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

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ClinicalTrials.gov Identifier: NCT04572243
Recruitment Status : Recruiting
First Posted : October 1, 2020
Last Update Posted : September 23, 2021
Sponsor:
Information provided by (Responsible Party):
Eisai Inc.

Tracking Information
First Submitted Date  ICMJE September 30, 2020
First Posted Date  ICMJE October 1, 2020
Last Update Posted Date September 23, 2021
Actual Study Start Date  ICMJE September 23, 2020
Estimated Primary Completion Date March 8, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Lorcaserin as Adjunctive Treatment in Participants With Dravet Syndrome
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Epilepsies, Myoclonic
Intervention  ICMJE
  • 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  ICMJE
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 30, 2020)
58
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 31, 2023
Estimated Primary Completion Date March 8, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Eisai Medical Information 1-888-274-2378 esi_medinfo@eisai.com
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04572243
Other Study ID Numbers  ICMJE 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  ICMJE
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/.
Responsible Party Eisai Inc.
Study Sponsor  ICMJE Eisai Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Eisai Inc.
Verification Date September 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP