Neramexane for tinnitus: Phase 2 miss and unpublished Phase 3 program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 (results never published)
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 and their efficacy results were NEVER PUBLISHED; the open-label extension was terminated (Dec 2011) and the program abandoned.

A cautionary publication-bias case: 'failure' cannot be verified from primary sources because no Phase 3 results exist in the literature — what is verifiable is completion, non-publication, termination of the extension, and abandonment.

Limitations and conflicts of interest

Phase 3 efficacy data unpublished — unable to verify.

Funding / conflicts: Sponsor-run (Merz).

Primary sources

Used as evidence for

Off-label oral drugs (antidepressants, benzodiazepines, gabapentin, betahistine)

This is an original summary from the Tinnitus Evidence verified database, checked against the primary source — not a reproduction of the publisher's abstract.