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Levodopa-carbidopa Intestinal Gel Open-label Study in Advanced PD

2014-08-27 03:44:14 | BioPortfolio

Summary

The primary objective of this study will be to provide further evidence of the long-term safety and tolerability of levodopa-carbidopa intestinal gel (Duodopa®) over 12-months in subjects with advanced Parkinson's Disease (PD) and severe motor-fluctuations

Study Design

Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Advanced Parkinson's Disease

Intervention

Levodopa-Carbidopa intestinal gel, CADD-Legacy® 1400

Location

Site 114
Birmingham
Alabama
United States

Status

Recruiting

Source

Solvay Pharmaceuticals

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:44:14-0400

Clinical Trials [1561 Associated Clinical Trials listed on BioPortfolio]

Open Label Continuation Treatment Study With Levodopa-Carbidopa Intestinal Gel in Advanced PD

The primary objective is to provide continued access to subjects who would like to continue levodopa-carbidopa intestinal gel (LCIG), after completion of an open-label study (S187.3.003 or...

Safety/Efficacy Study of Levodopa-Carbidopa Intestinal Gel in Parkinson's Subjects

Long term safety and efficacy (12 months) of levodopa-carbidopa intestinal gel (Duodopa®).

DAPHNE (Duodopa in Advanced Parkinson's: Health Outcomes & Net Economic Impact)

Health economics long-term study

An Study Comparing Efficacy of Levodopa-Carbidopa Intestinal Gel/Carbidopa-Levodopa Enteral Suspension and Optimized Medical Treatment on Dyskinesia in Subjects With Advanced Parkinson's Disease

The primary objective of this study is to examine the effect of levodopa-carbidopa intestinal gel (LCIG) compared with optimized medical treatment (OMT) on dyskinesia in participants with ...

Carbidopa/Levodopa/Entacapone Versus Immediate Release (IR) Carbidopa/Levodopa on Non-Motor Symptoms in Patients With Idiopathic Parkinson's Disease

The purpose of this study is to test the effects of carbidopa/levodopa/entacapone compared to the effects of immediate-release carbidopa/levodopa on end-of-dose wearing off in persons who ...

PubMed Articles [6574 Associated PubMed Articles listed on BioPortfolio]

Levodopa-carbidopa intestinal gel infusion and weight loss in Parkinson's disease.

Weight loss (WL) is a frequent yet under-recognized complication of levodopa/carbidopa intestinal gel (LCIG) infusion, as well as a milestone of Parkinson disease (PD) disability progression. The comp...

Levodopa-carbidopa intestinal gel treatment introduced by surgical gastrostomy in a patient of Parkinson's disease after Billroth II gastrojejunostomy.

A 68-year-old man, who had received Billroth II gastrojejunostomy because of duodenal ulcer at the age of 20, was diagnosed to have Parkinson's disease at age 57 years. The drug therapy has been effec...

Sensor-based algorithmic dosing suggestions for oral administration of levodopa/carbidopa microtablets for Parkinson's disease: a first experience.

Dosing schedules for oral levodopa in advanced stages of Parkinson's disease (PD) require careful tailoring to fit the needs of each patient. This study proposes a dosing algorithm for oral administra...

A Man Made Manic: Levodopa-Carbidopa-Induced Mania in Traumatic Brain Injury.

Traumatic brain injury (TBI) has had increased notoriety in light of chronic traumatic encephalopathy in professional sports. However, despite the increased rate at which mood disorders affect this po...

Vitamin B6 deficiency caused by the use of levodopa.

There are indications that the use of levodopa/carbidopa can cause symptomatic vitamin B6 deficiency. However, this has only been described for patients who used the product in the form of an intestin...

Medical and Biotech [MESH] Definitions

An inhibitor of DOPA DECARBOXYLASE, preventing conversion of LEVODOPA to dopamine. It is used in PARKINSON DISEASE to reduce peripheral adverse effects of LEVODOPA. It has no antiparkinson actions by itself.

A selective, irreversible inhibitor of Type B monoamine oxidase. It is used in newly diagnosed patients with Parkinson's disease. It may slow progression of the clinical disease and delay the requirement for levodopa therapy. It also may be given with levodopa upon onset of disability. (From AMA Drug Evaluations Annual, 1994, p385) The compound without isomeric designation is Deprenyl.

An inhibitor of DOPA DECARBOXYLASE that does not enter the central nervous system. It is often given with LEVODOPA in the treatment of parkinsonism to prevent the conversion of levodopa to dopamine in the periphery, thereby increasing the amount that reaches the central nervous system and reducing the required dose. It has no antiparkinson actions when given alone.

A condition caused by the lack of intestinal PERISTALSIS or INTESTINAL MOTILITY without any mechanical obstruction. This interference of the flow of INTESTINAL CONTENTS often leads to INTESTINAL OBSTRUCTION. Ileus may be classified into postoperative, inflammatory, metabolic, neurogenic, and drug-induced.

Proteins associated with sporadic or familial cases of PARKINSON DISEASE.

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