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This trial is complete. It is no longer accepting participants. Results may be available on ClinicalTrials.gov.

NCT05364021

NCT05364021
Completed Phase 2 🇦🇺 Australian site

Who may be able to join

Who might be able to join this trial:

  • You are male, or female and not currently pregnant or breastfeeding, and are between 12 and 65 years old
  • You have been diagnosed with Dravet syndrome, Lennox-Gastaut syndrome, or another similar condition involving both developmental challenges and epilepsy
  • You have a minimum number of seizures within every 4-week period while already taking between 1 and 4 seizure medications
  • All of your current seizure medications and epilepsy treatments have been the same for at least 4 weeks before the study starts, and are expected to stay the same throughout the study
  • You (or your parent or caregiver) are able and willing to attend study appointments, keep a daily diary, and take the study medication as directed

Who may not be able to join:

  • You have a current or past history of heart or blood vessel problems, such as heart valve disease, heart attack, stroke, high pressure in the lung arteries, or abnormal blood pressure
  • You have glaucoma (a condition affecting eye pressure), kidney problems, liver disease, or any other health condition that could affect your ability to take part or could put you at risk
  • You currently have, or recently have had, moderate or severe depression, an eating disorder such as anorexia or bulimia, or you are considered at risk of suicidal thoughts or behaviour
  • You are currently taking certain medications, including appetite suppressants, a type of antidepressant called MAOIs, or specific drugs that affect serotonin levels — including fenfluramine, atomoxetine, vortioxetine, or other weight loss medications
  • You test positive for drugs on a screening test, unless the only substance detected is THC (cannabis) and you have been prescribed cannabidiol (a cannabis-based medicine)

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.

Trial details

Status
Completed
Phase
Phase 2
Sponsor
Longboard Pharmaceuticals
Registry
clinicaltrials_gov
Start date
3 March 2022
Est. completion
16 November 2023

Where this trial is recruiting

🇦🇺 Australia 🇺🇸 United States

5 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Treatment-emergent Adverse Events; Columbia-Suicide Severity Rating Scale (C-SSRS) Response; Patient Health Questionnaire-9 Total Score and Question 9 Score; Percent Change from Baseline in Observed Countable Motor Seizure Frequency (per 28 Days) During the Treatment Period; Percent Change from Baseline in Observed Countable Motor Seizure Frequency (per 28 Days) During the Maintenance Period

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 30 June 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

View original record on ClinicalTrials.gov