Menière's DiseasePhase 2NCT01973114
Latanoprost for the Treatment of Menière's Disease
A Phase 2 study testing Latanoprost in people with Menière's Disease, run by Synphora AB at 12 sites in Sweden.
Trial summary
The purpose of the study is to evaluate the dose regimen, efficacy and safety of latanoprost for the treatment of Menière's disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Menière's Disease
- What is being tested?
- Latanoprost
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 12 sitesSweden
- Study dates
- Oct 2013to May 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 18 years of age
- Definitive unilateral Menière's disease (AAO-HNS 1995)
- Disease stage II - III: PTA4 (Pure Tone Average) (0.5, 1.0, 2.0 and 3.0kHz) between 25dB and 70dB
- Speech discrimination score in silence: No better than 85%
- At least three vertigo attacks (lasting ≥ 20 minutes) during the last three months prior to inclusion
- Tinnitus during the last three months prior to inclusion
- Signed written informed consent
Who cannot join
- Medical or psychiatric conditions which could jeopardize or would compromise the subject's ability to participate in the trial or decrease the likelihood of obtaining satisfactory data to achieve the objective of the trial, dementia, alcohol or substance abuse.
- Bilateral Menière's disease
- Chronic otitis media on the ear affected by Menière's disease
- Subjects not fluent in Swedish language
- Bronchial asthma
- Previous intratympanic injection of gentamicin or surgical therapy
Show all 10Show fewer
- Previous intratympanic steroid therapy less than six months prior to inclusion
- Known hypersensitivity to local anesthetics
- Pregnant women
- Nursing mothers
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
Sweden12 sites
Falu Lasarett
Falun
Sahlgrenska Universitetssjukhuset
Gothenburg
Blekinge Hospital
Karlskrona
Centralsjukhuset i Karlstad
Karlstad
Centralsjukhuset i Kristianstad
Kristianstad
Linköping University Hospital
Linköping
Sunderby Sjukhus
Luleå
Lund University Hospital
Lund
University Hospital Örebro
Örebro
Karolinska Universitetssjukhuset
Stockholm
Uppsala University Hospital
Uppsala
Västmanlands Sjukhus i Västerås
Västerås
About this study
Official title: A Randomized, Double Blind, Placebo-controlled, Parallel Group Study to Determine the Efficacy, the Duration of Action, and Safety of Latanoprost in Patients With Menière's Disease
The purpose of the study is to evaluate the dose regimen, efficacy and safety of latanoprost for the treatment of Menière's disease.
- Conditions
- Menière's Disease
- Being tested
- Latanoprost, Placebo
- Keywords
- Menière's disease, Vertigo, Hearing loss, Tinnitus
- Medical subject headings
- Vertigo, Hearing Loss, Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LatanoprostDrug
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | One intratympanic injection of latanoprost (Day1) Receives: Drug: Latanoprost |
| Group 2 | Placebo comparator | One intratympanic injection of placebo Receives: Other: Placebo |
| Group 3 | Experimental | Three intratympanic injections of latanoprost (Day 1, 2 and 3) Receives: Drug: Latanoprost |
| Group 4 | Placebo comparator | Three intratympanic injections of placebo (Day 1, 2 and 3) Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in speech discrimination score in noise from Baseline
Measured: 2 weeks
Secondary outcomes (7)
Change in speech discrimination score in noise from Baseline
Measured: 3 months
Change in pure tone audiometry from Baseline
Measured: 3 months
Change in THI-25 (Tinnitus Handicap Inventory) score from Baseline
Measured: 3 months
Change in hearing (Likert scale), tinnitus (Likert scale) and vertigo (Likert scale) from run-in period
Measured: 3 months
Change in proportion of days with vertigo attacks from run-in period
Measured: 3 months
Comparison of number of drop attacks in each treatment arm
Measured: 3 months
Evaluation of adverse events and vital signs as measure of safety and tolerability
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2013 (estimated)
- Study startOct 2013
- Primary completionMay 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Menière's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Synphora AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mikael Karlberg, MD, PhD, Principal investigator, Lund University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01973114
- Sponsor's protocol ID
- M 05 - 2013
- Status last verified
- Mar 2016
- First submitted
- 17 Oct 2013
- Last updated
- 23 Mar 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Blind, Placebo-controlled, Parallel Group Study to Determine the Efficacy, the Duration of Action, and Safety of Latanoprost in Patients With Menière's Disease
- ClinicalTrials.gov ID
- NCT01973114
- Acronym / sponsor ID
- M 05 - 2013
- Conditions
- Menière's Disease
- Keywords
- Menière's disease, Vertigo, Hearing loss, Tinnitus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Synphora ABIndustry (pharma, biotech, devices)
- Study start
- Oct 2013
- Primary completion
- May 2016 (estimated)
- First posted
- 31 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to evaluate the dose regimen, efficacy and safety of latanoprost for the treatment of Menière's disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: LatanoprostOne intratympanic injection of latanoprost (Day1) |
| Group 2 | Placebo comparator | Other: PlaceboOne intratympanic injection of placebo |
| Group 3 | Experimental | Drug: LatanoprostThree intratympanic injections of latanoprost (Day 1, 2 and 3) |
| Group 4 | Placebo comparator | Other: PlaceboThree intratympanic injections of placebo (Day 1, 2 and 3) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- At least 18 years of age
- Definitive unilateral Menière's disease (AAO-HNS 1995)
- Disease stage II - III: PTA4 (Pure Tone Average) (0.5, 1.0, 2.0 and 3.0kHz) between 25dB and 70dB
- Speech discrimination score in silence: No better than 85%
- At least three vertigo attacks (lasting ≥ 20 minutes) during the last three months prior to inclusion
Key exclusion criteria (10 listed)
- Medical or psychiatric conditions which could jeopardize or would compromise the subject's ability to participate in the trial or decrease the likelihood of obtaining satisfactory data to achieve the objective of the trial, dementia, alcohol or substance abuse.
- Bilateral Menière's disease
- Chronic otitis media on the ear affected by Menière's disease
- Subjects not fluent in Swedish language
- Bronchial asthma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Latanoprost | Drug | Group 1, Group 3 |
| Placebo | Other | Group 2, Group 4 |
Primary outcome
Change in speech discrimination score in noise from Baseline
Time frame: 2 weeks
7 secondary outcomes
Change in speech discrimination score in noise from Baseline
Time frame: 3 months
Change in pure tone audiometry from Baseline
Time frame: 3 months
Change in THI-25 (Tinnitus Handicap Inventory) score from Baseline
Time frame: 3 months
Change in hearing (Likert scale), tinnitus (Likert scale) and vertigo (Likert scale) from run-in period
Time frame: 3 months
Change in proportion of days with vertigo attacks from run-in period
Time frame: 3 months
Comparison of number of drop attacks in each treatment arm
Time frame: 3 months
Evaluation of adverse events and vital signs as measure of safety and tolerability
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2016.
Related trials for Menière's Disease
RecruitingObservational study
Genetic and Biohumoral Factors Involved in Menière's Disease and Their Correlation With Phenotypes
Vertigo, Meniere's Disease
RecruitingPhase 3
The Effecttiveness of Intratympanic Methylprednisolon Injections Compared to Placebo in the Treatment of Vertigo Attacks in Meniere's Disease
Meniere Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mikael Karlberg, MD, PhD principal investigator
Lund University Hospital
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Latanoprost in people with Menière's Disease, run by Synphora AB at 12 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in speech discrimination score in noise from Baseline (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2016.