In short
Clinical trials in this article include studies where Hydroxyzine Hydrochloride is used as part of research plans. The trials look at safety, tolerability, and treatment effects in different patient groups, including people with rare metabolic diseases, adults with neuroendocrine tumors, and patients with refractory chronic cluster headache.
Key points
- Clinical trials that include Hydroxyzine Hydrochloride cover several very different patient groups. The studies listed involve rare metabolic diseases such as isolated methylmalonic acidemia and phenylketonuria, adult gastroenteropancreatic neuroendocrine tumours, and refractory chronic cluster headache. The trial phases range from Phase 1/2 to Phase 3, showing both early and later-stage research. Main outcomes include safety, tolerability, scan results, and changes in headache frequency. In some studies, Hydroxyzine Hydrochloride is used as part of the study plan or as an active placebo rather than being the main treatment being tested.
Overview of the trials
The trial data show four interventional studies that include Hydroxyzine Hydrochloride in different ways. These studies are not all testing the same condition, and the main study goals also differ from one trial to another.
Across the set, the studies focus on safety, tolerability, imaging results, and symptom change. The patient groups include people with rare metabolic diseases, adults with a certain type of tumor, and patients with a difficult headache condition.
Patient groups studied
One study includes participants with isolated methylmalonic acidemia, also called MMA, due to methylmalonyl-coenzyme A mutase, or MUT, deficiency. This is a rare inherited metabolic disease, which means the body has trouble processing certain substances because of a gene-related enzyme problem.
Another study includes adults with gastroenteropancreatic neuroendocrine tumours, or GEP-NETs, and focuses on those with dominant liver metastases, meaning the cancer has spread to the liver and the liver lesions are the main area of concern.
A third study includes participants with phenylketonuria, a rare metabolic condition, and the fourth study includes patients with refractory chronic cluster headache, which means a long-lasting and very severe headache condition that has not improved with the usual recommended treatments.
Trial phases and study design
The studies range from Phase 1/2 to Phase 3. Phase 1/2 studies are early-stage and usually look first at safety, while Phase 3 studies are later-stage and compare treatment effects in larger groups.
All four trials are interventional, which means the researchers assign a treatment or procedure and then measure what happens. The listed enrollment ranges from 23 to 90 participants, so the studies are relatively small to moderate in size.
Main outcomes being measured
In the isolated MMA study, the main outcome is the incidence and severity of TEAEs, which means how often treatment-emergent adverse events happen and how serious they are. The study also looks at adverse events related to the study drug, special interest events, serious adverse events, and events that lead to treatment stopping.
In the GEP-NET study, the main outcome is uptake of 68Ga-DOTA-peptides on a PET scan, measured as Maximum Standardized Uptake Value or SUVmax, in up to five liver metastases after intra-hepatic injection. This helps researchers compare how much tracer is taken up after different routes of radiolabeled somatostatin analog infusion.
In the phenylketonuria study, the main outcome is the number of participants with TEAEs, which again shows that safety is the central focus. The study brief also says it is evaluating safety and tolerability of multiple escalating doses of IV mRNA-3210.
In the chronic cluster headache study, the main outcome is change in weekly frequency of crisis during days 7 to 13 compared with the period before treatment. This tells researchers whether the treatment plan changes how often headache attacks happen.
How Hydroxyzine Hydrochloride is used in these studies
In the trial records, Hydroxyzine Hydrochloride is not always the main research drug. In one study it appears as part of the treatment plan for participants with MMA, and in another study it is described as an active placebo, meaning a control treatment used to help compare study groups more fairly.
This means the trial data should be read as research on the full study design, not as a single medicine-only study. The main questions are about the trial objectives, the patient groups, and the measured outcomes rather than a general description of the drug itself.
Trial-by-trial details
NCT05295433 is a Phase 1/2 extension study in participants with isolated MMA due to MUT deficiency. It is authorised, includes 41 participants, and mainly evaluates long-term safety of mRNA-3705 in people who have already taken part in earlier mRNA-3705 studies.
NCT04837885 is a Phase 2 study in adults with GEP-NETs. It is authorised, includes 23 participants, and measures tracer uptake on PET scans after intra-hepatic and intravenous radiolabeled somatostatin analog administration.
NCT06147856 is a completed Phase 1/2 dose-finding study in participants with phenylketonuria. It includes 54 participants and evaluates the safety and tolerability of multiple dose levels of IV mRNA-3210.
NCT04814381 is a completed Phase 3 study in refractory chronic cluster headache with 90 participants. It compares a single infusion strategy and uses Hydroxyzine RENAUDIN as the active placebo control while measuring change in weekly crisis frequency.