Efficacy and Safety Study of MYOBLOC in the Treatment of Sialorrhea in Pediatric Subjects (NCT05097079) | Clinical Trial Compass
WithdrawnPhase 3
Efficacy and Safety Study of MYOBLOC in the Treatment of Sialorrhea in Pediatric Subjects
Stopped: Company/sponsor business decision
0Started 2021-11
Plain-language summary
This study will evaluate the efficacy and safety of MYOBLOC for the treatment of chronic sialorrhea in pediatric subjects.
Who can participate
Age range
3 Years – 17 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
. Written informed consent obtained from the subject's parent or legally authorized representative(s) (LAR)/guardian(s) in accordance with local laws and Institutional Review Board (IRB)/Independent Ethics Committee (IEC) requirements.
. Written minor assent obtained from the subject, as applicable and in accordance with local laws and IRB/IEC requirements.
. Male or female ages 3 to \< 17 years at the time of signing informed consent (and assent, if applicable) at Screening.
. Minimum weight of 10 kg at Screening and Baseline (prior to randomization).
. Chronic sialorrhea due to a neurological disorder (e.g., cerebral palsy (CP), or traumatic brain injury (TBI)) for at least 3 months prior to Screening.
. A mTDS score ≥ 5 at Screening and Baseline (prior to randomization).
. A minimum USFR of 0.2 g/min at Screening and Baseline (prior to randomization).
. Females of childbearing potential (FOCP) must be either sexually inactive (abstinent) or, if sexually active, must agree to use/practice one of the following acceptable methods of contraception beginning during screening period prior to baseline (randomization, injection), for the duration of the study, and 2 months after study completion:
Exclusion criteria
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
The change from baseline in the Unstimulated Saliva Flow Rate (USFR) at Week 4 post-injection.
Timeframe: Baseline and Week 4
2
The Clinical Global Impression of Change (CGI-C) score at Week 4 post-injection.
Timeframe: Week 4
Trial details
NCT IDNCT05097079
SponsorSolstice Neurosciences, LLC, a subsidiary of MDD US Operations, LLC
. FOCP subjects who are pregnant, lactating/breastfeeding and/or sexually active and not agreeing to use one of the acceptable birth control methods throughout the study.
. History of drug or alcohol abuse within 6 months before Screening.
. Treatment with an investigational drug, device, or biological agent within 30 days before Screening or while participating in this study.
. Major surgery (requiring general anesthesia) within 3 months before screening, or any anticipated or scheduled surgery during the study period (with or without general anesthesia).
. Aspiration pneumonia within 6 months before Screening.
. History of moderate dysphagia or severe dysphagia (defined as an inability to swallow liquids, solids or both without choking or medical intervention) within 6 months before screening. Subjects who require gastrostomy tube feeding are not excluded provided tube placement was at least 30 days prior to Baseline (Day 1; injection).
. Requires general anesthesia for study drug administration.
. Prior botulinum toxin type A (BoNT/A) or BoNT/B treatment for sialorrhea or cervical dystonia within 20 weeks before screening. Prior BoNT/A or BoNT/B treatment in other anatomical locations is not exclusionary, but must have occurred at least 12 weeks prior to screening. Prior toxin exposure must have been well tolerated and without any significant long-term side effects in cases of repeated prior exposure.