NCT00918177

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for phase_2

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 1, 2009

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 11, 2009

Completed
20 days until next milestone

Study Start

First participant enrolled

July 1, 2009

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
Last Updated

May 28, 2014

Status Verified

February 1, 2010

Enrollment Period

3.3 years

First QC Date

June 1, 2009

Last Update Submit

May 25, 2014

Conditions

Parkinson's Disease

Outcome Measures

Primary Outcomes (1)

  • To evaluate blood level profiles and safety of the AP09004

Secondary Outcomes (1)

  • Efficacy of AP09004 on motor scores in Parkinson's patients

Study Arms (2)

Early patients

EXPERIMENTAL
Drug: AP09004Drug: Carbidopa/Levodopa, immediate release

Moderate Patients

EXPERIMENTAL
Drug: AP09004Drug: Carbidopa/Levodopa, immediate release

Interventions

AP09004DRUG
Early patientsModerate Patients
Carbidopa/Levodopa, immediate releaseDRUG
Early patientsModerate Patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Barzilai Medical Center, Department of Neurology, Movement disorders unit,

Ashkelon, Israel

Location

Department of Neurology, Clalit University Medical Center

Beersheba, Israel

Location

Rambam Health Care Campus, Haifa, Movement Disorders and Parkinson's Disease

Haifa, Israel

Location

Edith Wolfson , Dept. of Neurology, Movement Disorders Unit.

Holon, Israel

Location

Rabin Medical Center

Petah Tikva, Israel

Location

Sheba Medical Center

Ramat Gan, Israel

Location

TASMC

Tel Aviv, Israel

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

carbidopa, levodopa drug combination

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • T Gurevich, MD

    Tel-Aviv Sourasky Medical Center

    PRINCIPAL INVESTIGATOR

  • R. Djaldetti, Prof. MD

    Rabin Medical Center

    PRINCIPAL INVESTIGATOR

  • O. Cohen, MD

    Sheba Medical Center

    PRINCIPAL INVESTIGATOR

  • Ilana Schlesinger Schlesinger, MD

    Rambam Health Care Campus, Haifa, Movement Disorders and Parkinson's Disease

    PRINCIPAL INVESTIGATOR

  • Ron Milo, M.D

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

    PRINCIPAL INVESTIGATOR

  • Peter Farkas, M.D

    Department of Neurology, Clalit University Medical Center

    PRINCIPAL INVESTIGATOR

  • Marieta Anca-Herschkovitsch, M.D

    Edith Wolfson , Dept. of Neurology, Movement Disorders Unit.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 1, 2009

First Posted

June 11, 2009

Study Start

July 1, 2009

Primary Completion

October 1, 2012

Last Updated

May 28, 2014

Record last verified: 2010-02

Locations

IL(7)