Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03646240 · ClinicalTrials.gov registry record · Phase 1
ABI-009 (Nab-rapamycin) for Surgically-Refractory Epilepsy (RaSuRE)
A Phase 1 study, sponsored by Seattle Children's Hospital.
- Completed
- Registry status
- Phase 1
- Development phase
- 14
- Enrollment target
NCT03646240: Completed Phase 1 study, sponsored by Seattle Children's Hospital.
NCT03646240 is a Phase 1 study that has completed, run by Seattle Children's Hospital. The registered enrollment target is 14 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03646240, a Phase 1 study, has completed, sponsored by Seattle Children's Hospital.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 14 participants
- Enrollment target
Study Summary
This is a prospective, single-center, phase 1 safety study to investigate the safety, tolerability, seizure control, and quality of life in participants with medically-refractory epilepsy who failed epilepsy surgery. These participants will have continued seizures despite being at least 3 months post-epilepsy surgery (resective surgery with an intent to cure).
Primary Outcome
Incidence of AEs in each treatment arm will be tabulated by seriousness, severity, and relationship to study drug from baseline will be summarized by treatment group.
Interventions
- DRUG ABI-009
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2018-07-31 |
| Est. Completion | 2022-12-31 |
| Phase | Phase 1 |
What the finished NCT03646240 record still lists
NCT03646240 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 1 intervention - of which ABI-009 is the first listed.
NCT03646240 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03646240 about?
NCT03646240 is a clinical study titled "ABI-009 (Nab-rapamycin) for Surgically-Refractory Epilepsy (RaSuRE)". This is a prospective, single-center, phase 1 safety study to investigate the safety, tolerability, seizure control, and quality of life in participants with medically-refractory epilepsy who failed epilepsy surgery. These participants will have continued seizures despite being at least 3 months pos...
What is the current status of trial NCT03646240?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 14 participants. The study started on 2018-07-31. Estimated completion is 2022-12-31.
What interventions are being tested in trial NCT03646240?
The interventions under investigation include: ABI-009 (DRUG).
Who is sponsoring clinical trial NCT03646240?
This trial is sponsored by Seattle Children's Hospital, which has 168 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03646240's enrollment target sits among peer trials
14 1844th of 2000 higher than 154 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
- NCT02523092 · 14 participants · Phase 4
Use of CXCL9 as a Biomarker of Acthar Efficacy
- NCT04263285 · 14 participants · NA
Treatment of Depression Post-SCI
- NCT04743271 · 14 participants · NA
Food and Circadian Timing
- NCT05065671 · 14 participants · Phase 1
Microbiome Derived Metabolism and Pharmacokinetics
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT06358040 · started 2026-10 · NA
Opioid Dispenser for Microdiscectomy/Laminectomy