Gastric Retentive Carbidopa/ Levodopa in Parkinson's Patients; a One Year, Open Label, Safety Extension Study
Gastric Retentive Carbidopa/ Levodopa in Parkinson's Patients; a One Year, Open Label, Safety Extension Study
An extension of study IN 09 004 testing the long term safety of the Accordion Pill
 Carbidopa/Levodopa (AP-CD/LD)
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