Meniere's DiseasePhase 2NCT03325790

SPI-1005 for the Treatment of Patients With Meniere's Disease

A Phase 2 study testing 200mg SPI-1005 BID and 400mg SPI-1005 BID in people with Meniere's Disease, run by Sound Pharmaceuticals, Incorporated at 13 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

This study will evaluate the safety, efficacy, and Pharmacokinetics (PK) of two dose levels of SPI-1005 administered for 28 days compared to placebo in patients with Meniere's disease. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Meniere's Disease
What is being tested?: 200mg SPI-1005 BID and 400mg SPI-1005 BID
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 149 participants
Where: 13 sitesUnited States
Study dates: 28 Sep 2017to 30 Apr 2019
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Adult male and female patients, 18-75 years of age at the time of enrollment.
Diagnosis of probable or definitive Meniere's disease by American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNS) 1995 criteria.
Two of three active symptoms including vertigo or disequilibrium, fluctuating hearing loss, or tinnitus within the 3 months prior to study enrollment.
Hearing loss of ≥ 30 decibels (dBHL) at either 250, 500 or 1000 Hz.
Voluntary consent to participate in the study.
Male subjects that are willing to use condoms throughout the study period and 90-days following study completion even if not fertile.

Show all 12Show fewer

Females of childbearing potential should either be sexually inactive (abstinent) for 14 days prior to screening and throughout the study or be using one of the following acceptable birth control methods:
Intrauterine Device in place for at least 3 months prior to study; or
Barrier method (condom or diaphragm) with spermicide for at least 14 days prior to screening through study completion; or
Stable hormonal contraceptive for at least 3 months prior to study and through study completion; or
Surgical sterilization (vasectomy) of partner at least 6 months prior to study enrollment.
Females of non-childbearing potential should be surgically sterile (bilateral tubal ligation with surgery at least 6 months prior to study enrollment, hysterectomy, or bilateral oophorectomy at least 2 months prior to study) or be at least 1 year since last menses.

Who cannot join

Current use of or within 60 days prior to study IV ototoxic medications such as chemotherapy including cisplatin, carboplatin, or oxaliplatin; aminoglycoside antibiotics including gentamicin, amikacin, tobramycin, kanamycin, or streptomycin; or loop diuretics including furosemide.
History of otosclerosis or vestibular schwannoma.
History of significant middle ear or inner ear surgery.
Current conductive hearing loss, otitis media, or mixed hearing loss.
Significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, or psychiatric disease.
Current use or within 30 days prior to study enrollment systemic steroids or drugs known to be strong inhibitors or inducers of cytochrome P450 enzymes.

Show all 9Show fewer

Hypersensitivity or idiosyncratic reaction to compounds related to ebselen or selenium.
Female patients who are pregnant or breastfeeding.
Participation in another interventional drug or device study within 30 days prior to study consent.

Trial locations and contacts

13 sites in 1 country.

City, postcode or hospital

13 sites in 1 country

United States13 sites

MUSC
Charleston, South Carolina, 29425
CEENTA
Charlotte, North Carolina, 28210
UT Southwestern
Dallas, Texas, 75390
Ccent/Cccr
Fresno, California, 93720
KUMC
Kansas City, Kansas, 66160
Advanced ENT & Allergy
Louisville, Kentucky, 40207
UMiami
Miami, Florida, 33146
ENT and Allergy Associates, LLP
New York, New York, 10017
TJU
Philadelphia, Pennsylvania, 19144
UCSD
San Diego, California, 92093
UCSF
San Francisco, California, 94115
Northwest Ear, Inc.
Seattle, Washington, 98104
Georgetown University
Washington D.C., District of Columbia, 20057

Other trials in United States

About this study

Official title: A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study To Evaluate The Safety And Efficacy of SPI-1005 in Meniere's Disease

This study will evaluate the safety, efficacy, and Pharmacokinetics (PK) of two dose levels of SPI-1005 administered for 28 days compared to placebo in patients with Meniere's disease.

