Cerebral PalsyEarly Phase 1NCT05164367
Pharmacokinetics of Atropine Oral Gel
A Early Phase 1 study testing Atropine sulfate gel (0.01%) in people with Cerebral Palsy and Sialorrhea, run by University of Utah at 1 site in United States.
Trial summary
To evaluate the single-dose pharmacokinetics of atropine gel formulation after topical administration in the oral cavity of healthy adults. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Cerebral Palsy, Sialorrhea
- What is being tested?
- Atropine sulfate gel (0.01%)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2022to 10 Dec 2024
- Phase
- Early Phase 1
- 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 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Provide written informed consent and authorization.
- Study participants must be able to complete consent, and all study evaluations written in the English language.
Who cannot join
- Female subjects who are pregnant or nursing at the time of screening
- Chemotherapy or radiotherapy treatment within the last three months
- Severe renal impairment defined as estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2 calculated using the CKD-EPI creatinine equation:
- eGFR (mL/min/1.73 m2) = 141 x min(Scr/k, 1)α x max(Scr/k,1)-1.209 x 0.993Age x 1.018 [if female] x 1.159 [if black]
- Where,
- k=0.7 if female
Show all 31Show fewer
- k=0.9 if male
- α=-0.329 if female
- α=-0.411 if male
- min=The minimum of Scr/k or 1
- max=The maximum of Scr/k or 1
- Scr = serum creatinine (mg/dL)
- Acute hepatitis in the prior 6 months, a prior history of cirrhosis, acute hepatic failure, or acute decompensation of chronic hepatic failure; and/or any of the following blood test results, for any individual, when assessed for eligibility:
- Bilirubin > 3 x upper limit of normal (ULN). [ULN for bilirubin = 1.4 mg/dL]
- Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) > 3 x ULN values used by the laboratory performing the test. [ULN for AST = 40 U/L, ULN for ALT = 60 U/L]
- Alkaline phosphatase (ALP) > 3 x ULN [ULN for ALP = 126 U/L)
- Deforming lesions of the oral cavity
- Previous head and/or neck radiotherapy
- Patients with a history of hypersensitivity reaction towards atropine and/or Carbopol 980 NF or any carbomers
- Patients with heart conditions such as congenital heart disease, heart failure, coronary heart disease, myocardial infarction, and arrhythmia
- Patients with acute glaucoma that may be exacerbated with atropine administration.
- Patients with partial pyloric stenosis or other diseases related to gastrointestinal obstruction.
- Patients diagnosed with urinary retention
- Treatment with any other investigational drug during the 30 days prior to enrollment into the study
- Patients receiving anticholinergic medications at baseline.
- Patients who are receiving immunosuppression
- Patients who are actively being treated for an infection
- Patients with a history of salivary gland obstruction or stones
- Patients with a history of chronic lung disease or chronic obstructive pulmonary disease (COPD)
- Patients with an artificial airway (tracheostomy)
- Patient taking monoamine oxidase inhibitors
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Single-Dose Pharmacokinetics of Atropine Oral Gel in Healthy Adults
To evaluate the single-dose pharmacokinetics of atropine gel formulation after topical administration in the oral cavity of healthy adults.
Read the detailed description
This study is a single-dose, single-center, open-label study of the pharmacokinetics of atropine gel (0.01% w/w) after topical oral administration in healthy adults. Study participants will be recruited by Drs. Murphy, Darro, and Yellepeddi at the Center for Clinical and Translation Science (CCTS), University of Utah. Participants who meet eligibility criteria will be recruited in the study after signing informed consent. Each of the 10 participants will receive 1 gram of atropine gel (0.01% w/w) containing 0.1 mg atropine via self-administration of gel into the oral cavity. Dr. Yellepeddi is a licensed pharmacist in the State of Utah and will train subjects in the administration of atropine gel in the oral cavity. A series of timed blood samples (0, 5, 10, 15, 30, 60 minutes, and 2, 4, 6, 8, and 24 hours, 7 mL each time point) will be collected in commercial tubes, and plasma will be separated by centrifugation. The plasma samples will be stored frozen until further analysis by the Center for Human Toxicology (CHT), University of Utah.
