A Phase 3 interventional study of Oral Glycopyrrolate Liquid in Cerebral Palsy, Neurological Conditions and Mental Retardation, sponsored by Shionogi. Completed at 7 sites in United States. Open to participants aged 3 Years to 18 Years. Per ClinicalTrials.gov, last updated 2012-07-09.
Sponsored by Shionogi · Phase 3, Interventional, and Treatment
Among 372 studies in Cerebral Palsy with a site in United States — 76 open to participants now, 105 under way, none of them phase 3. Cerebral Palsy · United States.
Among the 372 studies in Cerebral Palsy with a site in United States, this one is the 19th largest by enrollment of the 296 interventional ones that give a count, is one of 12 that started in 2007, is one of 17 in phase 3, and was the 35th registered.
1,936 studies on the registry are indexed under Cerebral Palsy; 458 are open to participants now.
Browse Cerebral Palsy studies →76 of the 372 studies in Cerebral Palsy with a site in United States are open now. Recruiting first, the newest first:
The Foundation for Orthopaedics and Regenerative Medicine · Sites in United States, Greece
University of Washington · Sites in United States
University of Wisconsin, Madison · Sites in United States
Columbia University · Sites in United States
Martin Piazza · Sites in United States
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 270 Cerebral Palsy studies recruiting now, 27 (10%) set no upper age limit and 235 (87%) stop at 75 or younger; 255 take children under 18; 51 take healthy volunteers.
This study: 3 Years to 18 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
372 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 36 · Phase 2 31 · Phase 3 18 · Phase 4 7
First in 1987; this study’s year is marked. 12 started in 2007.
This study's enrollment of 137 is above the median of 34 across 1,431 interventional studies indexed under Cerebral Palsy.
Median enrollment 25 across the 296 interventional studies, 61 across the 71 observational. Of the 224 that completed or were terminated, 82 (37%) have results posted.
This tab as a report to print or save as PDF → With an account.
34 of 372 have an industry lead sponsor. The 10 most frequent:
Shionogi is the lead sponsor of 105 studies on the registry; 10 are open to participants now.
Of its 39 completed or terminated interventional studies of FDA-regulated products, 21 (54%) have results posted.
Shionogi has 1 study filed under Cerebral Palsy — fewer than ten, so there is no comparison to draw.
26 of the studies in Cerebral Palsy with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07516067Martin PiazzaSpinal Cord Stimulation for Children With Cerebral Palsy | 2026-11 |
| NCT04630392Georgia State UniversityEffects of Treadmill Training and Whole-body Vibration in Children With Cerebral Palsy | 2026-11-20 |
| NCT05339932Grand Valley State UniversityGrand Valley State University (GVSU) Skills on Wheels | 2026-11-30 |
| NCT06377085Shirley Ryan AbilityLabRepurposing 5-Azacytidine for the Treatment of Muscle Contractures in Children With Cerebral Palsy | 2026-12 |
| NCT04897347Teachers College, Columbia UniversityRobotic TruST-Postural Intervention for Children With Cerebral Palsy | 2026-12 |
Among the 372 studies in Cerebral Palsy with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This is an open-label clinical research study of an oral glycopyrrolate liquid for the treatment of chronic moderate to severe drooling in patients with cerebral palsy or other neurological conditions. Patients participating in the study will receive oral glycopyrrolate liquid (1 mg/5 ml) three times a day (TID) for study duration of 24 weeks. After a washout, screening, and 2-day baseline period, patients will be enrolled in a 4-week dose titration period. Glycopyrrolate liquid doses will be titrated using dose levels in the Dose Titration Schedule. Titration will begin at 0.02 mg/kg per dose TID and sequentially increased in 0.02 mg/kg per dose increments TID every 5-7 days during the first four weeks until optimal individualized response is obtained for each patient or a maximum dose of 0.1 mg/kg TID is reached, not exceeding 3 mg TID or Dose-level 5 in the Dose Titration Schedule, whichever is lesser. Optimal dose for each patient is the dose at which he/she is receiving the maximum benefit from the study drug (greatest improvement in drooling) while experiencing minimum side effects. All patients will receive close attention by study staff throughout the study.
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.
To be included in this study, patients must meet the following criteria:
Exclusion Criteria:
Patients are excluded from this study if they meet any of the following criteria:
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.
