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

Parkinson's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00918177
• Other study ID #: IN 09 004
• Status: Completed
• Phase: Phase 2
• First received: June 1, 2009
• Last updated: May 25, 2014
• Start date: July 2009

Study information

• Verified date: February 2010
• Source: Intec Pharma Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Drug:
• AP09004

• Carbidopa/Levodopa, immediate release

Locations

Country	Name	City	State
Israel	Barzilai Medical Center, Department of Neurology, Movement disorders unit,	Ashkelon,
Israel	Department of Neurology, Clalit University Medical Center	Beer-Sheva
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

Sponsors (1)

Lead Sponsor	Collaborator
Intec Pharma Ltd.

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate blood level profiles and safety of the AP09004			Yes
Secondary	Efficacy of AP09004 on motor scores in Parkinson's patients