Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ABT-639 · 2 trials · 1 indication
Spontaneous activity in peripheral c-nociceptor measured through microneurography
Daily questions asked on a hand held diary
| Arm | Type | Description |
|---|---|---|
| ABT-639 | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Lidocaine | ACTIVE_COMPARATOR | - |
| pregabalin | ACTIVE_COMPARATOR | pregabalin starting dose twice daily for week one then titrated up to maintenance dose twice daily for duration of the study |
| Name | Type | Description |
|---|---|---|
| ABT-639 | DRUG | two 50 mg oral capsules |
| Placebo | DRUG | 2 placebo capsules |
| Lidocaine | DRUG | 3mg/kg infusion over 30 minutes |
| pregabalin | DRUG | pregabalin starting dose twice daily for 1 week then titrated to maintenance dose twice daily for the remainder of the study. |
Inclusion Criteria * Subject is between the ages of 18 to 75 years with a diagnosis of diabetes mellitus and must have a diagnosis of painful distal symmetric diabetic polyneuropathy and presence of ongoing pain due to diabetic peripheral neuropathy for at least 6 months. * Subject must have an ave...
ABT-639 was studied for the treatment of diabetic neuropathic pain, a nerve pain condition associated with diabetes. Both of its Phase 2 clinical trials enrolled adults with diabetic peripheral neuropathy. It is an investigational drug and is not approved for any indication.
ABT-639 targets CACNA1H, a T-type calcium channel. It acts as a blocker of this channel, which is the proposed mechanism for its analgesic effect in neuropathic pain. ABT-639 is a small molecule developed by AbbVie.
ABT-639 is developed by AbbVie Inc., which trades on the New York Stock Exchange under the ticker ABBV. AbbVie sponsored both Phase 2 trials of the compound in diabetic neuropathic pain.
ABT-639 is in Phase 2 development. It is an investigational small molecule and has not been approved by the FDA for any indication. Both of its Phase 2 trials in diabetic neuropathic pain have been completed, and no trials are currently active.
ABT-639 has been evaluated in two completed Phase 2 trials. NCT01345045 was a multicenter, placebo-controlled study of analgesic effects and safety in 193 subjects with diabetic neuropathic pain. NCT01589432 was a randomized, double-blind, placebo- and active-controlled study of 39 patients with diabetic peripheral neuropathy in the United Kingdom.
The two completed Phase 2 trials of ABT-639 enrolled a total of 232 participants. NCT01345045 enrolled 193 subjects across the United States, Czechia, France, Germany, and Mexico, while NCT01589432 enrolled 39 patients in the United Kingdom. Both studies were randomized, double-blind, and placebo-controlled.