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

NCT ID: NCT00947037

Last Updated: 2015-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Brief Summary

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

Detailed Description

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Conditions

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Parkinson's Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Extension

Open label extension, 1 arm

Group Type EXPERIMENTAL

AP-CD/LD

Intervention Type DRUG

Interventions

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AP-CD/LD

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Intec Pharma Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Rambam Medical Center

Haifa, , Israel

Site Status

Wolfson Medical Center

Holon, , Israel

Site Status

Rabin Medical Center

Petah Tikva, , Israel

Site Status

Sheba Medical Center

Ramat Gan, , Israel

Site Status

TASMC

Tel Aviv, , Israel

Site Status

Countries

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Israel

Other Identifiers

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IN 12 005

Identifier Type: -

Identifier Source: org_study_id