InsomniaPhase 3NCT04009577

A Study to Evaluate Next-Dose Transition From Zolpidem to Lemborexant (LEM) for the Treatment of Insomnia

A Phase 3 study testing LEM 5 mg and LEM 10 mg in people with Insomnia, run by Eisai Inc. at 17 sites in United States.

Completed

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

Trial summary

The primary objective of the study is to evaluate the proportion of adult [greater than or equal to (>=) 18 years] participants with insomnia disorder taking zolpidem tartrate immediate release (ZOL-IR) or zolpidem tartrate extended release (ZOL-ER), intermittently or frequently, who transition to lemborexant 5… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Insomnia
What is being tested?: LEM 5 mg and LEM 10 mg
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 53 participants
Where: 17 sitesUnited States
Study dates: 15 Jul 2019to 26 Jun 2020
Phase: Phase 3
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Meets the Diagnostic and Statistical Manual of Mental Disorders, 5th ed (DSM-5) criteria for Insomnia Disorder, either currently or prior to zolpidem use, as follows:
Complains of dissatisfaction with nighttime sleep, in the form of difficulty staying asleep and/or awakening earlier in the morning than desired despite adequate opportunity for sleep
Frequency of complaint >=3 times per week
Duration of complaint >=3 months
Associated with complaint of daytime impairment
Reports spending at least 7 hours in bed per night

Show all 10Show fewer

History of intermittent [taking zolpidem at least 3 or 4 nights per week], or frequent use (at least 5 nights per week) of ZOL-IR or ZOL-ER, for at least 1 month
Confirmation of intermittent or frequent use of zolpidem (based on review of drug use data). Intermittent use is defined as taking zolpidem at least 3 but fewer than 5 nights per week, for at least 2 weeks each of the 3-week Screening Period. Frequent use is defined as taking zolpidem at least 5 nights per week, during, at minimum, the last 2 weeks of the 3-week Screening Period
Willing and able to comply with all aspects of the protocol, including staying in bed for at least 7 hours each night
Willing not to start another pharmacologic treatment for the management of insomnia during the participant's participation in the study

Who cannot join

Females who are breastfeeding or pregnant at screening or baseline (as documented by a positive serum pregnancy test). A separate baseline assessment is required if a negative screening pregnancy test was obtained more than 72 hours before the first dose of study drug
Females of childbearing potential who:
Within 28 days before study entry, did not use a highly effective method of contraception, which includes any of the following:
total abstinence (if it is their preferred and usual lifestyle)
an intrauterine device or intrauterine hormone-releasing system (IUS)
a contraceptive implant

