Study RAD-GRIN-201 is a phase 1B/2A trial to assess safety, tolerability, pharmacokinetics (PK), and potential efficacy of radiprodil in participants with Tuberous Sclerosis Complex (TSC) or Focal Cortical Dysplasia (FCD) type II. The study is open-label, so all participants will be treated with radiprodil. Subjects' participation in the study is expected to last up to six months in Part A and one year in Part B/long-term treatment period. The treatment period in Part B may be extended based on a favorable benefit/risk profile.
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Incidence of Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs (SAEs), Adverse Drug Reactions (ADRs), TEAEs Leading to Discontinuation and Severity of TEAEs
Timeframe: from Baseline to End-of-study: 1 year 6 months
Plasma concentration of radiprodil and maximum plasma concentration (Cmax)
Timeframe: Titration Visit 1 (week 7): Pre-dose to 12 hours post-dose. Titration Visits 2,3,4 (week 8 to 13) and Maintenance Visit 7 (week 25): pre-dose to 5 hours post-dose
Plasma concentration of radiprodil versus time, area under the curve (AUCt)
Timeframe: Titration Visit 1 (week 7): Pre-dose to 12 hours post-dose. Titration Visits 2,3,4 (week 8 to 13) and Maintenance Visit 7 (week 25): pre-dose to 5 hours post-dose
Pharmacokinetic plasma concentration of radiprodil: half-life (T1/2)
Timeframe: Titration Visit 1 (week 7): Pre-dose to 12 hours post-dose. Titration Visits 2,3,4 (week 8 to 13) and Maintenance Visit 7 (week 25): pre-dose to 5 hours post-dose
Pharmacokinetic plasma concentration of radiprodil: time to Cmax (Tmax)
Timeframe: Titration Visit 1 (week 7): Pre-dose to 12 hours post-dose. Titration Visits 2,3,4 (week 8 to 13) and Maintenance Visit 7 (week 25): pre-dose to 5 hours post-dose
Pharmacokinetic plasma concentration of radiprodil, clearance (Cl)
Timeframe: Titration Visit 1 (week 7): Pre-dose to 12 hours post-dose. Titration Visits 2,3,4 (week 8 to 13) and Maintenance Visit 7 (week 25): pre-dose to 5 hours post-dose
Number of participants with abnormal laboratory tests results
Timeframe: from Baseline to End-of-study: 1 year 6 months
Number of participants with abnormal physical and neurological examination findings
Timeframe: Baseline, MV7, and in Part B: Month 3, 6, 9, 12: week 6, week 28, week 40, week 52, week 64, week 76
Clinically relevant changes in safety parameters: systolic blood pressure
Timeframe: from Baseline to End-of-study: 1 year 6 months
Clinically relevant changes in safety parameters: diastolic blood pressure
Timeframe: from Baseline to End-of-study: 1 year 6 months
Clinically relevant changes in safety parameters: pulse rate
Timeframe: from Baseline to End-of-study: 1 year 6 months
12-Lead ECG: Mean change from Baseline to End-of-Treatment in RR interval
Timeframe: from Baseline to End-of-study: 1 year 6 months
12-Lead ECG: Mean change from Baseline to End-of-Treatment in PR interval
Timeframe: from Baseline to End-of-study: 1 year 6 months
12-Lead ECG: Mean change from Baseline to End-of-Treatment in QRS interval
Timeframe: from Baseline to End-of-study: 1 year 6 months
12-Lead ECG: Mean change from Baseline to End-of-Treatment in QT interval
Timeframe: from Baseline to End-of-study: 1 year 6 months
12-Lead ECG: Mean change from Baseline to End-of-Treatment in QTcF interval
Timeframe: from Baseline to End-of-study: 1 year 6 months