Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01589432 | A Randomized, Double-blind, Placebo- and Active-controlled Study of the Electric Current Effects of ABT-639 on the Spontaneous Activity of Pain Sensory Receptors in Patients With Diabetic Peripheral Neuropathy | PHASE2 | COMPLETED | 39 | — | — | Apr 1, 2012 | Nov 1, 2012 | Jan 3, 2013 | 1 | United Kingdom |
| NCT01345045 | A Multicenter Study Comparing the Analgesic Effects and Safety of ABT-639 Compared to Placebo in Subjects With Diabetic Neuropathic Pain | PHASE2 | COMPLETED | 193 | — | — | Apr 1, 2011 | Oct 1, 2011 | Jan 8, 2013 | 35 | United States, Czechia +3 |
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...