Gastric Retentive Carbidopa/ Levodopa in Parkinson's Patients; a One Year, Open Label, Safety Extension Study

• Register: ClinicalTrials.gov
• Last refreshed on: 7 December 2015
• Main ID: NCT00947037
• Date of registration: 24/07/2009
• Prospective Registration: Yes
• Primary sponsor: Intec Pharma Ltd.
• Public title: Gastric Retentive Carbidopa/ Levodopa in Parkinson's Patients; a One Year, Open Label, Safety Extension Study
• Scientific 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
• Date of first enrolment: August 2012
• Target sample size: 0
• Recruitment status: Withdrawn
• URL: https://clinicaltrials.gov/show/NCT00947037
• Study type: Interventional
• Study design: Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

Israel

Key inclusion & exclusion 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



Age minimum: 30 Years
Age maximum: 95 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Parkinson's Disease

Intervention(s)

Drug: AP-CD/LD

Primary Outcome(s)

To assess patient and investigator global evaluation of, and degree of satisfaction with, AP-CD/LD (CGI, GSS) [Time Frame: Yes]

Secondary Outcome(s)

Efficacy measures of motor symptoms

Quality of Life questionnaires [Time Frame: No]

Daytime sleepiness [Time Frame: Yes]

Secondary ID(s)

IN 12 005

Source(s) of Monetary Support

Please refer to primary and secondary sponsors