Trial · NCT07593391
Registered outcomes21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 21
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Long-term safety and tolerability of NNZ-2591 as assessed by the incidence of adverse events across participants | Baseline through Safety Follow-Up (Month 12) | Incidence of TEAEs, AESI and SAEs across participants |
| Primary | Long-term safety and tolerability of NNZ-2591 as assessed by changes from Baseline assessments of ECG parameters events across participants. | Baseline through Month 12 | Change from Baseline in ECG Heart Rate (bpm) |
| Primary | Long-term safety and tolerability of NNZ-2591 as assessed by changes from Baseline assessments of ECG parameters events across participants. | Baseline through Safety Follow-Up (Month 12) | Change from Baseline PR Interval (ms QRS interval (ms) |
| Primary | Long-term safety and tolerability of NNZ-2591 as assessed by changes from Baseline assessments of ECG parameters events across participants. | Baseline through Safety Follow-Up (Month 12) | Change from Baseline in QT interval (ms) |
| Primary | Long-term safety and tolerability of NNZ-2591 as assessed by changes from Baseline assessments of ECG parameters events across participants. | Baseline through Safety Follow-Up (Month 12) | Change from Baseline in QTcB interval (ms) |
| Primary | Long-term safety and tolerability of NNZ-2591 as assessed by changes from Baseline assessments of ECG parameters events across participants. | Baseline through Safety Follow-Up (Month 12) | Change from Baseline in QTcF interval (ms) |
| Primary | Long-term safety and tolerability of NNZ-2591 as assessed by changes from Baseline assessments of ECG parameters events across participants. | Baseline through Safety Follow-Up (Month 12) | Change from Baseline in RR interval (ms) |
| Primary | Long-term safety and tolerability of NNZ-2591 as assessed by changes from Baseline assessments of vital sign parameters events across participants. | Baseline through Month 12 | Change from Baseline for heart rate (bpm) |
| Primary | Long-term safety and tolerability of NNZ-2591 as assessed by changes from Baseline assessments of vital sign parameters events across participants. | Baseline through Month 12 | Change from Baseline for respiration rate (breaths per minute) |
| Primary | Long-term safety and tolerability of NNZ-2591 as assessed by changes from Baseline assessments of vital sign parameters events across participants. | Baseline through Month 12 | Change from Baseline for Temperature (Celsius) |
| Primary | Long-term safety and tolerability of NNZ-2591 as assessed by changes from Baseline assessments of vital sign parameters events across participants. | Baseline through Month 12 | Change from Baseline for Diastolic Blood Pressure (mm Hg) |
| Primary | Long-term safety and tolerability of NNZ-2591 as assessed by changes from Baseline assessments of vital sign parameters events across participants. | Baseline through Month 12 | Change from Baseline for Systolic Blood Pressure (mm Hg) |
| Primary | Long-term safety and tolerability of NNZ-2591 as incidence of abnormal, clinically significant clinical laboratory parameters events across participants. | Baseline through Month 12 | Incidence of abnormal and clinically significant laboratory parameters |
| Primary | Long-term safety and tolerability of NNZ-2591 as incidence of abnormal, clinically significant physical examination findings across participants. | Baseline through Month 12 | Incidence of abnormal, clinically significant physical examination findings |
| Secondary | Efficacy of NNZ-2591 as measured by the Phelan-McDermid Syndrome Assessment of Change (PMSA-C) overall score | Months 3 and 12 | Efficacy of NNZ-2591 as measured by the Phelan-McDermid Syndrome Assessment of Change (PMSA-C) overall score. The PMSA-C scores range from 1 to 7 with 1 indicating very much improved and 7 indicating very much worse. |
| Secondary | Efficacy of NNZ-2591 as measured by the change from baseline in the Vineland Adaptive Behavior Scales-3, Interview version (Vineland-3) receptive communication subdomain raw score. | Months 3 and 12 | Efficacy of NNZ-2591 as measured by the change from baseline in the Vineland Adaptive Behavior Scales-3, Interview version (Vineland-3) receptive communication subdomain raw score. A higher raw score for the receptive communication subdomain indicates better adaptive behavior. |
| Secondary | Efficacy of NNZ-2591 as measured by the Phelan-McDermid Syndrome Assessment of Change (PMSA-C) domain scores. | Months 3 and 12 | Efficacy of NNZ-2591 as measured by the Phelan-McDermid Syndrome Assessment of Change (PMSA-C) domain scores. The PMSA-C domain scores range from 1 to 7 with 1 indicating very much improved and 7 indicating very much worse. |
| Secondary | Efficacy of NNZ-2591 as measured by the Caregiver Impression of Change (CIC) domain scores. | Months 3 and 12 | Efficacy of NNZ-2591 as measured by the Caregiver Impression of Change (CIC) domain scores. The CIC scores range from 1 to 7 with 1 indicating very much improved and 7 indicating very much worse. |
| Secondary | Efficacy of NNZ-2591 as measured by the change from baseline in Phelan-McDermid Syndrome Assessment of Severity (PMSA-S) domain scores. | Months 3 and 12 | Efficacy of NNZ-2591 as measured by the change from baseline in Phelan-McDermid Syndrome Assessment of Severity (PMSA-S) domain scores. The PMSA-S scores range from 1 to 7 with 1 indicating typical for age, not at all impaired and 7 among the most severely impaired. |
| Secondary | Efficacy of NNZ-2591 as measured by the change from baseline in Phelan-McDermid Syndrome Assessment of Severity (PMSA-S) overall score. | Months 3 and 12 | Efficacy of NNZ-2591 as measured by the change from baseline in Phelan-McDermid Syndrome Assessment of Severity (PMSA-S) overall score. The PMSA-S scores range from 1 to 7 with 1 indicating typical for age, not at all impaired and 7 among the most severely impaired. |
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
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GET https://conductscience.org/api/trials/v1/NCT07593391/registered