- Conditions
- Cerebral Palsy, Sialorrhea
- Being tested
- Atropine sulfate gel (0.01%)
- Keywords
- Pharmacokinetics, Cerebral Palsy, Sialorrhea, Atropine sulfate gel
- Medical subject headings
- Cerebral Palsy, Sialorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atropine sulfate gel (0.01%)Drug
Also called Atropine gel, mucoadhesive atropine gel
A research nurse will measure 1 gram of gel using a calibrated measuring spoon and will provide it to the participant for self-administration.
| Study group | Role | What they receive |
|---|---|---|
| 0.1 mg of atropine | Experimental | 1 gram of gel by topical application in the oral cavity once. Receives: Drug: Atropine sulfate gel (0.01%) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate pharmacokinetic parameter time to reach maximum plasma concentration (Tmax) in healthy adults to see if atropine will reach detectable concentrations in plasma following topical oral administration in gel formulation.
Calculate the pharmacokinetic parameter Tmax after topical oral administration of 0.01% atropine gel.
Measured: The Tmax will be evaluated at timepoints 0, 5, 10, 15, 30, 60 minutes, and 2, 4, 6, 8, and 24 hours after administration of gel to the oral cavity.
Evaluate pharmacokinetic parameter time to reach maximum plasma concentration (Cmax) in healthy adults to see if atropine will reach detectable concentrations in plasma following topical oral administration in gel formulation.
Calculate the pharmacokinetic parameter Cmax after topical oral administration of atropine gel
Measured: The Cmax will be evaluated at timepoints 0, 5, 10, 15, 30, 60 minutes, and 2, 4, 6, 8, and 24 hours after administration of gel to the oral cavity.
Evaluate pharmacokinetic parameter area under the curve (AUC) in healthy adults to see if atropine will reach detectable concentrations in plasma following topical oral administration in gel formulation.
Calculate the pharmacokinetic parameter AUC after topical oral administration of atropine gel
Measured: The AUC will be evaluated at timepoints 0, 5, 10, 15, 30, 60 minutes, and 2, 4, 6, 8, and 24 hours after administration of gel to the oral cavity.
Evaluate pharmacokinetic parameter volume of distribution (Vd) in healthy adults to see if atropine will reach detectable concentrations in plasma following topical oral administration in gel formulation.
Calculate the pharmacokinetic parameter Vd after topical oral administration of atropine gel
Measured: The Vd will be evaluated at timepoints 0, 5, 10, 15, 30, 60 minutes, and 2, 4, 6, 8, and 24 hours after administration of gel to the oral cavity.
Evaluate pharmacokinetic parameter clearance (CL) in healthy adults to see if atropine will reach detectable concentrations in plasma following topical oral administration in gel formulation.
Calculate the pharmacokinetic parameter CL after topical oral administration of atropine gel
Measured: The CL will be evaluated at timepoints 0, 5, 10, 15, 30, 60 minutes, and 2, 4, 6, 8, and 24 hours after administration of gel to the oral cavity.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2021
- Study start1 Oct 2022
- Primary completion30 Jun 2023
- Study completion10 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Venkata Yellepeddi, University of Utah
- Investigators
- Venkata K. Yellepeddi, PhD, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05164367
- Sponsor's protocol ID
- 144918
- Status last verified
- Dec 2024
- First submitted
- 22 Nov 2021
- Last updated
- 18 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Reid SM, Westbury C, Chong D, Johnstone BR, Guzys A, Reddihough DS. Long-term impact of saliva control surgery in children with disability. J Plast Reconstr Aesthet Surg. 2019 Jul;72(7):1193-1197. doi: 10.1016/j.bjps.2019.02.020. Epub 2019 Mar 2.
