Brain activity changes under treatment with Montelukast.

Pharmaco-EEG for Montelukast. Can we detect neural changes during medication with Montelukast in the EEG?

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-003061-25-AT

Enrollment

Registered

2016-09-23

Start date

2016-12-14

Completion date

Unknown

Last updated

2020-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Montelukast is indicated for prophylaxis and chronic treatment of asthma and for the relief of symptoms of seasonal allergic rhinitis. We investigate side effects of Montelukast, specifically potential effects on brain activity.

Interventions

Trade Name: Singulair Product Name: Singulair Pharmaceutical Form: Coated tablet INN or Proposed INN: Montelukast CAS Number: 158966-92-8 Other descriptive name: MONTELUKAST Concentration unit: mg mil

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: We recruit 24 patients starting a monotherapy or an add-on therapy with Montelukast because of asthma or allergic rhinitis. Patients should be between 18 and 80 years old and be able to give informed consent. 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 18 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 6

Exclusion criteria

Exclusion criteria: According to the criteria for pharmaco-EEG studies (Jobert et al., 2012), all participants with a history of • excessive, regular consumption of alcohol (more than 3 units/day for women or 4 units/day for men; 1 unit is 1/4 l of vine or 1/2 l of beer) tobacco (more than 5 cigarettes per day), or caffeine (more than 4 cups per day) • a rapidly progressive neurological disorder (e.g. dementia, parkinson, multiple sclerosis), • a psychiatric history, • or substance abuse will be excluded. We exclude women with child-bearing potential.

Design outcomes

Primary

Measure	Time frame
Main Objective: We want to examine effects of Montelukast on brain activity.;Secondary Objective: We want to correlate CNS effects with cognitive or psychiatric side effects under treatment with Montelukast. We want to predict cognitive or psychiatric side effects under treatment with Montelukast by baseline EEG-characteristics.;Primary end point(s): 1. Differences in EEG characteristics between baseline (before treatment) and follow up (after 8 weeks of treatment). ;Timepoint(s) of evaluation of this end point: After study completion (after 1 year) on whole sample.	—

Measure

Time frame

Main Objective: We want to examine effects of Montelukast on brain activity.;Secondary Objective: We want to correlate CNS effects with cognitive or psychiatric side effects under treatment with Montelukast. We want to predict cognitive or psychiatric side effects under treatment with Montelukast by baseline EEG-characteristics.;Primary end point(s): 1. Differences in EEG characteristics between baseline (before treatment) and follow up (after 8 weeks of treatment). ;Timepoint(s) of evaluation of this end point: After study completion (after 1 year) on whole sample.

—

Secondary

Measure	Time frame
Secondary end point(s): 2. Correlation of changes in EEG characteristics and neuropsychological scales from baseline to follow up. 3. Predictive value of EEG characteristics at baseline for changes on neuropsychological scales.;Timepoint(s) of evaluation of this end point: After study completion (after 1 year) on whole sample.	—

Countries

Austria

Contacts

Public ContactScientific lead of the study

Department of Neurology, Christian Doppler Medical Center, Paracelsus Medical University Salzburg

y.hoeller@salk.at

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026