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Fenfluramine Hydrochloride for Photosensitive Epilepsy
Study Summary
This trial will test if fenfluramine is an effective, safe and well tolerated treatment for Sunflower Syndrome, a rare epileptic disorder.
- Photosensitive Epilepsy
Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2022 Phase 2 trial • 7 Patients • NCT03861871Trial Design
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Who is running the clinical trial?
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- You have seizures that cause you to stare at light and wave your hand in front of your eye. You experience an average of 6 of these seizures per week.You have Sunflower Syndrome and your current treatment plan doesn't fully control your seizures.
- Group 1: Treatment group
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
How can I become a subject in this experiment?
"The investigators conducting this study are looking for 20 participants that have photosensitive epilepsy and fall in the 4-25 age range."
How many subjects are enrolled in this clinical trial?
"No, this study is no longer looking for new participants. The listing was created on May 31st, 2019 and last edited September 16th, 2022. There are 242 other trials currently enrolling patients with photosensitive epilepsy and 6 studies using Fenfluramine Hydrochloride if you are seeking out active clinical trials."
Are there any historical instances of Fenfluramine Hydrochloride being used in medical research?
"There are 6 total clinical trials studying Fenfluramine Hydrochloride. 5 of those trials are currently in progress, with the final stage of testing. Most of the research for this medication is conducted in Boston, Massachusetts; however, there are 236 medical centres running trials for Fenfluramine Hydrochloride across the globe."
Does this type of clinical trial exist anywhere else in the world?
"Zogenix, Inc.'s subsidiary Zogenix International Limited, Inc. first sponsored a Fenfluramine Hydrochloride study in 2016 with 373 participants. After the successful initial trial, the medication received Phase 3 drug approval and there are now 6 ongoing clinical trials involving 56 cities and 15 countries."
Could patients over the age of thirty-five be involved in this research project?
"This study is looking for participants who are aged 4 to 25 years old."
Are there any short or long-term dangers to patients when taking Fenfluramine Hydrochloride?
"There is some evidence of efficacy and multiple rounds of safety data, so Fenfluramine Hydrochloride was given a score of 3."
Is it currently possible to sign up for this experiment?
"Unfortunately, this specific trial is not actively recruiting patients right now. It was originally posted on May 31st, 2019 and the last edit was made on September 16th, 2020. With that said, there are 248 other trials that are currently looking for participants."
What are researchers hoping to discover or prove with this clinical trial?
"The primary outcome of this study, which will be evaluated based on Subject's Seizure frequency recorded at 28 days, 56 Days and 84 Days after receiving the first dose of medication, with completion determined 84 days after initial dosing. The secondary outcomes include Changes in Cognitive Functioning as assessed by the Weschler Intelligence Scale for Children (WISC-V) -Working Memory subtests and WAIS-IV -Processing Speed and Working Memory subtests (for participants aged 17 to 25 years old), as well as changes in self-concept according to the Beck Self Report Inventory."
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