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

Lundbeck

Status and phase: Terminated; Phase 1

Conditions: Focal Epilepsy

Treatments: Drug: Placebo; Drug: Lu AG06466

Study type: Interventional

Funder types: Industry

Identifiers

NCT05081518

19367A

Details and patient eligibility

About

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.

Full 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).

Enrollment: 1 patient

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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1 participants in 2 patient groups

Sequence 1: Lu AG06466-Placebo

Experimental group

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.

Treatment:

Drug: Placebo

Drug: Lu AG06466

Sequence 2: Placebo-Lu AG06466

Experimental group

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.

Treatment:

Drug: Placebo

Drug: Lu AG06466