Myasthenia GravisPhase 2NCT05045248
Efficacy of Apraclonidine Eye Drops in the Treatment of Ptosis Secondary to Myasthenia Gravis
A Phase 2 study testing Apraclonidine Hcl 0.5% Oph Soln in people with Myasthenia Gravis and Ocular Myasthenia Gravis, run by American University of Beirut Medical Center at 1 site in Lebanon.
Trial summary
This study is aimed at assessing the efficacy of Apraclonidine eye drops in the treatment of ptosis secondary to myasthenia gravis. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Myasthenia Gravis, Ocular Myasthenia Gravis
- What is being tested?
- Apraclonidine Hcl 0.5% Oph Soln
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteLebanon
- Study dates
- 1 Jun 2020to 15 Apr 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients aged 18 or older with a diagnosis of ocular or generalized myasthenia gravis with ocular involvement.
Who cannot join
- Patients receiving mono-amino-oxidase inhibitors.
- Patients with history of hypertension, cardiac, or cerebrovascular disease.
- Women with confirmed pregnancy.
Trial locations and contacts
1 site in 1 country.
About this study
This study is aimed at assessing the efficacy of Apraclonidine eye drops in the treatment of ptosis secondary to myasthenia gravis.
Read the detailed description
The rationale behind using Apraclonidine is that it acts on Muller's muscle which is a sympathetic-innervated muscle. As such, this muscle is expected to be spared from the effects of the autoantibodies that attack the postsynaptic portion of the neuromuscular junction in myasthenia gravis.
- Conditions
- Myasthenia Gravis, Ocular Myasthenia Gravis
- Being tested
- Apraclonidine Hcl 0.5% Oph Soln
- Keywords
- myasthenia gravis, ocular myasthenia, apraclonidine
- Medical subject headings
- Myasthenia Gravis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Apraclonidine Hcl 0.5% Oph SolnDrug
Also called Iopidine 0.5%
Each patient is administered 2 drops of Apraclonidine 0.5% solution to the most affected eye
| Study group | Role | What they receive |
|---|---|---|
| Patients | Experimental | Each patient is administered 2 drops of Apraclonidine 0.5% solution to the most affected eye. Objective measurements of ptosis will be taken before drug administration and at 1, 5, 30, 60 minutes after drug administration in order to analyze any change in ptosis. Receives: Drug: Apraclonidine Hcl 0.5% Oph Soln |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in palpebral fissure height (PF)
Change in PF measurements
Measured: Before administration, at 1, 5, 30, and 60 minutes after administration
Change in marginal reflex distance-1 (MRD1)
Change in MRD1 measurements
Measured: Before administration, at 1, 5, 30, and 60 minutes after administration
Change in marginal reflex distance-2 (MRD2)
Change in MRD2 measurements
Measured: Before administration, at 1, 5, 30, and 60 minutes after administration
Change in levator function (LF)
Change in LF measurements
Measured: Before administration, at 1, 5, 30, and 60 minutes after administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2021
- Study start1 Jun 2020
- Primary completion15 Apr 2021
- Study completion15 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Myasthenia GravisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- American University of Beirut Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Johnny Salameh, American University of Beirut Medical Center
- Investigators
- Johnny Salameh, MD, Principal investigator, American University of Beirut Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05045248
- Sponsor's protocol ID
- BIO-2019-0027
- Status last verified
- Sep 2021
- First submitted
- 29 Aug 2021
- Last updated
- 16 Sep 2021
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Agha M, Ismail H, Sawaya R, Salameh J. Efficacy of apraclonidine eye drops in treating ptosis secondary to myasthenia gravis: A pilot clinical trial. Muscle Nerve. 2023 Aug;68(2):206-210. doi: 10.1002/mus.27851. Epub 2023 May 31.
