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Hydroxyzine Hydrochloride

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.

Table of contents

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.[1][2][3][4]

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.[1][2][3][4]

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.[1]

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.[2]

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.[3][4]

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.[1][3][4]

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.[1][2][3][4]

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.[1]

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.[2]

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.[3]

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.[4]

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.[1][4]

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.[1][2][3][4]

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.[1]

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.[2]

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.[3]

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.[4]

Trial ID Phase Condition studied Status Enrollment
NCT05295433 Phase 1/2 Isolated methylmalonic acidemia (MMA) due to MUT deficiency Authorised 41
NCT04837885 Phase 2 Gastroenteropancreatic neuroendocrine tumours (GEP-NETs) in adults Authorised 23
NCT06147856 Phase 1/2 Phenylketonuria Completed 54
NCT04814381 Phase 3 Refractory chronic cluster headache Completed 90

FAQ

  • What is being studied in trials that include Hydroxyzine Hydrochloride? The trials use Hydroxyzine Hydrochloride in different research settings, often as a control or supportive medicine. The main goals are to measure safety, tolerability, or treatment effects in the target patient group.
  • Who may take part in these trials? The studies listed include participants with isolated methylmalonic acidemia, adults with gastroenteropancreatic neuroendocrine tumours, participants with phenylketonuria, and patients with refractory chronic cluster headache. Each trial has its own eligibility rules.
  • What trial phases are included? The trials shown include Phase 1/2, Phase 2, and Phase 3 studies. This means some studies are early research, while others are later studies that test how well a treatment works.
  • What kinds of outcomes are measured? The outcomes include treatment-related side effects, serious side effects, need to stop treatment, uptake on PET scans, and change in weekly headache frequency. These endpoints help researchers judge safety and possible benefit.
  • Is Hydroxyzine Hydrochloride always the main study drug? No. In some trials it appears as an active placebo or as one of several medicines used in the study plan. The main research focus may be another drug or a treatment strategy.

Ongoing Clinical Trials on Hydroxyzine Hydrochloride

  • Study of Intra-Arterial Infusion of Lutetium (177Lu) Oxodotreotide for Adults with Gastroenteropancreatic Neuroendocrine Tumors with Liver Metastases

    Recruiting

    2 1 1 1
    Investigated drugs:
    France

  • Study on Long-Term Safety of mRNA-3705 for Patients with Methylmalonic Acidemia (MMA)

    Recruiting

    2 1 1 1
    Investigated drugs:
    France The Netherlands Spain

  • Study on Ketamine and Magnesium Sulfate for Treating Chronic Cluster Headache in Patients Unresponsive to Standard Treatments

    Not recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    France

  • Study to Evaluate mRNA-3210 for Safety and Tolerability in Patients with Phenylketonuria

    Not recruiting

    2 1 1 1
    Investigated drugs:
    France Italy Spain

Glossary

  • Clinical trial: A research study in people that tests a medical treatment, procedure, or strategy.
  • Interventional study: A trial where researchers give a treatment or procedure and then measure the results.
  • Phase 1/2: An early-stage trial that looks at safety first and may also check early signs of benefit.
  • Phase 2: A mid-stage trial that usually checks whether a treatment shows a useful effect and continues safety monitoring.
  • Phase 3: A later-stage trial that compares treatments in larger groups and looks more closely at how well they work.
  • Enrollment: The number of people planned or included in a study.
  • Primary outcome: The main result the researchers want to measure.
  • TEAEs: Treatment-emergent adverse events, meaning unwanted health problems that appear during the study.
  • SAEs: Serious adverse events, meaning major medical problems that need urgent attention or cause major harm.
  • PET-scan: An imaging test that shows how active tissues are in the body.
  • SUVmax: Maximum Standardized Uptake Value, a number that shows how much of a tracer is taken up by tissue on a scan.
  • Active placebo: A control treatment that may cause some effects, used to help compare study groups more fairly.

References

  1. https://clinicaltrials.gov/study/NCT05737511
  2. https://clinicaltrials.gov/study/NCT01675986
  3. https://clinicaltrials.gov/study/NCT01055236
  4. https://clinicaltrials.gov/study/NCT03806270
  5. https://clinicaltrials.gov/study/NCT01372670
  6. https://clinicaltrials.gov/study/NCT03808805
  7. https://clinicaltrials.gov/study/NCT00661674