A Phase 3 interventional study of MYOBLOC Low Dose and MYOBLOC High Dose in Sialorrhea, sponsored by Solstice Neurosciences, LLC, a subsidiary of MDD US Operations, LLC. Withdrawn. Open to participants aged 3 Years to 17 Years. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by Solstice Neurosciences, LLC, a subsidiary of MDD US Operations, LLC (part of Supernus Pharmaceuticals, Inc.) · Phase 3, Interventional, and Treatment
This study will evaluate the efficacy and safety of MYOBLOC for the treatment of chronic sialorrhea in pediatric subjects.
This is a multicenter, randomized, double-blind, placebo-controlled, single treatment study designed to assess the efficacy, safety, and tolerability of 2 dose levels of MYOBLOC vs placebo for the treatment of chronic sialorrhea in pediatric subjects ages 3 to \< 17 years. Eligible subjects will be randomized 1:1:1 to receive single treatment of the low dose of MYOBLOC (60 Units/kg), the high dose of MYOBLOC (100 Units/kg), or volume-matched placebo via intraglandular injection.
60 studies on the registry are indexed under Sialorrhea; 5 are open to participants now.
Browse Sialorrhea studies →Solstice Neurosciences, LLC, a subsidiary of MDD US Operations, LLC is the lead sponsor of 3 studies on the registry; none are open to participants now.
First submitted after Solstice Neurosciences, LLC became part of Supernus Pharmaceuticals, Inc..
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Females of (FOCP) must be either sexually inactive (abstinent) or, if sexually active, must agree to use/practice one of the following acceptable methods of beginning during screening period prior to baseline (randomization, injection), for the duration of the study, and 2 months after study completion:
Exclusion Criteria:
Has one or more screening clinical laboratory test values outside the reference range that, in the opinion of the Investigator, are clinical significant, or any of the following:
Has any of the following cardiac findings at Screening:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
MYOBLOC Low Dose will be administered as a single treatment via intraglandular injection (60 Units/kg)
Drug: MYOBLOC Low Dose
MYOBLOC High Dose will be administered as a single treatment via intraglandular injection (100 units/kg)
Drug: MYOBLOC High Dose
Volume-matched placebo will be administered as a single treatment via intraglandular injection
Drug: Placebo
Subjects assigned to the MYOBLOC Low Dose treatment group will be administered MYOBLOC (60 units/kg; maximum 1800 units) as a single treatment via intraglandular injection (5.0 units/kit per submandibular gland \[maximum 150 units\] and 25.0 units/kg per parotid gland \[maximum 750 units\])
Also known as: rimabotulinumtoxinB
Subjects assigned to the MYOBLOC High Dose treatment group will be administered MYOBLOC (100 units/kg; maximum 3000 units) as a single treatment via intraglandular injection (25.0 units/kit per submandibular gland \[maximum 300 units\] and 40.0 units/kg per parotid gland \[maximum 1200 units\])
Also known as: rimabotulinumtoxinB
Subjects assigned to the Placebo treatment group will be administered volume-matched placebo (1:1)
Also known as: PBO
The change from baseline in the Unstimulated Saliva Flow Rate (USFR) at Week 4 post-injection.
At each study visit, the subject's saliva is collected for at least 3 minutes and weighed (grams). The Unstimulated Saliva Flow Rate (USFR; grams/minute) for each visit is calculated for by dividing the 'total grams of saliva collected during the collection period' by the 'total minutes of the collection period. The USFR at Week 4 post-injection visit subtracted from the USFR at Baseline visit (prior to injection) yields the change from baseline USFR. A change from baseline USFR \<0 grams/minutes represents a better outcome.
Time frame: Baseline and Week 4
The Clinical Global Impression of Change (CGI-C) score at Week 4 post-injection.
The Clinical Global Impression of Change (CGI-C) scale is a single item clinician assessment of how much the subject's condition (sialorrhea) has improved, worsened or has not changed relative to subject's state at baseline prior to treatment (injection). The CGI-C is rated on a 7-point scale from 1 to 7, where 1 = "Very much improved", 2 = "Much improved", 3 = "Minimally improved", 4 = "No change", 5 = "Minimally worse", 6 = "Much worse", and 7 = "Very much worse". A CGI-C score \<4 represents a better outcome.
Time frame: Week 4
The Parent/Guardian Global Impression of Change (PGI-C) score at Week 4 post-injection.
