A RCT study of Montelukast in Parkinson’s disease

Parkinson’s disease (PD) is the fastest growing neurodegenerative disease, and the development of a disease-modifying therapy is the most important unmet goal in the therapy of PD. Preclinical and clinical studies have shown promising results of the anti-inflammatory agent  Montelukast in PD.

We have now designed a multi-center, randomized, double-blind, placebo-controlled trial with Montelukast in PD.PICO Population: Diagnosis of PD. Males or Females. H&Y stage ≤ 2. ≥35 and ≤80-years of age. Signed informed consent to participate in the trial. Clinical diagnosis < 4-years. Ability to self-administer the trial drug.

Intervention: 18 months of daily buccal Montelukast 2x30 mg. Control: Placebo. Primary outcome: Change of MDS-UPDRS motor score in OFF medication state at 18 months. Secondary outcomes are changes in effects on non-motor symptoms of Montelukast using MDS-NMSS and HADS.

There is also a safety objective and several exploratory outcomes.Ninty patients with early-moderate PD in Stockholm, Lund, Uppsala, Göteborg and London will be recruited. Ethical permits and MPA applications will be submitted in the beginning of 2023.

Patient recruitment will start in April 2023 and the last patient follow-up will be in March 2026 followed by data analysis/reporting. The study is endorsed by the Swedish PD patientorganization and Cure Parkinson. If this RCT is successful and since Montelukast is repurposed, patients will soon benefit from the therapy.