Open-Lable, Long-Term Treatment Study, to Assess the Long-Term Safety and Tolerability and Efficacy of Neramexane in Patients With Subjective Tinnitus - Full Text View

Open-Lable, Long-Term Treatment Study, to Assess the Long-Term Safety and Tolerability and Efficacy of Neramexane in Patients With Subjective Tinnitus (OLLTT)

This study is enrolling participants by invitation only.

First Received: January 21, 2009 Last Updated: May 18, 2009 History of Changes

Sponsored by:	Merz Pharmaceuticals GmbH
Information provided by:	Merz Pharmaceuticals GmbH
ClinicalTrials.gov Identifier:	NCT00827008

Purpose

The purpose of this study is to investigate the long-term safety and tolerability and efficacy of neramxane mesylate in the long-term treamtent of subjective tinnitus after a double-blind randomized placebo controlled study

Condition	Intervention	Phase
Subjective Tinnitus	Drug: Neramexane mesylate	Phase III

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	An Open-Lable, Long-Term Treatment Study to Assess the Long-Term Safety and Tolerability and Efficacy of Neramexane With Ssubjetive Tinntius

Resource links provided by NLM:

MedlinePlus related topics: Tinnitus Toe Injuries and Disorders

Drug Information available for: Neramexane Neramexane Mesylate

U.S. FDA Resources

Further study details as provided by Merz Pharmaceuticals GmbH:

Primary Outcome Measures:

Descriptive analyses of TBF-12 (Tinnitus-Beeinträchtigungs-Fragebogen 12 "Tinnitus Handicap Inventory 12")total score and its subscores, of the Tinnitus Rating Scale and its single items as well as of SF-36 and safety/tolerability parameters [ Time Frame: 54 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	1200
Study Start Date:	January 2009

Arms	Assigned Interventions
1, verum: Experimental	Drug: Neramexane mesylate Up-titration treatment period of 5 weeks up to 75mg Neramexane mesylate oral per day followed by 49 weeks treatment maintenance

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Main Inclusion Criteria:

Male or female patients who have succesfully completed one of the double-blind Phase 3 studys of Merz with Neramxane mesylate
patients aged equal or older 18 but not older than 75 years with clinical diagnosis of first onset, persisteant (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.)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00827008

Locations

Austria
Prim. Dr. Robert Jakse
Graz, Austria, 8020
Dr. Christof Pauli (PI: Prim. Dr. Peter Ostertag
Kufstein, Austria, 6330
Dr. Susanne Groblschegg
Vienna, Austria, 1090
Germany
Dr. Robert Bodlaj
Lichtenfels, Germany, 96215
Dr. PD Suckfüll
Munich, Germany, 81377
Dr. Gieselmann, Werner
Heiligenhaus, Germany, 42579
Dr. Dannesberger
Lorsch, Germany, 64653
Dr. Norbert Staab
Schlüchtern, Germany, 36381
Dr. Klaus Peter Jayme
Darmstadt, Germany, 64283
Dr. Susanne Wiedemann
Nuernberg, Germany, 90443
Dr. Christian Dörr
Dresden, Germany, 01277
Dr. med. Frank Reintjes
Braunschweig, Germany, 38100
Dr. med. Ulrike Walter
Nürnberg, Germany, 90402
Dr. Wolfgang Lotte
Iserlohn, Germany, 58642
Dr. Reiner Lehmann
Berlin, Germany, 13125
Dr. med. Norbert Pasch
Aachen, Germany, 52074
DM Helena Sigal
Chemnitz, Germany, 09120
Dr. Hannelore Neumaier
Wiesbaden, Germany, 65183
Dr. Dr. med. Hans-Detlev Stahl
Leipzig, Germany, 04103
Germany, Saale
Dr. Kühne, Elisabeth
Halle, Saale, Germany, 06112

Sponsors and Collaborators

Merz Pharmaceuticals GmbH

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Merz Pharmaceuticals GmbH ( Dr. Janos Csikos, Medical Expert )
Study ID Numbers:	MRZ 92579/TI/3004, EudraCTNumber 2008-001432-13
Study First Received:	January 21, 2009
Last Updated:	May 18, 2009
ClinicalTrials.gov Identifier:	NCT00827008 History of Changes
Health Authority:	Austria: Ethikkommission; United States: Food and Drug Administration

Study placed in the following topic categories:

Signs and Symptoms
Sensation Disorders
Hearing Disorders
Otorhinolaryngologic Diseases

Neurologic Manifestations
Ear Diseases
Tinnitus

Additional relevant MeSH terms:

Signs and Symptoms
Sensation Disorders
Hearing Disorders
Otorhinolaryngologic Diseases

Nervous System Diseases
Neurologic Manifestations
Ear Diseases
Tinnitus

ClinicalTrials.gov processed this record on September 11, 2009