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Parkinson's Disease clinical trials

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NCT ID: NCT00143026 Completed - Parkinson's Disease Clinical Trials

Study to Compare the Effect of Treatment With Carbidopa/Levodopa/Entacapone on the Quality of Life of Patients With Parkinson's Disease. This Study is Not Recruiting in the United States

Start date: July 2005
Phase: Phase 4
Study type: Interventional

This study examines the effect of treatment of levodopa/entacapone on quality of life, as measured by the Parkinson's Disease-Questionnaire 8 (PDQ-8), in Parkinson's disease patients with no or minimal, non-disabling motor fluctuations.

NCT ID: NCT00142363 Terminated - Epilepsy Clinical Trials

Cohorts and Collections: Clinical and Genetic Study of Parkinson's Disease and Epilepsies

Start date: May 2004
Phase: Phase 1
Study type: Observational

The DNA and Cell Bank of Instituts Federatifs de Recherche (IFR) of Neurosciences has been running for the last 15 years at the Institut National de la Santé Et de la Recherche Médicale (INSERM) Unit 679 (former unit 289). Since its creation, this structure has been the support of research projects in genetics for neurological and psychiatric disorders. The cohorts established have led to discoveries in monogenic disorders, such as cerebellar ataxias, spastic paraplegias, frontotemporal dementias, epilepsies, Parkinson’s and Alzheimer’s disease, Charcot-Marie-Tooth disease and related entities. The research projects based on the study of the genetic bases in Parkinson’s disease and epilepsies are especially developed for this grant. Concerning Parkinson’s disease, the project is based on the extension of the existing cohort throughout the French Parkinson’s Disease Study Group network. Concerning epilepsies, this project is the occasion to build this network with the constitution of a new cohort. The specific aims of the scientific projects are the following for Parkinson’s disease: - to evaluate the frequency, the nature and the phenotype associated with parkin mutations in familial or sporadic forms of the disease, according to the age at onset, and - to identify the genetic susceptibility factors in Parkinson’s disease with the study of affected sibpairs and with case/controls association studies. For epilepsies, the aims are: - to evaluate the frequency, the nature and the phenotype associated with SCN1A, SCNab and GABR2 gene mutations in familial or sporadic forms of the affection associated with febrile seizures, and - to search for an intervention SCN1A, SCN1B and GABRG2 as susceptible genes in these forms of epilepsies.

NCT ID: NCT00142311 Terminated - Parkinson's Disease Clinical Trials

Functional Characterization of Parkin + Patients

Start date: November 2003
Phase: Phase 1
Study type: Observational

Parkinson’s disease is one of the most frequent neurodegenerative diseases, and for which the mechanisms remains unknown. Since the implication of susceptibility factors is highly suspect, we have recently shown that one monogenic form due to alterations in the Parkin gene was responsible for an important proportion of early onset familial and isolated cases. Nevertheless, it not has been determined yet the relationship between idiopathic Parkinson’s disease and secondary Parkinson’s disease with a Parkin gene mutation at the clinical, neuropsychological, metabolic and physiopathological levels. For establishing phenotype-genotype correlations, we propose to compare the phenotype of patients carrying a Parkin mutation (parkin « + », n=25) to those of early onset parkinsonians without a Parkin mutation (Parkin ” - ”, n = 25), and for some aspects (neuropsychological, behavioural and psychiatric evaluations) to the healthy brothers and sisters of Parkin cases “+”(n = 25). The evaluation will carry on the clinical aspects (quantification of the parkinsonian syndrome and reactivity to levodopa, neuropsychological, behavioural and psychiatric evaluations), molecular (types of abnormalities in the Parkin gene) and metabolic (PET – tomography by positron emission) of the disease. Parkinson’s disease caused by Parkin gene mutations is associated with an important and homogeneous loss of dopaminergic neurons of the substantia nigra pars compacta, which is different from those observed during the idiopathic Parkinson’s disease. The corresponding dopaminergic deficit should be associated with an excellent reactivity to levodopa, to a cognitive deficit and to behavioural and/or psychiatric attitudes, in relation with the massive alteration of dopaminergic efferences. This multidisciplinary approach on Parkin cases will be performed in the centers for of clinical investigations of Grenoble and Paris, with the help of the French Parkinson’s Disease Study Group, and two centers for TEP (Lyon and Orsay). This project will allow to a better definition of diagnostic criteria of Parkin « + » cases, which will help for the molecular diagnosis in early onset cases, and will study precisely the clinical, psychiatric and metabolic consequences of a massive and homogeneous dopaminergic denervation, which seems to be different of idiopathic Parkinson’s disease.

NCT ID: NCT00139880 Completed - Parkinson's Disease Clinical Trials

A Single Center, Randomized, Double-blind, Crossover Pilot Trial Comparing the Onset of Action of Parcopa™ With Sinemet® in Subjects With Stable Parkinson's Disease

Start date: June 2005
Phase: Phase 3
Study type: Interventional

To test whether Parcopa, a new Orally Disintegrating Tablet of Carbidopa-Levodopa, has a faster onset of action, changes in the UPDRS Motor Exam score at intervals after a single dose of Parcopa or Sinemet are being compared in 10 subjects with Parkinson's disease. Subjects 40 years or older having idiopathic PD with Hoehn and Yahr state II or III are eligible if taking a stable dose of < 200 mg carbidopa and < 2000 mg levodopa daily. At both treatment visits, either Parcopa or Sinemet, plus a placebo of the opposite tablet (ODT or conventional) are administered. The dose is the same as the subject's prestudy regimen. The primary efficacy variable, time to onset of action, is the first postdose time when a 30% decrease (30% improvement) in the total score is achieved. All UPDRS evaluations are done by a rater blinded to the active treatment received by the subject.

NCT ID: NCT00139867 Completed - Parkinson's Disease Clinical Trials

A Multicenter, Open-label Trial to Assess Subject Preference of PARCOPA, Carbidopa/Levodopa Orally Disintegrating Tablets, Compared to Conventional Carbidopa/Levodopa Tablets in Subjects With Stable Parkinson's Disease

Start date: January 2004
Phase: Phase 3
Study type: Interventional

The objective of this trial was to assess subject preference for PARCOPA, carbidopa/levodopa Orally Disintegrating Tablets (ODT), compared with conventional carbidopa/levodopa tablets, in subjects with stable Parkinson's disease.

NCT ID: NCT00136721 Active, not recruiting - Parkinson's Disease Clinical Trials

Parkin Mutations and Their Functional Consequences

Start date: June 2002
Phase: Phase 1
Study type: Observational

Parkinson's disease (PD) is the most frequent neurodegenerative disease with a prevalence of 2% over 65 years and because of this high prevalence as the population ages, it is a major problem of public health. An exhaustive repertory of not only parkin mutations in autosomal recessive forms of PD but also in other known genes such as DJ-1, PINK1 and LRRK2, is of major importance for both genetic counseling in families affected with PD and physiopathological approaches to this disease. Through a French network for the study of Parkinson's disease genetics and extended collaborations with European, Mediterranean and other various countries, a total of 2934 subjects including 1683 patients and 1251 unaffected individuals has been collected since 2002. These samples consisted of 122 families with autosomal recessive PD, 285 cases of isolated early onset PD, 110 autosomal recessive and 129 autosomal dominant families with late onset PD, 201 isolated late onset PD cases and 250 matched controls. DNAs from all subjects are now available, lymphocytes and lymphoblastoid cell lines have been stored for most patients from France and recently, fresh fibroblasts have been obtained for some individuals. The genetic approach to autosomal recessive PD is focused on the identification of mutations in the parkin gene but also on the screening of DJ-1, PINK1 and LRRK2 genes.

NCT ID: NCT00134966 Completed - Parkinson's Disease Clinical Trials

A Study to Evaluate Fixed Dose Carbidopa/Levodopa/Entacapone Versus Immediate Release Carbidopa/Levodopa

Start date: August 2005
Phase: Phase 3
Study type: Interventional

The purpose of this study is to achieve approval for the use of carbidopa/levodopa/entacapone in early Parkinson's disease (PD) by demonstrating that when used as initial levodopa therapy in early PD, carbidopa/levodopa/entacapone provides significantly greater symptomatic benefit than immediate release carbidopa/levodopa administered at the same levodopa dosage level of 100 mg three times a day (t.i.d.).

NCT ID: NCT00134251 Completed - Parkinson's Disease Clinical Trials

Ascending Dose Tolerability/Safety of SLV308 for the Treatment of Parkinson's Disease

Start date: October 2005
Phase: Phase 3
Study type: Interventional

This study is a multicenter, randomized, double-blind, placebo controlled, parallel group study of a seven-week ascending dose period of SLV308 adjunctive to L-dopa treatment in patients with advanced stage Parkinson's disease (PD) and dose-dependent motor fluctuations. Patients (outpatients) will be randomized to one of three different treatment arms.

NCT ID: NCT00132626 Completed - Parkinson's Disease Clinical Trials

Study of Brain Imaging With Nuclear Technology in Individuals With Parkinsonian Syndrome

Start date: September 1992
Phase: Phase 2
Study type: Interventional

This study assesses dopamine transporter density using single photon emission computed tomography (SPECT) brain imaging with an investigational radiopharmaceutical, [123I]ß-CIT, in research participants with Parkinson's disease.

NCT ID: NCT00125138 Completed - Parkinson's Disease Clinical Trials

Melperone (an Anti-Psychotic) in Patients With Psychosis Associated With Parkinson's Disease

Start date: July 2005
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety and efficacy of three target doses of melperone compared to placebo in the treatment of psychosis associated with Parkinson's disease. Subjects will be enrolled at approximately 20 investigational sites in the United States (U.S.) and 15 Ex-US sites. The maximum study duration will be 10 weeks. Subjects will have the option of continuing in an open-label extension study.