Trial · NCT07593391
An Open-label Study of NNZ-2591 in Pediatric Participants With Phelan-McDermid Syndrome
NCT07593391, Phase 3, Recruiting, Neuren Pharmaceuticals Limited
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. An Open-label Study of NNZ-2591 in Pediatric Participants With Phelan-McDermid Syndrome. Trials, record NCT07593391. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07593391
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- An Open-label Study of NNZ-2591 in Pediatric Participants With Phelan-McDermid Syndrome
- NCT number
- NCT07593391
- Status
- Recruiting
- Phases
- Phase 3
- Enrollment
- 180 participants, estimated
- Lead sponsor
- Neuren Pharmaceuticals Limited
- Conditions
- Phelan-McDermid Syndrome
- Interventions
- NNZ-2591
- First posted
- 2026-05-18
- Last updated
- 2026-11-09
Source ClinicalTrials.gov
Registered outcomes21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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) |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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 trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07593391
GET https://conductscience.org/api/trials/v1/NCT07593391/registered?page=2