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MOMENTUM 1 Trial Summary
This trial will compare the effectiveness of lorcaserin to a placebo in reducing convulsive seizures in people with Dravet syndrome.
MOMENTUM 1 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowMOMENTUM 1 Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.MOMENTUM 1 Trial Design
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Who is running the clinical trial?
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- My epilepsy medication dose has been stable for the last 4 weeks and will remain so.I haven't taken fenfluramine in the last 2 months, and I've never had heart valve issues related to it.I have had at least 4 convulsive seizures in the last 4 weeks.I haven't taken lorcaserin in the last 4 weeks, nor stopped it due to side effects or it not working.I am currently taking or have recently taken medications that affect serotonin levels.My condition is worsening and it's not Dravet syndrome.I am at least 2 years old.I have been diagnosed with epilepsy that is specifically Dravet syndrome.
- Group 1: Lorcaserin (Core Study and Open-label Extension Phase)
- Group 2: Placebo (Core Study) + Lorcaserin (Open-label Extension Phase)
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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 many people are signing up to participate in this clinical trial?
"Eisai Inc. is sponsoring a clinical trial that needs 58 patients who fit the eligibility requirements. The trial will be conducted at NorthWell Health in New york, New York and University of Hospital of Cleveland in Cleveland, Ohio."
Which hospitals are conducting this research?
"There are 28 sites running this trial at the moment. You can find them in New york, Cleveland, Hollywood, and other cities. If you enroll, it might be helpful to pick a location that's closest to you to minimize travel demands."
Are new participants being accepted for this clinical trial?
"Yes, this study is currently looking for participants according to the website clinicaltrials.gov. This information was last updated on 9/16/2022, and the study was originally posted on 9/23/2020."
Has the FDA cleared Lorcaserin for public consumption?
"Lorcaserin has received a 3 for safety. This is due to it being a Phase 3 trial, thus having both efficacy and multiple rounds of safety data."
What is the Lorcaserin research landscape like?
"Lorcaserin was first studied in 2014 at the VA Long Beach medical facility. So far, there have been 18308 completed trials involving this medication. Currently, 3 studies are actively recruiting patients; a large number of these trials are based in New york City."
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