NMC Movement Disorder Specialists report success in late-phase clinical trial for new inhalable drug for “off” periods
BATON ROUGE, LA,
Movement disorder specialists at The NeuroMedical Center in Baton Rouge, Louisiana are pleased to announce their involvement in advancing a potential break-through treatment for Parkinson’s disease. A late-phase clinical trial investigating Acorda Therapeutic’s inhalable formulation of levodopa (L-dopa) showed statistically significant improvement in motor function in people with Parkinson’s disease experiencing “Off” periods. The results from the Phase 3 CVT-301-004 clinical trial performed at The NeuroMedical Center and other sites across the country are so promising, Acorda intends to soon file for permission to begin marketing the new drug in the U.S.
CVT-301 is being developed as a self-administered, inhaled levodopa therapy for the treatment of symptoms of “Off” periods in people with Parkinson’s disease taking an oral carbidopa/L-dopa regimen. “Off” periods refer to stages experienced by patients with Parkinson’s disease when medication is not working well, and symptoms are exacerbated. CVT-301 aims to deliver a precise dose of a dry powder formulation of L-dopa to the lung to offer faster symptom control than tablets.
Phase 3 enrolled a total of 339 participants who were on a stable regimen of oral carbidopa/levodopa and randomized them to receive one of two doses of CVT-301 or a placebo. Subjects self-delivered the inhaled formulation up to five times a day for 12 weeks. At the completion of the trial, CVT-301 showed statistically significant improvement of motor function compared to the placebo.
The NeuroMedical Center’s Dr. Rebecca E. Whiddon, served as the trial’s principal investigator. Fellow Movement Disorder Specialists including The NeuroMedical Center’s Chief of Neurology, Dr. Gerald J. Calegan, and Dr. Glenn Kidder, served as sub-investigators for the study.
“We are greatly encouraged by the efficacy of this trial conducted at The NeuroMedical Center and hope that our involvement will advance this potentially important therapy for patients everywhere who are suffering with Parkinson’s,” said Dr. Whiddon. “Off periods can be very disruptive and uncomfortable for people with Parkinson’s, and we look forward to the future possibility of offering our patients another important treatment option to further manage symptoms of this extremely challenging disease.”
About Parkinson’s Disease and OFF Periods
Parkinson’s is a progressive neurodegenerative disorder resulting from the gradual loss of certain neurons responsible for producing dopamine. It causes a range of symptoms including impaired movement, muscle stiffness and tremors. “Off” periods refer to the phenomenon of Parkinson’s medications wearing off before the next dose of medication is taken. When this occurs, patients typically have to take medications more often; some patients have to take medications every 2-3 hours to prevent the medications from wearing off. “Off” periods typically begin several years after diagnosis/treatment of PD. “Off” periods are usually very uncomfortable, and patients often experience some or all of the following symptoms during an “Off” period – tremors, stiffness, painful spasms, shuffling gait, anxiety, panic, trouble thinking, dizziness, major increase or decrease in blood pressure, hot or cold sweats, as well as other symptoms.
Approximately one million people in the U.S. are diagnosed with Parkinson’s disease. “Off” periods are experienced by approximately 350,000 Americans, or one-third of patients with Parkinson’s disease.
About Acorda Therapeutics
Founded in 1995, Acorda Therapeutics is a biotechnology company focused on developing therapies that restore function and improve the lives of people with neurological disorders.
About The NeuroMedical Center
The NeuroMedical Center in Baton Rouge, Louisiana has led the South in expert neurological care since 1978. It is home to the region’s largest team of board certified and fellowship trained neurologists who work in detailed collaboration with other neurological specialists including neurosurgeons, physical medicine and rehabilitation (PM&R) specialists, pain medicine physicians, neuropsychologists, and neuroradiologists to deliver the most innovative, patient-centered care available for you and your loved ones. Our Neurology department and Clinical Research department is located on the 4th floor of The NeuroMedical Center Clinic located at 10101 Park Rowe Avenue. For appointments, please call (225) 768-2050.
http://www.satprnews.com/2017/02/16/the-neuromedical-center-in-baton-rouge-helps-advance-new-parkinsons-treatment/
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