The study is designed to answer the question: will nicotine at doses that do not cause serious side effects, show feasibility in treatment of levodopa-induced dyskinesia in patients with Parkinson's disease?
Nicotine will be employed at daily doses lower than those available OTC as smoking-cessation patches, in parkinsonian patients experiencing disabling dyskinesias due to their levodopa treatment. The principal adverse effect from this dose level of nicotine is expected to be nausea on acute administration to nicotine-naive patients. Because tolerance to the effects of nicotine is achieved by repeated dose, the study is designed to gradually escalate from 6 to 24 mg per day, taken in 6 separate oral doses of 6 mg each. The study is designed to see if doses which can be tolerated by parkinsonian patients will also reduce the severity and frequency of the dyskinesias experienced following administration of levodopa, the gold standard medication for Parkinson's disease.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
65
Oral capsule self administered in escalating doses from 1 mg to 6 mg, 4 times a day. Each dose is is taken for two weeks, except the highest dose, which is taken for 4 weeks. At the end of 10 weeks, the dose is tapered down over 9 days. Subject is continued on study through week 14.
oral capsules containing only excipient will be self-administered with the same regimen as the active drug, 4 times a day, approximately every 6 hours for 10 weeks and nine days. Study is continued through week 14.
Barrow Neurology Clinics at St. Joseph's Hospital and Medical Center
Phoenix, Arizona, United States
Keck/USC School of Medicine -Department of Neurology
Los Angelis, California, United States
Pacific Neuroscience Medical Group
frequency and severity of adverse events, active vs placebo
Time frame: Every two weeks during dosing (week 0 to week 12) and weekly thereafter for 2 weeks following cessation of dosing
measure of impulse control (rMIDI), active vs placebo
Time frame: at screening and 4 weeks, 10 weeks, 12 weeks and 14 weeks
measure of frequency and severity of dyskinesia (USDysRS), active vs placebo
Time frame: At screen and every two weeks through week 10
Parkinson's disease severity (UPDRS part II,III,IV), active vs placebo
Time frame: At screen and every two weeks through week 10
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Oxnard, California, United States
Colorado Neurological Institute
Englewood, Colorado, United States
Parkinson's Disease & Movement Disorders Ctr of Boca Raton
Boca Raton, Florida, United States
Collier Neurologic Specialists, LLC
Naples, Florida, United States
Strurers Parkinson's Center
Golden Valley, Minnesota, United States
David L. Kreitzman, M.D., P.C.
Commack, New York, United States
108-14 72nd Ave, Second floor
Forest Hills, New York, United States
Duke University Medical Center, Department of Neurology
Durham, North Carolina, United States
...and 2 more locations