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

Primary Purpose

Parkinson's Disease

Status

Completed

Phase

Phase 2

Locations

Israel

Study Type

Interventional

Intervention

AP09004

Carbidopa/Levodopa, immediate release

About this trial

This is an interventional treatment trial for Parkinson's Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Subjects between the ages of 18 and 75 years of age inclusive;
For early patients only: Subject with Parkinson's disease with a stable response to Levodopa (not suffering from "wearing off") and currently treated with IR-Carbidopa/Levodopa containing 300-500mg Levodopa per day up to 4 doses per day.
For group 3 only: Subject with Parkinson's disease experiencing predictable motor fluctuations, end of dose "wearing off", defined by the patient's report of at least two episodes daily of a decline in function from peak benefit, with at least 2-3 hours OFF a day at the discretion of the PI (does not include early morning akinesia). Only patients with end of dose wearing off for at least 3 months will be included.
For moderate patients only: patients who are currently treated with IR-Carbidopa/Levodopa containing 600-900mg Levodopa, in divided dose, per day.
Subject has been stable at current CD/LD dose for at least 1 months
Hoehn and Yahr stages I-III
If subject is taking dopamine agonists, the dose has been stable for at least 1 month
Other then Parkinson's disease, the subject is in satisfactory health, as assessed by physical examination, blood test (biochemistry and hematology). No abnormality on clinical examination and blood tests that in the opinion of the Physician responsible will compromise safety or interfere with study procedures.

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.

Sites / Locations

Barzilai Medical Center, Department of Neurology, Movement disorders unit,
Department of Neurology, Clalit University Medical Center
Rambam Health Care Campus, Haifa, Movement Disorders and Parkinson's Disease
Edith Wolfson , Dept. of Neurology, Movement Disorders Unit.
Rabin Medical Center
Sheba Medical Center
TASMC

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Early patients

Moderate Patients

Arm Description

Outcomes

Primary Outcome Measures

To evaluate blood level profiles and safety of the AP09004

Secondary Outcome Measures

Efficacy of AP09004 on motor scores in Parkinson's patients

Full Information

NCT ID

NCT00918177

First Posted

June 1, 2009

Last Updated

May 25, 2014

Sponsor

Intec Pharma Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT00918177

Brief Title

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

Official Title

Dual Release Gastric Retentive AP09004, Vs. Active Control; a Pharmacokinetic/Pharmacodynamic, Comparative, Safety Evaluation in Parkinson's Patients

Study Type

Interventional

2. Study Status

Record Verification Date

February 2010

Overall Recruitment Status

Completed

Study Start Date

July 2009 (undefined)

Primary Completion Date

October 2012 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Intec Pharma Ltd.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Parkinson's Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

72 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Early patients

Arm Type

Experimental

Arm Title

Moderate Patients

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

AP09004

Intervention Type

Drug

Intervention Name(s)

Carbidopa/Levodopa, immediate release

Primary Outcome Measure Information:

Title

To evaluate blood level profiles and safety of the AP09004

Secondary Outcome Measure Information:

Title

Efficacy of AP09004 on motor scores in Parkinson's patients

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Subjects between the ages of 18 and 75 years of age inclusive; For early patients only: Subject with Parkinson's disease with a stable response to Levodopa (not suffering from "wearing off") and currently treated with IR-Carbidopa/Levodopa containing 300-500mg Levodopa per day up to 4 doses per day. For group 3 only: Subject with Parkinson's disease experiencing predictable motor fluctuations, end of dose "wearing off", defined by the patient's report of at least two episodes daily of a decline in function from peak benefit, with at least 2-3 hours OFF a day at the discretion of the PI (does not include early morning akinesia). Only patients with end of dose wearing off for at least 3 months will be included. For moderate patients only: patients who are currently treated with IR-Carbidopa/Levodopa containing 600-900mg Levodopa, in divided dose, per day. Subject has been stable at current CD/LD dose for at least 1 months Hoehn and Yahr stages I-III If subject is taking dopamine agonists, the dose has been stable for at least 1 month Other then Parkinson's disease, the subject is in satisfactory health, as assessed by physical examination, blood test (biochemistry and hematology). No abnormality on clinical examination and blood tests that in the opinion of the Physician responsible will compromise safety or interfere with study procedures. 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.

Overall Study Officials: