Effects of the Montelukast drug on brain inflammation in Parkinson's disease.

• Register: EUCTR
• Last refreshed on: 13 September 2021
• Main ID: EUCTR2020-000148-76-SE
• Date of registration: 25/02/2020
• Prospective Registration: Yes
• Primary sponsor: Stockholm Health Care Services
• Public title: Effects of the Montelukast drug on brain inflammation in Parkinson's disease.
• Scientific title: Effects of Montelukast on neuroinflammation in Parkinson's Disease. An open-label single-center trial.
• Date of first enrolment: 04/08/2021
• Target sample size: 15
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2020-000148-76
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no; Randomised: no; Open: yes; Single blind: no; Double blind: no; Parallel group: no; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: no; Placebo: no; Other: no
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Sweden

Contacts

• Name: Academic Specialist Center
• Affiliation: Stockholm Health Care Services

• Name: Academic Specialist Center
• Affiliation: Stockholm Health Care Services

Key inclusion & exclusion criteria

Inclusion criteria:
• Diagnosis of clinically probable Parkinson’s disease according to the MDS clinical diagnostic criteria for PD(1)
• Males or Females.
• Hoehn and Yahr stage = 2 in the ON medication state. This implies that all patients will be mobile without assistance during their best “ON” medication periods.
• All patients will be =35 and =80 years of age.
• Signed informed consent to participate in the trial.
• High- and mixed affinity binder on TSPO rs6971 polymorphism gene sequencing

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 5
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion criteria:
• Extended treatment adjustment or significant motor fluctuations during the last 30 days.
• Atypical or other causes of parkinsonism. Patients with suspected Multiple System Atrophy, Progressive Supranuclear Palsy, drug-induced parkinsonism, vascular parkinsonism, dystonic or essential tremor will not be included in the trial.
• Prior intra-cerebral surgical intervention for Parkinson’s disease. Patients who have previously undergone Deep Brain Stimulation, intra-cerebral administration of growth factors, gene therapy or cell therapies will not be eligible.
• Already actively participating in a trial of a device, drug or surgical treatment for Parkinson’s disease.
• Previous exposure to Montelukast of more than six months during the last 12 months and not in the last month before entering the trial.
• Known abnormality on CT or MRI brain imaging considered likely to compromise compliance with trial protocol/FDG-PET acquisition.
• Congenital or acquired abnormal lumbar anatomy which might affect safety and comfort during lumbar puncture procedure.
• Co-morbidity with severe heart/lung disease (including asthma), liver disease, dementia, depression or autoimmune disease
• Known hypersensitivity to Montelukast or any of the inactive ingredients.
• Pregnancy



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Parkinson's disease

Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Intervention(s)

Trade Name: Montelukast
Product Name: Montelukast Krka
Pharmaceutical Form: Film-coated tablet

Primary Outcome(s)

Main Objective: Safety and tolerability of Montelukast treatment in Parkinson's disease.

Primary end point(s): • Documentation and evaluation of adverse events.

Timepoint(s) of evaluation of this end point: at 4 and 12 week clinic visits and 2, 6 and 9 week telephone follow up.

Secondary Objective: To study the anti-inflammatory properties of Montelukast in the brain.
To study the inflammatory response in Parkinson’s disease by measuring biomarkers in cerebrospinal fluid, urine and blood.
To study pharmacokinetic properties of Montelukast by measuring levels of Montelukast in cerebrospinal fluid and serum.

Secondary Outcome(s)

Secondary end point(s): 1. TSPO expression as measured by [11C]PBR28 PET
2. MDS-UPDRS and NMSquest scores
3. Concentration of Montelukast in CSF, plasma and urine
4. Levels of inflammatory and neurodegeneration biomarkers in plasma and CSF

Timepoint(s) of evaluation of this end point: 1. Baseline and 12 weeks
2. Baseline, 4 and 12 weeks
3. Baseline and 4 weeks
4. Baseline, 4 and 12 weeks

Secondary ID(s)

3.0

Source(s) of Monetary Support

Axel och Margaret Ax:son Johnson’s foundation

Ethics review

Status: Approved
Approval date: 04/08/2021
Contact: