At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 108 enrolled
Drug / intervention
Gleolandrug
Likely dose
Gleolan 20 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 3 Multicenter Study of Gleolan (Aminolevulinic Acid Hydrochloride) to Enhance Visualization of Tumor in Patients With Newly Diagnosed or Recurrent Meningiomas
In Brief
A Phase 3 clinical trial evaluating Gleolan for Meningioma. Completed, enrolled 108 participants across 17 sites in 3 countries.
Detailed Summary
This Phase 3 open-label single-arm study is designed to investigate the safety, diagnostic performance, and clinical usefulness of Gleolan for the real time detection and visualization of meningiomas during tumor resection surgery. The study is planned to run for 15 months with individual study participation lasting for approximately 2 months.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMeningioma
CountriesAustria, Germany, United States
Collaborators--
Timeline
Phase 3CompletedFinished
202120222023202420252026
First PostedMar 2020
Enrollment StartOct 2020
Primary CompletionNov 2022
Study CompletionDec 2022
TodayJul 2026
First PostedMar 12, 2020
Enrollment StartOct 28, 2020
Primary CompletionNov 7, 2022
Study CompletionDec 13, 2022
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 6.3 years ago
Interventions
Gleolandrug
One time oral dose on day of surgery (20 mg/kg bodyweight)