Narcolepsy with cataplexy research hub
9 indexed studies · 0 currently recruiting
- ongoing, recruitingHuman Pharmacology (Phase I)- Other
Randomized, double-blind, placebo-controlled study assessing the safety, tolerability, pharmacokinetics and pharmacodynamics of pitolisant after repeated oral ascending doses for 14 days, including the pitolisant effect on cardiac repolarization in healthy volunteers.
This study is looking at a new medicine called pitolisant for narcolepsy, a condition that makes you very sleepy. We want to see if it's safe to take in different doses and how it affects the body over 14 days in healthy men.
Belgium - ongoing, recruitingHuman Pharmacology (Phase I)- Other
A clinical study of MK-6552 in healthy adults (MK-6552-002)
This study is testing a new medicine, MK-6552, in healthy adults. It's an early-stage study to see how the medicine works in the body and if it's safe. The goal is to learn more about this potential treatment for narcolepsy.
Belgium - ongoing, recruitingHuman Pharmacology (Phase I)- Other
Open label, single-center, cross-over randomized, relative bioavailability study comparing 4 new BF2.649 (pitolisant) tablet formulations versus the reference pitolisant (Wakix®) tablet formulation after single oral administrations in healthy male subjects.
This study is testing new versions of a drug called pitolisant, which helps people with narcolepsy. Researchers want to see if the new tablets work as well as the current one. Healthy male volunteers are needed to take different versions of the drug and have their bodies checked.
Belgium - ongoing, recruitingHuman Pharmacology (Phase I)- Other
Open label, single-center, four-part registration pharmacokinetic study: Part I: Pilot 2-way cross-over randomized, comparative pharmacokinetic study of a new gastro-resistant 20 mg pitolisant hydrochloride formulation versus the reference formulation, after a single 20 mg oral administration in twelve healthy subjects, in order to evaluate the adequate sample size to demonstrate the bioequivalence. Part II: One sequence cross-over, drug-drug interaction pharmacokinetic study between a proton pump inhibitor (PPI) (pantoprazole 40 mg) and a new gastro-resistant 20 mg pitolisant hydrochloride formulation in eighteen healthy subjects. Part III: Pivotal 4-way replicate design cross-over randomized, bioequivalence study of a new gastro-resistant 20 mg pitolisant hydrochloride formulation versus the reference formulation, after single oral 20 mg administration in healthy subjects. Part IV: 2-way cross-over randomized, food effect study of a new gastro-resistant 20 mg pitolisant hydrochloride formulation administered under fasting conditions and after a standard FDA High Fat Breakfast in eighteen healthy subjects.
This study looks at a new way to give a medicine called pitolisant. It checks how the body handles this new medicine compared to the old one, how it interacts with another common stomach medicine, and if food affects it. It's for healthy volunteers.
Belgium - ongoing, recruitingTherapeutic confirmatory (Phase III)
An Open-Label, Multicenter Switch Study Evaluating Changes in Blood Pressure in Participants With Narcolepsy Switching From High-Sodium Oxybate to XYWAV
This study looks at how a new medicine, JZP258 (also called XYWAV), affects blood pressure in people with narcolepsy. It compares XYWAV to another similar narcolepsy medicine to see if it lowers blood pressure.
Czechia · France · Belgium - ongoing, recruitingHuman Pharmacology (Phase I)- Other
Open label, single-center, cross-over randomized, relative bioavailability study comparing a new pitolisant hydrochloride tablet formulation at 4 different strengths versus the marketed pitolisant (Wakix®) tablet formulation after single oral administrations in healthy subjects
This study is testing a new version of the medication pitolisant (Wakix®) in healthy volunteers. It compares how well the new tablet works at different strengths compared to the current tablet, to make sure it's absorbed properly in the body.
Belgium - ongoing, recruitingTherapeutic confirmatory (Phase III)
Double blind, multicentre, randomized, placebo-controlled trial to evaluate safety and efficacy of pitolisant in children from 6 to less than 18 years with narcolepsy with/without cataplexy, followed by a prolonged open-label period
This study is looking at a medicine called pitolisant for children aged 6 to 17 with narcolepsy. Researchers want to see if it makes their daytime sleepiness and muscle weakness (cataplexy) better and if it's safe to use.
Italy · France - ongoing, recruitingHuman Pharmacology (Phase I)- Other
Open label, single-center, cross-over randomized, relative bioavailability study comparing a new pitolisant hydrochloride tablet formulation versus the marketed pitolisant (Wakix®) tablet formulation after single oral administrations in healthy subjects.
This study is testing a new version of the existing medicine, pitolisant (Wakix®), which is used for narcolepsy. Researchers want to see if the new tablet works in the body similarly to the current one. Healthy adults will take both versions to compare them.
Belgium - authorisedPhase II and Phase III (Integrated)
CIRAANO: Multimodal exploration (including radiopharmaceuticals Amyvid® and Tauvid®) of theater actors, memory athletes, and patients with various memory pathologies: evaluation of mnesic strategies and their cerebral substrates, and contribution to the treatment of memory pathologies.
This study looks at memory in different groups, including actors, memory athletes, and people with memory problems like Alzheimer's. It uses special brain scans to understand how different memory strategies work in the brain and how this might help treat memory conditions.
France