Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
LY545694 · 2 trials · 2 indications
This scale measured 24-hour APS scores. Data were recorded daily (preferably at bedtime) on an 11-point Likert scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). Least Squares (LS) Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction.
This scale measured 24-hour APS scores. Data were recorded daily (preferably at bedtime) on an 11-point Likert scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). Least Squares (LS) Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules thrice daily (TID) po for 6 weeks |
| Pregabalin | ACTIVE_COMPARATOR | Pregabalin thrice daily (TID) oral for 6 weeks: 50 mg TID po for Week 1, 100 mg TID po for Weeks 2 - 5, and 50 mg TID po taper for Week 6 LY545694 placebo BID po for 5 weeks |
| LY545694 21 mg | EXPERIMENTAL | LY545694 21 milligrams (mg) BID po for 1 week Pregabalin placebo TID po for 6 weeks |
| LY545694 49 mg | EXPERIMENTAL | LY545694 escalated to 49 mg BID po during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment. Pregabalin placebo TID po for 6 weeks |
| LY545694 105 mg | EXPERIMENTAL | LY545694 escalated to 105 mg BID po during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment. Pregabalin placebo TID po for 6 weeks |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | LY545694 placebo BID po for 5 weeks Pregabalin placebo capsules TID po for 6 weeks |
| Pregabalin | DRUG | Pregabalin TID po for 6 weeks: 50 mg TID po for Week 1, 100 mg TID po for Weeks 2 - 5, and 50 mg TID po taper for Week 6 LY545694 placebo BID po for 5 weeks |
| LY545694 21 mg | DRUG | LY545694 21 mg BID po for 1 week Pregabalin placebo TID po for 6 weeks |
| LY545694 49 mg | DRUG | LY545694 escalated to 49 mg BID po for 1 week during Week 2. Pregabalin placebo TID po for 6 weeks. |
| LY545694 105 mg | DRUG | LY545694 105 mg BID po for 5 weeks Pregabalin placebo TID po for 6 weeks |
Inclusion Criteria: * Have pain due to peripheral neuropathy based on disease diagnostic criteria: must have Type 1 or Type 2 diabetes mellitus, pain must being in the feet, with relatively symmetrical onset, daily pain must be present for at least 6 months, and diagnosis must be confirmed by a sco...
LY545694 is an investigational small molecule being studied for the treatment of painful diabetic neuropathy and osteoarthritis knee pain. It was evaluated in Phase 2 clinical trials for these pain conditions, though it remains in clinical development and is not approved.
LY545694 is being developed by Eli Lilly and Company, a pharmaceutical company traded on the NYSE under the ticker symbol LLY. The company sponsored the clinical trials for this investigational drug.
LY545694 is in Phase 2 clinical development. Two Phase 2 trials have been completed, one for painful diabetic neuropathy and one for osteoarthritis knee pain. The drug is investigational and has not been approved.
LY545694 has been studied in two completed Phase 2 trials. NCT00785577 enrolled 273 patients with painful diabetic neuropathy in the United States, Mexico, and Puerto Rico. NCT00790790 enrolled 147 patients with osteoarthritis knee pain in the United States, Puerto Rico, and Romania.
LY545694 is the primary identifier for this investigational compound developed by Eli Lilly. No alternative names have been reported for this drug in the available clinical trial information.