Open-Label, Long-Term Treatment Study, to Assess the Long-Term Safety and Tolerability and Efficacy of Neramexane in Patients With Subjective Tinnitus (OLLTT)
Status and phase
Terminated
Phase 3
Conditions
Subjective Tinnitus
Treatments
Drug: Neramexane mesylate
Study type
Interventional
Funder types
Industry
Identifiers
Details and patient eligibility
About
The purpose of this study is to investigate the long-term safety and tolerability and efficacy of neramexane mesylate in the long-term treatment of subjective tinnitus after a completed double-blind randomized placebo controlled study
Enrollment
821 patients
Sex
All
Ages
18 to 75 years old
Volunteers
No Healthy Volunteers
Inclusion and exclusion criteria
Main Inclusion Criteria:
- Male or female patients who have successfully completed one of the double-blind Phase 3 tinnitus studies of Merz with Neramexane mesylate
- patients aged equal or older 18 but not older than 75 years with clinical diagnosis of first onset, persistent (i.e. tinnitus should never be absent for more than 24 hours in a row), subjective, uni-or bilateral subacute tinnitus at the timepoint of the lead-in study
Main Exclusion Criteria:
- clinical diagnosis of intermittent or pulsatile tinnitus
- Patients who have tinnitus as a concomitant symptom of an otological/neurological disease (such as otitis media, Meniére´s disease, otosclerosis etc.)
Trial design
Primary purpose
Treatment
Allocation
Non-Randomized
Interventional model
Single Group Assignment
Masking
None (Open label)
821 participants in 1 patient group
1, verum
Experimental group
Treatment:
Drug: Neramexane mesylate
Trial contacts and locations
135
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Data sourced from clinicaltrials.gov
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