Show all 34Show fewer

an oral contraceptive (Participant must be on a stable dose of the same oral contraceptive product for at least 28 days before dosing and throughout the study and for 28 days after study drug discontinuation)
have a vasectomized partner with confirmed azoospermia
Do not agree to use a highly effective method of contraception (as described above) throughout the entire study period and for 28 days after study drug discontinuation NOTE: All females will be considered to be of childbearing potential unless they are postmenopausal (amenorrheic for at least 12 consecutive months, in the appropriate age group, and without other known or suspected cause) or have been sterilized surgically (ie, bilateral tubal ligation, total hysterectomy, or bilateral oophorectomy, all with surgery at least 1 month before dosing)
Any history of moderate or severe obstructive sleep apnea (OSA)
Current evidence of a clinically significant, active respiratory disorder other than mild OSA. This includes bronchiectasis, emphysema, asthma, chronic obstructive pulmonary disease or any other pulmonary disorder identified by review of medical history or physical examination, and which in the opinion of the investigator, could compromise the participant's safety or interfere with study assessments
A current diagnosis of periodic limb movement disorder, restless legs syndrome, circadian rhythm sleep disorder, or an exclusionary score on screening instruments to rule out individuals with symptoms of certain sleep disorders other than insomnia as follows:
STOP-Bang score >=5 (participants previously diagnosed with mild OSA are not excluded)
International Restless Legs Scale (IRLS) score >=16
Habitually naps during the day more than 3 times per week
Reports symptoms potentially related to narcolepsy, that in the clinical opinion of the investigator indicates the need for referral for a diagnostic evaluation for the presence of narcolepsy
Reports a history of sleep-related violent behavior, or sleep driving, or any other complex sleep-related behavior (eg, making phone calls or preparing and eating food while sleeping), whether spontaneous or associated with a pharmacological sleep agent
Takes a dose of ZOL-IR greater (>)10 mg per night, or ZOL-ER >12.5 mg per night
Takes a dose of zolpidem that is lower than what is prescribed
Reports having altered zolpidem tablets
Unwilling to forgo alcohol consumption within 3 hours of bedtime for the duration of participation in the study
Used any prohibited prescription or over-the-counter concomitant medications within 1-week or 5 half-lives, whichever is longer, before the first dose of study medication (A list of prohibited concomitant medications is presented in the protocol)
Used any pharmacologic modality of treatment for insomnia other than zolpidem, including marijuana, within 1-week or 5 half-lives, whichever is longer, before the Screening Period
A prolonged difference between QTc corrected by Fridericia's formulas (QTcF) interval [QTcF >450 millisecond (ms)] as demonstrated by a repeated electrocardiogram
Any suicidal ideation with intent with or without a plan at Screening or within 6 months of Screening (ie, answering "Yes" to questions 4 or 5 on the Suicidal Ideation section of the Columbia-Suicide Severity Rating Scale [C-SSRS])
Any lifetime suicidal behavior (per the Suicidal Behavior section of the C-SSRS)
Evidence of clinically significant disease (eg, cardiac, respiratory, gastrointestinal, and renal disease) that in the opinion of the investigator(s) could affect the participant's safety or interfere with the study assessments. Participants for whom a sedating drug would be contraindicated for safety reasons because of the participant's occupation or activities are also excluded
Hypersensitivity to LEM or any of the excipients
Any history of or concomitant medical condition that in the opinion of the investigator(s) would compromise the participant's ability to safely complete the study
Planned surgery that requires general, spinal, or epidural anesthesia that would take place during the study. Planned surgery, which requires only local anesthesia and which can be undertaken as a day case without inpatient stay postoperatively, need not result in exclusion if in the opinion of the investigator this operation does not interfere with the study procedures and patient safety
Psychotic disorder(s) or unstable recurrent affective disorder(s) evident by use of antipsychotics or prior suicide attempt(s) within approximately the last 2 years
History of drug or alcohol dependency or abuse within approximately the last 2 years
Currently enrolled in another clinical study or used any investigational drug or device within 28 days or 5 times the half-life, whichever is longer, preceding informed consent
Previously participated in any clinical trial of LEM

Trial locations and contacts

17 sites in 1 country.

City, postcode or hospital

17 sites in 1 country

United States17 sites

Albuquerque Neurosciences Inc
Albuquerque, New Mexico, 87109
NeuroTrials Research Inc. - BTC - PPDS
Atlanta, Georgia, 30342
FutureSearch Trials of Neurology
Austin, Texas, 78731
Chicago Research Center Inc - ClinEdge - PPDS
Chicago, Illinois, 60634
CTI Clinical Research Center - ClinEdge - PPDS
Cincinnati, Ohio, 45212
Centennial Medical Group - Elkridge - Rx Trials
Elkridge, Maryland, 21075
Fleming Island Center For Clinical Research - ERN-PPDS
Fleming Island, Florida, 32003
PACT
Glendale, Arizona, 85306
MD Clinical
Hallandale, Florida, 33009
Clinical Neuroscience Solutions Inc
Jacksonville, Florida, 32256
Clinical Neuroscience Solutions Inc
Memphis, Tennessee, 38119
Clinilabs Drug Development Corporation
New York, New York, 10019
Clinical Neuroscience Solutions Inc
Orlando, Florida, 32801
Northern California Research Corp
Sacramento, California, 95821
Artemis Institute For Clinical Research LLC - San Diego - ClinEdge - PPDS
San Diego, California, 92103
SDS Clinical Trials, Inc.
Santa Ana, California, 92705
SleepCare Research Institute Inc
Stockbridge, Georgia, 30281

Other trials in United States

About this study

Official title: A Multicenter, Pilot Study to Evaluate Next-Dose Transition From Zolpidem to Lemborexant for the Treatment of Insomnia

Conditions: Insomnia
Being tested: LEM 5 mg, LEM 10 mg
Keywords: Insomnia, Sleep Initiation and Maintenance Disorders, Insomnia Disorder, Sleeplessness, E2006, Zolpidem, Lemborexant
Medical subject headings: Sleep Initiation and Maintenance Disorders

What participants receive

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

LEM 5 mgDrug
Also called E2006, Lemborexant
LEM tablet.
LEM 10 mgDrug
Also called E2006, Lemborexant
LEM tablet.

Study groups in NCT04009577
Study group	Role	What they receive
Cohort 1 (LEM 5 mg)	Experimental	Participants who were taking zolpidem tartrate (ZOL) at least 3 but fewer than 5 nights per week, for each of at least 2 weeks of the 3-week Screening Period, will initially receive LEM 5 mg administered as a tablet, orally for up to 2 weeks. Participants who meet both criteria for intermittent (Cohort 1) and frequent ZOL use (Cohort 2A and 2B) for 1 week each of the last 2 weeks of the 3-week Screening Period will be assigned to Cohort 1 and also will receive LEM 5mg. Receives: Drug: LEM 5 mg
Cohort 2A (LEM 5 mg)	Experimental	Participants who were taking ZOL at least 5 nights per week, during, at minimum, the last 2 weeks of the 3-week Screening Period, will initially receive LEM 5 mg administered as a tablet, orally for up to 2 weeks. Receives: Drug: LEM 5 mg
Cohort 2B (LEM 10 mg)	Experimental	Participants who were taking ZOL at least 5 nights per week, during, at minimum, the last 2 weeks of the 3-week Screening Period, will initially receive LEM 10 mg administered as a tablet, orally for up to 2 weeks. Receives: Drug: LEM 10 mg

What is being measured

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

Percentage of Overall Participants Who Transitioned to LEM at the End of the Titration Period of Core Study
Transition to LEM was defined as participant who remained on LEM at the end of the 2-week titration period and either 1) entered the extension phase, or 2) chooses to not enter the extension phase for reasons not related to LEM (including, but not limited to, time commitment related to the study, study-related travel expenses or preference to continue insomnia management with another health care provider).
Measured: Up to 2 Weeks

Secondary outcomes (4)

Percentage of Participants Who Transitioned to LEM at the End of the 2-Week Titration Period of Core Study Within Each Cohort
Transition to LEM was defined as participant who remained on LEM at the end of the 2-week titration period and either 1) entered the extension phase, or 2) chooses to not enter the extension phase for reasons not related to LEM (including, but not limited to, time commitment related to the study, study-related travel expenses or preference to continue insomnia management with another health care provider).
Measured: Up to 2 Weeks
Percentage of Participants in the LEM5 Treatment Groups With Dose Increasing to LEM10 at the End of the Titration Period of Core Study by Cohort and Overall
This outcome measure was planned for Cohort 1A, 1B and 2A. As there was no dose increase happened in Cohort 2B, this Outcome Measure is not applicable for Cohort 2B.
Measured: Up to 2 Weeks
Percentage of Participants in LEM10 Treatment Group With Dose Decreasing to LEM5 at the End of the Titration Period of Core Study in Cohort 2
This outcome measure was planned for Cohort 2B. As dose decrease happened in Cohort 2B only, this Outcome Measure is not applicable for Cohort 1A, 1B and 2A.
Measured: Up to 2 Weeks
Percentage of Participants With Positive Medication Effect Rating on Each Patient Global Impression of Insomnia (PGI-I) Item at the End of the 2-Week Titration Period of Core Study by Cohort and Overall Using End of the Titration Period Treatment
The PGI-I was a self-report assessment of participant perception of the effects of a medication on their sleep. The PGI-I had 3 items related to study medication effects (a) helped/worsened sleep, (b) decreased/increased time to fall asleep, (c) increased/decreased total sleep time, and 1 item related to perceived appropriateness of study medication strength. The first 3 items were answered on a 3-point scale (1=positive medication effect, 2=neutral medication effect, 3=negative medication effect) and the last item on a different 3 point scale (medication: 1=too strong, 2=just right, 3=too weak), only 'positive medication effects' and 'just right' are reported here.
Measured: Up to 2 Weeks

Timeline

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

15 Jul 201926 Jun 2020

First posted5 Jul 2019
Study start15 Jul 2019
Primary completion17 Mar 2020
Study completion26 Jun 2020

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.
Other trials for InsomniaStudies of the same condition, open and under way.
More trials run by Eisai Inc.The sponsor's other registered studies.
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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 53 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04009577
Sponsor's protocol ID: E2006-A001-312
Status last verified: Feb 2020
First submitted: 3 Jul 2019
Last updated: 12 Apr 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: Eisai's data sharing commitment and further information on how to request data can be found on our website https://eisaiclinicaltrials.com/

