Exploratory Study of Dipraglurant (ADX48621) for the Treatment of Patients With Blepharospasm (NCT05027997) | Clinical Trial Compass
CompletedPhase 2
Exploratory Study of Dipraglurant (ADX48621) for the Treatment of Patients With Blepharospasm
United States15 participantsStarted 2021-10-06
Plain-language summary
This study is designed to assess the safety and tolerability of dipraglurant in patients with blepharospasm (BSP) (randomized 1:1:1 to receive dipraglurant 50 mg, 100 mg or placebo) and explore the efficacy of 50 mg and 100 mg immediate release tablets (versus placebo) on the severity and frequency of BSP signs and symptoms using objective measures, clinical ratings and patient reported outcomes.
Who can participate
Age range
18 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients with an established diagnosis of idiopathic benign essential blepharospasm
* Must have had prior response to to botulinum toxin (BoNT) reported on last 2 consecutive injection cycles
* Last injection of BoNT at least 8 weeks prior to Screening assessments
* Patient is experiencing features of Blepharospasm (BSP) of moderate severity/frequency at study entry.
Exclusion Criteria:
* BSP that is known or suspected to be associated with a known cause such as neuroleptic exposure, brain injury or lesion, stroke, Parkinson's disease, or related Parkinsonisms
* History of surgical intervention (e.g., deep brain stimulation) or orbital myectomy for dystonia
* Disabling eyelid opening apraxia
* Other neurological disease (including psychiatric disease and/or cognitive impairment) that, in the opinion of the investigator, would affect the patient's ability to complete study assessments.
* Other significant medical condition that may affect the safety of the patient or preclude adequate participation in the study.
Other protocol-defined inclusion and exclusion criteria may apply
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Safety and tolerability of dipraglurant as measured by incidence of adverse events
Timeframe: Baseline to Day 2
2
Computerized Motor Objective Rater (CMOR) analysis of blinking activity
Timeframe: Baseline to Day 2
3
Skintronics wearable analysis of blinking activity