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TRV045

Clinical trials are studying TRV045 in healthy adults and in people with pain or epilepsy-related conditions. These studies mainly look at safety, how the body responds, and early signs of effect. Both trials are Phase 1 and are completed.

Table of Contents

Trial overview

Two completed interventional studies investigated TRV045 in early human research.[1][2] Both trials were Phase 1 studies with 24 participants each.[1][2]

These studies focused on different conditions: one on pain linked to diabetic peripheral neuropathy, and one on epilepsy.[1][2] The trial records show that both studies are completed.[1][2]

Pain study in neuropathic pain

The first study was titled as a study of the pain-relieving effects of a new drug in healthy adults, and it focused on acute and chronic neuropathic pain secondary to diabetic peripheral neuropathy.[1] Its brief summary says the goal was to evaluate the analgesic, or pain-relieving, effects of TRV045 using PainCart, including the UVB burn inflammatory model.[1]

This study included TRV045 300 mg taken by mouth and a TRV045 placebo for comparison.[1] The main outcome was pharmacodynamic measurements with the UVB pain model, which means the researchers wanted to see how the study drug changed pain-related responses in the body.[1]

Epilepsy study in healthy adults

The second study looked at the safety, tolerability, absorption, excretion, and effects of a new drug for the treatment of epilepsy.[2] Its brief summary says the study evaluated how TRV045 affects the ability of brain cells to conduct electrical stimulation, also called cortical excitability, in healthy male adults.[2]

This study compared TRV045 250 mg taken by mouth with a placebo.[2] The main outcome was the change from baseline in motor evoked potential, measured as peak-to-peak amplitude in microvolts, which is a way to test how the nervous system responds to stimulation.[2]

What the studies measured

The pain study used pharmacodynamic measurements, which are tests that show how a treatment affects the body, especially in relation to pain.[1] The UVB pain model and PainCart were used to look at pain responses in a controlled research setting.[1]

The epilepsy study measured motor evoked potential, which is a signal recorded after stimulation to show how well the brain and nerves can pass electrical messages.[2] The specific endpoint was the change from baseline in peak-to-peak amplitude, meaning the study compared the result after treatment with the starting value.[2]

Who took part

One study involved healthy adults and the other specifically mentioned healthy male adults.[1][2] The pain study also targeted people with conditions related to diabetic peripheral neuropathy, while the epilepsy study focused on epilepsy as the condition of interest.[1][2]

Because both studies were Phase 1, they were early studies with small enrollment numbers rather than large treatment trials.[1][2] This kind of research is usually used to learn basic information before larger studies are done.[1][2]

Study design and phase

Both trials were interventional, meaning the researchers gave a study treatment and compared it with placebo.[1][2] Each study was completed and had 24 participants, which shows they were small early-stage trials.[1][2]

The records do not show later-phase testing here, so the available information is limited to these early Phase 1 studies.[1][2]

Trial ID Phase Condition studied Status Enrollment
2022-501804-80-00 Phase 1 Acute and chronic neuropathic pain secondary to diabetic peripheral neuropathy Completed 24
2022-502638-17-00 Phase 1 Epilepsy Completed 24

FAQ

  • What is being studied in TRV045 clinical trials? The trials are looking at TRV045 in two main areas: pain related to diabetic peripheral neuropathy and epilepsy. They study early safety and how the body and nervous system respond.
  • Who took part in the TRV045 studies? The trials enrolled healthy adult volunteers, including healthy male adults in one study. The pain study also focused on adults connected to neuropathic pain secondary to diabetic peripheral neuropathy.
  • What phase are the TRV045 trials? Both studies are Phase 1 trials. Phase 1 usually means early testing in people to learn more about safety and the first signs of effect.
  • What conditions were studied with TRV045? The studies looked at acute and chronic neuropathic pain secondary to diabetic peripheral neuropathy, and epilepsy. These are different conditions, so the trials explored more than one possible use.
  • What did the trials measure? One study measured pharmacodynamic changes using the UVB pain model and PainCart. The epilepsy study measured motor evoked potential, which is a test of how well the brain can send electrical signals.

Ongoing Clinical Trials on TRV045

  • A study of TRV045 to test its effects on brain cell electrical activity in healthy adult men for epilepsy treatment development

    Not recruiting

    1
    Investigated diseases:
    Investigated drugs:
    The Netherlands

  • A study testing TRV045 for pain relief in healthy adults to understand its effects on nerve pain from diabetic peripheral neuropathy

    Not recruiting

    1
    Investigated drugs:
    The Netherlands

Glossary

  • Phase 1: An early stage of clinical research. It is usually the first time a study drug is tested in people to learn about safety and how the body responds.
  • Interventional study: A study where researchers give a treatment or placebo and then measure what happens.
  • Placebo: A look-alike treatment with no active study drug. It helps researchers compare results fairly.
  • Neuropathic pain: Pain caused by nerve damage or nerve problems. It can be long-lasting and hard to treat.
  • Diabetic peripheral neuropathy: Nerve damage caused by diabetes, often affecting the feet and hands.
  • Pharmacodynamic measurements: Tests that show what effect a treatment has on the body or on a body function.
  • UVB pain model: A research method that uses UVB light to create a controlled skin pain and inflammation response for study.
  • PainCart: A study tool used to measure pain responses in a controlled way.
  • Motor evoked potential: A test that measures how well the brain can send signals to muscles through the nervous system.
  • Cortical excitability: How easily brain cells can become active and send electrical signals.

References

  1. https://clinicaltrials.gov/study/2022-501804-80-00
  2. https://clinicaltrials.gov/study/2022-502638-17-00