iNGENū CRO, a specialist Contract Research Organization with deep expertise in the complex field of sleep medicine, is pleased to announce that two clinical trials targeting rare and debilitating sleep disorders—Idiopathic Hypersomnia and Narcolepsy—have received ethics approval and are now actively enrolling patients. These pivotal studies are being spearheaded by Dr. Sud Agarwal, Specialist Anaesthesiologist and Clinical Research Physician at iNGENū CRO.
Melbourne, Australia, April 16, 2025 (GLOBE NEWSWIRE) — iNGENū CRO, a specialist Contract Research Organization with deep expertise in the complex field of sleep medicine, is pleased to announce that two clinical trials targeting rare and debilitating sleep disorders—Idiopathic Hypersomnia and Narcolepsy—have received ethics approval and are now actively enrolling patients. These pivotal studies are being spearheaded by Dr. Sud Agarwal, Specialist Anaesthesiologist and Clinical Research Physician at iNGENū CRO.
Renowned for its leadership in complex trial design and execution, iNGENū brings unique capabilities to the sleep research space, including direct access to clinical sites with accredited sleep laboratories and a seasoned team of sleep medicine experts.
The two studies are designed to advance treatment options for challenging sleep conditions:
- Idiopathic Hypersomnia Trial – A pivotal study evaluating therapeutic response using the Epworth Sleepiness Scale (ESS) as the primary endpoint.
- Narcolepsy Trial – Targeting both narcolepsy with and without cataplexy, with primary endpoints including the Maintenance of Wakefulness Test (MWT) and frequency of cataplexy episodes.
In line with iNGENu’s commitment to innovation and patient-centric design, both studies will incorporate decentralised trial components, including the use of wearable cataplexy monitoring technology to enable real-time remote assessment of symptoms.
“These conditions are not only complex to diagnose and treat, but also notoriously difficult to study. Our team’s deep therapeutic knowledge and operational experience in sleep medicine allows us to design and deliver trials that can produce real, translatable outcomes,” said Dr. Sud Agarwal. “We’re proud to be leading these important studies and contributing to the future of sleep disorder therapeutics.”
About iNGENū CRO:
iNGENū CRO is a specialist Contract Research Organization (CRO) dedicated to providing comprehensive clinical trial management services. With a particular focus on complex therapeutic areas, including sleep medicine, iNGENū leverages its deep expertise, innovative technologies, and strong network of clinical sites to deliver high-quality, efficient, and patient-centric research.
CONTACT: Name: Amanda DeVito Email: press@ingenuCRO.com Job Title: Head of Marketing
