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

NCT00918177 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2014-05-28

No results posted yet for this study

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.

Conditions

Interventions

DRUG

AP09004

DRUG

Carbidopa/Levodopa, immediate release

Sponsors & Collaborators

  • Intec Pharma Ltd.

    lead INDUSTRY

Principal Investigators

  • T Gurevich, MD · Tel-Aviv Sourasky Medical Center

  • R. Djaldetti, Prof. MD · Rabin Medical Center

  • O. Cohen, MD · Sheba Medical Center

  • Ilana Schlesinger Schlesinger, MD · Rambam Health Care Campus, Haifa, Movement Disorders and Parkinson's Disease

  • Ron Milo, M.D · Barzilai Medical Center, Department of Neurology, Movement disorders unit, Ashkelon, Israel

  • Peter Farkas, M.D · Department of Neurology, Clalit University Medical Center

  • Marieta Anca-Herschkovitsch, M.D · Edith Wolfson , Dept. of Neurology, Movement Disorders Unit.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2012-10-31

Countries

  • Israel

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00918177 on ClinicalTrials.gov