NCT01302873

Brief Summary

This study will assess the efficacy of a two week treatment with BGG492 in patients with chronic subjective Tinnitus.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2011

Shorter than P25 for phase_2

Geographic Reach
2 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 7, 2011

Completed
17 days until next milestone

First Posted

Study publicly available on registry

February 24, 2011

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

March 22, 2017

Status Verified

March 1, 2017

Enrollment Period

1 year

First QC Date

February 7, 2011

Last Update Submit

March 20, 2017

Conditions

Chronic Subjective Tinnitus

Keywords

TinnitusAMPA Receptor antagonist

Outcome Measures

Primary Outcomes (2)

  • Change in tinnitus loudness using a visual analogue scale (VAS)

    after 15 days of treatment

  • Change in Clinical status of tinnitus (patients' reaction to tinnitus) using the TBF-12 (Tinnitus Impairment Questionnaire)

    after 15 days of treatment

Study Arms (2)

BGG492

EXPERIMENTAL
Drug: BGG492A

Placebo

PLACEBO COMPARATOR
Drug: BGG492A

Interventions

BGG492ADRUG
BGG492

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients diagnosed with THI (Tinnitus Handicap Inventory) severity grade 3, 4 or 5 (moderate, severe or catastrophic), chronic (\> 6 months and \< 36 months) subjective tinnitus
  • Willing to abstain from activities that require focused attention, e.g. driving a car or other vehicles, operating machines or engaging in potentially dangerous activities that require focused attention and intact physical balance
  • Willing and able to refrain from engaging in activities or work involving loud noise exposure

You may not qualify if:

  • Patients diagnosed with tinnitus of THI severity grade equal to 2 or 1
  • Patients with diagnosis of intermittent or pulsatile tinnitus
  • Patients who have tinnitus as a concomitant symptom of a treatable otological disease (such as otitis media, Menière's disease, otosclerosis), neurological tumors or/and have temporo-mandibular joint disorders
  • Patients with a history of frequent middle ear infections (\> 3 infections per year during the last 3 years)
  • Patients with diagnosed anxiety disorders, depression, schizophrenia or other significant psychiatric diseases requiring current drug treatment or patients who required treatment in the previous 3 months for these diseases.
  • Patients with current unilateral or bilateral hearing loss of 75 dB or more in one or more tested frequencies (125 Hz, 250 Hz, 1 kHz, 2 kHz, 4 kHz, 6 kHz, 8 kHz)
  • Patients with Vestibular Schwannoma
  • Patients with a cochlear implant
  • Patients with regular intake of central nervous system acting drugs for the treatment of tinnitus in the previous 6 months prior to initial dosing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Novartis Investigative Site

Berlin, 10117, Germany

Location

Novartis Investigative Site

Frankfurt, Germany

Location

Novartis Investigative Site

Lepzig, Germany

Location

Novartis Investigative Site

Groningen, 9700, Netherlands

Location

Related Publications (1)

  • Kucher K, Johns D, Wagner F, Abd-Elaziz K, Derne C, Sverdlov O, Pfister CU, Langguth B. Efficacy and safety of single- and repeated-selurampanel dosing for 2 weeks in patients with chronic subjective tinnitus: Results of a randomized, double-blind, placebo-controlled, cross-over, proof-of-concept phase IIa study. Prog Brain Res. 2021;260:423-440. doi: 10.1016/bs.pbr.2020.12.004. Epub 2021 Jan 20.

    PMID: 33637230DERIVED

MeSH Terms

Conditions

Tinnitus

Condition Hierarchy (Ancestors)

Hearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 7, 2011

First Posted

February 24, 2011

Study Start

January 1, 2011

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

March 22, 2017

Record last verified: 2017-03

Locations

DE(3)NL(1)