In short
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.
Key points
- TRV045 is being studied in two completed Phase 1 clinical trials. One trial looked at pain linked to diabetic peripheral neuropathy, including acute and chronic neuropathic pain. The other trial studied epilepsy in healthy male adults and examined early nervous system effects. Both studies were small, with 24 participants each. The trials focused on early research questions such as safety, body response, and measured effects rather than long-term treatment results.
Trial overview
Two completed interventional studies investigated TRV045 in early human research. Both trials were Phase 1 studies with 24 participants each.
These studies focused on different conditions: one on pain linked to diabetic peripheral neuropathy, and one on epilepsy. The trial records show that both studies are completed.
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. 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.
This study included TRV045 300 mg taken by mouth and a TRV045 placebo for comparison. 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.
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. 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.
This study compared TRV045 250 mg taken by mouth with a placebo. 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.
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. The UVB pain model and PainCart were used to look at pain responses in a controlled research setting.
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. 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.
Who took part
One study involved healthy adults and the other specifically mentioned healthy male adults. 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.
Because both studies were Phase 1, they were early studies with small enrollment numbers rather than large treatment trials. This kind of research is usually used to learn basic information before larger studies are done.
Study design and phase
Both trials were interventional, meaning the researchers gave a study treatment and compared it with placebo. Each study was completed and had 24 participants, which shows they were small early-stage trials.
The records do not show later-phase testing here, so the available information is limited to these early Phase 1 studies.