Clinical trial • Phase III • Neurology
QRL-101 (novel formulation) for Epilepsy | Amyotrophic lateral sclerosis | Neuropathy
Phase III trial of QRL-101 (novel formulation) for Epilepsy | Amyotrophic lateral sclerosis | Neuropathy. 48 participants.
Overview
- Trial Therapeutic Area
- Neurology
- Trial Disease
- Epilepsy | Amyotrophic lateral sclerosis | Neuropathy
- Trial Stage
- Phase III
Key dates
- Initial CTIS Submission Date
- 24-11-2025
- First CTIS Authorization Date
- 23-01-2026
Trial design
Phase III trial across 1 site in Netherlands.
- Target Sample Size
- 48
- Trial Duration For Participant
- 210
Eligibility
Recruits 48 Vulnerable population selected: true. No details provided on consent, assent, or specific protections in the record..
- Vulnerable Population
- Vulnerable population selected: true. No details provided on consent, assent, or specific protections in the record.
Recruitment
- Planned Sample Size
- 48
- Recruitment Window Months
- 6
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 48
Netherlands
- Earliest CTIS Part Ii Submission Date
- 20-01-2026
- Latest Decision Or Authorization Date
- 23-01-2026
- Processing Time Days
- 3
- Number Of Sites
- 1
- Number Of Participants
- 48
Sites
- Site Name
- Pharmaceutical Research Associates Group B.V.
- Department Name
- Program Management
- Principal Investigator Name
- Salah Hadi
- Principal Investigator Email
- Salah.Hadi@iconplc.com
- Contact Person Name
- Salah Hadi
- Contact Person Email
- Salah.Hadi@iconplc.com
Sponsor
Primary sponsor
- Full Name
- Quralis Corp.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Investigational products
- Investigational Product Name
- QRL-101 (novel formulation)
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