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Parkinson's DiseasePhase 1/2NCT00957918

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

A Phase 1/2 study testing nicotine in people with Parkinson's Disease, run by Neuraltus Pharmaceuticals, Inc. at 12 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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? Read more about this study

Who is it for?
Ages 30 to 83 years
Conditions the study is for
Parkinson's Disease
What is being tested?
nicotine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
65 participants
Where
12 sitesUnited States
Study dates
Oct 2009to Sep 2010
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 83 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 9Show fewer
  • 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

Who cannot join

  • 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
Show all 25Show fewer
  • 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.

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

United States12 sites

  • Parkinson's Disease & Movement Disorders Ctr of Boca Raton

    Boca Raton, Florida, 33486

  • David L. Kreitzman, M.D., P.C.

    Commack, New York, 11725

  • Duke University Medical Center, Department of Neurology

    Durham, North Carolina, 27705

  • Colorado Neurological Institute

    Englewood, Colorado, 80113

  • 108-14 72nd Ave, Second floor

    Forest Hills, New York, 11375

  • Strurers Parkinson's Center

    Golden Valley, Minnesota, 55427

  • Keck/USC School of Medicine -Department of Neurology

    Los Angelis, California, 90033

  • Collier Neurologic Specialists, LLC

    Naples, Florida, 34102

  • Pacific Neuroscience Medical Group

    Oxnard, California, 93030

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

    Philadelphia, Pennsylvania, 19107

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

    Phoenix, Arizona, 85013

  • The Movement Disordedr Clinic of Oklahoma

    Tusla, Oklahoma, 74137

Other trials in United States

About this study

Official title: Randomized, Double-Blind, Parallel Group, Placebo Controlled Safety, Tolerability and Efficacy Study of NP002 in Subjects With Idiopathic Parkinson's Disease With Dyskinesias Due to Levodopa Therapy

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?

Read the detailed description

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.

Being tested
nicotine, placebo comparator
Keywords
levodopa-induced dyskinesia, Parkinson's disease, parkinsonian, levodopa-induced dyskinesias in Parkinson's disease
Medical subject headings
Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • nicotineDrug

    Also called NP002

    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 comparatorOther

    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.

Study groups in NCT00957918
Study groupRoleWhat they receive
NicotineExperimentalActive drug is nicotine dihydrate bitartrate, provided as an oral capsule at escalating doses, 1 mg to 6 mg, once every 6 hours
Receives: Drug: nicotine
placeboPlacebo comparatorSubjects in this arm receive placebo capsules orally
Receives: Other: placebo comparator

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. frequency and severity of adverse events, active vs placebo

    Measured: Every two weeks during dosing (week 0 to week 12) and weekly thereafter for 2 weeks following cessation of dosing

  2. measure of impulse control (rMIDI), active vs placebo

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

Secondary outcomes (2)

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

    Measured: At screen and every two weeks through week 10

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

    Measured: At screen and every two weeks through week 10

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Aug 2009 (estimated)
  2. Study startOct 2009
  3. Primary completionSep 2010
  4. Study completionSep 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
65 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00957918
Sponsor's protocol ID
NP002-09-001
Status last verified
Sep 2011
First submitted
11 Aug 2009
Last updated
5 Oct 2011
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 31133957

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing nicotine in people with Parkinson's Disease, run by Neuraltus Pharmaceuticals, Inc. at 12 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00957918, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2011.

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