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mTOR inhibitor

ABI-009 for Epilepsy

Phase 1
Waitlist Available
Led By Jason Hauptman, MD, PhD
Research Sponsored by Seattle Children's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 months
Awards & highlights

Study Summary

This study is evaluating whether a new drug may help reduce seizures for individuals who have had epilepsy surgery but continue to have seizures.

Eligible Conditions
  • Epilepsy

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Maximum tolerated dose
Secondary outcome measures
Percentage reduction in seizure rate

Side effects data

From 2019 Phase 1 & 2 trial • 21 Patients • NCT02009332
25%
Abnormal urine analysis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Phase 1: ABI-009 200 mg/Week
Phase 1: ABI-009 100 mg 2×/Week
Phase 1: ABI-009 300 mg/Week
Phase 1: ABI-009 400 mg/Week
Phase 2: ABI-009 400 mg/Week + Gemcitabine 2000 mg/Week
Phase 1: ABI-009 100 mg/Week

Trial Design

1Treatment groups
Experimental Treatment
Group I: Dosing armExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ABI-009
2007
Completed Phase 2
~70

Find a Location

Who is running the clinical trial?

Seattle Children's HospitalLead Sponsor
301 Previous Clinical Trials
5,216,963 Total Patients Enrolled
1 Trials studying Epilepsy
210 Patients Enrolled for Epilepsy
Aadi Bioscience, Inc.Industry Sponsor
16 Previous Clinical Trials
527 Total Patients Enrolled
Jason Hauptman, MD, PhDPrincipal Investigator - Seattle Children's Hospital
Seattle Children's Hospital

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
ABI-009 (Nab-rapamycin) for Surgically-Refractory Epilepsy (RaSuRE)
Jason Hauptman 2018. "ABI-009 (Nab-rapamycin) for Surgically-Refractory Epilepsy (RaSuRE)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03646240.
~2 spots leftby Apr 2025
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