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Long-Term Safety Study of KW-6002 (Istradefylline) in Parkinson's Disease Patients

2014-08-27 03:20:08 | BioPortfolio

Summary

Patients with Parkinson's disease who completed the prior double-blind study 6002-009 are eligible to enter into this long-term study. The purpose of this study is to evaluate the safety and efficacy of KW-6002 administered long-term in patients with advanced Parkinson's disease treated with levodopa.

Study Design

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

Conditions

Parkinson's Disease

Intervention

Istradefylline

Location

Tokyo
Japan

Status

Recruiting

Source

Kyowa Hakko Kirin Company, Limited

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:20:08-0400

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Study of KW-6002 (Istradefylline) in Parkinson's Disease in Patients With Motor Response Complications on Levodopa

The purpose of this study is to confirm the long term tolerability and safety of oral 20 or 40 mg/d doses of Istradefylline.

A Phase 2b Study of Istradefylline (KW-6002) for the Treatment of Parkinson's Disease in Patients Taking Levodopa

The purpose of this study is to establish the efficacy of 20 mg/day and 40 mg/day doses of istradefylline for reducing the mean total hours of awake time per day spent in the OFF state in ...

Study of KW-6002 (Istradefylline) for the Treatment of Parkinson's Disease in Patients Taking Levodopa

The purpose of this study is to establish the efficacy of 20 mg/day and 40 mg/day doses of istradefylline for reducing the mean total hours of awake time per day spent in the OFF state in ...

A Study of Istradefylline (KW-6002) for the Treatment of Parkinson's Disease in Patients Taking Levodopa

To establish the efficacy of a 20 mg/day dose of istradefylline for reducing the percentage of OFF time in patients with advanced Parkinson's disease (PD) treated with levodopa.

A Study of Istradefylline (KW-6002) for the Treatment of Parkinson’s Disease in Patients Taking Levodopa

To establish the efficacy of 20 mg/day and 40 mg/day doses of istradefylline for reducing the percentage of OFF time in patients with advanced Parkinson’s disease (PD) treated with levod...

PubMed Articles [14583 Associated PubMed Articles listed on BioPortfolio]

Safety and effectiveness of istradefylline in patients with Parkinson's disease: interim analysis of a post-marketing surveillance study in Japan.

Istradefylline is a first-in-class, non-dopaminergic, selective adenosine A receptor antagonist for the treatment of Parkinson's disease (PD) in patients experiencing the wearing-off phenomenon with l...

Occupancy of adenosine A receptors by istradefylline in patients with Parkinson's disease using C-preladenant PET.

Istradefylline, an adenosine A receptor (AR) antagonist, is effective as an adjunct to levodopa and can alleviate "off" time and motor symptoms in patients with Parkinson's disease (PD). The present s...

Long-term Outcome of Adenosine A2A Receptor Antagonist on Lower Urinary Tract Symptoms in Male Parkinson Disease Patients.

In addition to motor symptoms, bladder dysfunction is a major clinical issue in patients with Parkinson disease (PD). Istradefylline is adenosine A2A receptor antagonist approved for PD patients with ...

Mild Cognitive Impairment in Parkinson's Disease-What Is It?

Mild cognitive impairment is a common feature of Parkinson's disease, even at the earliest disease stages, but there is variation in the nature and severity of cognitive involvement and in the risk of...

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To investigate whether diabetes mellitus is associated with Parkinson-like pathology in people without Parkinson disease and to evaluate the effect of diabetes mellitus on markers of Parkinson patholo...

Medical and Biotech [MESH] Definitions

Proteins associated with sporadic or familial cases of PARKINSON DISEASE.

A condition caused by the neurotoxin MPTP which causes selective destruction of nigrostriatal dopaminergic neurons. Clinical features include irreversible parkinsonian signs including rigidity and bradykinesia (PARKINSON DISEASE, SECONDARY). MPTP toxicity is also used as an animal model for the study of PARKINSON DISEASE. (Adams et al., Principles of Neurology, 6th ed, p1072; Neurology 1986 Feb;36(2):250-8)

A group of disorders which feature impaired motor control characterized by bradykinesia, MUSCLE RIGIDITY; TREMOR; and postural instability. Parkinsonian diseases are generally divided into primary parkinsonism (see PARKINSON DISEASE), secondary parkinsonism (see PARKINSON DISEASE, SECONDARY) and inherited forms. These conditions are associated with dysfunction of dopaminergic or closely related motor integration neuronal pathways in the BASAL GANGLIA.

Parkinsonism following encephalitis, historically seen as a sequella of encephalitis lethargica (Von Economo Encephalitis). The early age of onset, the rapid progression of symptoms followed by stabilization, and the presence of a variety of other neurological disorders (e.g., sociopathic behavior; TICS; MUSCLE SPASMS; oculogyric crises; hyperphagia; and bizarre movements) distinguish this condition from primary PARKINSON DISEASE. Pathologic features include neuronal loss and gliosis concentrated in the MESENCEPHALON; SUBTHALAMUS; and HYPOTHALAMUS. (From Adams et al., Principles of Neurology, 6th ed, p754)

Conditions which feature clinical manifestations resembling primary Parkinson disease that are caused by a known or suspected condition. Examples include parkinsonism caused by vascular injury, drugs, trauma, toxin exposure, neoplasms, infections and degenerative or hereditary conditions. Clinical features may include bradykinesia, rigidity, parkinsonian gait, and masked facies. In general, tremor is less prominent in secondary parkinsonism than in the primary form. (From Joynt, Clinical Neurology, 1998, Ch38, pp39-42)

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