Trial · NCT02610868
Outcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Occurrence, Seriousness, Severity, and Causality Assessment of Treatment Emergent Adverse Events (TEAE) | Visits at Weeks 4 and 13 combined for each TS; including Visit at Week 8 for TS1 | Per protocol participants were only required to complete two treatment sessions with a maximum of 4 treatment sessions allowed.~All subjects received 3500 U doses except for 13 subjects who had decreased doses at Treatment Session 2 and/or 3 (2500 U or 3000 U). | participants | NUMBER |
| PRIMARY | Occurrence of Adverse Events of Special Interest (AESI) | Visits at Weeks 4 and 13 combined for each TS; including Visit at Week 8 for TS1 | Per protocol participants were only required to complete two treatment sessions with a maximum of 4 treatment sessions allowed.~All subjects received 3500 U doses except for 13 subjects who had decreased doses at Treatment Session 2 and/or 3 (2500 U to 3000 U). | participants | NUMBER |
| PRIMARY | Columbia Suicide Rating Scale (C-SSRS): Suicidal Ideation, Behavior Scores and Intensity Scores | Baseline (Day 1) of each TS to the following: TS1 Visits at Weeks 4, 8, 13; TS2-4 Visits at Weeks 4, 13 | participants | NUMBER | |
| PRIMARY | Occurrence of Dental Adverse Events | Visits at Weeks 4 and 13 combined for each TS; including Visit at Week 8 for TS1 | Per protocol participants were only required to complete two treatment sessions with a maximum of 4 treatment sessions allowed.~All subjects received 3500 U doses except for 13 subjects who had decreased doses at Treatment Session 2 and/or 3 (2500 U to 3000 U). | participants | NUMBER |
| SECONDARY | Change From Baseline in Unstimulated Salivary Flow Rate (USFR): Treatment Sessions 1-4 | Baseline (Day 1) of each TS to the following: TS1 Visits at Weeks 4, 8, 13; TS2-4 Visits at Weeks 4, 13 | Per protocol participants were only required to complete two treatment sessions with a maximum of 4 treatment sessions allowed.~All subjects received 3500 U doses except for 13 subjects who had decreased doses at Treatment Session 2 and/or 3 (2500 U to 3000 U). | g/minute | MEAN |
| SECONDARY | Change From Baseline in Clinical Global Impression of Severity (CGI-S) | Baseline (Day 1) of each TS to the following: TS1 Visits at Weeks 4, 8, 13; TS2-4 Visits at Weeks 4, 13 | Per protocol participants were only required to complete two treatment sessions with a maximum of 4 treatment sessions allowed.~All subjects received 3500 U doses except for 13 subjects who had decreased doses at Treatment Session 2 and/or 3 (2500 U to 3000 U). | units on a scale | MEAN |
| SECONDARY | Clinical Global Impression of Change (CGI-C) | TS1 Visits at Weeks 4, 8, 13; TS2-4 Visits at Weeks 4, 13 | Per protocol participants were only required to complete two treatment sessions with a maximum of 4 treatment sessions allowed.~All subjects received 3500 U doses except for 13 subjects who had decreased doses at Treatment Session 2 and/or 3 (2500 U to 3000 U). | units on a scale | MEAN |
| SECONDARY | Change From Baseline in Drooling Frequency and Severity Scale Performed by Trained Assessor (DFSS-I) | Baseline (Day 1) of each TS to the following: TS1 Visits at Weeks 4, 8, 13; TS2-4 Visits at Weeks 4, 13 | Per protocol participants were only required to complete two treatment sessions with a maximum of 4 treatment sessions allowed.~All subjects received 3500 U doses except for 13 subjects who had decreased doses at Treatment Session 2 and/or 3 (2500 U to 3000 U). | units on a scale | MEAN |
| SECONDARY | Change From Baseline in Drooling Frequency and Severity Scale Performed by Subject (DFSS-S) | Baseline (Day 1) of each TS to the following: TS1 Visits at Weeks 4, 8, 13; TS2-4 Visits at Weeks 4, 13 | Per protocol participants were only required to complete two treatment sessions with a maximum of 4 treatment sessions allowed.~All subjects received 3500 U doses except for 13 subjects who had decreased doses at Treatment Session 2 and/or 3 (2500 U to 3000 U). | units on a scale | MEAN |
| SECONDARY | Change From Baseline in Patient Global Impression of Severity (PGI-S) | Baseline (Day 1) of each TS to the following: TS1 Visits at Weeks 4, 8, 13; TS2-4 Visits at Weeks 4, 13 | Per protocol participants were only required to complete two treatment sessions with a maximum of 4 treatment sessions allowed.~All subjects received 3500 U doses except for 13 subjects who had decreased doses at Treatment Session 2 and/or 3 (2500 U to 3000 U). | units on a scale | MEAN |
| SECONDARY | Patient Global Impression of Change (PGI-C) | TS1 Visits at Weeks 4, 8, 13; TS2-4 Visits at Weeks 4, 13 | Per protocol participants were only required to complete two treatment sessions with a maximum of 4 treatment sessions allowed.~All subjects received 3500 U doses except for 13 subjects who had decreased doses at Treatment Session 2 and/or 3 (2500 U to 3000 U). | units on a scale | MEAN |
| SECONDARY | Change From Baseline in Drooling Impact Score (DIS) | Baseline (Day 1) of each TS to the following: TS1 Visits at Weeks 4, 8, 13; TS2-4 Visits at Weeks 4, 13 | Per protocol participants were only required to complete two treatment sessions with a maximum of 4 treatment sessions allowed.~All subjects received 3500 U doses except for 13 subjects who had decreased doses at Treatment Session 2 and/or 3 (2500 U to 3000 U). | units on a scale | MEAN |
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/NCT02610868/outcomes