An Evaluation of the Pharmacokinetics and Pharmacodynamics of AP09004 in Patients With Parkinson's Disease

Phase 2

Completed

• Conditions: Parkinson's Disease
• Interventions: Drug: AP09004; Drug: Carbidopa/Levodopa, immediate release

• Registration Number: NCT00918177
• Lead Sponsor: Intec Pharma Ltd.

Brief Summary

The purpose of this study is to evaluate blood level profiles of multiple oral doses of AP09004 vs. active control and to determine its safety and efficacy in Parkinson's patients.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-06-01
• Study First Submitted QC: 2009-06-09
• Study First Posted: 2009-06-11
• Study Start: 2009-07
• Status Verified: 2010-02
• Primary Completion: 2012-10
• Last Update Submitted: 2014-05-25
• Last Update Posted: 2014-05-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

Not provided

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Exclusion Criteria

• Subjects who have participated in another clinical trial within the last 30 days;
• 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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Early patients	AP09004	-
Early patients	Carbidopa/Levodopa, immediate release	-
Moderate Patients	AP09004	-
Moderate Patients	Carbidopa/Levodopa, immediate release	-

Primary Outcome Measures

Name	Time	Method
To evaluate blood level profiles and safety of the AP09004

Secondary Outcome Measures

Name	Time	Method
Efficacy of AP09004 on motor scores in Parkinson's patients

Trial Locations

Locations (7)

Barzilai Medical Center, Department of Neurology, Movement disorders unit,; 🇮🇱 Ashkelon,, Israel

Sheba Medical Center; 🇮🇱 Ramat Gan, Israel

Rambam Health Care Campus, Haifa, Movement Disorders and Parkinson's Disease; 🇮🇱 Haifa, Israel

Department of Neurology, Clalit University Medical Center; 🇮🇱 Beer-Sheva, Israel

Edith Wolfson , Dept. of Neurology, Movement Disorders Unit.; 🇮🇱 Holon, Israel

Rabin Medical Center; 🇮🇱 Petah Tikva, Israel

TASMC; 🇮🇱 Tel Aviv, Israel