Effect of NBI-921355 on Corticospinal Excitability in Epilepsy
- Trial ID
- 2025-524134-26-00
- Protocol
- NBI-921355-1785
- Sponsor
- Neurocrine Biosciences Inc.
Trial statistics
Diseases & Conditions
Objectives
The primary objective of this study is to evaluate the effect of NBI-921355 on corticospinal excitability in healthy participants. This assessment is clinically relevant for understanding the potential modulation of motor pathways associated with epilepsy. The study scope involves pharmacodynamics.
Participants
The sponsor did not provide information regarding the total number of participants. The study population consists of healthy volunteers within the age range corresponding to code 3. Both males and females are included in the study. The clinical focus involves individuals with epilepsy.
Plans and Procedures
This Phase 3 clinical trial is designed to evaluate the effect of NBI-921355 on corticospinal excitability in healthy participants. The research methodology utilizes a controlled study design to assess physiological changes. The sequence of study visits begins with a screening visit to determine eligibility. Subsequent follow-up visits are scheduled to monitor the pharmacological effects, concluding with an end-of-study visit. The total duration of participant involvement is determined by the established protocol schedule. Early termination of participation may occur if specific predefined conditions are met.
Treatment
Efficacy
The assessment of efficacy in this Phase 3 clinical trial for epilepsy will be conducted according to the established study protocol. The specific parameters, measurement methodologies, and scheduled timepoints for evaluating clinical outcomes are not specified.
Trial Status by Country
| Country | Status | Start of Recruitment | Planned Patients |
|---|---|---|---|
The Netherlands | Recruiting | 04 May 2026 | — |
Netherlands | — | — | 24 |

