NCT03865121

Brief Summary

The widely observed inverse relationship between smoking and Parkinson's Disease (PD) and the results of numerous preclinical studies indicating neuroprotective effects of nicotine, suggest a possible novel intervention in PD. In our opinion, an optimal nicotinic therapy in PD would consist of pulsatile nicotine delivery (e.g. via nasal spray) similar to pulsatile nicotine obtained via smoking. The investigators believe that pulsatile stimulation of the central nicotinic receptors (achievable via nasal spray) would affect the dynamic of the nicotinic receptors much more desirably and similar to smoking compared to continuous nicotine administration via patch, which might result in continuous nicotinic receptor desensitization. Thus, this pilot trial seeks to evaluate the efficacy of nicotine nasal spray (Nicotrol NS®) in symptomatology of PD. For this purpose, a total of 6 non-smoking patients at intermediate disease stages (2-3 of Hoehn and Yahr scale) and receiving conventional therapy for PD will be recruited at the "Instituto Nacional de Neurología y Neurocirugía, (Manuel Velasco Suárez)" in Mexico City. Nicotrol NS® in incremental dosing (up to 10 mg/day) regimens will be added to the current medications to each patient during the first week. This will be maintained for up to 1 month. Motor and non-motor aspects of PD will be evaluated. The investigators expect significant improvement of motor and non-motor symptoms in all patients receiving Nicotrol NS® during therapy and a reversal during withdrawal.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for phase_2 parkinson-disease

Timeline
Completed

Started Mar 2019

Shorter than P25 for phase_2 parkinson-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 26, 2019

Completed
6 days until next milestone

Study Start

First participant enrolled

March 4, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 6, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 2, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 2, 2019

Completed
Last Updated

November 6, 2019

Status Verified

November 1, 2019

Enrollment Period

8 months

First QC Date

February 26, 2019

Last Update Submit

November 4, 2019

Conditions

Parkinson Disease

Keywords

Parkinson DiseaseNicotineTransnasal

Outcome Measures

Primary Outcomes (1)

  • Change from in motor dysfunction as assessed by MDS-UPDRS (Movement Disorder Society Unified Parkinson Disease subscale 3, range 0 best -56 worse ).

    Change from baseline in motor dysfunction as assessed by MDS-UPDRS (Movement Disorder Society Unified Parkinson Disease subscale 3, range 0 best -56 worse ).

    1 month

Study Arms (1)

Nicotine Nasal Spray 10 MG/ML

EXPERIMENTAL

Patients will receive incremental doses of Nicotine Nasal Spray 10 MG/ML (0.5 MG/SPRAY) starting with 3 bilateral puffs per day (3 mg total) for 3 days, followed by 5 bilateral puffs per day (5 mg) for 3 days, followed by 8 bilateral puffs per day (8 mg) for 4 days, followed by 10 bilateral puffs per day (10 mg) for 10 days.

Drug: Nicotine Nasal Spray 10 MG/ML (0.5 MG/SPRAY)

Interventions

Nicotine Nasal Spray 10 MG/ML (0.5 MG/SPRAY)DRUG

Patients will receive incremental doses of Nicotine Nasal Spray 10 MG/ML (0.5 MG/SPRAY) starting with 3 bilateral puffs per day (3 mg total) for 3 days, followed by 5 bilateral puffs per day (5 mg) for 3 days, followed by 8 bilateral puffs per day (8 mg) for 4 days, followed by 10 bilateral puffs per day (10 mg) for 10 days.

Also known as: Nicotine Nasal Spray
Nicotine Nasal Spray 10 MG/ML

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects over 60 years of age with a clinical diagnosis of Parkinson's disease
  • Stages of the disease 2-3 of Hoehn and Yahr
  • Not exposed to tobacco during any stage of their life
  • No history of lung diseases
  • No laboratory abnormalities
  • No history of adverse reactions to nicotine
  • Able to use nicotine nasal spray
  • Residents of Mexico City able to attend for evaluations
  • Under current treatment with levodopa at a stable dose
  • Not currently receiving a monoamine oxidase inhibitor treatment

You may not qualify if:

  • Unable to complete follow-up protocol
  • Drug adverse reaction
  • Death

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto Nacional de Neurología y Neurocirugía MVS

Mexico City, 14269, Mexico

Location

Related Publications (5)

  • Quik M. Smoking, nicotine and Parkinson's disease. Trends Neurosci. 2004 Sep;27(9):561-8. doi: 10.1016/j.tins.2004.06.008.

    PMID: 15331239RESULT

  • Tizabi Y, Getachew B. Nicotinic Receptor Intervention in Parkinson's Disease: Future Directions. Clin Pharmacol Transl Med. 2017;1(1):14-19. Epub 2017 Mar 6.

    PMID: 29863173RESULT

  • Tizabi Y, Getachew B, Rezvani AH, Hauser SR, Overstreet DH. Antidepressant-like effects of nicotine and reduced nicotinic receptor binding in the Fawn-Hooded rat, an animal model of co-morbid depression and alcoholism. Prog Neuropsychopharmacol Biol Psychiatry. 2009 Apr 30;33(3):398-402. doi: 10.1016/j.pnpbp.2008.09.010. Epub 2008 Sep 19.

    PMID: 18835320RESULT

  • 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.

    PMID: 17941858RESULT

  • Villafane G, Thiriez C, Audureau E, Straczek C, Kerschen P, Cormier-Dequaire F, Van Der Gucht A, Gurruchaga JM, Quere-Carne M, Evangelista E, Paul M, Defer G, Damier P, Remy P, Itti E, Fenelon G. High-dose transdermal nicotine in Parkinson's disease patients: a randomized, open-label, blinded-endpoint evaluation phase 2 study. Eur J Neurol. 2018 Jan;25(1):120-127. doi: 10.1111/ene.13474. Epub 2017 Oct 23.

    PMID: 28960663RESULT

MeSH Terms

Conditions

Parkinson Disease

Interventions

Tobacco Use Cessation Devices

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Mayela Rodríguez Violante, MSc.

    El Instituto Nacional de Neurologia Manuel Velasco Suarez

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Uncontrolled Pilot Trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending Neurologist

Study Record Dates

First Submitted

February 26, 2019

First Posted

March 6, 2019

Study Start

March 4, 2019

Primary Completion

November 2, 2019

Study Completion

November 2, 2019

Last Updated

November 6, 2019

Record last verified: 2019-11

Locations

ME(1)