Read the detailed description

Study participants will be randomized to SPI-1005 or placebo in this double-blind study to evaluate both safety and efficacy of the investigational treatment. Participants, aged 18-75 years, with probable or definite Meniere's disease will undergo baseline testing to assess severity of sensorineural hearing loss, tinnitus and vertigo. During the study, and 28 days after completion of treatment, participants will be evaluated for safety (adverse events, physical examinations, vital signs and clinical laboratory testing (CBC,serum chemistry). Trough plasma levels of ebselen and its major metabolite will be determined using liquid chromatography-mass spectrometry (LCMS) at specified visits. Additionally, plasma will be analyzed for selenium at the corresponding visits. The effect of SPI-1005 on hearing and balance will be evaluated. Tinnitus (TFI) and vertigo (VSS) will be evaluated at baseline, during and study treatment.

Conditions: Meniere's Disease
Being tested: 200mg SPI-1005 BID, 400mg SPI-1005 BID, Placebo
Keywords: Meniere's disease, Hearing Loss, Vertigo, Tinnitus, Ebselen, Pharmacokinetics, Safety, Efficacy, Speech
Medical subject headings: Meniere Disease, Hearing Loss, Vertigo, Tinnitus, Speech

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

200mg SPI-1005 BIDDrug
Also called ebselen
Active: low dose
400mg SPI-1005 BIDDrug
Also called ebselen
Active: high dose
PlaceboOther
Placebo Comparator

Study groups in NCT03325790
Study group	Role	What they receive
Placebo	Placebo comparator	Placebo Receives: Other: Placebo
200mg SPI-1005 twice daily (BID)	Experimental	200mg SPI-1005 BID Receives: Drug: 200mg SPI-1005 BID
400mg SPI-1005 BID	Experimental	400mg SPI-1005 BID Receives: Drug: 400mg SPI-1005 BID

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Treatment Emergent Adverse Events (TEAE)
Number and severity of adverse events in patients treated with placebo versus SPI-1005.
Outcome Measure 1 includes all adverse events, including those which are not reported in the Adverse Event module, i.e., adverse events which did not result in death, were not Serious Adverse Events, and which were below the frequency threshold (5%) in any arm as required for reporting.
Measured: 8 weeks
Efficacy of SPI-1005 on Hearing Loss
Improvement in sensorineural hearing loss from baseline using Pure Tone Audiometry
Measured: 8 weeks
Efficacy of SPI-1005 on Word Recognition Score
Improvement in Words-in-Noise (WIN) test score from baseline. WIN test score, 0-35 words, in which a higher score means a better outcome.
Measured: 8 weeks
Efficacy of SPI-1005 on Tinnitus
Improvement in the Tinnitus Functional Index (TFI) from baseline. TFI Total Score: 0-100, in which a higher score means a worse outcome.
Measured: 8 weeks
Efficacy of SPI-1005 on Tinnitus Loudness
Improvement in Tinnitus Loudness (TL) on response to Tinnitus Functional Index Question Number 2.
Question Number 2: "How Strong or Loud is your tinnitus?": 0-10, in which a higher score means a worse outcome.
Measured: 8 weeks
Efficacy of SPI-1005 on Vertigo
Improvement in Vertigo Symptom Scale (VSS) from baseline. VSS Total Scale: 0-60, in which a higher score means a worse outcome
Measured: 8 weeks

Secondary outcomes (1)

Trough Plasma Concentration of SPI-1005
Trough plasma concentration of SPI-1005 (ebselen) will be determined at certain time intervals
Measured: 2 weeks, 4 weeks, 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Sep 201730 Apr 2019

