Insomnia DisorderPhase 2/3ZOLP_18_01NCT03885141
Biolab Zolpidem Orodispersible 1.0 mg, 1.75 mg and 3.5 mg to Treat Maintenance Insomnia Disorder.
A Phase 2/3 study testing Zolpidem in people with Insomnia Disorder, run by Biolab Sanus Farmaceutica.
Trial summary
Biolab Sanus is developing a product in the form of orodispersible tablet containing 1.0 mg, 1.75 mg and 3.5 mg of Zolpidem®. Thus, it is intended to evaluate the efficacy of Zolpidem® Orodispersible 1.0 mg or 1.75 mg in women and Zolpidem Orodispersible 1.75 mg or 3.5 mg in men for the improvement of the maintenance… Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Insomnia Disorder
- What is being tested?
- Zolpidem
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 366 participants
- Where
- No sites listed yet
- Study dates
- Mar 2021to Dec 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 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Men and women ≥ 18 years and ≤ 64 years of age
- Participants willing and able to provide a written informed consent form, after an explanation of the nature of the study, and prior to any procedures related to the study.
- Adults with clinical diagnosis of insomnia, as defined by the Diagnostic and Statistical Manual of Mental Disorders (DSM-V-TR) and who complain of difficulty in maintaining sleep, starting more than three months before the study initiation, and for three or more sleepless nights per week.
- Participants with ability to understand and willingness to comply with the study procedures
Who cannot join
- History of Allergy or Hypersensitivity to Zolpidem;
- All initial and secondary insomnia;
- Basal polysomnography with apnea and hypopnea index> 20 events / hour and PLM (Periodic Leg Movements)> 15 events / hour.
- Participants who used central nervous system medication or other medication known to interfere with the sleep / wake up cycle within 15 days prior to enrollment in the study, at the discretion of the study investigator.
- Clinically significant diseases or surgeries, at the discretion of the principal investigator, within 30 days prior to study inclusion.
- History of chemical dependence or alcohol abuse.
Show all 11Show fewer
- Any significant neurological and psychiatric disease or laboratory findings present, unless adequately controlled with medication allowed in the protocol.
- Participants who received any investigational medication in the last 12 months prior to study inclusion.
- Women who are pregnant or breastfeeding or who wish to become pregnant or who refuse to use safe contraceptive methods during the study.
- Any disorder of the circadian cycle.
- Regular night shift work within the last 2 weeks prior to study enrollment or expected to work in shifts during the study.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Phase II / III Study, One Center, Double-Blind, With Placebo Use, in Parallel Groups to Assess the Efficacy and Safety of Zolpidem® Orodispersible in Adult Subjects (Females and Males) in the Treatment of Maintenance Insomnia Disorder.
Biolab Sanus is developing a product in the form of orodispersible tablet containing 1.0 mg, 1.75 mg and 3.5 mg of Zolpidem®. Thus, it is intended to evaluate the efficacy of Zolpidem® Orodispersible 1.0 mg or 1.75 mg in women and Zolpidem Orodispersible 1.75 mg or 3.5 mg in men for the improvement of the maintenance insomnia disorder, through the evaluation of the Insomnia Severity Index, and using a Sleep Diary throughout the study, as well as to evaluate the latency of the sleep after a spontaneous or provoked wake up measured by polysomnography.
Read the detailed description
Information provided evidence for the therapeutic use of Zolpidem® in the treatment of insomnia. Several studies have emphasized the importance of using Zolpidem® in small doses, in the orodispersible form, in the treatment of insomnia. Accordingly, Biolab Sanus is developing a product in the form of orodispersible tablet containing 1.0 mg, 1.75 mg and 3.5 mg of Zolpidem®. Thus, it is intended to evaluate the efficacy of Zolpidem® Orodispersible 1.0 mg or 1.75 mg in women and Zolpidem Orodispersible 1.75 mg or 3.5 mg in men for the improvement of the maintenance insomnia disorder, through the evaluation of the Insomnia Severity Index, and using a Sleep Diary throughout the study, as well as to evaluate the latency of the sleep after a spontaneous or provoked wake up measured by polysomnography.
- Conditions
- Insomnia Disorder
- Being tested
- Zolpidem
- Keywords
- Insomnia, Zolpidem
- 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.
ZolpidemDrug
Zolpidem or Placebo if there is a wake up during the night
| Study group | Role | What they receive |
|---|---|---|
| Men - Placebo | Placebo comparator | Men - Placebo, 1 tablet if a wake up occurs Receives: Drug: Zolpidem |
| Men - Zolpidem 1.75 mg | Experimental | Men - Zolpidem 1.75 mg, 1 tablet if a wake up occurs Receives: Drug: Zolpidem |
| Men - Zolpidem 3.5 mg | Experimental | Men - Zolpidem 3.5 mg, 1 tablet if a wake up occurs Receives: Drug: Zolpidem |
| Women - Placebo | Placebo comparator | Women - Placebo, 1 tablet if a wake up occurs Receives: Drug: Zolpidem |
| Women - Zolpidem 1.0 mg | Experimental | Women - Zolpidem 1.0 mg, 1 tablet if a wake up occurs Receives: Drug: Zolpidem |
| Women - Zolpidem 1.75 mg | Experimental | Women - Zolpidem 1.75 mg, 1 tablet if a wake up occurs Receives: Drug: Zolpidem |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference Insomnia Severity Index (ISI) as assessed by questionnaire before treatment and after the treatment
To analyse the efficacy of Zolpidem® Orodispersible treatment 1.0 mg or 1.75 mg in women and 1.75 mg and 3.5 mg in men, compared to placebo, after taking the medication when a spontaneous wake up occurs during 28 days. The assessement will be performed by means of the standard questionnaire before and at the end of the treatment period. The computed mean difference for each treatment will be compared by ANOVA (treatment doses vs placebo in each gender) in order to assess its statistical significance.
Measured: 28 days
Secondary outcomes (3)
Total Sleep Time (polysomnography parameter)
Total Sleep Time after a provoked wake up, and the administration of 1 tablet of Zolpidem® Orodispersible 1.0 mg or 1.75 mg in women and 1.75 mg or 3.5 mg in men, as compared to placebo administration after a provoked wake up.
Measured: 1 day
Sleep Efficiency (polysomnography parameter)
Sleep Efficiency after a provoked wake up, and the administration of 1 tablet of Zolpidem® Orodispersible 1.0 mg or 1.75 mg in women and 1.75 mg or 3.5 mg in men, as compared to placebo administration after a provoked wake up.
Measured: 1 day
Sleep Latency (polysomnography parameter)
Sleep Latency after a provoked wake up, and the administration of 1 tablet of Zolpidem® Orodispersible 1.0 mg or 1.75 mg in women and 1.75 mg or 3.5 mg in men, as compared to placebo administration after a provoked wake up.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2019
- Study startMar 2021 (estimated)
- Primary completionDec 2021 (estimated)
- Study completionDec 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
- Model description
- Assessment of the efficacy of Zolpidem treatment. The following will be evaluated: improvement of maintenance insomnia through the Sleep Diary and the Severity Index of the Insomnia (IGI), as well as sleep latency through polysomnography and treatment safety through the reporting of adverse events and laboratory tests.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 366 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biolab Sanus Farmaceutica
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03885141
- Sponsor's protocol ID
- ZOLP_18_01
- Acronym
- ZOLP_18_01
- Status last verified
- Jul 2020
- First submitted
- 14 Mar 2019
- Last updated
- 27 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II / III Study, One Center, Double-Blind, With Placebo Use, in Parallel Groups to Assess the Efficacy and Safety of Zolpidem® Orodispersible in Adult Subjects (Females and Males) in the Treatment of Maintenance Insomnia Disorder.
- ClinicalTrials.gov ID
- NCT03885141
- Acronym / sponsor ID
- ZOLP_18_01 / ZOLP_18_01
- Conditions
- Insomnia Disorder
- Keywords
- Insomnia, Zolpidem
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 366 participants (estimated)
- Lead sponsor
- Biolab Sanus FarmaceuticaIndustry (pharma, biotech, devices)
- Study start
- Mar 2021 (estimated)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 21 Mar 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.
Biolab Sanus is developing a product in the form of orodispersible tablet containing 1.0 mg, 1.75 mg and 3.5 mg of Zolpidem®. Thus, it is intended to evaluate the efficacy of Zolpidem® Orodispersible 1.0 mg or 1.75 mg in women and Zolpidem Orodispersible 1.75 mg or 3.5 mg in men for the improvement of the maintenance insomnia disorder, through the evaluation of the Insomnia Severity Index, and using a Sleep Diary throughout the study, as well as to evaluate the latency of the sleep after a spontaneous or provoked wake up measured by polysomnography.
