Dravet SyndromePhase 4FAST-DSNCT07112365
The FINTEPLA as an Anti-SUDEP Therapy in Dravet Syndrome Project
A Phase 4 study testing Fenfluramine treatment (Fintepla) and Hypercapnia Challenge using the device (RespirAct) in people with Dravet Syndrome, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
This study investigates cerebrovascular reactivity (CVR) and functional brain connectivity in Dravet Syndrome (DS) patients with convulsive seizures. Using functional MRI (fMRI), we will define differences in brain responses to CO₂ changes before administration of the drug Fintepla (Baseline), with a library of… Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Dravet Syndrome
- What is being tested?
- Fenfluramine treatment (Fintepla) and Hypercapnia Challenge using the device (RespirAct)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Apr 2026to 31 Mar 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- DS patients (with or without SCN1A pathogenic mutations)
- Generalized convulsive seizures
Who cannot join
- known cardiorespiratory, hepatic or renal disease, and/or
- allergic reactions or other contraindications to fenfluramine and/or
- on Stiripentol treatment, and/or
- on serotonergic medications, and/or
- contraindications to Midazolam anesthesia
- taken the following drugs within 14 days: monoamine oxidase inhibitors (MAOIs), anti-depressants (Selective Serotonin Reuptake Inhibitors (SSRIs), Serotonin and norepinephrine reuptake inhibitors (SNRIs), and Tricyclic antidepressants (TCAs)), St. John's Wort, Tryptophan, and Dextromethorphan
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
Samden Lhatoo, MD, FRCP, (713) 500-7106, Samden.D.Lhatoo@uth.tmc.edu
Sandhya Rani, (713) 500-7499, M.R.Sandhya.Rani@uth.tmc.edu
About this study
Official title: The FINTEPLA as an Anti-SUDEP Therapy in Dravet Syndrome (FAST-DS) Project.
This study investigates cerebrovascular reactivity (CVR) and functional brain connectivity in Dravet Syndrome (DS) patients with convulsive seizures. Using functional MRI (fMRI), we will define differences in brain responses to CO₂ changes before administration of the drug Fintepla (Baseline), with a library of healthy controls and with those obtained after administration of Fintepla (Day ~60). Changes in CVR and their relation to ventilatory responses will also be assessed during fMRI.
- Conditions
- Dravet Syndrome
- Being tested
- Fenfluramine treatment (Fintepla), Hypercapnia Challenge using the device (RespirAct)
- Keywords
- epilepsy, Sudden Unexpected Death in Epilepsy (SUDEP)
- Medical subject headings
- Epilepsies, Myoclonic, Epilepsy, Sudden Unexpected Death in Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fenfluramine treatment (Fintepla)Drug
Also called Fenfluramine
Participants will receive Fintepla starting at 0.2 mg/kg/day, up to a maximum of 0.6 mg/kg/day (or 5.9 mL/day, whichever is lower), per FDA guidelines. Dosing will be adjusted as tolerated. After Day ~60, the dose will be gradually tapered.
Hypercapnia Challenge using the device (RespirAct)Device
Also called RespirAct
Participants will undergo a hypercapnia challenge using the RespirAct device during fMRI. The protocol includes alternating one minute blocks of controlled CO₂ increases and normocapnia under normoxic conditions.
| Study group | Role | What they receive |
|---|---|---|
| Fintepla plus Hypercapnia Challenge using the Respiract Device | Experimental | Not described Receives: Drug: Fenfluramine treatment (Fintepla); Device: Hypercapnia Challenge using the device (RespirAct) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in blood oxygenation level in response to CO₂
Measures how much blood oxygenation level dependent (BOLD) signal changes in response to CO₂, using fMRI.
Measured: Baseline, Day ~60
Change in speed of cerebrovascular response to CO₂
Measures how quickly the brain responds to CO₂ exposure during fMRI.
Measured: Baseline, Day ~60
Secondary outcomes (1)
Change in breathing response to CO₂
Assesses how the participant's breathing rate changes when CO₂ levels are increased.
Measured: Baseline, Day ~60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2025
- Study start27 Apr 2026
- Primary completion30 Sep 2027 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dravet SyndromeStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samden Lhatoo, The University of Texas Health Science Center, Houston
- Investigators
- Samden Lhatoo, MD, FRCP, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07112365
- Sponsor's protocol ID
- HSC-MS-23-0940
- Acronym
- FAST-DS
- Status last verified
- Jul 2026
- First submitted
- 1 Aug 2025
- Last updated
- 15 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The FINTEPLA as an Anti-SUDEP Therapy in Dravet Syndrome (FAST-DS) Project.
- ClinicalTrials.gov ID
- NCT07112365
- Acronym / sponsor ID
- FAST-DS / HSC-MS-23-0940
- Conditions
- Dravet Syndrome
- Keywords
- epilepsy, Sudden Unexpected Death in Epilepsy (SUDEP)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 27 Apr 2026 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 8 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study investigates cerebrovascular reactivity (CVR) and functional brain connectivity in Dravet Syndrome (DS) patients with convulsive seizures. Using functional MRI (fMRI), we will define differences in brain responses to CO₂ changes before administration of the drug Fintepla (Baseline), with a library of healthy controls and with those obtained after administration of Fintepla (Day ~60). Changes in CVR and their relation to ventilatory responses will also be assessed during fMRI.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fintepla plus Hypercapnia Challenge using the Respiract Device | Experimental | Drug: Fenfluramine treatment (Fintepla), Device: Hypercapnia Challenge using the device (RespirAct) |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- DS patients (with or without SCN1A pathogenic mutations)
- Generalized convulsive seizures
Key exclusion criteria (6 listed)
- known cardiorespiratory, hepatic or renal disease, and/or
- allergic reactions or other contraindications to fenfluramine and/or
- on Stiripentol treatment, and/or
- on serotonergic medications, and/or
- contraindications to Midazolam anesthesia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fenfluramine treatment (Fintepla)Also: FenfluramineParticipants will receive Fintepla starting at 0.2 mg/kg/day, up to a maximum of 0.6 mg/kg/day (or 5.9 mL/day, whichever is lower), per FDA guidelines. Dosing will be adjusted as tolerated. After Day ~60, the dose will be gradually tapered. | Drug | Fintepla plus Hypercapnia Challenge using the Respiract Device |
| Hypercapnia Challenge using the device (RespirAct)Also: RespirActParticipants will undergo a hypercapnia challenge using the RespirAct device during fMRI. The protocol includes alternating one minute blocks of controlled CO₂ increases and normocapnia under normoxic conditions. | Device | Fintepla plus Hypercapnia Challenge using the Respiract Device |
Primary outcome
Change in blood oxygenation level in response to CO₂
Time frame: Baseline, Day ~60
Measures how much blood oxygenation level dependent (BOLD) signal changes in response to CO₂, using fMRI.
Change in speed of cerebrovascular response to CO₂
Time frame: Baseline, Day ~60
Measures how quickly the brain responds to CO₂ exposure during fMRI.
1 secondary outcome
Change in breathing response to CO₂
Time frame: Baseline, Day ~60
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Samden Lhatoo, MD, FRCP principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fenfluramine treatment (Fintepla) and Hypercapnia Challenge using the device (RespirAct) in people with Dravet Syndrome, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Samden Lhatoo, MD, FRCP ((713) 500-7106, Samden.D.Lhatoo@uth.tmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in blood oxygenation level in response to CO₂ (time frame: Baseline, Day ~60). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2026.