PubMed 30885525Speyer R, Cordier R, Kim JH, Cocks N, Michou E, Wilkes-Gillan S. Prevalence of drooling, swallowing, and feeding problems in cerebral palsy across the lifespan: a systematic review and meta-analyses. Dev Med Child Neurol. 2019 Nov;61(11):1249-1258. doi: 10.1111/dmcn.14316. Epub 2019 Jul 22.
PubMed 31328797Parkes J, Hill N, Platt MJ, Donnelly C. Oromotor dysfunction and communication impairments in children with cerebral palsy: a register study. Dev Med Child Neurol. 2010 Dec;52(12):1113-9. doi: 10.1111/j.1469-8749.2010.03765.x. Epub 2010 Aug 31.
PubMed 20813020Reid SM, McCutcheon J, Reddihough DS, Johnson H. Prevalence and predictors of drooling in 7- to 14-year-old children with cerebral palsy: a population study. Dev Med Child Neurol. 2012 Nov;54(11):1032-6. doi: 10.1111/j.1469-8749.2012.04382.x. Epub 2012 Aug 9.
PubMed 22881219Reid SM, Westbury C, Guzys AT, Reddihough DS. Anticholinergic medications for reducing drooling in children with developmental disability. Dev Med Child Neurol. 2020 Mar;62(3):346-353. doi: 10.1111/dmcn.14350. Epub 2019 Sep 8.
PubMed 31495925Norderyd J, Graf J, Marcusson A, Nilsson K, Sjostrand E, Steinwall G, Arleskog E, Bagesund M. Sublingual administration of atropine eyedrops in children with excessive drooling - a pilot study. Int J Paediatr Dent. 2017 Jan;27(1):22-29. doi: 10.1111/ipd.12219. Epub 2015 Dec 27.
PubMed 26708211Protus BM, Grauer PA, Kimbrel JM. Evaluation of atropine 1% ophthalmic solution administered sublingually for the management of terminal respiratory secretions. Am J Hosp Palliat Care. 2013 Jun;30(4):388-92. doi: 10.1177/1049909112453641. Epub 2012 Jul 24.
PubMed 22833553De Simone GG, Eisenchlas JH, Junin M, Pereyra F, Brizuela R. Atropine drops for drooling: a randomized controlled trial. Palliat Med. 2006 Oct;20(7):665-71. doi: 10.1177/0269216306071702.
PubMed 17060265Lawrence R, Bateman N. Surgical Management of the Drooling Child. Curr Otorhinolaryngol Rep. 2018;6(1):99-106. doi: 10.1007/s40136-018-0188-2. Epub 2018 Mar 20.
PubMed 29651363Leung JG, Schak KM. Potential problems surrounding the use of sublingually administered ophthalmic atropine for sialorrhea. Schizophr Res. 2017 Jul;185:202-203. doi: 10.1016/j.schres.2016.12.028. Epub 2016 Dec 30. No abstract available.
PubMed 28043733Singla AK, Chawla M, Singh A. Potential applications of carbomer in oral mucoadhesive controlled drug delivery system: a review. Drug Dev Ind Pharm. 2000 Sep;26(9):913-24. doi: 10.1081/ddc-100101318.
PubMed 10914315Keegan G, Smart J, Ingram M, Barnes L, Rees G, Burnett G. An in vitro assessment of bioadhesive zinc/carbomer complexes for antimicrobial therapy within the oral cavity. Int J Pharm. 2007 Aug 1;340(1-2):92-6. doi: 10.1016/j.ijpharm.2007.03.023. Epub 2007 Mar 24.
PubMed 17452085Kelly HM, Deasy PB, Busquet M, Torrance AA. Bioadhesive, rheological, lubricant and other aspects of an oral gel formulation intended for the treatment of xerostomia. Int J Pharm. 2004 Jul 8;278(2):391-406. doi: 10.1016/j.ijpharm.2004.03.022.
