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Idiopathic Parkinson's DiseasePhase 2NICOPARK2NCT00873392

Efficacy of Transdermal Nicotine, on Motor Symptoms in Advanced Parkinson's Disease

A Phase 2 study testing Transdermal nicotine and Usual drug treatment of Parkinson's disease in people with Idiopathic Parkinson's Disease, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

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

Medical treatment of idiopathic Parkinson disease motor symptoms requires dopaminergic drugs, with long term disabling side effects. (fluctuations, dyskinesia, ON/OFF phenomena). Use of nicotine in Parkinson's disease has been suggested by the lowest prevalence of smokers among Parkinsonian patients. Read more about this study

Who is it for?
Ages 35 to 70 years
Conditions the study is for
Idiopathic Parkinson's Disease
What is being tested?
Transdermal nicotine and Usual drug treatment of Parkinson's disease
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteFrance
Study dates
Feb 2009to May 2013
Phase
Phase 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 35 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with idiopathic Parkinson's disease according to the United Kingdom Parkinson's Disease Society Brain Bank (UKPDSBB), since at least three years,or treated by L-dopa for 2 years minimum with motor fluctuations (amendment 12/10/2010)
  • Patients aged between 35 and 70 years inclusive,
  • L-Dopa responders: L-Dopa test with an improvement of over 30 % of UPDRS-III motor score,
  • L-Dopa treatment since at least three years,
  • Patients with Parkinson's disease stage maximum IV ("OFF" state) according to the modified Hoehn and Yahr classification (without treatment since at least 12 hours), and III maximum in "ON" state,
  • Non smoker,
  • Signed Informed Consent

Who cannot join

  • Previous neurosurgery for Parkinson's disease,
  • Weight < 45 kg or > 100 kg,
  • Previous Parkinson's disease treatment by transdermal nicotine-therapy discontinued less than 6 months before inclusion,
  • History of allergy to Nicotine,
  • History of allergy to transdermal device,
  • Cutaneous disorders wich could disturb use of transdermal device,
Show all 24Show fewer
  • Cognitive disorders, (Mattis score < 125)
  • History or detection at inclusion of cardiac arrhythmia,
  • History of coronary failure,
  • History of cardiac failure, (NYHA from II to IV \& ejection fraction (EF) < 40%)
  • Severe arterial hypertension (diastolic > 100 mmHg) or uncontrolled,
  • Symptomatic orthostatic hypotension, (2 points of differential in standing position and systolic <100mm Hg or clinical evidence)
  • History of stroke or occlusive peripheral vascular disease,
  • History of hyperthyroid,
  • History or detection at inclusion of type I or II diabetes, (HbA1c < 11%)
  • History of pulmonary disease: asthma, chronic obstructive pulmonary disease (COPD),
  • History of auto-immune disease,
  • Progressive depression, suicide attack, acute psychosis, invasive hallucinations, psychiatrist opinion harmful for a correct compliance to experimentation,
  • History or recent gastroduodenal ulcer, (< 3 months)
  • History or detection at inclusion of hepatobiliary or renal failure, (clearance< 60 mL/min)
  • Pregnancy, breast-feeding,
  • Absence of effective contraception in women in childbearing potential,
  • Treatment by nifedipine, beta-blockers, diuretics, insulin and H2 antihistaminics for potential side effects in combination with nicotine,
  • Patients unlikely to be compliant or to fully cooperate during the study.

Trial locations and contacts

1 site in 1 country.

France1 site

  • Groupe Hospitalier Albert Chenevier Henri Mondor

    Créteil, 94000

Other trials in France

About this study

Official title: Efficacy of Transdermal Nicotine, on Motor Symptoms in Advanced Parkinson's Disease(One Daily Administration).A Controlled Randomised Study, in Two Parallel Groups and Single Blind in 40 Patients.

Medical treatment of idiopathic Parkinson disease motor symptoms requires dopaminergic drugs, with long term disabling side effects. (fluctuations, dyskinesia, ON/OFF phenomena). Use of nicotine in Parkinson's disease has been suggested by the lowest prevalence of smokers among Parkinsonian patients. However, controlled studies provided conflicting results. One of our patients showed a substantial decrease of his parkinsonian symptoms under transdermal nicotine-therapy. Currently, this patient has been treated since 8 years with an excellent safety, especially on cardiovascular level. Otherwise, the investigators performed an open pilot safety and feasibility study in 6 patients, which demonstrated the possibility of a controlled study. In this study, all patients received daily doses during several months until 105 mg/day and could, in parallel, decrease their L-Dopa and agonists doses, improving their motor scores.

The investigators now propose a phase II, controlled, single blind and randomised efficacy study (n=40) in 2 parallel groups. (1 group transdermal nicotine-therapy / 1 control group without additional therapy) The main objective is to verify the correlation between UPDRS (score III) motor score and the administrated nicotine dose. This study will also allow the evaluation of nicotine neuroprotective effect. The incrementation phase by weekly steps of 5 mg until 20 mg, then 10 mg to reach 90 mg/j or the maximal tolerated dose, will last on 11 weeks and will be followed by a 28 weeks phase at this stable dose. After this maximal dose "plateau phase", treatment will be progressively decreased by 15 mg weekly steps, over a de 6-week period followed by a five-week wash out phase.

Taking into account results from the pilot study, a long-term high doses treatment, seems to be liable to improve patients who deeply suffer from their disease. This is why the investigators now propose this monocentric institutional project.

Read the detailed description

Experimental plan

Phase II controled study, in 40 patients, randomised in single blind, and in 2 groups:

  • One group treated by transdermal nicotine-therapy (N= 20),
  • One group without additional therapy (N= 20).

This study will consist in :

  • One phase of weekly incrementations of dose during 11 weeks,
  • Steps of 5 mg until 20 mg
  • Then steps of 10 mg until the dose of 90mg or the maximal tolerated dose
  • One stable dose phase, (90 mg or maximal tolerated dose) during 28 weeks,
  • One phase of decrementing: treatment will be progressively decreased in a 6 weeks period,
Being tested
Transdermal nicotine, Usual drug treatment of Parkinson's disease
Keywords
Parkinson's disease, Motor fluctuation, Nicotine, Drug treatment, neuroprotection
Medical subject headings
Parkinson Disease

What participants receive

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

  • Transdermal nicotineDrug

    Steps of 5 mg until 20 mg Then steps of 10 mg until the dose of 90mg or the maximal tolerated dose One stable dose phase, (90 mg or maximal tolerated dose) during 28 weeks

  • Usual drug treatment of Parkinson's diseaseOther

    Usual drug treatment of Parkinson's disease

Study groups in NCT00873392
Study groupRoleWhat they receive
1ExperimentalExperimental drug
Receives: Drug: Transdermal nicotine
2Active comparatorUsual treatment
Receives: Other: Usual drug treatment of Parkinson's disease

What is being measured

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

  1. Comparison of motor scores in defined off condition : UPDRS III motor score assessed in "defined OFF" condition in comparison with control group.

    Measured: after 20/39 weeks of treatment at maximal administered dose of nicotine

Secondary outcomes (15)

  1. Evaluation of UPDRS III motor score assessed in "defined OFF" condition

    Measured: after 20 weeks of treatment in comparison with control group

  2. Improvement of UPDRS III motor score assessed in "defined ON" condition

    Measured: after a 12 hours discontinuation of antiparkinsonian treatments after 11, 20 and 39 weeks of treatment

  3. Evaluation of motor benefit (UPDRS "OFF" and "ON")

    Measured: after a 28 weeks treatment period at stable dose of 90 mg

  4. Evaluation of neuroprotection, (SPECT DaTSCAN and UPDRS "OFF")

    Measured: after 5 weeks of study treatment discontinuation

  5. Persistence of motor benefit (UPDRS "OFF" and "ON")

    Measured: after 5 weeks of study treatment discontinuation

  6. Decrease of total daily L-Dopa dose (or calculated equivalent in case of polytherapy)

    Measured: after 20 and 39 weeks of treatment

  7. Improvement of quality of life (ADL and PDQ 39 scales)

    Measured: after 20 and 39 weeks of treatment

  8. Decrease of daily percentage of "OFF" phase

    Measured: after 20 and 39 weeks of treatment

  9. Improvement of dyskinesia score, (UPDRS IV)

    Measured: during the study

  10. Relation dose / effect of nicotine

    Measured: end of the study

  11. Estimation of the most effective and tolerated dose of nicotine per kg

    Measured: end of the study

  12. Improvement of cognitive functions assessed by Mattis scale

    Measured: after 39 weeks of treatment

  13. Comparison of all parameters between the 2 groups of patients

    Measured: after study treatment discontinuation, (Week 50)

  14. Compliance to nicotine treatment

    Measured: during treatment

  15. Tolerance of transdermal nicotine

    Measured: during the treatment

Timeline

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

  1. First posted1 Apr 2009 (estimated)
  2. Study startFeb 2009
  3. Primary completionDec 2012
  4. Study completionMay 2013

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00873392
Sponsor's protocol ID
P 051031
Acronym
NICOPARK2
Status last verified
Dec 2013
First submitted
31 Mar 2009
Last updated
31 Dec 2013
Results posted
No
Data monitoring committee
Yes

Publications

  • Villafane G, Cesaro P, Rialland A, Baloul S, Azimi S, Bourdet C, Le Houezec J, Macquin-Mavier I, Maison P. Chronic high dose transdermal nicotine in Parkinson's disease: an open trial. Eur J Neurol. 2007 Dec;14(12):1313-6. doi: 10.1111/j.1468-1331.2007.01949.x. Epub 2007 Oct 17.

    PubMed 17941858

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Transdermal nicotine and Usual drug treatment of Parkinson's disease in people with Idiopathic Parkinson's Disease, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

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 7 inclusion and 24 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 31 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

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?

Comparison of motor scores in defined off condition : UPDRS III motor score assessed in "defined OFF" condition in comparison with control group. (time frame: after 20/39 weeks of treatment at maximal administered dose of nicotine). 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 NCT00873392, 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 31 Dec 2013.

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