Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Efficacy, Safety and Tolerability of Neramexane in Patients With Subjective Tinnitus (EASE)

This study has been completed.
Sponsor:
Information provided by:
Merz Pharmaceuticals GmbH
ClinicalTrials.gov Identifier:
NCT00739635
First received: August 21, 2008
Last updated: March 25, 2010
Last verified: March 2010
  Purpose

The purpose of this study is to investigate the safety and efficacy of neramexane mesylate in the treatment of subjective tinnitus in comparison to placebo.


Condition Intervention Phase
Subjective Tinnitus
Drug: Neramexane mesylate
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Clinical Evaluation of the Efficacy, Safety and Tolerability of Neramexane in Patients With Subjective Tinnitus

Resource links provided by NLM:


Further study details as provided by Merz Pharmaceuticals GmbH:

Primary Outcome Measures:
  • TBF-12 (Tinnitus-Beeinträchtigungs-Fragebogen-12 "Tinnitus Handicap Inventory-12") total score change from baseline to end of treatment [ Time Frame: Screening, Baseline, week 5, 13, 17 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • TBF-12 factorial scores, individual responder rate, Tinnitus Rating Scale, Sleep Questionnaire, population pharmacokinetics, optional pharmacogenetics [ Time Frame: 17 weeks ] [ Designated as safety issue: No ]
  • safety parameters [ Time Frame: 17 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 400
Study Start Date: September 2008
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Neramexane mesylate
Double-blind treatment period of 17 weeks up to 75 mg Neramexane mesylate per day
Placebo Comparator: 2 Drug: Placebo
Double-blind treatment period of 17 weeks placebo

  Eligibility

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

Inclusion Criteria:

  • Patients aged 18 to 75 years with a clinical diagnosis of first onset,
  • Persistent (i.e. tinnitus should never be absent for > 24 hours in a row), subjective, uni- or bilateral tinnitus present for at least 3 months but not more than 12 months

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, Menière's disease, otosclerosis, etc)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00739635

  Show 54 Study Locations
Sponsors and Collaborators
Merz Pharmaceuticals GmbH
  More Information

Additional Information:
No publications provided

Responsible Party: Irena Pulte, MD, Clinical R & D CNS
ClinicalTrials.gov Identifier: NCT00739635     History of Changes
Other Study ID Numbers: MRZ 92579/TI/3001, EudraCT Number 2007-007835-16
Study First Received: August 21, 2008
Last Updated: March 25, 2010
Health Authority: Austria: AGES PharmMed Bundesamt für Sicherheit im Gesundheitswesen
Germany: Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM)Fachregistratur Z 172
Portugal: INFARMED Autoridade Nacional do Medicamento e Produtos de Saúde, I.P.
Spain: Agencia Española de Medicamentos y Productos Sanitarios (AEMPS)
UK: MHRA The Clinical Trials Unit, Department of Health

Additional relevant MeSH terms:
Tinnitus
Ear Diseases
Hearing Disorders
Nervous System Diseases
Neurologic Manifestations
Otorhinolaryngologic Diseases
Sensation Disorders
Signs and Symptoms

ClinicalTrials.gov processed this record on November 25, 2014