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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