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.
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.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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.
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.
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.
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.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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.
Arm receiving study drug
Drug: Oral Glycopyrrolate Liquid
Study medication is administered three times a day at 7-8 AM, 1-2 PM, and 7-8 PM by the parent/caregiver
Proportion of Responders According to the Modified Teacher's Drooling Scale (mTDS)
The primary efficacy variable was patient's response status using the change from baseline to Week 24 evaluations of the mTDS assessment. Each patient was classified as a responder or non-responder according to the change in their mean mTDS rating from baseline to Week 24. Responders were patients who had at least a 3-point decrease in mTDS rating from baseline
Time frame: 6 months
Parent/Caregiver's Assessment of the Extent of Drooling Using Visual Analog Scale (VAS)
Parents/caregivers were to complete a 10 cm "Parent/Caregiver's Assessment of Extent of Drooling for the Day" VAS assessment (0 = normal; 10 = extremely wet) to provide an overall assessment of the extent of drooling for that day.
Time frame: Baseline
Parent/Caregiver's Assessment of the Extent of Drooling Using VAS
Parents/caregivers were to complete a 10 cm "Parent/Caregiver's Assessment of Extent of Drooling for the Day" VAS assessment (0 = normal; 10 = extremely wet) to provide an overall assessment of the extent of drooling for that day.
Time frame: Week 24
Parent/Caregiver's Global Assessment of Treatment
The parent/caregiver performed an overall evaluation of glycopyrrolate liquid for the treatment of drooling, benefits, and side effects over the duration of the study. The parent/caregiver selected one of the following choices to assess if 'This is a worthwhile treatment': 1 = strongly agree, 2 = agree, 3 = neutral, 4 = disagree, 5 = strongly disagree. A dichotomous global assessment was also performed and summarized with the categories 'responder' (strongly agree and agree responses aggregated) and 'non-responder'(neutral, disagree, and strongly disagree responses aggregated)
Time frame: Week 24
Investigator's Global Assessment of Treatment
The investigator performed an overall evaluation of glycopyrrolate liquid for the treatment of drooling, benefits, and side effects over the duration of the study. The investigator selected one of the following choices to assess if 'This is a worthwhile treatment': 1 = strongly agree, 2 = agree, 3 = neutral, 4 = disagree, 5 = strongly disagree. A dichotomous global assessment was also performed and summarized with the categories 'responder' (strongly agree and agree responses aggregated) and 'non-responder' (neutral, disagree, and strongly disagree responses aggregated)
Time frame: Week 24
First patient was enrolled on April 03, 2007 and last patient completed on May 30, 2008
| Milestone | Patients With Chronic Drooling |
|---|---|
| Started | 137 |
| Completed | 103 |
| Not completed | 34 |
| Withdrew: Adverse event | 14 |
| Withdrew: Withdrawal by subject | 5 |
| Withdrew: Death | 3 |
| Withdrew: Lost to follow-up | 3 |
| Withdrew: Lack of efficacy | 2 |
| Withdrew: Other-failed to meet any criteria | 2 |
| Withdrew: Physician decision | 2 |
| Withdrew: Protocol violation | 2 |
| Withdrew: Other-intake of prohibited medication | 1 |
The primary efficacy variable was patient's response status using the change from baseline to Week 24 evaluations of the mTDS assessment. Each patient was classified as a responder or non-responder according to the change in their mean mTDS rating from baseline to Week 24. Responders were patients who had at least a 3-point decrease in mTDS rating from baseline
| Participants | Patients With Chronic Drooling |
|---|---|
| Responders | 68 |
| Non-Responders | 62 |
| Missing | 7 |
Parents/caregivers were to complete a 10 cm "Parent/Caregiver's Assessment of Extent of Drooling for the Day" VAS assessment (0 = normal; 10 = extremely wet) to provide an overall assessment of the extent of drooling for that day.
| VAS score | Patients With Chronic Drooling |
|---|---|
| Parent/Caregiver's Assessment of the Extent of Drooling Using Visual Analog Scale (VAS) | 6.56 ± 2.34 |
Parents/caregivers were to complete a 10 cm "Parent/Caregiver's Assessment of Extent of Drooling for the Day" VAS assessment (0 = normal; 10 = extremely wet) to provide an overall assessment of the extent of drooling for that day.
| VAS score | Patients With Chronic Drooling |
|---|---|
| Parent/Caregiver's Assessment of the Extent of Drooling Using VAS | 3.21 ± 2.20 |
The parent/caregiver performed an overall evaluation of glycopyrrolate liquid for the treatment of drooling, benefits, and side effects over the duration of the study. The parent/caregiver selected one of the following choices to assess if 'This is a worthwhile treatment': 1 = strongly agree, 2 = agree, 3 = neutral, 4 = disagree, 5 = strongly disagree. A dichotomous global assessment was also performed and summarized with the categories 'responder' (strongly agree and agree responses aggregated) and 'non-responder'(neutral, disagree, and strongly disagree responses aggregated)
| Participants | Patients With Chronic Drooling |
|---|---|
| Responders | 101 |
| Non-Responders | 20 |
| Missing | 16 |
The investigator performed an overall evaluation of glycopyrrolate liquid for the treatment of drooling, benefits, and side effects over the duration of the study. The investigator selected one of the following choices to assess if 'This is a worthwhile treatment': 1 = strongly agree, 2 = agree, 3 = neutral, 4 = disagree, 5 = strongly disagree. A dichotomous global assessment was also performed and summarized with the categories 'responder' (strongly agree and agree responses aggregated) and 'non-responder' (neutral, disagree, and strongly disagree responses aggregated)
| Participants | Patients With Chronic Drooling |
|---|---|
| Responders | 109 |
| Non-Responders | 18 |
| Missing | 10 |
Collected over 6 months. Non-serious events are listed at a 3% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Patients With Chronic Drooling | — | 14/137 (10.2%) | 122/137 (89.1%) |
| Event | Patients With Chronic Drooling |
|---|---|
| PneumoniaInfections and infestations | 3/137 |
| NystagmusNervous system disorders | 1/137 |
| ConvulsionNervous system disorders | 1/137 |
| HydrocephalusNervous system disorders | 1/137 |
| Anoxic encephalopathyNervous system disorders | 1/137 |
| Urinary tract infectionInfections and infestations | 1/137 |
| Otitis mediaInfections and infestations | 1/137 |
| Esophageal candidiasisInfections and infestations | 1/137 |
| CellulitisInfections and infestations | 1/137 |
| Tonsillar hypertrophyRespiratory, thoracic and mediastinal disorders | 1/137 |
| Event | Patients With Chronic Drooling |
|---|---|
| ConstipationGastrointestinal disorders | 28/137 |
| DiarrheaGastrointestinal disorders | 24/137 |
| VomitingGastrointestinal disorders | 24/137 |
| PyrexiaGeneral disorders | 20/137 |
| Dry mouthGastrointestinal disorders | 15/137 |
| Nasal congestionRespiratory, thoracic and mediastinal disorders | 15/137 |
| FlushingVascular disorders | 15/137 |
| Otitis mediaInfections and infestations | 11/137 |
| Upper respiratory tract infectionInfections and infestations | 11/137 |
| RashSkin and subcutaneous tissue disorders | 11/137 |
| Age, Categorical(Participants) | Patients With Chronic Drooling |
|---|---|
| <=18 years | 137 |
| Between 18 and 65 years | 0 |
| >=65 years | 0 |
| Age Continuous(years) | Patients With Chronic Drooling |
|---|---|
| Mean | 11.0 ± 4.35 |
| Sex: Female, Male(Participants) | Patients With Chronic Drooling |
|---|---|
| Female | 60 |
| Male | 77 |
| Ethnicity (NIH/OMB)(Participants) | Patients With Chronic Drooling |
|---|---|
| Hispanic or Latino | 15 |
| Not Hispanic or Latino | 121 |
| Unknown or Not Reported | 1 |
| Race (NIH/OMB)(Participants) | Patients With Chronic Drooling |
|---|---|
| American Indian or Alaska Native | 1 |
| Asian | 4 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 29 |
| White | 98 |
| More than one race | 0 |
| Unknown or Not Reported | 5 |
The record gives a start of Mar 2007, a primary completion of May 2008 and a completion of Jun 2008. It does not say whether these dates are actual or estimated.
Results were first posted in Jul 2012, 4 years 2 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2012. You cannot join it, but the record below documents what was studied.
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