Study of NP002 in Subjects With Idiopathic Parkinson's Disease to Treat Dyskinesias Due to Levodopa Therapy

NCT00957918 | Completed Phase 1

• 1 other identifier: NP002-09-001
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 12

Brief Summary

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?

Conditions

Parkinson's Disease

Keywords

levodopa-induced dyskinesia; Parkinson's disease; parkinsonian; levodopa-induced dyskinesias in Parkinson's disease

Outcome Measures

Primary Outcomes (2)

• frequency and severity of adverse events, active vs placebo

  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

  at screening and 4 weeks, 10 weeks, 12 weeks and 14 weeks

Secondary Outcomes (2)

• measure of frequency and severity of dyskinesia (USDysRS), active vs placebo

  At screen and every two weeks through week 10

• Parkinson's disease severity (UPDRS part II,III,IV), active vs placebo

  At screen and every two weeks through week 10

Study Arms (2)

Nicotine

EXPERIMENTAL

Active drug is nicotine dihydrate bitartrate, provided as an oral capsule at escalating doses, 1 mg to 6 mg, once every 6 hours

Drug: nicotine

placebo

PLACEBO COMPARATOR

Subjects in this arm receive placebo capsules orally

Other: placebo comparator

Interventions

nicotine DRUG

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.

Also known as: NP002

Nicotine

placebo comparator OTHER

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.

placebo

Eligibility Criteria

• Age: 30 Years - 83 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• clinical diagnosis of probable idiopathic Parkinson's disease
• 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

You may not qualify if:

• Secondary or non-idiopathic Parkinson's disease
• 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

Sponsors & Collaborators

• Neuraltus Pharmaceuticals, Inc.: lead

Study Sites (12)

Barrow Neurology Clinics at St. Joseph's Hospital and Medical Center

Phoenix, Arizona, 85013, United States

Location

Keck/USC School of Medicine -Department of Neurology

Los Angelis, California, 90033, United States

Location

Pacific Neuroscience Medical Group

Oxnard, California, 93030, United States

Location

Colorado Neurological Institute

Englewood, Colorado, 80113, United States

Location

Parkinson's Disease & Movement Disorders Ctr of Boca Raton

Boca Raton, Florida, 33486, United States

Location

Collier Neurologic Specialists, LLC

Naples, Florida, 34102, United States

Location

Strurers Parkinson's Center

Golden Valley, Minnesota, 55427, United States

Location

David L. Kreitzman, M.D., P.C.

Commack, New York, 11725, United States

Location

108-14 72nd Ave, Second floor

Forest Hills, New York, 11375, United States

Location

Duke University Medical Center, Department of Neurology

Durham, North Carolina, 27705, United States

Location

The Movement Disordedr Clinic of Oklahoma

Tusla, Oklahoma, 74137, United States

Location

Parkinson's Disease and Movement Center, Penn Comprehensive Neuroscience Center

Philadelphia, Pennsylvania, 19107, United States

Location

Related Publications (1)

• 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.

  PMID: 31133957 DERIVED

MeSH Terms

Conditions

Parkinson Disease

Interventions

Nicotine

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Abrahan N Lieberman, MD

  St. Joseph's Hospital and Medical Center, Barrow Neurology Clinics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2009
• First Posted: August 13, 2009
• Study Start: October 1, 2009
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: October 5, 2011

Record last verified: 2011-09

Locations

US (12)