The phase 3 trial MOMENTUM 1 (Study 304, NCT number pending) of loracaserin (Belviq; Eisai, Woodcliff Lake, NJ), for treatment of Dravet syndrome (DS) has begun, and an expanded access program (EAP) MOMENTUM 2 (Study 405, NCT04457687) is being continued. After withdrawal of lorcaserin from the market, patients, caregivers, and health care professionals requested continued access to help treat DS and other refractory epilepsies. Although lorcaserin was not marketed or approved by the FDA for treatment of DS, it was prescribed by health care professionals who believed it was medically appropriate for that use.
After consultation with the FDA, the manufacturer believes it is important that these vulnerable patients continue to have access to lorcaserin to the extent their health care providers believe continued access is medically appropriate. As a result, the MOMENTUM 2 (Study 405) clinical trial is also continuing. MOMENTUM 2 is a centralized EAP that includes participants with DS and other refractory epilepsies who were prescribed lorcaserin by their treating physician prior to the market withdrawal.
Target enrollment for MOMENTUM 1 is 58 participants who will be randomly assigned to receive locaserin or placebo and evaluated at approximately 20 sites in the United States. The trial will measure efficacy as percent change in frequency of convulsive seizures per 28 days and will also evaluate whether lorcaserin has superior efficacy compared to placebo on the 50% responder rate, and freedom from seizure. Safety, tolerability, and pharmacokinetics will also be evaluated. The dose of lorcaserin will be flexible during the program. Dosing and visit intervals for the EAP will be as clinically indicated per the judgment of the treating physician.
"We commend the FDA for recognizing the tremendous unmet medical needs of patients living with DS and for providing Eisai with the opportunity to conduct the phase 3 MOMENTUM 1 clinical study," said Lynn Kramer, MD, Chief Clinical Officer, Neurology Business Group. "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."
Lorcaserin is a selective serotonin receptor agonist that may increase GABA-mediated inhibition and result in reduced seizure activity in DS. Approved for treatment of obesity, lorcaserin was voluntarily withdrawn from the market in February 2020 after FDA analysis suggested there may be a slightly increased risk of cancer in those treated with lorcaserin for 5 years.
Carlos E.V. Sollero, MD; Hsin-Pin Lin, MD; Miguel Chuquilin, MD; James Wymer, MD; and Aaron M. Carlson, MD
Adam M. Staffaroni, PhD; Elena Tsoy, PhD; Jack Taylor, BS; Adam L. Boxer, MD, PhD; and Katherine L. Possin, PhD
Julio C. Rojas, MD, PhD