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F0434 · 1 trial · 2 indications
Neuropathic pain score included 10 pain descriptors (intensity, stinging, burning, dull pain, coldness, sensitivity, numbness, depth, superficial and unpleasant) quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable). Questionnaire generated a score in each of the relevant dimensions and a total score of 0-100. Higher score indicated a greater intensity of pain.
Neuropathic pain score included 10 pain descriptors (intensity, stinging, burning, dull pain, coldness, sensitivity, numbness, depth, superficial and unpleasant) quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable). Questionnaire generated a score in each of the relevant dimensions and a total score of 0-100. Higher score indicated a greater intensity of pain.
Neuropathic pain score included 10 pain descriptors (intensity, stinging, burning, dull pain, coldness, sensitivity, numbness, depth, superficial and unpleasant) quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable). Questionnaire generated a score in each of the relevant dimensions and a total score of 0-100. Higher score indicated a greater intensity of pain.
Neuropathic pain score included 10 pain descriptors (intensity, stinging, burning, dull pain, coldness, sensitivity, numbness, depth, superficial and unpleasant) quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable). Questionnaire generated a score in each of the relevant dimensions and a total score of 0-100. Higher score indicated a greater intensity of pain.
| Arm | Type | Description |
|---|---|---|
| F0434 | EXPERIMENTAL | - |
| Gabapentin | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| F0434 | DRUG | F0434 will be administered orally with an initial dosage of 3 capsules per day divided into 3 doses with a time interval of 8 hours between each dose. The subject will continue with this dosage for one week and afterwards, the initial dosage will be increased from 3 capsules per day divided into 3 doses with the same time interval between doses, until visit 3 (week 2). |
| Gabapentin | DRUG | Gabapentin will be administered orally with an initial dosage of 3 capsules per day divided into 3 doses with a time interval of 8 hours between each dose. The subject will continue with this dosage for one week and afterwards, the initial dosage will be increased from 3 capsules per day divided into 3 doses with the same time interval between doses, until visit 3 (week 2) |
Inclusion Criteria: * Subjects diagnosed with diabetes mellitus type 2 * Subjects with a history of neuropathic pain in the last 3 Months * Men and women in reproductive age with a family planning method * Subjects aged between 18 to 70 years * Subjects with glycosylated haemoglobin (HbA1c) greater...
F0434 is an investigational small molecule being studied for the treatment of diabetic neuropathies, specifically painful polyneuropathies associated with diabetes. It is intended to manage neuropathic pain in this patient population. The drug is currently in clinical development and has not been approved by regulatory authorities.
F0434 is being developed by Merck KGaA, a German multinational pharmaceutical company. The company's stock is listed under the ticker MKGAF. Merck KGaA is conducting clinical trials to evaluate the safety and efficacy of F0434 for the treatment of diabetic neuropathies.
F0434 is in Phase 3 clinical development. A Phase 3 trial has been completed, which represents the final stage of testing before potential regulatory submission. However, F0434 remains investigational and is not yet approved for commercial use. The completed trial provides data on its efficacy and safety in patients with diabetic neuropathies.
F0434 has been studied in one completed Phase 3 clinical trial registered as NCT01263132, titled 'Neuropathic Pain Management'. This randomized, double-blind, active-controlled study enrolled 104 participants with diabetic neuropathies and polyneuropathies in Mexico. The trial included adults aged 18 years and older of all sexes.
No alternative names for F0434 have been disclosed. The drug is identified solely by its code name F0434 in clinical trial registries and development documentation. It is a distinct investigational compound being developed by Merck KGaA for diabetic neuropathies.