InsomniaPhase 2NCT03814135
Efficacy and Safety of Two Doses of Hipnos in the Treatment of Adults With Insomnia
A Phase 2 study testing Hipnos 3 and Hipnos 5 in people with Insomnia, run by EMS.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of three doses of Hipnos medication in adults with insomnia. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Insomnia
- What is being tested?
- Hipnos 3 and Hipnos 5
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2021to Mar 2022
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants aged 50 years or more;
- Diagnosis of insomnia disorder according to criteria defined by the DSM-V;
- Sleep latency ≥ 20 minutes obtained through polysomnography performed prior to the randomization visit.
Who cannot join
- Any clinical and laboratory findings that, in the judgment of the investigator, may interfere with the safety of research participants;
- Known hypersensitivity to the formula components used during the clinical trial;
- Decompensated diabetes mellitus, hypothyroidism or hyperthyroidism;
- History of hepatic impairment;
- Current smoking;
- Pregnancy or risk of pregnancy and lactating patients;
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- History of sleep-disordered breathing, sleep disorders associated with changes in circadian rhythm and severe neurological and psychiatric disorders;
- Diagnosis of clinical diseases that interfere with sleep;
- Participants who have used psychostimulant medications, antidepressants and/ or antipsychotic with sedative effects and/or antiepileptic;
- Participation in clinical trial in the year prior to this study.
About this study
Official title: Randomized, Double-blind, Double-dummy, National, Phase II Clinical Trial to Evaluate the Efficacy and Safety of Two Doses of Hipnos Medication in the Treatment of Adults With Insomnia
The purpose of this study is to evaluate the efficacy and safety of three doses of Hipnos medication in adults with insomnia.
- Conditions
- Insomnia
- Being tested
- Hipnos 3, Hipnos 5, Hipnos 5 Placebo, Hipnos 3 Placebo
- Keywords
- insomnia
- 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.
Hipnos 3Drug
Also called EMS tablet
1 tablet, oral, once a day.
Hipnos 5Drug
Also called EMS tablet
1 tablet, oral, once a day.
Hipnos 5 PlaceboOther
Also called Placebo
1 tablet, oral, once a day.
Hipnos 3 PlaceboOther
Also called Placebo
1 tablet, oral, once a day.
| Study group | Role | What they receive |
|---|---|---|
| HIPNOS 3 | Experimental | The study is double-dummy. Thus, the patient will take 2 tablets, as follow:
1 tablet Hipnos 3 and 1 placebo tablet, oral, once a day. Receives: Drug: Hipnos 3; Other: Hipnos 5 Placebo |
| HIPNOS 5 | Experimental | The study is double-dummy. Thus, the patient will take 2 tablets, as follow:
1 tablet Hipnos 5 and 1 placebo tablet, oral, once a day. Receives: Drug: Hipnos 5; Other: Hipnos 3 Placebo |
| HIPNOS Placebo | Placebo comparator | The study is double-dummy. Thus, the patient will take 2 tablet of placebo, oral, once a day. Receives: Other: Hipnos 5 Placebo; Other: Hipnos 3 Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in sleep latency time, obtained through polysomnography, performed before and at the end of treatment.
Measured: 4 weeks
Secondary outcomes (1)
Incidence and severity of adverse events recorded during the study.
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2019
- Study startJan 2021 (estimated)
- Primary completionFeb 2022 (estimated)
- Study completionMar 2022 (estimated)
Why it stopped: Sponsor decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsomniaStudies of the same condition, open and under way.
- More trials run by EMSThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- EMS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03814135
- Sponsor's protocol ID
- EMS0518 - HIPNOS
- Status last verified
- Mar 2021
- First submitted
- 22 Jan 2019
- Last updated
- 1 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind, Double-dummy, National, Phase II Clinical Trial to Evaluate the Efficacy and Safety of Two Doses of Hipnos Medication in the Treatment of Adults With Insomnia
- ClinicalTrials.gov ID
- NCT03814135
- Acronym / sponsor ID
- EMS0518 - HIPNOS
- Conditions
- Insomnia
- Keywords
- insomnia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsor decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- EMSIndustry (pharma, biotech, devices)
- Study start
- Jan 2021 (estimated)
- Primary completion
- Feb 2022 (estimated)
- Study completion
- Mar 2022 (estimated)
- First posted
- 23 Jan 2019 (actual)
- 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 this study is to evaluate the efficacy and safety of three doses of Hipnos medication in adults with insomnia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HIPNOS 3 | Experimental | Drug: Hipnos 3, Other: Hipnos 5 PlaceboThe study is double-dummy. Thus, the patient will take 2 tablets, as follow: 1 tablet Hipnos 3 and 1 placebo tablet, oral, once a day. |
| HIPNOS 5 | Experimental | Drug: Hipnos 5, Other: Hipnos 3 PlaceboThe study is double-dummy. Thus, the patient will take 2 tablets, as follow: 1 tablet Hipnos 5 and 1 placebo tablet, oral, once a day. |
| HIPNOS Placebo | Placebo comparator | Other: Hipnos 5 Placebo, Other: Hipnos 3 PlaceboThe study is double-dummy. Thus, the patient will take 2 tablet of placebo, oral, once a day. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participants aged 50 years or more;
- Diagnosis of insomnia disorder according to criteria defined by the DSM-V;
- Sleep latency ≥ 20 minutes obtained through polysomnography performed prior to the randomization visit.
Key exclusion criteria (10 listed)
- Any clinical and laboratory findings that, in the judgment of the investigator, may interfere with the safety of research participants;
- Known hypersensitivity to the formula components used during the clinical trial;
- Decompensated diabetes mellitus, hypothyroidism or hyperthyroidism;
- History of hepatic impairment;
- Current smoking;
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 |
|---|---|---|
| Hipnos 3Also: EMS tablet1 tablet, oral, once a day. | Drug | HIPNOS 3 |
| Hipnos 5Also: EMS tablet1 tablet, oral, once a day. | Drug | HIPNOS 5 |
| Hipnos 5 PlaceboAlso: Placebo1 tablet, oral, once a day. | Other | HIPNOS 3, HIPNOS Placebo |
| Hipnos 3 PlaceboAlso: Placebo1 tablet, oral, once a day. | Other | HIPNOS 5, HIPNOS Placebo |
Primary outcome
Change in sleep latency time, obtained through polysomnography, performed before and at the end of treatment.
Time frame: 4 weeks
1 secondary outcome
Incidence and severity of adverse events recorded during the study.
Time frame: 5 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2021.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Hipnos 3 and Hipnos 5 in people with Insomnia, run by EMS.
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 3 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: withdrawn, as of the sponsor's last update on 1 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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 sleep latency time, obtained through polysomnography, performed before and at the end of treatment. (time frame: 4 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 1 Apr 2021.