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Antisense Oligonucleotide
STK-001 for Dravet Syndrome
Phase 2
Waitlist Available
Research Sponsored by Stoke Therapeutics, Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up dosing (day 1) until week 32 (last study drug dosing day)
Awards & highlights
Study Summary
This trial is testing the long-term safety of a drug for Dravet syndrome. The drug has been studied before, but this trial will measure seizures, quality of life, and clinical status over time.
Who is the study for?
This trial is for patients with Dravet syndrome who completed the STK-001 study STK-001-DS-101, showed a good safety profile, and were compliant with that study's procedures. They shouldn't be on certain antiepileptic drugs like sodium channel blockers or have unstable medical conditions besides epilepsy.Check my eligibility
What is being tested?
The trial tests the long-term safety of repeated doses of STK-001 in those previously treated for Dravet syndrome. It's an open-label extension where changes in seizure frequency, overall health status, and quality of life are also monitored.See study design
What are the potential side effects?
Specific side effects aren't listed here but generally include any adverse reactions observed during previous treatments with STK-001. The focus is on long-term tolerability and any new side effects that might emerge from extended use.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ dosing (day 1) until week 32 (last study drug dosing day)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~dosing (day 1) until week 32 (last study drug dosing day)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Safety of multiple doses of STK-001
Secondary outcome measures
Change in Quality of Life
Change in overall clinical status
Exposure of STK-001 in Cerebrospinal Fluid (CSF)
+2 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: STK-001 multiple dose levelsExperimental Treatment1 Intervention
Enrollment of patients after completion of study STK-001-DS-101 if eligible for additional dosing in this extension study. Patients will receive IT administration of study drug STK-001 at the dose level they received while participating in Study STK-001-DS-101, or at a dose level recommended by the Safety Monitoring Committee (SMC).The highest dose administered in this study may not exceed that which has already been evaluated in an STK-001 Phase 1/2 study, and doses above 30 mg/dose in this study require approval from the Food and Drug Administration (FDA). Patients will initially receive 3 doses, one every approximately 4 months (16 weeks). Patients who are tolerating treatment may continue treatment with doses approximately every 4 months, with an End of Study/Follow-up Visit 24 weeks after the last dose of study drug. Patients who do not continue treatment after the third dose will have a Follow-up Visit (V5) at Week 48 and an End of Study Visit at Week 56.
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Who is running the clinical trial?
Stoke Therapeutics, IncLead Sponsor
1 Previous Clinical Trials
78 Total Patients Enrolled
Ann Dandurand, MDStudy DirectorMedical Director
6 Previous Clinical Trials
547 Total Patients Enrolled
Javier Avendaño, MDStudy DirectorMedical Director
1 Previous Clinical Trials
78 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have any unstable health conditions except for epilepsy.You are currently using or have used an experimental drug other than STK-001 after joining Study STK-001-DS-101.I am currently on medication for epilepsy that includes drugs like phenytoin or carbamazepine.I don't have any major health issues apart from epilepsy.I have a spinal condition or a CSF drainage shunt that might affect spinal fluid flow.I finished my STK-001 treatment and was deemed safe to proceed by my doctor.
Research Study Groups:
This trial has the following groups:- Group 1: STK-001 multiple dose levels
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are the potential risks associated with STK-001 usage?
"Preliminary safety data suggests that STK-001 is relatively safe, so it received a rating of 2. However, as this trial is only in Phase 2 there has yet to be any evidence demonstrating its efficacy."
Answered by AI
Are there openings available for this research endeavor?
"Per the clinicaltrials.gov listing, this experiment is not presently recruiting patients. Initially posted on January 21st 2021 and last edited February 17th 2022, it is no longer enrolling participants; however, 1386 other studies are currently seeking volunteers."
Answered by AI
How many healthcare settings are conducting this experiment?
"According to the clinical trial, patients are being accepted at Children's National Medical Center in Washington D.C., NYU Comprehensive Epilepsy Center in New york City, and MultiCare Health System Institute for Research and Innovation in Tacoma, Washington alongside 9 other medical sites."
Answered by AI
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