A Study of Lu AG06466 in Participants With Treatment Resistant Focal Epilepsy

NCT05081518 | Terminated Phase 1 DMC FDA Drug

• 1 other identifier: 19367A
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Focal Epilepsy

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline (Day -1) up to Day 29 of each treatment period

Study Arms (2)

Sequence 1: Lu AG06466-Placebo

EXPERIMENTAL

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.

Drug: Lu AG06466; Drug: Placebo

Sequence 2: Placebo-Lu AG06466

EXPERIMENTAL

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.

Drug: Lu AG06466; Drug: Placebo

Interventions

Lu AG06466 DRUG

Lu AG06466 - capsule

Sequence 1: Lu AG06466-Placebo; Sequence 2: Placebo-Lu AG06466

Placebo DRUG

Placebo - capsule

Sequence 1: Lu AG06466-Placebo; Sequence 2: Placebo-Lu AG06466

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• H. Lundbeck A/S: lead

Study Sites (1)

Mid-Atlantic Epilepsy and Sleep Center

Bethesda, Maryland, 20817, United States

Location

MeSH Terms

Conditions

Epilepsies, Partial

Condition Hierarchy (Ancestors)

Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Email contact via H. Lundbeck A/S

  LundbeckClinicalTrials@Lundbeck.com

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2021
• First Posted: October 18, 2021
• Study Start: September 29, 2021
• Primary Completion: April 14, 2022
• Study Completion: April 14, 2022
• Last Updated: November 9, 2022

Record last verified: 2022-11

Locations

US (1)