Insomnia DisorderPhase 2/3MorfeuNCT02798367
Melatonin 3mg and 5mg Compared to Cognitive Behavioral Therapy for Insomnia (CBT-I) in the Treatment of Insomnia
A Phase 2/3 study testing CBT-I plus Melatonin 3 mg and CBT-I plus Melatonin 5 mg in people with Insomnia Disorder, run by Ache Laboratorios Farmaceuticos S.A. at 8 sites in Brazil.
Trial summary
National clinical trials, phase II/III, combined in two stages, randomized, double-blind, controlled, parallel, study of superiority, in which three hundred and seven (307) participants of both sexes, aged equal or more than 55 years will be randomly allocated to one of three treatment groups. In the first stage. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Insomnia Disorder
- What is being tested?
- CBT-I plus Melatonin 3 mg and CBT-I plus Melatonin 5 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 307 participants
- Where
- 8 sitesBrazil
- Study dates
- 22 Mar 2018to 30 Nov 2021
- Phase
- Phase 2/3
- 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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Fulfill the criteria for insomnia disorder, according to DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, 5th Edition);
- Complaint of difficulty falling asleep;
- Ability to understand and consent their participation in this clinical study, expressed by signing the Informed Consent Form (ICF).
Who cannot join
- Any finding of clinical/physical observation or laboratory examination to be interpreted by the investigator as a risk to the inclusion of the participant in the clinical study;
- Known hypersensitivity to drug components used during the study;
- Participant have any family relationship to the second degree or bond with employees or employees of Sponsor and Sites;
- Participant has used beta-blockers (in the last 30 days prior to screening visit), psychoactive drugs or sedative effect, such as, but not limited to: sedatives (in the last 14 days prior to screening visit), hypnotics (in the last 07 days prior to screening visit), muscle relaxants (in the last 11 days prior to screening visit), antihistamines first generation (in the last 08 days prior to screening visit), and antidepressants, antiepileptics, antipsychotics, among others (in the last 30 days prior to screening visit);
- Participants diagnosed with clinical diseases that interfere with sleep, such as chronic pain, nocturia, hypothyroidism, hyperthyroidism, severe heart disease, serious neurological and psychiatric disorders according to the assessment of the investigator;
- Participants diabetics insulin dependent;
Show all 17Show fewer
- Sleep apnea moderate to severe - AHI > 20 (Apnoea-Hypopnoea Index) assessed by polysomnography at the baseline;
- Participants who work at night;
- Participant who has BMI ≥ 30;
- Participant score above 50 in Anxiety Inventory to assess the degree of anxiety;
- Participant with cognitive impairment, based on the result obtained in the Mini-Mental State Examination. The cognitive impairment will be considered with score below 13 points for illiterates, below 18 for participants with one to eight incomplete years of schooling, below 26 for those with education of eight or more years;
- Participant score above 20 on the Beck Inventory to assess depression;
- Abuse of alcohol or illicit drugs, according to the assessment of the investigator;
- Male participants who do not agree to use acceptable methods of contraception; 1) male participants: barrier methods, except surgically sterile (vasectomy) or participants who declare to perform sexual practices on a not to reproductive way. 2) methods of contraception for the male participant's partner: oral contraceptives, injectable contraceptives, intrauterine device (IUD), hormonal implants, hormonal patch, tubal ligation and barrier methods; except surgically sterile (bilateral oophorectomy or hysterectomy) or the menopausal for at least one year;
- Female participants who are in the reproductive age and do not agree to use acceptable methods of contraception (oral contraceptives, injectable contraceptives, intrauterine device (IUD), hormonal implants, barrier methods, hormonal patch and tubal ligation); except surgically sterile (bilateral oophorectomy or hysterectomy), the menopausal for at least one year and participants who declare to perform sexual practices on a not to reproductive way;
- Women in gestation period or who are breastfeeding;
- Participant who has participated in clinical trial protocols in the last twelve (12) months (CNS Resolution 251 of August 7, 1997, Part III, sub-item J), unless the investigator considers that there may be a direct benefit to the same.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Brazil8 sites, 5 recruiting
- Recruiting
Allergisa Pesquisa Dermato Cosmética Ltda.
Campinas, São Paulo
Mauro Crippa Jr., +55 19 3789-8615
- Terminated
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-903
- Recruiting
Hospital das Clinicas da Faculdade de Medicina de Ribeirão Preto USP
Ribeirão Preto, São Paulo, 14048-900
Alan Eckeli
- Terminated
Centro de Estudos Multidisciplinar CEPES da Faculdade de Medicina do ABC
Santo André, São Paulo
- Recruiting
Dr Consulta Clinica Medica Ltda
São Paulo, 01141-020
Tatiana Hirakawa
- Terminated
Centro Paulista de Investigação Clínica e Serviços Médicos Ltda.
São Paulo, 04266-010
- Recruiting
Centro de Desenvolvimento em Estudo Clínicos Brasil - CDEC Brasil
São Paulo
Dalva Poyares, +55 11 5579 0373
- Recruiting
CEDOES - Centro de Diagnóstico e Pesquisa da Osteoporose do Espirito Santo.
Vitória, Espírito Santo, 29055-450
Karina Oliveira
About this study
Official title: National, Phase II/III, Multicenter, Randomized, Double-blind, Controlled, Parallel,Effect of Melatonin 3mg and 5mg Plus Cognitive Behavioral Therapy for Insomnia (CBT-I) Compared to the CBT-I Alone in the Treatment of Insomnia Disorder
National clinical trials, phase II/III, combined in two stages, randomized, double-blind, controlled, parallel, study of superiority, in which three hundred and seven (307) participants of both sexes, aged equal or more than 55 years will be randomly allocated to one of three treatment groups. In the first stage. The group 01 will use Melatonin 3mg plus CBT-I, the group 02 will use Melatonin 5mg plus CBT-I and the group 03 will use CBT-I plus placebo.
Based on the results of an interim analysis will be making a decision on whether to proceed with the study and, if so, on which the doses will be selected for the second stage of the study, to be better studied. The final analysis of the treatments, melatonin in the selected dose plus CBT-I versus CBT-I alone and placebo, will include participants from both stages.
Read the detailed description
The treatment of insomnia disorder can be accomplished through pharmacological and nonpharmacological approaches. Behavioral techniques of Sleep Hygiene and Stimuli control are the most used. The Sleep hygiene is a psychoeducational intervention that teaches patients to prevent external or environmental factors generate adverse effects and harmful to sleep. The stimulus control technique is based on five instructions that encourages the patient to establish a proper sleep-wake rhythm and strengthens the links between the way for a quick sleep and well established. Melatonin is a hormone that participates in the regulation of the sleep-wake cycle, which is produced and secreted primarily by the pineal gland in the dark period and prepares the individual to sleep. Melatonin is involved in the induction of sleep and has proven therapeutic action in insomnia disorders, and may also play a role in the circadian timing system of mammals and serve as a marker for "biological clock".
- Conditions
- Insomnia Disorder
- Being tested
- CBT-I plus placebo, CBT-I plus Melatonin 3 mg, CBT-I plus Melatonin 5 mg
- Keywords
- insomnia, cognitive behavioral therapy for insomnia, melatonin
- 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.
CBT-I plus placeboBehavioural
Behavioral techniques of Sleep Hygiene and Stimulus Control standardized in clinical protocol plus placebo (01 tablet, orally, always at night one hour before bedtime) for 21(±2) days)
CBT-I plus Melatonin 3 mgDrug
Also called Melatonin
Behavioral techniques of Sleep Hygiene and Stimulus Control standardized in clinical protocol plus Melatonin 3 mg (01 tablet, orally, always at night one hour before bedtime) for 21(±2) days.
CBT-I plus Melatonin 5 mgDrug
Also called Melatonin
Behavioral techniques of Sleep Hygiene and Stimulus Control standardized in clinical protocol plus Melatonin 5 mg (01 tablet, orally, always at night one hour before bedtime) for 21(±2) days.
| Study group | Role | What they receive |
|---|---|---|
| CBT-I plus Melatonin 3 mg | Experimental | It's a tablet manufactured by Aché S.A., composed of melatonin 3mg. Melatonin 3mg tablet will be dispensed to 65 participants (first stage) of this group in a cartridge of 3 blisters with 10 tablets each, totalizing 30 tablets. If this arm is the best set for the second stage, more 56 participants will be randomly allocated in this group.The participant shall administer 01 tablet orally every 24 hours one hour before bedtime. The duration of treatment may be 21(±2) days.
CBT-I is a non-pharmacological effective treatment for insomnia disorder. Behavioral techniques of Sleep Hygiene and Stimuli control are the most used. The CBT-I guidelines are standardized in protocol. Receives: Behavioral: CBT-I plus placebo; Drug: CBT-I plus Melatonin 3 mg |
| CBT-I plus Melatonin 5 mg | Experimental | It's a tablet manufactured by Aché S.A., composed of melatonin 5mg. Melatonin 5mg tablet will be dispensed to 65 participants (first stage) of this group in a cartridge of 3 blisters with 10 tablets each, totalizing 30 tablets. If this arm is the best set for the second stage, more 56 participants will be randomly allocated in this group.The participant shall administer 01 tablet orally every 24 hours one hour before bedtime. The duration of treatment may be 21(±2) days.
CBT-I is a non-pharmacological effective treatment for insomnia disorder. Behavioral techniques of Sleep Hygiene and Stimuli control are the most used. The CBT-I guidelines are standardized in protocol. Receives: Behavioral: CBT-I plus placebo; Drug: CBT-I plus Melatonin 5 mg |
| CBT-I plus placebo | Other | It's a tablet manufactured by Aché S.A,. composed of placebo. The participants shall administer the placebo tablets to enable the double-blind study. Placebo will be dispensed to 65 (first stage) and 56 (second stage) participants of this group and shall administer 01 tablet orally every 24 hours one hour before bedtime for 21(±2) days.
Sleep hygiene is a psychoeducational intervention that teaches patients to prevent external or environmental factors generate adverse effects and harmful to sleep. The stimulus control technique is based on five instructions that encourages the patient to establish a proper sleep-wake rhythm and strengthens the links between the way for a quick and well consolidated sleep. The CBT-I guidelines are standardized in clinical protocol. Receives: Behavioral: CBT-I plus placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Sleep Latency after 21 (±2) days of the treatment.
Absolute change in sleep latency (in minutes) at the end of treatment compared to baseline. Sleep latency will be assessed by polysomnography.
Measured: 21 (±2) days
Secondary outcomes (9)
Quality of Sleep - Pittsburgh Sleep Quality Index
Absolute change the overall score PSQI-BR, at the end of treatment from baseline
Measured: 21 (±2) days
Wellness Day - Well-Being Index-5 (WHO-5)
Absolute change the overall score of the WHO-5 level, in the range of 0 to 100 points, at the end of treatment from baseline.
Measured: 21 (±2) days
Severity of Insomnia - Insomnia Severity Index
Absolute change the overall score of the Insomnia Severity Index at the end of treatment from baseline
Measured: 21 (±2) days
Total Sleep Time - Polysomnography
Evaluate the total sleep time by polysomnography at the end of treatment from baseline
Measured: 21 (±2) days
Sleep Architecture - the length and proportion of N1(non-rapid eyes movement) stages, N2, N3 and REM
Proportion of participants with sleep architecture classified as normal or abnormal, assessed by polysomnography at the end of treatment from baseline.
Measured: 21 (±2) days
Sleep Efficiency - Polysomnography
Sleep efficiency variation assessed by polysomnography at the end of treatment from baseline
Measured: 21 (±2) days
The Latency of Persistent Sleep - Polysomnography
Latency of persistent sleep variation assessed by polysomnography at the end of treatment from baseline
Measured: 21 (±2) days
Latency of REM (rapid eyes movement) Sleep - Polysomnography
Latency of REM sleep variation assessed by polysomnography at the end of treatment from baseline
Measured: 21 (±2) days
Satisfaction of the participants with the treatment.
Proportion of participants in each level of satisfaction category Likert 5 point (1. totally dissatisfied, 2. dissatisfied, 3. neither satisfied nor dissatisfied, 4. satisfied, 5. completely satisfied) evaluated comparing the groups at the end of treatment
Measured: 21 (±2) days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2016 (estimated)
- Study start22 Mar 2018
- Primary completion31 Oct 2021 (estimated)
- Study completion30 Nov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insomnia DisorderStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 307 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ache Laboratorios Farmaceuticos S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mauro Crippa Jr., Principal investigator, Allergisa Search Dermato Cosmetic Ltda.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02798367
- Sponsor's protocol ID
- ACH-MSZ-02-03(05/16)
- Acronym
- Morfeu
- Status last verified
- Sep 2020
- First submitted
- 9 Jun 2016
- Last updated
- 3 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National, Phase II/III, Multicenter, Randomized, Double-blind, Controlled, Parallel,Effect of Melatonin 3mg and 5mg Plus Cognitive Behavioral Therapy for Insomnia (CBT-I) Compared to the CBT-I Alone in the Treatment of Insomnia Disorder
- ClinicalTrials.gov ID
- NCT02798367
- Acronym / sponsor ID
- Morfeu / ACH-MSZ-02-03(05/16)
- Conditions
- Insomnia Disorder
- Keywords
- insomnia, cognitive behavioral therapy for insomnia, melatonin
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 307 participants (estimated)
- Lead sponsor
- Ache Laboratorios Farmaceuticos S.A.Industry (pharma, biotech, devices)
- Study start
- 22 Mar 2018 (actual)
- Primary completion
- 31 Oct 2021 (estimated)
- Study completion
- 30 Nov 2021 (estimated)
- First posted
- 14 Jun 2016 (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.
National clinical trials, phase II/III, combined in two stages, randomized, double-blind, controlled, parallel, study of superiority, in which three hundred and seven (307) participants of both sexes, aged equal or more than 55 years will be randomly allocated to one of three treatment groups. In the first stage. The group 01 will use Melatonin 3mg plus CBT-I, the group 02 will use Melatonin 5mg plus CBT-I and the group 03 will use CBT-I plus placebo.
Based on the results of an interim analysis will be making a decision on whether to proceed with the study and, if so, on which the doses will be selected for the second stage of the study, to be better studied. The final analysis of the treatments, melatonin in the selected dose plus CBT-I versus CBT-I alone and placebo, will include participants from both stages.
Detailed description
The treatment of insomnia disorder can be accomplished through pharmacological and nonpharmacological approaches. Behavioral techniques of Sleep Hygiene and Stimuli control are the most used. The Sleep hygiene is a psychoeducational intervention that teaches patients to prevent external or environmental factors generate adverse effects and harmful to sleep. The stimulus control technique is based on five instructions that encourages the patient to establish a proper sleep-wake rhythm and strengthens the links between the way for a quick sleep and well established. Melatonin is a hormone that participates in the regulation of the sleep-wake cycle, which is produced and secreted primarily by the pineal gland in the dark period and prepares the individual to sleep. Melatonin is involved in the induction of sleep and has proven therapeutic action in insomnia disorders, and may also play a role in the circadian timing system of mammals and serve as a marker for "biological clock".
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CBT-I plus Melatonin 3 mg | Experimental | Behavioral: CBT-I plus placebo, Drug: CBT-I plus Melatonin 3 mgIt's a tablet manufactured by Aché S.A., composed of melatonin 3mg. Melatonin 3mg tablet will be dispensed to 65 participants (first stage) of this group in a cartridge of 3 blisters with 10 tablets each, totalizing 30 tablets. If this arm is the best set for the second stage, more 56 participants will be randomly allocated in this group.The participant shall administer 01 tablet orally every 24 hours one hour before bedtime. The duration of treatment may be 21(±2) days. CBT-I is a non-pharmacological effective treatment for insomnia disorder. Behavioral techniques of Sleep Hygiene and Stimuli control are the most used. The CBT-I guidelines are standardized in protocol. |
| CBT-I plus Melatonin 5 mg | Experimental | Behavioral: CBT-I plus placebo, Drug: CBT-I plus Melatonin 5 mgIt's a tablet manufactured by Aché S.A., composed of melatonin 5mg. Melatonin 5mg tablet will be dispensed to 65 participants (first stage) of this group in a cartridge of 3 blisters with 10 tablets each, totalizing 30 tablets. If this arm is the best set for the second stage, more 56 participants will be randomly allocated in this group.The participant shall administer 01 tablet orally every 24 hours one hour before bedtime. The duration of treatment may be 21(±2) days. CBT-I is a non-pharmacological effective treatment for insomnia disorder. Behavioral techniques of Sleep Hygiene and Stimuli control are the most used. The CBT-I guidelines are standardized in protocol. |
| CBT-I plus placebo | Other | Behavioral: CBT-I plus placeboIt's a tablet manufactured by Aché S.A,. composed of placebo. The participants shall administer the placebo tablets to enable the double-blind study. Placebo will be dispensed to 65 (first stage) and 56 (second stage) participants of this group and shall administer 01 tablet orally every 24 hours one hour before bedtime for 21(±2) days. Sleep hygiene is a psychoeducational intervention that teaches patients to prevent external or environmental factors generate adverse effects and harmful to sleep. The stimulus control technique is based on five instructions that encourages the patient to establish a proper sleep-wake rhythm and strengthens the links between the way for a quick and well consolidated sleep. The CBT-I guidelines are standardized in clinical protocol. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Fulfill the criteria for insomnia disorder, according to DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, 5th Edition);
- Complaint of difficulty falling asleep;
- Ability to understand and consent their participation in this clinical study, expressed by signing the Informed Consent Form (ICF).
Key exclusion criteria (17 listed)
- Any finding of clinical/physical observation or laboratory examination to be interpreted by the investigator as a risk to the inclusion of the participant in the clinical study;
- Known hypersensitivity to drug components used during the study;
- Participant have any family relationship to the second degree or bond with employees or employees of Sponsor and Sites;
- Participant has used beta-blockers (in the last 30 days prior to screening visit), psychoactive drugs or sedative effect, such as, but not limited to: sedatives (in the last 14 days prior to screening visit), hypnotics (in the last 07 days prior to screening visit), muscle relaxants (in the last 11 days prior to screening visit), antihistamines first generation (in the last 08 days prior to screening visit), and antidepressants, antiepileptics, antipsychotics, among others (in the last 30 days prior to screening visit);
- Participants diagnosed with clinical diseases that interfere with sleep, such as chronic pain, nocturia, hypothyroidism, hyperthyroidism, severe heart disease, serious neurological and psychiatric disorders according to the assessment of the investigator;
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 |
|---|---|---|
| CBT-I plus placeboBehavioral techniques of Sleep Hygiene and Stimulus Control standardized in clinical protocol plus placebo (01 tablet, orally, always at night one hour before bedtime) for 21(±2) days) | Behavioural | CBT-I plus Melatonin 3 mg, CBT-I plus Melatonin 5 mg, CBT-I plus placebo |
| CBT-I plus Melatonin 3 mgAlso: MelatoninBehavioral techniques of Sleep Hygiene and Stimulus Control standardized in clinical protocol plus Melatonin 3 mg (01 tablet, orally, always at night one hour before bedtime) for 21(±2) days. | Drug | CBT-I plus Melatonin 3 mg |
| CBT-I plus Melatonin 5 mgAlso: MelatoninBehavioral techniques of Sleep Hygiene and Stimulus Control standardized in clinical protocol plus Melatonin 5 mg (01 tablet, orally, always at night one hour before bedtime) for 21(±2) days. | Drug | CBT-I plus Melatonin 5 mg |
Primary outcome
Change of Sleep Latency after 21 (±2) days of the treatment.
Time frame: 21 (±2) days
Absolute change in sleep latency (in minutes) at the end of treatment compared to baseline. Sleep latency will be assessed by polysomnography.
9 secondary outcomes
Quality of Sleep - Pittsburgh Sleep Quality Index
Time frame: 21 (±2) days
Wellness Day - Well-Being Index-5 (WHO-5)
Time frame: 21 (±2) days
Severity of Insomnia - Insomnia Severity Index
Time frame: 21 (±2) days
Total Sleep Time - Polysomnography
Time frame: 21 (±2) days
Sleep Architecture - the length and proportion of N1(non-rapid eyes movement) stages, N2, N3 and REM
Time frame: 21 (±2) days
Sleep Efficiency - Polysomnography
Time frame: 21 (±2) days
The Latency of Persistent Sleep - Polysomnography
Time frame: 21 (±2) days
Latency of REM (rapid eyes movement) Sleep - Polysomnography
Time frame: 21 (±2) days
Satisfaction of the participants with the treatment.
Time frame: 21 (±2) days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2020.
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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.
Mauro Crippa Jr. principal investigator
Allergisa Search Dermato Cosmetic Ltda.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing CBT-I plus Melatonin 3 mg and CBT-I plus Melatonin 5 mg in people with Insomnia Disorder, run by Ache Laboratorios Farmaceuticos S.A. at 8 sites in Brazil.
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 17 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 3 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Brazil. 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 combined 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.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elisangela Rorato (+55 11 2608-6130, elisangela.rorato@ache.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Sleep Latency after 21 (±2) days of the treatment. (time frame: 21 (±2) days). 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 3 Sep 2020.