Trial · NCT04873115
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Change in Drooling Impact Scale (DIS) between baseline and D84. | 84 days | DIS possible range is 10-100. Lower score indicates a better outcome. |
| Secondary | Change in Drooling Impact Scale (DIS) between baseline and D28. | 28 days | DIS possible range is 10-100. Lower score indicates a better outcome. |
| Secondary | Proportion of responders at D84 (a response is defined as a DIS improvement ≥ 13.6 points). | 84 days | DIS possible range is 10-100. Lower score indicates a better outcome. |
| Secondary | Proportion of responders at D28 (a response is defined as a DIS improvement ≥ 13.6 points). | 28 days | DIS possible range is 10-100. Lower score indicates a better outcome. |
| Secondary | Proportion of good responders at D84 (a good response is defined as a DIS improvement ≥ 28 points). | 84 days | DIS possible range is 10-100. Lower score indicates a better outcome. |
| Secondary | Changes in the number of used bibs or clothing over 7 days (Item 3 of the DIS) at D84 | 84 days | |
| Secondary | Changes in the number of used bibs or clothing over 7 days (Item 3 of the DIS) at D28 | 28 days | |
| Other | Change in the DIS 10-point item 9 from baseline. "To what extent did your child's drooling affect his or her life?" to D28 and D84. | 28 and 84 days | DIS possible range is 10-100. Lower score indicates a better outcome. |
| Other | Change in in the DIS 10-point item 10 from baseline. "To what extent did your child's dribbling affect you and your family's life?" to D28 and D84. | 28 and 84 days | DIS possible range is 10-100. Lower score indicates a better outcome. |
| Other | The change in DISABKIDS instrument from baseline to D84. | 84 days | |
| Other | Adverse events recorded from baseline to day 84, including all AEs and SAE. | 84 days | |
| Other | Changes in DIS Scale between baseline and D252 and between D84 and D252 in the previous 'Sialanar®-arm' patients. | up to 252 days | DIS possible range is 10-100. Lower score indicates a better outcome. |
| Other | Change in DIS Scale between D84 and D252 for patients previously taking placebo | 168 days | DIS possible range is 10-100. Lower score indicates a better outcome. |
| Other | Change in the DIS 10-point item 9. "To what extent did your child's drooling affect his or her life?" between baseline and D252. | 252 days | DIS question 9 possible range is 1-10. Lower score indicates a better outcome. |
| Other | Change in the DIS 10-point item 10. "To what extent did your child's dribbling affect you and your family's life?" between baseline and D252. | 252 days | DIS question 10 possible range is 1-10. Lower score indicates a better outcome. |
| Other | Change in DISABKIDS instrument score between baseline and D252. | 252 days | |
| Other | Adverse events recorded from D84 to D252 | 168 days |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT04873115/registered