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 was studied for the treatment of painful diabetic neuropathy and osteoarthritis knee pain. Both were Phase 2 programs, and the trials have been completed. The drug was investigated as a pain treatment in adults, including patients aged 40 years and older in the knee osteoarthritis study.
LY545694 was developed by Eli Lilly and Company, which trades on the New York Stock Exchange under the ticker LLY. Lilly sponsored the Phase 2 clinical program evaluating the compound in painful diabetic neuropathy and osteoarthritis knee pain.
LY545694 is in Phase 2 development. Two Phase 2 trials have been completed, and no active trials are currently listed. The studies were randomized, double-blind, and placebo-controlled, and the drug has not been approved by the FDA for any indication.
LY545694 was evaluated in two completed Phase 2 trials. NCT00790790 studied LY545694 in osteoarthritis knee pain with 147 patients across the United States, Puerto Rico, and Romania. NCT00785577 studied it in painful diabetic neuropathy with 273 patients across the United States, Mexico, and Puerto Rico.
The LY545694 clinical program enrolled 273 patients in the painful diabetic neuropathy trial, NCT00785577, and 147 patients in the osteoarthritis knee pain trial, NCT00790790. Both were randomized, double-blind, placebo-controlled Phase 2 studies, and both have been completed.