Inc. acting through its Impax Pharmaceuticals Division
• Public title: 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.
• Scientific title: 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: 26/07/2010
• Target sample size: 500
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-017182-38
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no; Randomised: Open: Single blind: Double blind: Parallel group: Cross over: Other: If controlled, specify comparator, Other Medicinial Product: Placebo: Other:
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Estonia, Germany, Latvia, Lithuania, Poland, Spain

Key inclusion & exclusion criteria

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

Health Condition(s) or Problem(s) studied

Enfermedad de Parkinson idiopática (parálisis agitante)
MedDRA version: 12.1 Level: LLT Classification code 10061536 Term: Parkinson's disease

Intervention(s)

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-

Primary Outcome(s)

Secondary Objective: Ninguno
None.

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).

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).

Secondary ID(s)

IPX066-B09-03

2009-017182-38-EE

Ethics review

Status: Approved
Approval date: 14/07/2010
Contact:

Results

• Results available: Yes
• Date Posted: 28/09/2017
• Date Completed: 19/10/2011
• URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2009-017182-38/results