Montelukast in Parkinson Disease

NCT06113640 — Phase 2 / Phase 3, Completed, 60 participants, Mostafa Bahaa

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Clinical Study to Investigate the Possible Efficacy and Safety of Montleukast in Parkinson Disease

Registry	NCT06113640
Status	Completed
Phase	Phase 2 / Phase 3
Study type	Interventional; randomized, parallel, masking: double, treatment
Enrollment	60 (Actual)
Sponsor	Mostafa Bahaa (Other)
Conditions	Parkinson Disease
Interventions	levodopa-carbidopa, Montelukast (Drug)
Dates	start 2023-11-05, primary completion 2026-08-20, completion 2026-08-20, first posted 2023-11-02, last updated 2026-10-02
Locations	1 site in Egypt

-Summary

Parkinson's disease (PD) is the second most common neurodegenerative disorder after Alzheimer's disease (AD). Clinical manifestations of PD can vary, but a formal diagnosis relies on the presence of bradykinesia with rigidity and/or rest tremor according to Movement Disorder Society (MDS) criteria for PD. Non-motor symptoms, such as hyposmia, constipation, depression, and rapid eye movement (REM) sleep behavior disorder, are common and can in many cases manifest before classical motor symptoms. In later years, more emphasis has been put on non-motor symptoms, especially in the early stages of PD and which is evident in the proposed prodromal PD criterion by MDS.

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+Detailed description

Leukotrienes are along with prostaglandins, lipoxins, and thromboxanes included in a group of long-chain fatty acids known as eicosanoids. They are known to play important parts in the inflammatory response such as leukocyte chemotaxis, vascular leakage, and astrocyte proliferation, and were first described by Bengt Samuelsson and colleagues in 1983. Leukotrienes (LT) are synthesized from free arachidonic acid (AA) by the enzyme 5-lipoxygenase (5-LOX) into LTA4, which is then further metabolized into LTB4, C4, D4, and E4. LTC4, D4, and E4 are grouped by their molecule structure to form the cysteinyl leukotrienes and they mainly activate two receptors, CysLT1 and CysLT2. CysLT1 is a Gq/11 family G-protein-coupled receptor with signaling through phospholipase C and Ca2+ mobilization

+Arms and interventions

Arm	Type	Interventions	Description
control group	Active comparator	Drug: levodopa-carbidopa	Control group (Levo-dopa group, n =30) who received levodopa/carbidopa (250/25 mg) three times daily for 12 months
Montelukast group	Active comparator	Drug: levodopa-carbidopa; Drug: Montelukast	who received levodopa/carbidopa (250/25 mg) three times daily plus Montelukast 10 mg once daily for 12 months

levodopa-carbidopa (Drug): Carbidopa/levodopa, also known as levocarb and co-careldopa, is the combination of the two medications carbidopa and levodopa. It is primarily used to manage the symptoms of Parkinson's disease
Montelukast (Drug): Montelukast and other CysLT1 antagonists are currently used as an adjuvant therapy for children and adults suffering from asthma. Other indications have been proposed and most evidence exists for the use of montelukast to treat allergic rhinitis, but its use in other inflammatory conditions, such as atherosclerosis and chronic obstructive pulmonary disease, have also been suggested.

+Outcome measures

Primary outcomes

Change in unified parkison disease rating scale [12 months]: The Unified Parkinson's Disease Rating Scale (UPDRS) is the most widely applied rating instrument for Parkinson disease (PD). The Total UPDRS score includes 31 items contributing to three subscales: (I) Mentation, Behavior, and Mood; (II) Activities of Daily Living; and (III) Motor Examination

+Eligibility

Sex: All, ages: 50 Years to 70 Years

Inclusion Criteria:

\- Age ≥ 50 years Both male and female will be included Negative pregnancy test and effective contraception. Diagnosed Parkinson's disease patient taking Levodopa

Exclusion Criteria:

\- Secondary causes of parkinsonism Patients taking anti-inflammatory drugs Atypical parkinsonian syndromes Prior stereotaxic surgery for Parkinson's disease Pregnancy and lactation Suffering from active malignancy Addiction to alcohol and / or drugs Known allergy to the studied medications

+Locations (1)

Facility	City	Country	Status
Faculty of Medicine, Tanta University	Tanta	Egypt