PubMed 37259693
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Apraclonidine Eye Drops in the Treatment of Ptosis Secondary to Myasthenia Gravis
- ClinicalTrials.gov ID
- NCT05045248
- Acronym / sponsor ID
- BIO-2019-0027
- Conditions
- Myasthenia Gravis, Ocular Myasthenia Gravis
- Keywords
- myasthenia gravis, ocular myasthenia, apraclonidine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- American University of Beirut Medical CenterUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 15 Apr 2021 (actual)
- Study completion
- 15 Apr 2021 (actual)
- First posted
- 16 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is aimed at assessing the efficacy of Apraclonidine eye drops in the treatment of ptosis secondary to myasthenia gravis.
Detailed description
The rationale behind using Apraclonidine is that it acts on Muller's muscle which is a sympathetic-innervated muscle. As such, this muscle is expected to be spared from the effects of the autoantibodies that attack the postsynaptic portion of the neuromuscular junction in myasthenia gravis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | Experimental | Drug: Apraclonidine Hcl 0.5% Oph SolnEach patient is administered 2 drops of Apraclonidine 0.5% solution to the most affected eye. Objective measurements of ptosis will be taken before drug administration and at 1, 5, 30, 60 minutes after drug administration in order to analyze any change in ptosis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients aged 18 or older with a diagnosis of ocular or generalized myasthenia gravis with ocular involvement.
Key exclusion criteria (3 listed)
- Patients receiving mono-amino-oxidase inhibitors.
- Patients with history of hypertension, cardiac, or cerebrovascular disease.
- Women with confirmed pregnancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Apraclonidine Hcl 0.5% Oph SolnAlso: Iopidine 0.5%Each patient is administered 2 drops of Apraclonidine 0.5% solution to the most affected eye | Drug | Patients |
Primary outcome
Change in palpebral fissure height (PF)
Time frame: Before administration, at 1, 5, 30, and 60 minutes after administration
Change in PF measurements
Change in marginal reflex distance-1 (MRD1)
Time frame: Before administration, at 1, 5, 30, and 60 minutes after administration
Change in MRD1 measurements
Change in marginal reflex distance-2 (MRD2)
Time frame: Before administration, at 1, 5, 30, and 60 minutes after administration
Change in MRD2 measurements
Change in levator function (LF)
Time frame: Before administration, at 1, 5, 30, and 60 minutes after administration
Change in LF measurements
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2021.
- Derived from this study: PubMed 37259693Agha M, Ismail H, Sawaya R, Salameh J. Efficacy of apraclonidine eye drops in treating ptosis secondary to myasthenia gravis: A pilot clinical trial. Muscle Nerve. 2023 Aug;68(2):206-210. doi: 10.1002/mus.27851. Epub 2023 May 31.
- Individual participant dataSharing planned: No
Related trials for Myasthenia Gravis
Active, not recruitingPhase 3
An Extension Study Evaluating 6-week Treatment Cycles of Rozanolixizumab in Pediatric Study Participants With Generalized Myasthenia Gravis
Generalized Myasthenia Gravis
RecruitingPhase 3
A Study to Evaluate the Efficacy and Safety of Rozanolixizumab in Adult Participants With Ocular Myasthenia Gravis
Ocular Myasthenia Gravis
Active, not recruiting
Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Neuromuscular Disease
Neuromuscular Diseases (NMD), Amyotrophic Lateral Sclerosis
RecruitingPhase 3
A Study to Evaluate The Long-Term Safety And Efficacy of Rozanolixizumab in Adult Participants With Ocular Myasthenia Gravis
Ocular Myasthenia Gravis
Recruiting
Holistic Assessment and Remote Digital MONitoring of mYasthenia Gravis Via MyoSense 360
Myasthenia Gravis, Generalized
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Johnny Salameh, MD principal investigator
American University of Beirut Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Apraclonidine Hcl 0.5% Oph Soln in people with Myasthenia Gravis and Ocular Myasthenia Gravis, run by American University of Beirut Medical Center at 1 site in Lebanon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lebanon. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in palpebral fissure height (PF) (time frame: Before administration, at 1, 5, 30, and 60 minutes after administration). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05045248, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2021.