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A Study Comparing the Tolerability of Two Dose Regimens of Fipamezole in Adult Patients With Parkinson's Disease Who Are Receiving Levodopa

2014-08-27 03:12:42 | BioPortfolio

Summary

The purpose of this clinical trial is to compare the safety and tolerability of two dose regimens of fipamezole in adult patients with Parkinson's Disease who are receiving levodopa.

Description

Parkinson's Disease is the second most common neurodegenerative disorder worldwide. While treatment with dopaminergic agents like levodopa, the mainstay of treatment, is effective in the early phases of the disease, their benefits decrease with disease progression, and problems such as dyskinesia and on-off phenomenon begin to manifest. This study investigates the safety and tolerability of fipamezole at two dose levels in patients with Parkinson's Disease.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator)

Conditions

Parkinson's Disease

Intervention

Fipamezole ODT, Fipamezole ODT Cohort 2

Location

Advanced Neurology Clinic
Metairie
Louisiana
United States
70006

Status

Recruiting

Source

Biovail Laboratories International SRL

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:12:42-0400

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Medical and Biotech [MESH] Definitions

Proteins associated with sporadic or familial cases of PARKINSON DISEASE.

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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)

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