Trials / Withdrawn
WithdrawnNCT04737174
ES-481 for Uncontrolled Glioma-Associated Epilepsy and Assessment for Potential Anti-Tumorigenic Effect in Patients With Isocitrate Dehydrogenase 1 (IDH1) Mutant Tumors
Adjunctive ES-481 for Uncontrolled Glioma-Associated Epilepsy and Assessment for Potential Anti-Tumorigenic Effect in Patients With Isocitrate Dehydrogenase 1 (IDH1) Mutant Tumors
- Status
- Withdrawn
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- ES Therapeutics Australia Pty Ltd · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Phase 2A single-arm exploratory clinical study in up to 12 adult subjects aged 18 and older with primary glioma, IDH1 mutation, and uncontrolled focal-onset seizure activity to determine the potential efficacy, safety and pharmacokinetics of ES-481 as adjunctive therapy in glioma-associated epilepsy and to assess for potential anti-tumorigenic effects.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ES-481 | 28-day screening period followed by 4-week dose escalation period followed by 16-week treatment period followed by 4-week dose washout period |
Timeline
- Start date
- 2021-03-25
- Primary completion
- 2021-10-01
- Completion
- 2022-04-01
- First posted
- 2021-02-03
- Last updated
- 2022-04-06
Source: ClinicalTrials.gov record NCT04737174. Inclusion in this directory is not an endorsement.