The mirogabalin ALDAY phase 3 program in pain associated with fibromyalgia: the lessons learned.

The mirogabalin ALDAY phase 3 program in pain associated with fibromyalgia: the lessons learned. Curr Med Res Opin. 2020 Feb 06;:1 Authors: Merante D Abstract Aims: The main aim of this work was to identify and to share the lessons learned from the negative outcome of the mirogabalin ALDAY phase 3 clinical program in pain associated with fibromyalgia. These lessons are important to improve planning and design of future phase 3 programs in fibromyalgia.Methods: A systematic review from Cochrane Library, Medline, Embase, clinicaltrials.gov, pharmaceutical companies and regulatory agencies' websites, was carried out starting from the development of gabapentin, the first α2δ ligand studied for the treatment of neuropathic pain and ending with the mirogabalin program.Results: Based on the outcome of the main fibromyalgia programs, several differences in design, primary endpoint choice, magnitude of placebo response, presence of an active comparator, and size of the entire clinical program were identified. This analysis focused on the negative primary results of the mirogabalin ALDAY program and identified several contributing factors. Above all, the magnitude of placebo response and the unprecedented size of the program were identified. The number of study visits and procedures was also high and highly demanding for all subjects involved in ALDAY.Outcome: In terms of main lessons learned from ALDAY, the first was the need for a comprehe...
Source: Current Medical Research and Opinion - Category: Research Tags: Curr Med Res Opin Source Type: research