Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02055638 · ClinicalTrials.gov registry record · Phase 1
Safety, Tolerability and Activity of SRX246 in Adults With Intermittent Explosive Disorder
A Phase 1 study, sponsored by Azevan Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 97
- Enrollment target
NCT02055638: Completed Phase 1 study, sponsored by Azevan Pharmaceuticals.
NCT02055638 is a Phase 1 study that has completed, run by Azevan Pharmaceuticals. The registered enrollment target is 97 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (62% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02055638, a Phase 1 study, has completed, sponsored by Azevan Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 97 participants
- Enrollment target
Study Summary
This study is designed to explore the safety and tolerability, and to compare the activity of SRX246 against placebo, in adults with Intermittent Explosive Disorder (IED). Adult Male and Female subjects with a current diagnosis of IED will be enrolled. After a two-week baseline lead-in phase, study subjects who continue to meet enrollment criteria will be randomized to either SRX246 or Placebo treatment groups. Study subjects will be examined and asked to answer questionnaires at weekly scheduled visits throughout the trial. The study results will be determined based on any changes observed over the study period.
Primary Outcome
measured as the number of participants with adverse events
Interventions
- DRUG Placebo
- DRUG SRX246
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 97 participants |
| Start Date | 2014-05 |
| Est. Completion | 2016-05 |
| Phase | Phase 1 |
What the finished NCT02055638 record still lists
NCT02055638 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 97 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (62% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02055638 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02055638 about?
NCT02055638 is a clinical study titled "Safety, Tolerability and Activity of SRX246 in Adults With Intermittent Explosive Disorder". This study is designed to explore the safety and tolerability, and to compare the activity of SRX246 against placebo, in adults with Intermittent Explosive Disorder (IED). Adult Male and Female subjects with a current diagnosis of IED will be enrolled. After a two-week baseline lead-in phase, study...
What is the current status of trial NCT02055638?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 97 participants. The study started on 2014-05. Estimated completion is 2016-05.
What interventions are being tested in trial NCT02055638?
The interventions under investigation include: Placebo (DRUG), SRX246 (DRUG).
Who is sponsoring clinical trial NCT02055638?
This trial is sponsored by Azevan Pharmaceuticals, which has 8 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02055638's enrollment target sits among peer trials
97 597th of 2000 higher than 1,401 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03948490 · 97 participants · NA
Rehabilitation and Longitudinal Follow-up of Cognition in Adult Lower Grade Gliomas
- NCT04140487 · 97 participants · Phase 1
Azacitidine, Venetoclax, and Gilteritinib in Treating Patients With Recurrent/Refractory FLT3-Mutated Acute Myeloid Leukemia, Chronic Myelomonocytic Leukemia, or High-Risk Myelodysplastic Syndrome/Myeloproliferative Neoplasm
- NCT04196413 · 97 participants · Phase 1
GD2 CAR T Cells in Diffuse Intrinsic Pontine Gliomas (DIPG) & Spinal Diffuse Midline Glioma(DMG)
- NCT05223816 · 97 participants · Phase 2
An Open-Label, Multiple-Center, Phase IIa/IIb Clinical Trial to Evaluate the Efficacy, Safety and Tolerability of VG161 as Monotherapy and in Combination With Nivolumab for Treatment of Patients With Hepatocellular Carcinoma or Intrahepatic Cholangiocarcinoma
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia