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

Phase 2

Withdrawn

• Conditions: Parkinson's Disease
• Interventions: Drug: AP-CD/LD

• Registration Number: NCT00947037
• Lead Sponsor: Intec Pharma Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-07-24
• Study First Submitted QC: 2009-07-24
• Study First Posted: 2009-07-27
• Study Start: 2012-08
• Primary Completion: 2012-08
• Status Verified: 2012-09
• Last Update Submitted: 2015-11-23
• Last Update Posted: 2015-11-24

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Extension	AP-CD/LD	Open label extension, 1 arm

Primary Outcome Measures

Name	Time	Method
To assess patient and investigator global evaluation of, and degree of satisfaction with, AP-CD/LD (CGI, GSS)

Secondary Outcome Measures

Name	Time	Method
Daytime sleepiness
Quality of Life questionnaires
Efficacy measures of motor symptoms

Trial Locations

Locations (5)

Rambam Medical Center; 🇮🇱 Haifa, Israel

Wolfson Medical Center; 🇮🇱 Holon, Israel

Rabin Medical Center; 🇮🇱 Petah Tikva, Israel

Sheba Medical Center; 🇮🇱 Ramat Gan, Israel

TASMC; 🇮🇱 Tel Aviv, Israel