Back to resultsA Study of Lu AG06466 in Participants With Treatment Resistant Focal Epilepsy
Primary Purpose
Focal Epilepsy
Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Lu AG06466
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Focal Epilepsy
Eligibility Criteria
Key Inclusion Criteria:
- The participant must have had the responsive neurostimulation system (RNS®) System implanted for more than 1 year and medically intractable focal onset epileptic seizures (history of persistent seizures refractory to 2 or more anti-epileptic drugs [AEDs]), with seizures from all foci represented in the implanted RNS electrodes.
- The participant is required to have a continuous period of at least 2 months prior to the Screening Visit with constant RNS stimulation settings as well as stable AED (that is, 60 days with no dose adjustments of more than 25%) as determined by medical history and the Patient Data Management System (PDMS). There must be at least 24 recorded long episodes available for review since last change of RNS detection setting.
- The participant is required to have approximately 7 or more long episodes per week, as assessed as an average over the last 2 months prior to the Screening Visit.
- The participant is required to have a demonstrated history of compliance with RNS scanning and uploading procedure in the past year (less than 20% missing long episode counts on the PDMS).
Key Exclusion Criteria:
- The participant has the RNS System implanted in other regions than the epileptic foci such as the thalamus.
- The participant has a RNS System with anticipated generator change in the coming 6 months.
- The participant has a cyclic pattern of long episodes in the last 2 months prior to the Screening Visit which exhibits, in the opinion of the investigator: a period of more than 3 weeks; and peak-to-trough differences of long episodes of more than half the peak level.
- The participant has or has had any clinically significant immunological, cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, haematological, dermatological, venereal, neurological (apart from epileptic diagnosis), or psychiatric disease or other major disorder, which in opinion of the investigator may influence efficacy or safety aspects in the study.
Other inclusion and exclusion criteria may apply.
Sites / Locations
- Mid-Atlantic Epilepsy and Sleep Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Sequence 1: Lu AG06466-Placebo
Sequence 2: Placebo-Lu AG06466
Arm Description
Participants will receive Lu AG06466 capsules once daily (QD) at a low dose for 4 days (Days 1 to 4), medium dose for 4 days (Days 5 to 8), and high dose for 21 days (Days 9 to 29) in treatment period 1. Participants will receive matching placebo capsules from Day 1 to Day 29 in treatment period 2. Each treatment period will be separated by a washout period of 7 to 11 days.
Participants will receive matching placebo capsules QD from Day 1 to Day 29 in treatment period 1. Participants will receive Lu AG06466 capsules QD at a low dose for 4 days (Days 1 to 4), medium dose for 4 days (Days 5 to 8), and high dose for 21 days (Days 9 to 29) in treatment period 2. Each treatment period will be separated by a washout period of 7 to 11 days.
Outcomes
Primary Outcome Measures
Number of "Long Episodes" (Electrocorticographic [ECoG] Seizures)
"Long Episodes" are abnormal events detected by the neurostimulator that do not return to baseline ECoG activity within a predefined period of time, typically 30 to 60 seconds. These often correspond to ECoG seizures.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05081518
Brief Title
A Study of Lu AG06466 in Participants With Treatment Resistant Focal Epilepsy
Official Title
Interventional, Randomized, Double-blind, Crossover, Placebo-controlled, Multiple-dose Lu AG06466 Phase 1 B Study in Patients With Focal Epilepsy Using EEG and PSG to Investigate Its Pharmacodynamic Effects on Prolonged Period of Inter- Icterical Spikes, Sleep and Neuroinflammation
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Terminated
Why Stopped
The study was terminated due to enrolment challenges
Study Start Date
September 29, 2021 (Actual)
Primary Completion Date
April 14, 2022 (Actual)
Study Completion Date
April 14, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
H. Lundbeck A/S
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The main purpose of this study is to investigate effects of Lu AG06466 on seizure activity after increasing daily doses during 4 weeks in participants with an implanted responsive neurostimulation system.
Detailed Description
This crossover study consists of 2 treatment periods, each of 29 days duration. On Day -1 of treatment period 1, eligible participants will be randomized (1:1) to a sequence of treatments (either Lu AG06466-placebo or placebo-Lu AG06466).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Focal Epilepsy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sequence 1: Lu AG06466-Placebo
Arm Type
Experimental
Arm Description
Participants will receive Lu AG06466 capsules once daily (QD) at a low dose for 4 days (Days 1 to 4), medium dose for 4 days (Days 5 to 8), and high dose for 21 days (Days 9 to 29) in treatment period 1. Participants will receive matching placebo capsules from Day 1 to Day 29 in treatment period 2. Each treatment period will be separated by a washout period of 7 to 11 days.
Arm Title
Sequence 2: Placebo-Lu AG06466
Arm Type
Experimental
Arm Description
Participants will receive matching placebo capsules QD from Day 1 to Day 29 in treatment period 1. Participants will receive Lu AG06466 capsules QD at a low dose for 4 days (Days 1 to 4), medium dose for 4 days (Days 5 to 8), and high dose for 21 days (Days 9 to 29) in treatment period 2. Each treatment period will be separated by a washout period of 7 to 11 days.
Intervention Type
Drug
Intervention Name(s)
Lu AG06466
Intervention Description
Lu AG06466 - capsule
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo - capsule
Primary Outcome Measure Information:
Title
Number of "Long Episodes" (Electrocorticographic [ECoG] Seizures)
Description
"Long Episodes" are abnormal events detected by the neurostimulator that do not return to baseline ECoG activity within a predefined period of time, typically 30 to 60 seconds. These often correspond to ECoG seizures.
Time Frame
Baseline (Day -1) up to Day 29 of each treatment period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria:
The participant must have had the responsive neurostimulation system (RNS®) System implanted for more than 1 year and medically intractable focal onset epileptic seizures (history of persistent seizures refractory to 2 or more anti-epileptic drugs [AEDs]), with seizures from all foci represented in the implanted RNS electrodes.
The participant is required to have a continuous period of at least 2 months prior to the Screening Visit with constant RNS stimulation settings as well as stable AED (that is, 60 days with no dose adjustments of more than 25%) as determined by medical history and the Patient Data Management System (PDMS). There must be at least 24 recorded long episodes available for review since last change of RNS detection setting.
The participant is required to have approximately 7 or more long episodes per week, as assessed as an average over the last 2 months prior to the Screening Visit.
The participant is required to have a demonstrated history of compliance with RNS scanning and uploading procedure in the past year (less than 20% missing long episode counts on the PDMS).
Key Exclusion Criteria:
The participant has the RNS System implanted in other regions than the epileptic foci such as the thalamus.
The participant has a RNS System with anticipated generator change in the coming 6 months.
The participant has a cyclic pattern of long episodes in the last 2 months prior to the Screening Visit which exhibits, in the opinion of the investigator: a period of more than 3 weeks; and peak-to-trough differences of long episodes of more than half the peak level.
The participant has or has had any clinically significant immunological, cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, haematological, dermatological, venereal, neurological (apart from epileptic diagnosis), or psychiatric disease or other major disorder, which in opinion of the investigator may influence efficacy or safety aspects in the study.
Other inclusion and exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Email contact via H. Lundbeck A/S
Organizational Affiliation
LundbeckClinicalTrials@Lundbeck.com
Official's Role
Study Director
Facility Information:
Facility Name
Mid-Atlantic Epilepsy and Sleep Center
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20817
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study of Lu AG06466 in Participants With Treatment Resistant Focal Epilepsy
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