PubMed 15196643Allison RR, Ambrad AA, Arshoun Y, Carmel RJ, Ciuba DF, Feldman E, Finkelstein SE, Gandhavadi R, Heron DE, Lane SC, Longo JM, Meakin C, Papadopoulos D, Pruitt DE, Steinbrenner LM, Taylor MA, Wisbeck WM, Yuh GE, Nowotnik DP, Sonis ST. Multi-institutional, randomized, double-blind, placebo-controlled trial to assess the efficacy of a mucoadhesive hydrogel (MuGard) in mitigating oral mucositis symptoms in patients being treated with chemoradiation therapy for cancers of the head and neck. Cancer. 2014 May 1;120(9):1433-40. doi: 10.1002/cncr.28553.
PubMed 24877167Alcon (2018). Viscotears® Liquid Gel [carbomer (polyacrylic acid)] - Patient Information Leaflet
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-Dose Pharmacokinetics of Atropine Oral Gel in Healthy Adults
- ClinicalTrials.gov ID
- NCT05164367
- Acronym / sponsor ID
- 144918
- Conditions
- Cerebral Palsy, Sialorrhea
- Keywords
- Pharmacokinetics, Cerebral Palsy, Sialorrhea, Atropine sulfate gel
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 10 Dec 2024 (actual)
- First posted
- 20 Dec 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.
To evaluate the single-dose pharmacokinetics of atropine gel formulation after topical administration in the oral cavity of healthy adults.
Detailed description
This study is a single-dose, single-center, open-label study of the pharmacokinetics of atropine gel (0.01% w/w) after topical oral administration in healthy adults. Study participants will be recruited by Drs. Murphy, Darro, and Yellepeddi at the Center for Clinical and Translation Science (CCTS), University of Utah. Participants who meet eligibility criteria will be recruited in the study after signing informed consent. Each of the 10 participants will receive 1 gram of atropine gel (0.01% w/w) containing 0.1 mg atropine via self-administration of gel into the oral cavity. Dr. Yellepeddi is a licensed pharmacist in the State of Utah and will train subjects in the administration of atropine gel in the oral cavity. A series of timed blood samples (0, 5, 10, 15, 30, 60 minutes, and 2, 4, 6, 8, and 24 hours, 7 mL each time point) will be collected in commercial tubes, and plasma will be separated by centrifugation. The plasma samples will be stored frozen until further analysis by the Center for Human Toxicology (CHT), University of Utah.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 0.1 mg of atropine | Experimental | Drug: Atropine sulfate gel (0.01%)1 gram of gel by topical application in the oral cavity once. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Provide written informed consent and authorization.
- Study participants must be able to complete consent, and all study evaluations written in the English language.
Key exclusion criteria (31 listed)
- Female subjects who are pregnant or nursing at the time of screening
- Chemotherapy or radiotherapy treatment within the last three months
- Severe renal impairment defined as estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2 calculated using the CKD-EPI creatinine equation:
- eGFR (mL/min/1.73 m2) = 141 x min(Scr/k, 1)α x max(Scr/k,1)-1.209 x 0.993Age x 1.018 [if female] x 1.159 [if black]
- Where,
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 |
|---|---|---|
| Atropine sulfate gel (0.01%)Also: Atropine gel, mucoadhesive atropine gelA research nurse will measure 1 gram of gel using a calibrated measuring spoon and will provide it to the participant for self-administration. | Drug | 0.1 mg of atropine |
Primary outcome
Evaluate pharmacokinetic parameter time to reach maximum plasma concentration (Tmax) in healthy adults to see if atropine will reach detectable concentrations in plasma following topical oral administration in gel formulation.
Time frame: The Tmax will be evaluated at timepoints 0, 5, 10, 15, 30, 60 minutes, and 2, 4, 6, 8, and 24 hours after administration of gel to the oral cavity.