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

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All Insomnia trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Pilot Study to Evaluate Next-Dose Transition From Zolpidem to Lemborexant for the Treatment of Insomnia
ClinicalTrials.gov ID: NCT04009577
Acronym / sponsor ID: E2006-A001-312
Conditions: Insomnia
Keywords: Insomnia, Sleep Initiation and Maintenance Disorders, Insomnia Disorder, Sleeplessness, E2006, Zolpidem, Lemborexant
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 53 participants (actual)
Lead sponsor: Eisai Inc.Industry (pharma, biotech, devices)
Study start: 15 Jul 2019 (actual)
Primary completion: 17 Mar 2020 (actual)
Study completion: 26 Jun 2020 (actual)
First posted: 5 Jul 2019 (actual)
Results: Posted 12 Apr 2021

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Cohort 1 (LEM 5 mg)	Experimental	Drug: LEM 5 mgParticipants who were taking zolpidem tartrate (ZOL) at least 3 but fewer than 5 nights per week, for each of at least 2 weeks of the 3-week Screening Period, will initially receive LEM 5 mg administered as a tablet, orally for up to 2 weeks. Participants who meet both criteria for intermittent (Cohort 1) and frequent ZOL use (Cohort 2A and 2B) for 1 week each of the last 2 weeks of the 3-week Screening Period will be assigned to Cohort 1 and also will receive LEM 5mg.
Cohort 2A (LEM 5 mg)	Experimental	Drug: LEM 5 mgParticipants who were taking ZOL at least 5 nights per week, during, at minimum, the last 2 weeks of the 3-week Screening Period, will initially receive LEM 5 mg administered as a tablet, orally for up to 2 weeks.
Cohort 2B (LEM 10 mg)	Experimental	Drug: LEM 10 mgParticipants who were taking ZOL at least 5 nights per week, during, at minimum, the last 2 weeks of the 3-week Screening Period, will initially receive LEM 10 mg administered as a tablet, orally for up to 2 weeks.

Who may qualify

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

Key inclusion criteria (10 listed)

Meets the Diagnostic and Statistical Manual of Mental Disorders, 5th ed (DSM-5) criteria for Insomnia Disorder, either currently or prior to zolpidem use, as follows:
Reports spending at least 7 hours in bed per night
History of intermittent [taking zolpidem at least 3 or 4 nights per week], or frequent use (at least 5 nights per week) of ZOL-IR or ZOL-ER, for at least 1 month
Confirmation of intermittent or frequent use of zolpidem (based on review of drug use data). Intermittent use is defined as taking zolpidem at least 3 but fewer than 5 nights per week, for at least 2 weeks each of the 3-week Screening Period. Frequent use is defined as taking zolpidem at least 5 nights per week, during, at minimum, the last 2 weeks of the 3-week Screening Period
Willing and able to comply with all aspects of the protocol, including staying in bed for at least 7 hours each night

Key exclusion criteria (34 listed)

Females who are breastfeeding or pregnant at screening or baseline (as documented by a positive serum pregnancy test). A separate baseline assessment is required if a negative screening pregnancy test was obtained more than 72 hours before the first dose of study drug
Females of childbearing potential who:
Within 28 days before study entry, did not use a highly effective method of contraception, which includes any of the following:
Any history of moderate or severe obstructive sleep apnea (OSA)
Current evidence of a clinically significant, active respiratory disorder other than mild OSA. This includes bronchiectasis, emphysema, asthma, chronic obstructive pulmonary disease or any other pulmonary disorder identified by review of medical history or physical examination, and which in the opinion of the investigator, could compromise the participant's safety or interfere with study assessments

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
LEM 5 mgAlso: E2006, LemborexantLEM tablet.	Drug	Cohort 1 (LEM 5 mg), Cohort 2A (LEM 5 mg)
LEM 10 mgAlso: E2006, LemborexantLEM tablet.	Drug	Cohort 2B (LEM 10 mg)

Primary outcome

Percentage of Overall Participants Who Transitioned to LEM at the End of the Titration Period of Core Study
Time frame: Up to 2 Weeks
Transition to LEM was defined as participant who remained on LEM at the end of the 2-week titration period and either 1) entered the extension phase, or 2) chooses to not enter the extension phase for reasons not related to LEM (including, but not limited to, time commitment related to the study, study-related travel expenses or preference to continue insomnia management with another health care provider).

