Study of NP002 in Subjects With Idiopathic Parkinson's Disease to Treat Dyskinesias Due to Levodopa Therapy
NCT ID: NCT00957918
Last Updated: 2011-10-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
65 participants
INTERVENTIONAL
2009-10-31
2010-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Nicotine
Active drug is nicotine dihydrate bitartrate, provided as an oral capsule at escalating doses, 1 mg to 6 mg, once every 6 hours
nicotine
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.
placebo
Subjects in this arm receive placebo capsules orally
placebo comparator
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.
Interventions
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nicotine
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.
placebo comparator
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* in stable health
* male and female aged 30-83 yrs
* Hoehn and Yahr stage II through IV inclusive
* levodopa-induced dyskinesias present greater than 25% of waking day; rating equal or greater than 2 on item 32 of UPDRS
* dyskinesias moderately or severely disabling as determined by a rating of equal or greater than 2 on item 33 of UPDRS
* Mini-Mental state (MMSE) score of equal or greater than 26
* on a stable dose of levodopa for at least 30 days
* if subjects are taking dopamine antagonists, amantadine, MAO-B inhibitors (rasagiline only) or COMT inhibitors, doses must have been stable for at least 30 days
Exclusion Criteria
* Subjects with parkinsonian symptoms who do not respond to levodopa therapy
* history of schizophrenia, or other DSM-IV TR axis 1 diagnosis sufficient to interfere with or affect study conduct or interpretation of results
* any history (past 5 years) of suicide or suicide attempt or thoughts or urges of suicide on direct questioning
* subjects who score 2 or higher on a single module of the Jay MIDI scale
* moderate or severe hallucinations, psychoses or delusions
* any medical condition or lab abnormality presenting an unwarranted risk in the opinion of the Investigator
* history of HIV positivity, AIDS, or active hepatitis determined by subject report
* female who is pregnant or breastfeeding
* female of childbearing potential not using double barrier method of birth control throughout the duration of the study
* receipt of a neurosurgical intervention (e.g. brain surgery)related to Parkinson's disease or any neurosurgical procedure sufficient to interfere with study conduct or interpretation of results
* must not have systolic blood pressure ≥150; diastolic ≥95.
* must not have ECG at screening judged clinically significantly abnormal by investigator
* must not have QTc \> 450 msec at ECG screen
* must not have current angina pectoris, history of ventricular arrhythmias, uncontrolled hyperthyroidism, known or suspected pheochromocytoma, symptomatic vasospastic disease, or active peptic ulcer
* must not have a history of stroke, transient ischemic attack (TIA) or myocardial infarction within the last 2 years
* must not have current drug or alcohol abuse within the last two years. Acceptable alcohol use is no more than 3 ounces of alcohol, 3 beers or 2 glasses of wine per day.
* must not be participating in another drug trial or have participated in another drug study in the last 30 days. Observational trials with no intervention are acceptable provided permission is obtained from the other study sponsor in writing.
* must not be unwilling or unable to swallow capsules
* must not have a positive urine test for cotinine at screening
* must not be a smoker, previous (less than 5 years since cessation) smoker or have regular exposure to second hand smoke
* must not be allergic to capsule excipients
* must not be allergic to ondansetron. If allergic, they may participate provided they understand there is no rescue medication for potential nausea or vomiting during the study
* must not have known sensitivity to nicotine or nicotine-containing products
* must not be taking any of the following medications or substances within a minimum of 30 days: nicotine, any form; CYP2A6 inducers or inhibitors during the course of the study or within 30 days of the planned initial dose (your investigator will have a full list of these drugs); Monoamine oxidase inhibitors (with the exception of rasagiline, which is allowed)(your investigator will have a full list of these drugs); apokyn (apomorphine), due to its contraindication with ondansetron); warfarin.
30 Years
83 Years
ALL
No
Sponsors
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Neuraltus Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Abrahan N Lieberman, MD
Role: PRINCIPAL_INVESTIGATOR
St. Joseph's Hospital and Medical Center, Barrow Neurology Clinics
Locations
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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
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
The Movement Disordedr Clinic of Oklahoma
Tusla, Oklahoma, United States
Parkinson's Disease and Movement Center, Penn Comprehensive Neuroscience Center
Philadelphia, Pennsylvania, United States
Countries
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References
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Lieberman A, Lockhart TE, Olson MC, Smith Hussain VA, Frames CW, Sadreddin A, McCauley M, Ludington E. Nicotine Bitartrate Reduces Falls and Freezing of Gait in Parkinson Disease: A Reanalysis. Front Neurol. 2019 May 7;10:424. doi: 10.3389/fneur.2019.00424. eCollection 2019.
Other Identifiers
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NP002-09-001
Identifier Type: -
Identifier Source: org_study_id