First posted30 Oct 2017
Study start28 Sep 2017
Primary completion30 Apr 2019
Study completion30 Apr 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (5)Papers the sponsor has linked to this study.
Other trials for Meniere'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
Model description: RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 149 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03325790
Sponsor's protocol ID: SPI-1005-251
Status last verified: Aug 2023
First submitted: 4 Oct 2017
Last updated: 18 Sep 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Kil J, Pierce C, Tran H, Gu R, Lynch ED. Ebselen treatment reduces noise induced hearing loss via the mimicry and induction of glutathione peroxidase. Hear Res. 2007 Apr;226(1-2):44-51. doi: 10.1016/j.heares.2006.08.006. Epub 2006 Oct 6.
PubMed 17030476
Lynch E, Kil J. Development of ebselen, a glutathione peroxidase mimic, for the prevention and treatment of noise-induced hearing loss. Semin Hear 2009; 30(1):47-55
Kil J, Lobarinas E, Spankovich C, Griffiths SK, Antonelli PJ, Lynch ED, Le Prell CG. Safety and efficacy of ebselen for the prevention of noise-induced hearing loss: a randomised, double-blind, placebo-controlled, phase 2 trial. Lancet. 2017 Sep 2;390(10098):969-979. doi: 10.1016/S0140-6736(17)31791-9. Epub 2017 Jul 14.
PubMed 28716314
Kil J, Harruff EE, Longenecker RJ. Development of ebselen for the treatment of sensorineural hearing loss and tinnitus. Hear Res. 2022 Jan;413:108209. doi: 10.1016/j.heares.2021.108209. Epub 2021 Feb 19.
PubMed 33678494
Nelson L, Johns JD, Gu S, Hoa M. Utilizing Single Cell RNA-Sequencing to Implicate Cell Types and Therapeutic Targets for SSNHL in the Adult Cochlea. Otol Neurotol. 2021 Dec 1;42(10):e1410-e1421. doi: 10.1097/MAO.0000000000003356.
PubMed 34510123

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
CI Following VS Removal or Labyrinthectomy
Vestibular Schwannoma, Meniere Disease
Active, not recruitingPhase 3
SPI-1005 for the Treatment of Meniere's Disease (Open Label)
Meniere's Disease, Ménière's Disease
RecruitingObservational study
Deep Phenotyping of Hearing Instability Disorders: Cohort Establishment, Biomarker Identification, Development of Novel Phenotyping Measures, and Discovery of Therapeutic Targets
Meniere's Disease, Enlarged Vestibular Aqueduct Syndrome
RecruitingPhase 4
Treatment of Meniere's Disease With Migraine Medications
Ménière
RecruitingPhase 2
Effects of Anakinra in Subjects With Corticosteroid-resistant/Intolerant Meniere's Disease and Autoimmune Inner Ear Disease
Autoimmune Inner Ear Disease, Meniere's Disease

All Meniere's Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study To Evaluate The Safety And Efficacy of SPI-1005 in Meniere's Disease
ClinicalTrials.gov ID: NCT03325790
Acronym / sponsor ID: SPI-1005-251
Conditions: Meniere's Disease
Keywords: Meniere's disease, Hearing Loss, Vertigo, Tinnitus, Ebselen, Pharmacokinetics, Safety, Efficacy
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 149 participants (actual)
Lead sponsor: Sound Pharmaceuticals, IncorporatedIndustry (pharma, biotech, devices)
Study start: 28 Sep 2017 (actual)
Primary completion: 30 Apr 2019 (actual)
Study completion: 30 Apr 2019 (actual)
First posted: 30 Oct 2017 (actual)
Results: Posted 14 Aug 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study will evaluate the safety, efficacy, and Pharmacokinetics (PK) of two dose levels of SPI-1005 administered for 28 days compared to placebo in patients with Meniere's disease.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3
Model description: RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED

Arm	Type	Receives
Placebo	Placebo comparator	Other: PlaceboPlacebo
200mg SPI-1005 twice daily (BID)	Experimental	Drug: 200mg SPI-1005 BID200mg SPI-1005 BID
400mg SPI-1005 BID	Experimental	Drug: 400mg SPI-1005 BID400mg SPI-1005 BID

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (12 listed)

Adult male and female patients, 18-75 years of age at the time of enrollment.
Diagnosis of probable or definitive Meniere's disease by American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNS) 1995 criteria.
Two of three active symptoms including vertigo or disequilibrium, fluctuating hearing loss, or tinnitus within the 3 months prior to study enrollment.
Hearing loss of ≥ 30 decibels (dBHL) at either 250, 500 or 1000 Hz.
Voluntary consent to participate in the study.

Key exclusion criteria (9 listed)

Current use of or within 60 days prior to study IV ototoxic medications such as chemotherapy including cisplatin, carboplatin, or oxaliplatin; aminoglycoside antibiotics including gentamicin, amikacin, tobramycin, kanamycin, or streptomycin; or loop diuretics including furosemide.
History of otosclerosis or vestibular schwannoma.
History of significant middle ear or inner ear surgery.
Current conductive hearing loss, otitis media, or mixed hearing loss.
Significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, or psychiatric disease.