4 secondary outcomes

Percentage of Participants Who Transitioned to LEM at the End of the 2-Week Titration Period of Core Study Within Each Cohort
Time frame: Up to 2 Weeks
Percentage of Participants in the LEM5 Treatment Groups With Dose Increasing to LEM10 at the End of the Titration Period of Core Study by Cohort and Overall
Time frame: Up to 2 Weeks
Percentage of Participants in LEM10 Treatment Group With Dose Decreasing to LEM5 at the End of the Titration Period of Core Study in Cohort 2
Time frame: Up to 2 Weeks
Percentage of Participants With Positive Medication Effect Rating on Each Patient Global Impression of Insomnia (PGI-I) Item at the End of the 2-Week Titration Period of Core Study by Cohort and Overall Using End of the Titration Period Treatment
Time frame: Up to 2 Weeks

Results and safety

Results posted to the registry on 12 Apr 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cohort 1A: LEM 5 or LEM 10 (Intermittent ZOL Use)	7	6
Cohort 1B: LEM 5 or LEM 10 (Mixed ZOL Use)	3	3
Cohort 2A: LEM 5 or LEM 10 (Frequent ZOL Use)	21	17
Cohort 2B: LEM 10 or LEM 5 (Frequent ZOL Use)	22	17

Primary outcome: Percentage of Overall Participants Who Transitioned to LEM at the End of the Titration Period of Core Study

Time frame: Up to 2 Weeks. Number. Unit: percentage of participants

Measure	Overall Cohort n = 53
Value	81.1

Population analysed: The FAS included participants who received at least 1 dose of lemborexant.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: From the first dose of study drug up to 22 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cohort 1A (Core Study): LEM 5	0 of 7 (0%)	0 of 7 (0%)	0 of 7
Cohort 1A (Core Study): LEM 10	0 of 3 (0%)	0 of 3 (0%)	0 of 3
Cohort 1B (Core Study): LEM 5	0 of 3 (0%)	0 of 3 (0%)	0 of 3
Cohort 1B (Core Study): LEM 10	0 of 2 (0%)	0 of 2 (0%)	0 of 2
Cohort 2A (Core Study): LEM 5	0 of 21 (0%)	2 of 21 (9.5%)	0 of 21
Cohort 2A (Core Study): LEM 10	0 of 10 (0%)	0 of 10 (0%)	0 of 10
Cohort 2B (Core Study) : LEM 5	0 of 5 (0%)	0 of 5 (0%)	0 of 5
Cohort 2B (Core Study): LEM 10	0 of 22 (0%)	6 of 22 (27.3%)	0 of 22
Cohort 1A (Extension Phase): LEM 5	0 of 6 (0%)	0 of 6 (0%)	0 of 6
Cohort 1A (Extension Phase): LEM 10	0 of 5 (0%)	0 of 5 (0%)	0 of 5
Cohort 1B (Extension Phase): LEM 5	0 of 3 (0%)	0 of 3 (0%)	0 of 3
Cohort 1B (Extension Phase): LEM 10	0 of 3 (0%)	0 of 3 (0%)	0 of 3
Cohort 2A (Extension Phase): LEM 5	0 of 15 (0%)	0 of 15 (0%)	0 of 15
Cohort 2A (Extension Phase): LEM 10	0 of 12 (0%)	0 of 12 (0%)	0 of 12
Cohort 2B (Extension Phase): LEM 5	0 of 8 (0%)	0 of 8 (0%)	0 of 8
Cohort 2B (Extension Phase): LEM 10	1 of 17 (5.9%)	5 of 17 (29.4%)	0 of 17

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. Eisai's data sharing commitment and further information on how to request data can be found on our website https://eisaiclinicaltrials.com/

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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.

The record lists no contact. Use the official record to reach the sponsor.

17 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing LEM 5 mg and LEM 10 mg in people with Insomnia, run by Eisai Inc. at 17 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 10 inclusion and 34 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 12 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 12 Apr 2021). 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?

Percentage of Overall Participants Who Transitioned to LEM at the End of the Titration Period of Core Study (time frame: Up to 2 Weeks). 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 NCT04009577.

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 12 Apr 2021; AzTrials last refreshed its copy on 30 Oct 2026.