Clinical Trials

Date: 2017-08-31

Type of information: Results

phase: 3

Announcement: results

Company: Daiichi Sankyo (Japan)

Product: mirogabalin (DS-5565)

Action mechanism: gabamimetic agent.

Disease: diabetic peripheral neuropathic pain - postherpetic neuralgia

Therapeutic area: CNS diseases - Neurological diseases

Country: Japan, Republic of Korea, Malaysia, Singapore, Taiwan, Thailand

Trial details:

• The global phase 3 clinical development program for mirogabalin consists of several phase 3 clinical trials, including NEUCOURSE (post-herpetic neuralgia), REDUCER (diabetic peripheral neuropathic pain) and ALDAY (pain associated with fibromyalgia). Upon completion of these phase 3 trials, more than 6,000 patients will have participated in the mirogabalin clinical development program. The results from the global clinical development program will serve as the basis for potential regulatory submissions in various countries.
• The REDUCER study will last 14 weeks and is being conducted at approximately 200 centers in Japan, Taiwan and Korea (NCT02318706).
• The NEUCOURSE study will also last 14 weeks and is being conducted at approximately 200 centers in Japan, Taiwan, Korea, Singapore, Malaysia and Thailand (NCT02318719). The studies will include about 750 patients each with either diabetic peripheral neuropathic pain or postherpetic neuralgia, respectively. The objectives of the double-blind studies are to evaluate safety and efficacy of mirogabalin by comparing change in the average daily pain score (ADPS) from baseline to Week 14 in patients receiving a total daily dose of either 15 mg, 20 mg or 30 mg of mirogabalin versus placebo. Both studies will be followed by one-year open-label extension studies to assess long-term safety and efficacy of mirogabalin. (NCT02187471 and NCT02146430)

Latest news:

• • On August 31, 2017, Daiichi-Sankyo announced top-line results from REDUCER (an Asian, phase 3, multicenter, RandomizEd, Double-blind, placebo-controlled 14-week stUdy of mirogabalin in patients with diabetiC pEripheral neuRopathic pain, followed by a 52-week open-label extension). In this trial, mirogabalin demonstrated statistically significant reduction compared to placebo in the primary endpoint, change in weekly average daily pain score (ADPS) from baseline to Week 14. Preliminary and ongoing analyses indicated no significant safety concerns in the trial. The REDUCER trial was followed by a 52-week open-label extension at approximately 200 centers in Japan, Taiwan, South Korea and Malaysia.
• The primary objective of the 14-week trial was to evaluate the efficacy of mirogabalin by comparing the change in the ADPS from baseline to Week 14 in patients receiving 10 mg or 15 mg of mirogabalin twice-daily versus placebo. Weekly ADPS is based on daily pain scores reported by the patient that best describes his or her pain over the previous 24 hours. Secondary objectives in the trial included a comparison of the change in ADPS from baseline to Week 14 in patients receiving mirogabalin 15 mg once-daily versus placebo, as well as a comparison of the proportion of patients by treatment group with greater than or equal to 30 and 50 reductions in ADPS from baseline to Week 14.
• • On June 30, 2017, Daiichi Sankyo announced top-line results from NEUCOURSE, a phase 3 clinical trial in patients with post-herpetic neuralgia, and the ALDAY phase 3 clinical trials in patients with fibromyalgia. In NEUCOURSE, a single phase 3, double-blind, placebo-controlled, 14-week study evaluating mirogabalin in Asian patients with post-herpetic neuralgia, mirogabalin met the primary efficacy endpoint by demonstrating a statistically significant reduction in the weekly average daily pain score (ADPS) from baseline to Week 14. The primary objective of the NEUCOURSE study was to evaluate the efficacy of mirogabalin in patients receiving 10 mg or 15 mg of mirogabalin twice-daily versus placebo. Weekly ADPS is based on daily pain scores reported by the patient that best describes his or her pain over the previous 24 hours. Key secondary objectives included a comparison of the change in ADPS from baseline to Week 14 in patients receiving mirogabalin 15 mg once-daily versus placebo, and a comparison of the proportion of patients with greater than or equal to 30 percent and greater than or equal to 50 percent reduction from baseline to Week 14 in ADPS receiving each dose of mirogabalin versus placebo. Patients who completed the double-blind phase were eligible to participate in the open-label extension phase, which explored the long-term safety and efficacy of mirogabalin in patients with post-herpetic neuralgia. Several additional secondary and exploratory objectives were also evaluated.
• In the three, 13-week, double-blind, global, phase 3 ALDAY clinical trials evaluating mirogabalin for the treatment of pain associated with fibromyalgia, mirogabalin did not meet the primary efficacy endpoint to demonstrate a statistically significant reduction in the weekly average of worst daily pain score from baseline to Week 13.
• The primary objective for each of the ALDAY clinical trials was to evaluate the efficacy of mirogabalin by comparing changes in patients’ weekly average of worst daily pain score from baseline to Week 13 in those receiving either mirogabalin 15 mg once-daily or mirogabalin 15 mg twice-daily versus placebo. Weekly average of worst daily pain score is based on the daily pain scores reported by the patient that best describes his or her worst pain over the previous 24 hours. Key secondary objectives of the ALDAY trials included a comparison of the proportion of patients with greater than or equal to 30 percent and greater than or equal to 50 percent reduction from baseline to Week 13 in weekly average of worst daily pain score receiving either dose of mirogabalin versus placebo. Several additional secondary and exploratory objectives were also evaluated.
• Preliminary and ongoing analyses indicated no unexpected safety concerns in the NEUCOURSE or ALDAY clinical trials. Full results from the trials will be disclosed in upcoming scientific mediums.
• •  On February 4, 2015, The phase 3 clinical program across Asia includes the REDUCER (An Asian, phase 3, multicenter, RandomizEd, Double-blind, placebo-controlled 14-week stUdy of DS-5565 in patients with diabetiC pEripheral neuRopathic pain followed by a 52-week open-label extension) study and the NEUCOURSE (An AsiaN, phasE 3, mUltiCenter, randomized, dOUble-blind, placebo-contRolled 14-week study of DS-5565 in patientS with postherpetic neuralgia followed by a 52-week open-label Extension) study which will evaluate investigational mirogabalin for the treatment of diabetic peripheral neuropathic pain (DPNP) and postherpetic neuralgia (PHN), respectively. The phase 3 global ALDAY (A Randomized, Double-Blind, Placebo- and Active-Controlled Study of DS-5565 in Patients with Pain Associated with Fibromyalgia) clinical program is ongoing and will evaluate mirogabalin for the treatment of pain associated with fibromyalgia in three identical studies.

Is general: Yes