Clinical trial NCT00947037: Gastric Retentive Carbidopa/ Levodopa in Parkinson's Patients; a One Year, Open Label, Safety Extension Study
Official title: An Open-Label, Multi-Center, Follow-Up Study Designed to Evaluate the Long-Term Effects of AP-CD/LD in Fluctuating Parkinson's Disease Subjects
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Parkinson's Disease
Lead sponsor: Intec Pharma Ltd.
Sponsor class: INDUSTRY
First posted: 2009-07-27
Enrollment: 0
Sex: ALL
Minimum age (years): 30
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: An extension of study IN 09 004 testing the long term safety of the Accordion Pill Carbidopa/Levodopa (AP-CD/LD)


Eligibility criteria: Inclusion Criteria:

* Subject satisfactorily completed study IN 09 004 and, in the opinion of the investigator, will benefit from participation in the extension study
* 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 hours OFF a day at the discretion of the PI (does not include early morning akinesia or nocturnal akinesia)
* Subject that has been treated for at least 3 months prior to the study with 500-1000 mg Levodopa + DDCI, in 4 or more divided doses per day
* Hoehn and Yahr stages I-III
* Subjects must be able to adhere to the visit schedule and protocol requirements and be available to complete the study
* Prepared and able to give written (signed and dated) informed consent, which includes compliance with study requirements and restrictions prior to admission to the study.

Exclusion Criteria

* Subject has undergone Deep brain stimulation (DBS) or any other neurological surgical procedure that affects neurological symptoms (e.g tremor, rigidity, stiffness, slowed movement, and walking problem)
* Subjects with any gastrointestinal surgery other than appendectomy or herniotomy, recent history of inflammatory bowel disease, irritable bowel syndrome, severe gastrointestinal narrowing, intestinal obstruction, or frequent nausea or emesis or diarrhea which, in the opinion of the investigator, contraindicates his/her participation
* Subjects with a recent history of clinically defined GERD, peptic ulcer or any gastrointestinal disorder likely to influence drug absorption which, in the opinion of the investigator, contraindicates his/her participation

Primary outcomes:
measure: To assess patient and investigator global evaluation of, and degree of satisfaction with, AP-CD/LD (CGI, GSS)
Secondary outcomes:
measure: Quality of Life questionnaires
measure: Daytime sleepiness
measure: Efficacy measures of motor symptoms
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam Medical Center
city: Holon
country: Israel
facility: Wolfson Medical Center
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:
References: