NCT03865121

Pilot Trial of Transnasal Nicotine in Parkinson Disease

Completed Phase 2 Last updated 6 November 2019

What this trial tests

Phase 2 trial testing Nicotine Nasal Spray 10 MG/ML (0.5 MG/SPRAY) in Parkinson Disease in 6 participants. Completed in 2 November 2019.

Timeline

4 March 2019

Primary endpoint
2 November 2019

2 November 2019

Quick facts

Lead sponsor	El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	6
Start date	4 March 2019
Primary completion	2 November 2019
Estimated completion	2 November 2019
Sites	1 location across Mexico

Drugs / interventions tested

• Nicotine Nasal Spray 10 MG/ML (0.5 MG/SPRAY) — full drug profile →

Conditions studied

• Parkinson Disease — all drugs for Parkinson Disease →

Sponsor

El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez — full company profile →

Who can join

60 and older, any sex, with Parkinson Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Signaling pathways in Parkinson's disease: molecular mechanisms and therapeutic interventions.
   Dong-Chen X, Yong C, Yang X, Chen-Yu S, et al · · 2023 · cited 258× · PMID 36810524 · DOI 10.1038/s41392-023-01353-3
2. Current Therapies in Clinical Trials of Parkinson's Disease: A 2021 Update.
   Prasad EM, Hung SY. · · 2021 · cited 66× · PMID 34451813 · DOI 10.3390/ph14080717
3. Recent Advances in Intranasal Administration for Brain-Targeting Delivery: A Comprehensive Review of Lipid-Based Nanoparticles and Stimuli-Responsive Gel Formulations.
   Koo J, Lim C, Oh KT. · · 2024 · cited 57× · PMID 38414526 · DOI 10.2147/ijn.s439181
4. Physiologic Functions and Therapeutic Applications of α7 Nicotinic Acetylcholine Receptor in Brain Disorders.
   Lee CH, Hung SY. · · 2022 · cited 33× · PMID 36678660 · DOI 10.3390/pharmaceutics15010031
5. An Update on Nondopaminergic Treatments for Motor and Non-motor Symptoms of Parkinson's Disease.
   Jing XZ, Yuan XZ, Luo X, Zhang SY, et al · · 2023 · cited 21× · PMID 35193486 · DOI 10.2174/1570159x20666220222150811
6. Arbutin effectively ameliorates the symptoms of Parkinson's disease: the role of adenosine receptors and cyclic adenosine monophosphate.
   Zhao J, Kumar M, Sharma J, Yuan Z. · · 2021 · cited 19× · PMID 33642391 · DOI 10.4103/1673-5374.308102
7. A Systematic Review on Drugs Acting as Nicotinic Acetylcholine Receptor Agonists in the Treatment of Dementia.
   Crestini A, Carbone E, Rivabene R, Ancidoni A, et al · · 2024 · cited 11× · PMID 38334629 · DOI 10.3390/cells13030237
8. The controversial effect of smoking and nicotine in SARS-CoV-2 infection.
   Salehi Z, Motlagh Ghoochani BFN, Hasani Nourian Y, Jamalkandi SA, et al · · 2023 · cited 8× · PMID 37264452 · DOI 10.1186/s13223-023-00797-0