NCT06113640

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2 parkinson-disease

Timeline
7mo left

Started Nov 2023

Typical duration for phase_2 parkinson-disease

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress80%
Nov 2023Dec 2026

First Submitted

Initial submission to the registry

October 28, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 2, 2023

Completed
3 days until next milestone

Study Start

First participant enrolled

November 5, 2023

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2026

Last Updated

March 13, 2026

Status Verified

March 1, 2026

Enrollment Period

3 years

First QC Date

October 28, 2023

Last Update Submit

March 12, 2026

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (1)

  • Change in unified parkison disease rating scale

    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

    12 months

Study Arms (2)

control group

ACTIVE COMPARATOR

Control group (Levo-dopa group, n =30) who received levodopa/carbidopa (250/25 mg) three times daily for 12 months

Drug: levodopa-carbidopa

Montelukast group

ACTIVE COMPARATOR

who received levodopa/carbidopa (250/25 mg) three times daily plus Montelukast 10 mg once daily for 12 months

Drug: levodopa-carbidopaDrug: Montelukast

Interventions

levodopa-carbidopaDRUG

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 groupcontrol group
MontelukastDRUG

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.

Montelukast group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- Age ≥ 18 years Both male and female will be included Negative pregnancy test and effective contraception. Diagnosed Parkinson's disease patient taking Levodopa

You may not qualify if:

  • \- 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine, Mansoura University

Al Mansurah, 35511, Egypt

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Interventions

carbidopa, levodopa drug combinationmontelukast

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
double blind
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Teaching assisstant

Study Record Dates

First Submitted

October 28, 2023

First Posted

November 2, 2023

Study Start

November 5, 2023

Primary Completion (Estimated)

November 20, 2026

Study Completion (Estimated)

December 20, 2026

Last Updated

March 13, 2026

Record last verified: 2026-03

Locations

EG(1)