The Parent/Guardian Global Impression of Change (PGI-C) scale is a single item parent/guardian assessment of how much the subject's condition (sialorrhea) has improved, worsened or has not changed relative to subject's state at baseline prior to treatment (injection). The PGI-C is rated on a 7-point scale from 1 to 7, where 1 = "Very much improved", 2 = "Much improved", 3 = "Minimally improved", 4 = "No change", 5 = "Minimally worse", 6 = "Much worse", and 7 = "Very much worse". A PGI-C score \<4 represents a better outcome
Time frame: Week 4
The change from baseline in the Unstimulated Saliva Flow Rate (USFR) at Weeks 2, 8 and 13 post-injection.
At each study visit, the subject's saliva is collected for at least 3 minutes and weighed (grams). The Unstimulated Saliva Flow Rate (USFR; grams/minute) for each visit is calculated for by dividing the 'total grams of saliva collected during the collection period' by the 'total minutes of the collection period'. The USFR at the post-injection visit subtracted from the USFR at Baseline visit (prior to injection) yields the change from baseline USFR. A change from baseline USFR \<0 grams/minutes represents a better outcome.
Time frame: Baseline and Weeks 2, 8 and 13
The Clinical Global Impression of Change (CGI-C) score at Weeks 2, 8, and 13 post-injection.
The Clinical Global Impression of Change (CGI-C) scale is a single item clinician assessment of how much the subject's the subject's condition (sialorrhea) has improved, worsened or has not changed relative to subject's state at baseline prior to treatment (injection). The CGI-C is rated on a 7-point scale from 1 to 7, where 1 = "Very much improved", 2 = "Much improved", 3 = "Minimally improved", 4 = "No change", 5 = "Minimally worse", 6 = "Much worse", and 7 = "Very much worse". A CGI-C score \<4 represents a better outcome.
Time frame: Weeks 2, 8 and 13
The Parent/Guardian Global Impression of Change (PGI-C) score at Week 2, 8, and 13 post-injection.
The Parent/Guardian Global Impression of Change (PGI-C) scale is a single item parent/guardian assessment of how much the subject's condition (sialorrhea) has improved, worsened or has not changed relative to subject's state at baseline prior to treatment (injection). The PGI-C is rated on a 7-point scale from 1 to 7, where 1 = "Very much improved", 2 = "Much improved", 3 = "Minimally improved", 4 = "No change", 5 = "Minimally worse", 6 = "Much worse", and 7 = "Very much worse". A PGI-C score \<4 represents a better outcome.
Time frame: Weeks 2, 8, and 13
The change from baseline in the Modified Teacher's Drooling Scale (mTDS) score at Week4 post injection.
The Modified Teacher's Drooling Scale (mTDS) is a single-item scale used to assess subject's drooling severity and frequency. It is rated by the parent/guardian on a 9-point scale (1-9); where 1 = "Dry: never drools"; 2 = "Mild: only the lips are wet, occasionally"; 3 = "Mild: only the lips are wet, frequently"; 4 = "Moderate: wet on the lips and chin, occasionally"; 5 = "Moderate: wet on the lips and chin, frequently"; 6 = "Severe: drools to the extent that clothing becomes damp, occasionally"; 7 = "Severe: drools to the extent that clothing becomes damp, frequently"; 8 = "Profuse: clothing, hands, tray, and objects become wet, occasionally"; 9 = "Profuse: clothing, hands, tray, and objects become wet, frequently". The mTDS score at Week 4 Post injection subtracted from the mTDS score at Baseline yields the change from baseline mTDS score. A change from baseline mTDS score \<0 represents a better outcome.
Time frame: Baseline and Week 4
The change from baseline in the Drooling Impact Scale (DIS) score at Week 4 post-injection.
The Drooling Impact Scale (DIS) is a 10-item questionnaire used to assess the frequency, severity, and impact of subject's drooling. Each item is rated by the parent/guardian on a 10-point end-anchor semantic differential scale (1 to 10; where 1 = "best outcome" to 10 = "worst outcome"). The sum of all 10 items yields a total score (ranging from 10-100). The DIS total score at Week 4 Post injection subtracted from the DIS total score at Baseline yields the change from baseline DIS total score. A change from baseline DIS score \<0 represents a better outcome.
Time frame: Baseline and Week 4
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This study is withdrawn, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: rimabotulinumtoxinB
Solstice Neurosciences, LLC, a subsidiary of MDD US Operations, LLC →