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
200mg SPI-1005 BIDAlso: ebselenActive: low dose	Drug	200mg SPI-1005 twice daily (BID)
400mg SPI-1005 BIDAlso: ebselenActive: high dose	Drug	400mg SPI-1005 BID
PlaceboPlacebo Comparator	Other	Placebo

Primary outcome

Number of Participants With Treatment Emergent Adverse Events (TEAE)
Time frame: 8 weeks
Number and severity of adverse events in patients treated with placebo versus SPI-1005. Outcome Measure 1 includes all adverse events, including those which are not reported in the Adverse Event module, i.e., adverse events which did not result in death, were not Serious Adverse Events, and which were below the frequency threshold (5%) in any arm as required for reporting.
Efficacy of SPI-1005 on Hearing Loss
Time frame: 8 weeks
Improvement in sensorineural hearing loss from baseline using Pure Tone Audiometry
Efficacy of SPI-1005 on Word Recognition Score
Time frame: 8 weeks
Improvement in Words-in-Noise (WIN) test score from baseline. WIN test score, 0-35 words, in which a higher score means a better outcome.
Efficacy of SPI-1005 on Tinnitus
Time frame: 8 weeks
Improvement in the Tinnitus Functional Index (TFI) from baseline. TFI Total Score: 0-100, in which a higher score means a worse outcome.
Efficacy of SPI-1005 on Tinnitus Loudness
Time frame: 8 weeks
Improvement in Tinnitus Loudness (TL) on response to Tinnitus Functional Index Question Number 2. Question Number 2: "How Strong or Loud is your tinnitus?": 0-10, in which a higher score means a worse outcome.
Efficacy of SPI-1005 on Vertigo
Time frame: 8 weeks
Improvement in Vertigo Symptom Scale (VSS) from baseline. VSS Total Scale: 0-60, in which a higher score means a worse outcome

1 secondary outcome

Trough Plasma Concentration of SPI-1005
Time frame: 2 weeks, 4 weeks, 8 weeks

Results and safety

Results posted to the registry on 14 Aug 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	42	41
200mg SPI-1005 Twice Daily (BID)	42	41
400mg SPI-1005 BID	42	38

Primary outcome: Number of Participants With Treatment Emergent Adverse Events (TEAE)

Time frame: 8 weeks. Count of participants. Unit: Participants

Measure	Placebo n = 42	200mg SPI-1005 Twice Daily (BID) n = 42	400mg SPI-1005 BID n = 42
Total Number of Patients with Treatment Emergent Adverse Events (TEAE)	19	20	20
Number of Patients with Mild TEAE	15	18	18
Number of Patients with Moderate TEAE	6	3	7
Number of Patients with Severe TEAE	0	0	2

Primary outcome: Efficacy of SPI-1005 on Hearing Loss

Time frame: 8 weeks. Count of participants. Unit: Participants

Measure	Placebo n = 41	200mg SPI-1005 Twice Daily (BID) n = 42	400mg SPI-1005 BID n = 41
Threshold Improvement from Baseline >=10 dB in at least 1 low frequency (250, 500, or 1000 Hz): Yes	15	16	25
Threshold Improvement from Baseline >=10 dB in at least 1 low frequency (250, 500, or 1000 Hz): No	26	26	16
Threshold Improvement >=10 dB in 2 adjacent low frequencies (250 and 500 Hz, or 500 and 1000 Hz): Yes	8	7	15
Threshold Improvement >=10 dB in 2 adjacent low frequencies (250 and 500 Hz, or 500 and 1000 Hz): No	33	35	25

Population analysed: Analysis population includes those participants who completed the outcome measure at baseline and 8-week follow-up.

Primary outcome: Efficacy of SPI-1005 on Word Recognition Score

Time frame: 8 weeks. Count of participants. Unit: Participants

Measure	Placebo n = 41	200mg SPI-1005 Twice Daily (BID) n = 41	400mg SPI-1005 BID n = 40
WIN Score Improvement from Baseline >=10%: Yes	23	23	30
WIN Score Improvement from Baseline >=10%: No	18	18	10
WIN Score Improvement from Baseline >=20%: Yes	19	17	27
WIN Score Improvement from Baseline >=20%: No	22	24	13
WIN Score Improvement from Baseline >= 4 words: Yes	14	13	24
WIN Score Improvement from Baseline >= 4 words: No	27	28	16

Population analysed: Analysis population includes those participants who completed the outcome measure at baseline and 8-week follow-up.

