A Study of Lorcaserin as Adjunctive Treatment in Participants With Dravet Syndrome (MOMENTUM 1)

• ClinicalTrials.gov Identifier: NCT04572243
• Recruitment Status: Recruiting
• First Posted: October 1, 2020
• Last Update Posted: December 14, 2022
• Sponsor: Eisai Inc.
• Information provided by (Responsible Party): Eisai Inc.

Tracking Information

• First Submitted Date: September 30, 2020
• First Posted Date: October 1, 2020
• Last Update Posted Date: December 14, 2022
• Actual Study Start Date: September 23, 2020
• Estimated Primary Completion Date: March 5, 2025 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 30, 2020)

Percent Change From Baseline in Convulsive Seizure Frequency Per 28 Days During the Core Treatment Period (14 Weeks) [ Time Frame: Baseline to Week 14 ]

Seizure frequency will be based on number of seizures per 28 days, calculated during the baseline period and treatment period as the number of seizures during each respective period divided by the number of non-missing days during each respective period, multiplied by 28.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: September 30, 2020)

• Percentage of 50% Responders for Convulsive Seizures in the Core Treatment Period (14 Weeks) Compared to Baseline [ Time Frame: Baseline to Week 14 ]
  A 50 percent (%) responder is defined as a participant with at least 50% reduction in frequency of convulsive seizures per 28 days compared to baseline.
• Percentage of Participants who are Free From Convulsive Seizures in the Core Treatment Period (14 Weeks) [ Time Frame: Up to 14 Weeks ]
• Maximum Lorcaserin Plasma Concentration at Steady-state (Cmax,ss) in the Core Treatment Period (14 Weeks) [ Time Frame: Up to 14 Weeks ]
• Area Under the Plasma Lorcaserin Concentration-time Curve at Steady-state (AUC,ss) in the Core Treatment Period (14 Weeks) [ Time Frame: Up to 14 Weeks ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Study of Lorcaserin as Adjunctive Treatment in Participants With Dravet Syndrome
• Official Title: A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study With Open-Label Extension Phase of Lorcaserin as Adjunctive Treatment in Subjects With Dravet Syndrome
• Brief Summary: The primary purpose of the study is to demonstrate that lorcaserin has superior efficacy compared to placebo on percent change in frequency of convulsive seizures per 28 days in participants with Dravet syndrome.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Epilepsies, Myoclonic

Intervention

• Drug: Placebo
  Placebo matching to lorcaserin oral tablet, administered as oral suspension.
• Drug: Lorcaserin
  Lorcaserin oral tablet, administered as oral suspension.
  Other Name: E2023

Study Arms

• Experimental: Lorcaserin (Core Study and Open-label Extension Phase)
  Participants will be randomized to receive lorcaserin administered as an oral suspension, twice daily for 14 weeks during the core treatment period. Dose will be based on body weight as follows: target dose for participants weighing 10 to less than (<) 20, 20 to <40, and greater than or equal to (>=) 40 kilogram (kg) will be 5, 10, and 20 milligram per day (mg/day) respectively. Based on clinical response and tolerability and within 2 weeks of treatment, dose can be increased up to 10, 20 mg/day for participants weighing 10 to <20, 20 to <40 kg respectively. Participants completing the core treatment period will enter a 12-week extension phase and will receive lorcaserin.
  Intervention: Drug: Lorcaserin
• Placebo Comparator: Placebo (Core Study) + Lorcaserin (Open-label Extension Phase)
  Participants will be randomized to receive lorcaserin matching placebo administered as an oral suspension, twice daily for 14 weeks during the core treatment period. Dose will be based on body weight as follows: target dose for participants weighing 10 to <20, 20 to <40, and >=40 kg will be 5, 10, and 20 mg/day respectively. Based on clinical response and tolerability and within 2 weeks of treatment, dose can be increased up to 10, 20 mg/day for participants weighing 10 to <20, 20 to <40 kg respectively. Participants completing the core treatment period will enter a 12-week extension phase and will receive lorcaserin.
  Interventions:

  • Drug: Placebo
  • Drug: Lorcaserin

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: September 30, 2020): 58
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: May 28, 2025
• Estimated Primary Completion Date: March 5, 2025 (Final data collection date for primary outcome measure)

Eligibility Criteria

Key Inclusion Criteria:

Participants must meet all of the following criteria to be included in this study:

1. Male or female, age 2 years and older at the time of informed consent
2. Diagnosis of epilepsy with Dravet syndrome
3. Has at least 4 convulsive seizures during the 4 weeks of baseline
4. Current treatment with antiepileptic drugs must be stable for at least 4 weeks before screening, and be expected to remain stable throughout the study

Key Exclusion Criteria:

Participants who meet any of the following criteria will be excluded from this study:

1. Use of lorcaserin within 4 weeks before screening, or any history of it being discontinued due to lack of efficacy or adverse reactions
2. Use of fenfluramine within 2 months before screening, any history of lack of fenfluramine efficacy, or any history of valvulopathy at baseline with history of fenfluramine use
3. Recent or concomitant use of serotonergic medications or monoamine oxidase inhibitors
4. Presence of progressive central nervous system disease other than Dravet syndrome

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 2 Years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Eisai Medical Information; 1-888-274-2378; esi_medinfo@eisai.com

• Listed Location Countries: Canada, United States

Administrative Information

• NCT Number: NCT04572243
• Other Study ID Numbers: E2023-A001-304
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Yes
• Plan Description: Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.

• Current Responsible Party: Eisai Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: Eisai Inc.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Eisai Inc.
• Verification Date: September 2022