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Montelukast in Parkinson Disease

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

Status
Recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06113640
Enrollment
60
Registered
2023-11-02
Start date
2023-11-05
Completion date
2026-12-20
Last updated
2026-03-13

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

Conditions

Parkinson Disease

Brief 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.

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

Interventions

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

DRUGMontelukast

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.

Sponsors

Mostafa Bahaa
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Masking description

double blind

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

\- Age ≥ 18 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

Design outcomes

Primary

MeasureTime frameDescription
Change in unified parkison disease rating scale12 monthsThe 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

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 14, 2026