Primary outcome: Efficacy of SPI-1005 on Tinnitus

Time frame: 8 weeks. Count of participants. Unit: Participants

Measure	Placebo n = 41	200mg SPI-1005 Twice Daily (BID) n = 42	400mg SPI-1005 BID n = 41
TFI Total Score >= 10pt. reduction from Baseline	20	19	13
No TFI Total Score >= 10pt. reduction from Baseline	21	23	28

Population analysed: Analysis population includes those participants who completed the outcome measure at baseline and 8-week follow-up.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 8 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 42 (0%)	3 of 42 (7.1%)	0 of 42
200mg SPI-1005 Twice Daily (BID)	0 of 42 (0%)	7 of 42 (16.7%)	0 of 42
400mg SPI-1005 BID	0 of 42 (0%)	8 of 42 (19%)	0 of 42

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 17030476Kil J, Pierce C, Tran H, Gu R, Lynch ED. Ebselen treatment reduces noise induced hearing loss via the mimicry and induction of glutathione peroxidase. Hear Res. 2007 Apr;226(1-2):44-51. doi: 10.1016/j.heares.2006.08.006. Epub 2006 Oct 6.
BackgroundLynch E, Kil J. Development of ebselen, a glutathione peroxidase mimic, for the prevention and treatment of noise-induced hearing loss. Semin Hear 2009; 30(1):47-55
Background: PubMed 28716314Kil J, Lobarinas E, Spankovich C, Griffiths SK, Antonelli PJ, Lynch ED, Le Prell CG. Safety and efficacy of ebselen for the prevention of noise-induced hearing loss: a randomised, double-blind, placebo-controlled, phase 2 trial. Lancet. 2017 Sep 2;390(10098):969-979. doi: 10.1016/S0140-6736(17)31791-9. Epub 2017 Jul 14.
Background: PubMed 33678494Kil J, Harruff EE, Longenecker RJ. Development of ebselen for the treatment of sensorineural hearing loss and tinnitus. Hear Res. 2022 Jan;413:108209. doi: 10.1016/j.heares.2021.108209. Epub 2021 Feb 19.
Derived from this study: PubMed 34510123Nelson L, Johns JD, Gu S, Hoa M. Utilizing Single Cell RNA-Sequencing to Implicate Cell Types and Therapeutic Targets for SSNHL in the Adult Cochlea. Otol Neurotol. 2021 Dec 1;42(10):e1410-e1421. doi: 10.1097/MAO.0000000000003356.
Sound Pharmaceuticals, Inc.Link provided by the sponsor.
Individual participant dataSharing planned: No

Related trials for Meniere's Disease

Active, not recruiting
CI Following VS Removal or Labyrinthectomy
Vestibular Schwannoma, Meniere Disease
Active, not recruitingPhase 3
SPI-1005 for the Treatment of Meniere's Disease (Open Label)
Meniere's Disease, Ménière's Disease
RecruitingObservational study
Deep Phenotyping of Hearing Instability Disorders: Cohort Establishment, Biomarker Identification, Development of Novel Phenotyping Measures, and Discovery of Therapeutic Targets
Meniere's Disease, Enlarged Vestibular Aqueduct Syndrome
RecruitingPhase 4
Treatment of Meniere's Disease With Migraine Medications
Ménière
RecruitingPhase 2
Effects of Anakinra in Subjects With Corticosteroid-resistant/Intolerant Meniere's Disease and Autoimmune Inner Ear Disease
Autoimmune Inner Ear Disease, Meniere's 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.

Jonathan Kil, MD study chair

Sound Pharmaceuticals, Inc.

13 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 200mg SPI-1005 BID and 400mg SPI-1005 BID in people with Meniere's Disease, run by Sound Pharmaceuticals, Incorporated at 13 sites in United States.

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 12 inclusion and 9 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: finished, as of the sponsor's last update on 18 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in United States. 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?

Yes. Results are posted in the registry (first posted 14 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Participants With Treatment Emergent Adverse Events (TEAE) (time frame: 8 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03325790, which also lists 5 linked publications.

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 18 Sep 2023.