Calculate the pharmacokinetic parameter Tmax after topical oral administration of 0.01% atropine gel.
Evaluate pharmacokinetic parameter time to reach maximum plasma concentration (Cmax) in healthy adults to see if atropine will reach detectable concentrations in plasma following topical oral administration in gel formulation.
Time frame: The Cmax will be evaluated at timepoints 0, 5, 10, 15, 30, 60 minutes, and 2, 4, 6, 8, and 24 hours after administration of gel to the oral cavity.
Calculate the pharmacokinetic parameter Cmax after topical oral administration of atropine gel
Evaluate pharmacokinetic parameter area under the curve (AUC) in healthy adults to see if atropine will reach detectable concentrations in plasma following topical oral administration in gel formulation.
Time frame: The AUC will be evaluated at timepoints 0, 5, 10, 15, 30, 60 minutes, and 2, 4, 6, 8, and 24 hours after administration of gel to the oral cavity.
Calculate the pharmacokinetic parameter AUC after topical oral administration of atropine gel
Evaluate pharmacokinetic parameter volume of distribution (Vd) in healthy adults to see if atropine will reach detectable concentrations in plasma following topical oral administration in gel formulation.
Time frame: The Vd will be evaluated at timepoints 0, 5, 10, 15, 30, 60 minutes, and 2, 4, 6, 8, and 24 hours after administration of gel to the oral cavity.
Calculate the pharmacokinetic parameter Vd after topical oral administration of atropine gel
Evaluate pharmacokinetic parameter clearance (CL) in healthy adults to see if atropine will reach detectable concentrations in plasma following topical oral administration in gel formulation.
Time frame: The CL will be evaluated at timepoints 0, 5, 10, 15, 30, 60 minutes, and 2, 4, 6, 8, and 24 hours after administration of gel to the oral cavity.
Calculate the pharmacokinetic parameter CL after topical oral administration of atropine gel
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 18 Dec 2024.
- Background: PubMed 30885525Reid SM, Westbury C, Chong D, Johnstone BR, Guzys A, Reddihough DS. Long-term impact of saliva control surgery in children with disability. J Plast Reconstr Aesthet Surg. 2019 Jul;72(7):1193-1197. doi: 10.1016/j.bjps.2019.02.020. Epub 2019 Mar 2.
- Background: PubMed 31328797Speyer R, Cordier R, Kim JH, Cocks N, Michou E, Wilkes-Gillan S. Prevalence of drooling, swallowing, and feeding problems in cerebral palsy across the lifespan: a systematic review and meta-analyses. Dev Med Child Neurol. 2019 Nov;61(11):1249-1258. doi: 10.1111/dmcn.14316. Epub 2019 Jul 22.
- Background: PubMed 20813020Parkes J, Hill N, Platt MJ, Donnelly C. Oromotor dysfunction and communication impairments in children with cerebral palsy: a register study. Dev Med Child Neurol. 2010 Dec;52(12):1113-9. doi: 10.1111/j.1469-8749.2010.03765.x. Epub 2010 Aug 31.
- Background: PubMed 22881219Reid SM, McCutcheon J, Reddihough DS, Johnson H. Prevalence and predictors of drooling in 7- to 14-year-old children with cerebral palsy: a population study. Dev Med Child Neurol. 2012 Nov;54(11):1032-6. doi: 10.1111/j.1469-8749.2012.04382.x. Epub 2012 Aug 9.
- Background: PubMed 31495925Reid SM, Westbury C, Guzys AT, Reddihough DS. Anticholinergic medications for reducing drooling in children with developmental disability. Dev Med Child Neurol. 2020 Mar;62(3):346-353. doi: 10.1111/dmcn.14350. Epub 2019 Sep 8.
