Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Nicotine patch · 1 trial · 1 indication
The ITC magnitude derived from the 40Hz ASSR is presented. ASSR is measured following a short stream of click trains with a 500 msec inter-train interval (duration), at standard tone and at 40Hz tone. The magnitude of ITC represents the phase consistency of oscillatory activities, in response to EEG coherence at 40Hz stimulation. ITC as a unit of measure is expressed as frequency (40Hz) vs time (msec).
| Arm | Type | Description |
|---|---|---|
| Panel A: Healthy Control Participants | EXPERIMENTAL | In Part 1, HC participants receive nicotine patch + capsule placebo, and patch placebo + capsule placebo, under a cross-over design in Periods 1 and 2. In Part 2 (Period 3), HC participants are randomly assigned to receive either MK-4334 250 mg capsule + patch placebo or capsule placebo + patch placebo. |
| Panel B: Participants with Mild-to-Moderate SZ | EXPERIMENTAL | In Part 1, participants with mild-to-moderate SZ receive nicotine patch + capsule placebo, and patch placebo + capsule placebo, under a cross-over design in Periods 1 and 2. In Part 2 (Period 3), SZ participants are randomly assigned to receive either MK-4334 250 mg capsule + patch placebo or capsule placebo + patch placebo. |
| Name | Type | Description |
|---|---|---|
| Nicotine patch | DRUG | Nicotine 21 mg transdermal nicotine patch. |
| MK-4334 | DRUG | MK-4334 250 mg capsule taken by mouth. |
| Placebo patch | DRUG | Placebo patch. |
| Placebo capsule | DRUG | Placebo capsule taken by mouth. |
Inclusion Criteria: HC Participants: * Is in generally good health * Has no history of clinically relevant neuropsychiatric illness * Is a mild-to-moderate tobacco user of ≥1-year duration, smoking the equivalent of \~10-15 cigarettes/day Participants with Mild-to-Moderate SZ: * Has a current di...
Nicotine patch is being investigated for the treatment of Cognitive Impairment Associated With Schizophrenia. It is a small molecule in Phase 1 clinical development. The drug is intended to address cognitive symptoms that occur in patients with schizophrenia, though it remains investigational and is not yet approved for this use.
Nicotine patch is being developed by Merck & Company, Inc., which trades under the ticker symbol MRK. The company is conducting clinical research on this drug for Cognitive Impairment Associated With Schizophrenia. Merck is responsible for the ongoing development and potential future commercialization of this investigational therapy.
Nicotine patch is in Phase 1 clinical development. It is an investigational drug being studied for Cognitive Impairment Associated With Schizophrenia. The drug has completed one Phase 1 trial and is not yet approved by regulatory authorities. Further clinical studies would be needed to establish its safety and efficacy.
Nicotine patch has been studied in one completed Phase 1 clinical trial, NCT05136690, titled "Evoked Responses as Pharmacodynamic Biomarkers in Healthy and Schizophrenic Participants (MK-4334-007)." This trial enrolled 38 participants in the United States and included healthy volunteers as well as individuals with Cognitive Impairment Associated With Schizophrenia.
The clinical trial for Nicotine patch is identified with the study number MK-4334-007, suggesting the drug may also be referred to as MK-4334. The trial title includes this identifier, indicating that Nicotine patch and MK-4334 likely refer to the same investigational compound being developed by Merck & Company.