Neramexane for tinnitus: Phase 2 miss and unpublished Phase 3 program
Record details
- Authors: Suckfüll M, et al. (Phase 2); Merz Pharmaceuticals (Phase 3 program)
- Journal / source: BMC Ear, Nose and Throat Disorders (Phase 2) (2011)
- Design: Phase 2 randomized placebo-controlled dose-ranging; three completed Phase 3 RCTs (no journal publication found; results posted on the EU register)
- Sample: Phase 2: 431; Phase 3 program: NCT00739635 (411), NCT00772980 (400), NCT00955799 (455)
- Primary endpoint: THI-12 change at week 16 (Phase 2)
- Randomized: Yes · Sham/placebo-controlled: Yes · Independent of the manufacturer: No
What this research found
Phase 2: primary endpoint NOT met at any dose (50 mg p=0.098). The three Phase 3 trials completed ~2010–2011; no journal publication of their efficacy results was found (the EU Clinical Trials Register posts results for several of the Merz neramexane tinnitus trials, first posted December 2016); the open-label extension was terminated (Dec 2011) and the program abandoned.
A cautionary publication-bias case: no journal publication of the Phase 3 efficacy results was found. The EU Clinical Trials Register posts results for several Merz neramexane trials, and the Emerging section reports no difference from placebo in the one Phase III result it read there; those figures have not yet been extracted into this record, so the rating rests on the non-publication, the terminated extension and the abandoned program.
Limitations and conflicts of interest
No journal publication of Phase 3 efficacy data; EU-register results not yet extracted into this record.
Funding / conflicts: Sponsor-run (Merz).
Primary sources
Used as evidence for
This is an original summary from the Tinnitus Evidence verified database, checked against the primary source — not a reproduction of the publisher's abstract.