- Background: PubMed 26708211Norderyd J, Graf J, Marcusson A, Nilsson K, Sjostrand E, Steinwall G, Arleskog E, Bagesund M. Sublingual administration of atropine eyedrops in children with excessive drooling - a pilot study. Int J Paediatr Dent. 2017 Jan;27(1):22-29. doi: 10.1111/ipd.12219. Epub 2015 Dec 27.
- Background: PubMed 22833553Protus BM, Grauer PA, Kimbrel JM. Evaluation of atropine 1% ophthalmic solution administered sublingually for the management of terminal respiratory secretions. Am J Hosp Palliat Care. 2013 Jun;30(4):388-92. doi: 10.1177/1049909112453641. Epub 2012 Jul 24.
- Background: PubMed 17060265De Simone GG, Eisenchlas JH, Junin M, Pereyra F, Brizuela R. Atropine drops for drooling: a randomized controlled trial. Palliat Med. 2006 Oct;20(7):665-71. doi: 10.1177/0269216306071702.
- Background: PubMed 29651363Lawrence R, Bateman N. Surgical Management of the Drooling Child. Curr Otorhinolaryngol Rep. 2018;6(1):99-106. doi: 10.1007/s40136-018-0188-2. Epub 2018 Mar 20.
- Background: PubMed 28043733Leung JG, Schak KM. Potential problems surrounding the use of sublingually administered ophthalmic atropine for sialorrhea. Schizophr Res. 2017 Jul;185:202-203. doi: 10.1016/j.schres.2016.12.028. Epub 2016 Dec 30. No abstract available.
- Background: PubMed 10914315Singla AK, Chawla M, Singh A. Potential applications of carbomer in oral mucoadhesive controlled drug delivery system: a review. Drug Dev Ind Pharm. 2000 Sep;26(9):913-24. doi: 10.1081/ddc-100101318.
- Background: PubMed 17452085Keegan G, Smart J, Ingram M, Barnes L, Rees G, Burnett G. An in vitro assessment of bioadhesive zinc/carbomer complexes for antimicrobial therapy within the oral cavity. Int J Pharm. 2007 Aug 1;340(1-2):92-6. doi: 10.1016/j.ijpharm.2007.03.023. Epub 2007 Mar 24.
- Prescribing information of Cuvposa-glycopyrrolate liquid.Link provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Cerebral Palsy
Not yet recruiting
Feasibility of a Robot-Guided Active Play Intervention for Children With Cerebral Palsy
Cerebral Palsy
RecruitingObservational study
Turkish Translation, Cross-Cultural Adaptation, Validity, and Reliability of the ABILHAND-Kids Young CP Scale
Cerebral Palsy
Not yet recruiting
Video-based Visual Feedback Combined With Task-oriented Physiotherapy Among Cerebral Palsy
Cerebral Palsy (CP)
Recruiting
Sensory Integration Therapy vs Conventional Physical Therapy in Children With Mixed Cerebral Palsy
Cerebral Palsy
Recruiting
Additional Effects on tDCS With AOT on Lower Limb Functions on Children With Diplegic CP
Diplegic Cerebral Palsy
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.
Venkata K. Yellepeddi, PhD principal investigator
University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Atropine sulfate gel (0.01%) in people with Cerebral Palsy and Sialorrhea, run by University of Utah at 1 site in United States.
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 2 inclusion and 31 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 18 Dec 2024. 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 United States. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Evaluate pharmacokinetic parameter time to reach maximum plasma concentration (Tmax) in healthy adults to see if atropine will reach detectable concentrations in plasma following topical oral administration in gel formulation. (time frame: The Tmax will be evaluated at timepoints 0, 5, 10, 15, 30, 60 minutes, and 2, 4, 6, 8, and 24 hours after administration of gel to the oral cavity.). The study lists 5 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 NCT05164367, which also lists 23 linked publications.
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 18 Dec 2024; AzTrials last refreshed its copy on 7 Nov 2026.