Following consultation with the U.S. Food and Drug Administration (FDA), Eisai has initiated a Phase 3 clinical trial called MOMENTUM 1 to evaluate lorcaserin as a potential treatment for Dravet syndrome.
Early data has suggested that lorcaserin may reduce the frequency of seizures among Dravet patients.
“We commend the FDA for recognizing the tremendous unmet medical needs of patients living with Dravet syndrome and for providing Eisai with the opportunity to conduct the Phase 3 MOMENTUM 1 clinical study,” Lynn Kramer, MD, chief clinical officer of the neurology business group at Eisai, said in a press release.
“This important research exemplifies our human health care mission as it was prompted by the limited number of approved treatments for this condition along with the voices of patients, caregivers, and health care professionals who reported their clinical experience with lorcaserin in this severe form of epilepsy,” Kramer said.
Lorcaserin is a selective agonist (activator) of 5-HT2c, a protein receptor for the neurotransmitter serotonin. It is believed that activating this receptor could reduce seizure frequency in people with Dravet. Indeed, preclinical data have supported the efficacy of lorcaserin in animal models of this syndrome.
The new Phase 3 clinical trial (NCT04572243), which will be conducted at about 20 sites in the U.S., aims to enroll approximately 58 people with Dravet syndrome who are at least 2 years old. In order to be eligible, prospective participants must be on a stable course of medication and still be experiencing convulsive seizures about once per week.
The trial is currently enrolling in Bethesda, Maryland. Additional information about trial locations and contacts is available here.
Participants will be randomly assigned to receive either lorcaserin or a placebo, taken by mouth twice per day, with dosing of the medication determined based on the individual’s weight. After the core study — which will last 14 weeks — participants will be allowed to enter a 12-week open-label extension phase, during which all participants will be given the active medication.
MOMENTUM 1’s main goal is to evaluate the treatment’s effect on the frequency of convulsive seizures in participants, with seizure frequency calculated per 28 days.
Other seizure-associated measurements also will be assessed, including the proportion of participants who have a 50% or greater reduction in seizure frequency after starting the trial, and the proportion of participants who remain seizure-free.
The trial also will evaluate the safety and tolerability of lorcaserin in people with Dravet syndrome, as well as the medication’s pharmacokinetics, or how it moves through the body.
“There is an urgent need to find new treatment options for Dravet syndrome, and we hope the new MOMENTUM 1 study will yield positive clinical outcomes for participants and a potential new therapy,” said Orrin Devinsky, MD, professor of neurology at the NYU Grossman School of Medicine and lead investigator of MOMENTUM 1.
In the U.S., lorcaserin was previously available, under the brand name Belviq, as a medication to aid in weight loss. However, earlier this year, the medication was voluntarily withdrawn from U.S. markets after a safety clinical trial showed a possible increased occurrence of cancer. Despite these concerns, the agency noted that the cause of the cancer was uncertain, and officials could not conclude that “lorcaserin contributes to the cancer risk.”
Although Belviq was not approved for Dravet syndrome, some health care professionals prescribed it off-label as a treatment for the disorder and other refractory epilepsies.
As such, when Belviq was approved, Eisai — after consultation with the FDA — initiated the clinical trial MOMENTUM 2 (NCT04457687). That trial serves the dual purpose of continuing to provide lorcaserin to these patients and collecting further data on the investigational medication. Additional information about participation in MOMENTUM 2 is available here.
“On behalf of Dravet syndrome patients and caregivers, we thank the FDA and Eisai for continuing to make lorcaserin available to appropriate patients in this vulnerable population through the expanded access program,” Devinsky said.
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