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A Long-term Study of the Safety and Effectiveness of RAP-219 in Adults With Focal Onset Seizures

ConditionsFocal EpilepsyEpilepsyRefractory Focal EpilepsySeizureFocal SeizureFocal Onset Seizure
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorRapport Therapeutics Inc.

About this trial

This is a clinical research study for an investigational drug called RAP-219 in patients with Refractory Focal Epilepsy. This study is being conducted to determine RAP-219 Long- term safety and open-label antiseizure activity in patients with Refractory Focal Epilepsy.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Completion of the associated parent study (RAP-219-FOS-201) treatment period with acceptable tolerability, per Investigator.

Diagnosis of refractory focal epilepsy

Stable RNS(c) system settings

A demonstrated history of compliance with RNS(c) system data interrogation and upload

Disqualifiers

Known of hypersensitivity to RAP-219

Any clinically unstable or serious medical, neurological (other than epilepsy), psychological, or behavioral problem; laboratory or ECG finding that would increase participant risk or should otherwise exclude the patient from participation, as assessed by Investigator

Pregnancy, lactation, or individuals of reproductive potential who do not agree to simultaneously use two effective birth-control methods

Trial design

Design model

Single group

Treatments tested in this trial

  • RAP-219

    Drug

    Participants will receive one RAP-219 0.125 mg capsule daily for 3 days followed by one 0.25mg tablet RAP-219 daily for 28 days, then one 0.75mg tablet daily for the remainder of the treatment period.

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: RAP-219Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of treatment-emergent adverse events (TEAEs)

Time frame
From the start of RAP-219 treatment through 8 weeks after last dose, up to Week 112

Secondary outcomes

1

Percent change in clinical seizure frequency

Group median percent change in clinical seizure frequency per 28-day period as reported in a clinical seizure diary

Time frame
Throughout the open-label period until 8 weeks after the last dose, up to Week 112, compared to the pre-treatment baseline period.
2

Clinical seizure 25%, 50%, 75%, and 100% responder proportions

Proportion of participants with at least 25%, 50%, 75%, or with 100% reduction in clinical seizure frequency per 28-day period as reported in a clinical seizure diary

Time frame
Throughout the open-label period until 8 weeks after the last dose, up to Week 112, compared to the pre-treatment baseline period.
3

Change in clinical seizure-free day frequency

Group median change in clinical seizure-free day frequency per 28-day period as reported in a clinical seizure diary

Time frame
Throughout the open-label period until 8 weeks after the last dose, up to Week 112, compared to the pre-treatment baseline period.
4

Longest clinical seizure-free interval

Duration, in days, of the longest continuous period of clinical seizure-free days per period as reported in a clinical seizure diary

Time frame
Throughout the open-label period until 8 weeks after the last dose, up to Week 112, compared to the pre-treatment baseline period.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Rapport Therapeutics Inc.

Lead sponsor

Source ClinicalTrials.gov
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