Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000545561
Ethics application status
Approved
Date submitted
15/01/2024
Date registered
30/04/2024
Date last updated
30/04/2024
Date data sharing statement initially provided
30/04/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Safety and efficacy studies of neostigmine administration as a topical ophthalmic solution for diagnosing ocular myasthenia gravis in adults presenting with ptosis
Scientific title
Safety and efficacy studies of neostigmine administration as a topical ophthalmic solution for diagnosing ocular myasthenia gravis in adults presenting with ptosis
Secondary ID [1] 311321 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Myasthenia gravis 332571 0
Condition category
Condition code
Neurological 329269 329269 0 0
Other neurological disorders
Eye 329894 329894 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will receive neostigmine solution delivered as eye drops. Each participants will be received only one of four dose level (1 drop of 1 mg/ml; 1 drop of 1.5 mg/ml; 1 drop of 2.5 mg/ml; 2 drops of 2.5 mg/ml) and only one time on day 1. There will be different cohorts for each dose level. Single instillation of eye drops will be administered into the symptomatic eye or the eye with more severe ptosis in patients with bilateral ptosis. The instillation will be performed by an ophthalmologist at the ophthalmology clinic.
Intervention code [1] 327765 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 337090 0
Safety of neostigmine
Timepoint [1] 337090 0
Baseline, 15, 30, 60, 90, 120, 180 minutes, 24 hours, and 7 days after instillation
Secondary outcome [1] 430646 0
Efficacy of neostigmine
Timepoint [1] 430646 0
Baseline, 15, 30, 60, 90, 120, 180 minutes and 24 hours after instillation

Eligibility
Key inclusion criteria
Patients aged 18 years or older who presented with ptosis and were diagnosed with myasthenia gravis by neuro-ophthalmologists or neurologists in the King Chulalongkorn Memorial Hospital
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with generalized myasthenia gravis currently requiring medications, ocular myasthenia gravis currently requiring immunosuppressants, aponeurotic ptosis, mechanical ptosis, traumatic ptosis, other diseases of myogenic or neurogenic ptosis, ophthalmic diseases requiring ophthalmic drops except lubrications, history of eyelid surgery or trauma, patients who had abnormal movement of the eyelids that interfere with the evaluation of the test e.g., eyelid myokymia, facial tics, blepharospasm, and facial spasm, history of neostigmine allergy, or contraindication to neostigmine.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 1
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
10/06/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
24
Accrual to date
Final
Recruitment outside Australia
Country [1] 26076 0
Thailand
State/province [1] 26076 0

Funding & Sponsors
Funding source category [1] 315573 0
University
Name [1] 315573 0
Ratchadapiseksompotch Fund, Faculty of Medicine, Chulalongkorn University
Country [1] 315573 0
Thailand
Primary sponsor type
University
Name
Faculty of Medicine, Chulalongkorn University
Address
Faculty of Medicine, Chulalongkorn University, 1873 Rama 4 road, Pathum Wan Bangkok 10330
Country
Thailand
Secondary sponsor category [1] 318215 0
None
Name [1] 318215 0
Address [1] 318215 0
Country [1] 318215 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314471 0
The Institutional Review Board (IRB) of the Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand
Ethics committee address [1] 314471 0
Faculty of Medicine, Chulalongkorn University, 1873 Rama 4 road, Pathum Wan Bangkok 10330
Ethics committee country [1] 314471 0
Thailand
Date submitted for ethics approval [1] 314471 0
27/06/2023
Approval date [1] 314471 0
17/08/2023
Ethics approval number [1] 314471 0

Summary
Brief summary
We aim to evaluate safety and efficacy of using various dosage of neostigmine as an ophthalmic administration for diagnosing myasthenia gravis. The first cohort of patients will be instilled with a starting dose of neostigmine solution which will be determined by the preclinical animal models, and the next cohort will receive the higher dose level of neostigmine in a stepwise pattern. We hypothesized that topical neostigmine is safe and can increase vertical palpebral fissure in myasthenia gravis patients presenting with ptosis.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 131698 0
Miss Chuthamas Ongprakobkul
Address 131698 0
Faculty of Medicine, Chulalongkorn University, 1873 Rama 4 road, Pathum Wan Bangkok 10330
Country 131698 0
Thailand
Phone 131698 0
+669 5814 5928
Fax 131698 0
Email 131698 0
[email protected]
Contact person for public queries
Name 131699 0
Chuthamas Ongprakobkul
Address 131699 0
Faculty of Medicine, Chulalongkorn University, 1873 Rama 4 road, Pathum Wan Bangkok 10330
Country 131699 0
Thailand
Phone 131699 0
+66 2 256 4000
Fax 131699 0
Email 131699 0
[email protected]
Contact person for scientific queries
Name 131700 0
Chuthamas Ongprakobkul
Address 131700 0
Faculty of Medicine, Chulalongkorn University, 1873 Rama 4 road, Pathum Wan Bangkok 10330
Country 131700 0
Thailand
Phone 131700 0
+66 2 256 4000
Fax 131700 0
Email 131700 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.