Clinical trial NCT00918177: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Parkinson's Disease
Lead sponsor: Intec Pharma Ltd.
Sponsor class: INDUSTRY
First posted: 2009-06-11
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: To evaluate blood level profiles and safety of the AP09004
Secondary outcomes:
measure: Efficacy of AP09004 on motor scores in Parkinson's patients
Other outcomes:
Locations:
city: Ashkelon,
country: Israel
facility: Barzilai Medical Center, Department of Neurology, Movement disorders unit,
city: Beer-Sheva
country: Israel
facility: Department of Neurology, Clalit University Medical Center
city: Haifa
country: Israel
facility: Rambam Health Care Campus, Haifa, Movement Disorders and Parkinson's Disease
city: Holon
country: Israel
facility: Edith Wolfson , Dept. of Neurology, Movement Disorders Unit.
city: Petah Tikva
country: Israel
facility: Rabin Medical Center
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
city: Tel Aviv
country: Israel
facility: TASMC
Study officials:
affiliation: Tel-Aviv Sourasky Medical Center
name: T Gurevich, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rabin Medical Center
name: R. Djaldetti, Prof. MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sheba Medical Center
name: O. Cohen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rambam Health Care Campus, Haifa, Movement Disorders and Parkinson's Disease
name: Ilana Schlesinger Schlesinger, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Barzilai Medical Center, Department of Neurology, Movement disorders unit, Ashkelon, Israel
name: Ron Milo, M.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Neurology, Clalit University Medical Center
name: Peter Farkas, M.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Edith Wolfson , Dept. of Neurology, Movement Disorders Unit.
name: Marieta Anca-Herschkovitsch, M.D
role: PRINCIPAL_INVESTIGATOR
References: