An Evaluation of the Pharmacokinetics and Pharmacodynamics of AP09004 in Patients With Parkinson's Disease
NCT ID: NCT00918177
Last Updated: 2014-05-28
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
72 participants
INTERVENTIONAL
2009-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Early patients
AP09004
Carbidopa/Levodopa, immediate release
Moderate Patients
AP09004
Carbidopa/Levodopa, immediate release
Interventions
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AP09004
Carbidopa/Levodopa, immediate release
Eligibility Criteria
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Exclusion Criteria
* Subjects with atypical Parkinsonism
* Subject has significant history of cardiac, pulmonary, hepatic or renal disease or other condition or any major complication/illness which, in the opinion of the physician responsible, contraindicates his/her participation.
* Subject with symptomatic gastroparesis with frequent vomiting (at least once a week).
* Subjects with a history of clinically defined GERD, peptic ulcer or any gastrointestinal surgery other than appendectomy or herniotomy, or with any gastrointestinal disorder likely to influence drug absorption, or with any history of inflammatory bowel disease, irritable bowel syndrome, severe gastrointestinal narrowing, or frequent nausea or emesis, regardless of etiology.
* Prior gastro-intestinal surgery or current gastrointestinal conditions of clinical significance including ulcers, diarrhea, vomiting, bleeding, intestinal obstruction or inflammatory bowel disease, which, in the opinion of the physician responsible, contraindicates his/her participation.
* History of drug or alcohol abuse.
* Subject has a history of allergy to any component of the dosage form or any other allergy, which, in the opinion of the physician responsible, contraindicates his/her participation.
* Subjects suffering from psychological disorders that in the opinion of the physician responsible may interfere with full participation.
18 Years
ALL
No
Sponsors
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Intec Pharma Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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T Gurevich, MD
Role: PRINCIPAL_INVESTIGATOR
Tel-Aviv Sourasky Medical Center
R. Djaldetti, Prof. MD
Role: PRINCIPAL_INVESTIGATOR
Rabin Medical Center
O. Cohen, MD
Role: PRINCIPAL_INVESTIGATOR
Sheba Medical Center
Ilana Schlesinger Schlesinger, MD
Role: PRINCIPAL_INVESTIGATOR
Rambam Health Care Campus, Haifa, Movement Disorders and Parkinson's Disease
Ron Milo, M.D
Role: PRINCIPAL_INVESTIGATOR
Barzilai Medical Center, Department of Neurology, Movement disorders unit, Ashkelon, Israel
Peter Farkas, M.D
Role: PRINCIPAL_INVESTIGATOR
Department of Neurology, Clalit University Medical Center
Marieta Anca-Herschkovitsch, M.D
Role: PRINCIPAL_INVESTIGATOR
Edith Wolfson , Dept. of Neurology, Movement Disorders Unit.
Locations
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Barzilai Medical Center, Department of Neurology, Movement disorders unit,
Ashkelon, , Israel
Department of Neurology, Clalit University Medical Center
Beersheba, , Israel
Rambam Health Care Campus, Haifa, Movement Disorders and Parkinson's Disease
Haifa, , Israel
Edith Wolfson , Dept. of Neurology, Movement Disorders Unit.
Holon, , Israel
Rabin Medical Center
Petah Tikva, , Israel
Sheba Medical Center
Ramat Gan, , Israel
TASMC
Tel Aviv, , Israel
Countries
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Other Identifiers
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IN 09 004
Identifier Type: -
Identifier Source: org_study_id
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