Detailed description
Information provided evidence for the therapeutic use of Zolpidem® in the treatment of insomnia. Several studies have emphasized the importance of using Zolpidem® in small doses, in the orodispersible form, in the treatment of insomnia. Accordingly, Biolab Sanus is developing a product in the form of orodispersible tablet containing 1.0 mg, 1.75 mg and 3.5 mg of Zolpidem®. Thus, it is intended to evaluate the efficacy of Zolpidem® Orodispersible 1.0 mg or 1.75 mg in women and Zolpidem Orodispersible 1.75 mg or 3.5 mg in men for the improvement of the maintenance insomnia disorder, through the evaluation of the Insomnia Severity Index, and using a Sleep Diary throughout the study, as well as to evaluate the latency of the sleep after a spontaneous or provoked wake up measured by polysomnography.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
- Model description
- Assessment of the efficacy of Zolpidem treatment. The following will be evaluated: improvement of maintenance insomnia through the Sleep Diary and the Severity Index of the Insomnia (IGI), as well as sleep latency through polysomnography and treatment safety through the reporting of adverse events and laboratory tests.
| Arm | Type | Receives |
|---|---|---|
| Men - Placebo | Placebo comparator | Drug: ZolpidemMen - Placebo, 1 tablet if a wake up occurs |
| Men - Zolpidem 1.75 mg | Experimental | Drug: ZolpidemMen - Zolpidem 1.75 mg, 1 tablet if a wake up occurs |
| Men - Zolpidem 3.5 mg | Experimental | Drug: ZolpidemMen - Zolpidem 3.5 mg, 1 tablet if a wake up occurs |
| Women - Placebo | Placebo comparator | Drug: ZolpidemWomen - Placebo, 1 tablet if a wake up occurs |
| Women - Zolpidem 1.0 mg | Experimental | Drug: ZolpidemWomen - Zolpidem 1.0 mg, 1 tablet if a wake up occurs |
| Women - Zolpidem 1.75 mg | Experimental | Drug: ZolpidemWomen - Zolpidem 1.75 mg, 1 tablet if a wake up occurs |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Men and women ≥ 18 years and ≤ 64 years of age
- Participants willing and able to provide a written informed consent form, after an explanation of the nature of the study, and prior to any procedures related to the study.
- Adults with clinical diagnosis of insomnia, as defined by the Diagnostic and Statistical Manual of Mental Disorders (DSM-V-TR) and who complain of difficulty in maintaining sleep, starting more than three months before the study initiation, and for three or more sleepless nights per week.
- Participants with ability to understand and willingness to comply with the study procedures
Key exclusion criteria (11 listed)
- History of Allergy or Hypersensitivity to Zolpidem;
- All initial and secondary insomnia;
- Basal polysomnography with apnea and hypopnea index> 20 events / hour and PLM (Periodic Leg Movements)> 15 events / hour.
- Participants who used central nervous system medication or other medication known to interfere with the sleep / wake up cycle within 15 days prior to enrollment in the study, at the discretion of the study investigator.
- Clinically significant diseases or surgeries, at the discretion of the principal investigator, within 30 days prior to study inclusion.
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 |
|---|---|---|
| ZolpidemZolpidem or Placebo if there is a wake up during the night | Drug | Men - Placebo, Men - Zolpidem 1.75 mg, Men - Zolpidem 3.5 mg, Women - Placebo, Women - Zolpidem 1.0 mg, Women - Zolpidem 1.75 mg |
Primary outcome
Difference Insomnia Severity Index (ISI) as assessed by questionnaire before treatment and after the treatment
Time frame: 28 days
To analyse the efficacy of Zolpidem® Orodispersible treatment 1.0 mg or 1.75 mg in women and 1.75 mg and 3.5 mg in men, compared to placebo, after taking the medication when a spontaneous wake up occurs during 28 days. The assessement will be performed by means of the standard questionnaire before and at the end of the treatment period. The computed mean difference for each treatment will be compared by ANOVA (treatment doses vs placebo in each gender) in order to assess its statistical significance.
3 secondary outcomes
Total Sleep Time (polysomnography parameter)
Time frame: 1 day
Sleep Efficiency (polysomnography parameter)
Time frame: 1 day
Sleep Latency (polysomnography parameter)
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2020.
- Individual participant dataSharing planned: No
Related trials for Insomnia Disorder
Recruiting
Addressing Nocturia in Older Women Utilizing Behavioral Sleep Intervention and Brief Mindfulness
Nocturia, Insomnia
Not yet recruiting
A Transdiagnostic Sleep Health Intervention for Veterans With PTSD
Stress Disorders, Post-Traumatic, Sleep Initiation and Maintenance Disorders
Recruiting
Effect of Cyclic Sighing Breathing Exercise on CRBD, Pain, and Sleep Quality in Patients Undergoing TUR
Transurethral Resection of Bladder Tumor, Transurethral Resection of the Prostate (TURP)
Recruiting
Evaluation of Cognitive Behavioral Therapy for Insomnia (CBT-I) in Individuals With Mild Traumatic Brain Injury (mTBI)
Sleep Architecture, Mild Traumatic Brain Injury
RecruitingPhase 3
A Trial to See if Daridorexant Can Help Adults and Elderly People With Insomnia Sleep Better During the Night and Function Better During the Day
Insomia Disorder
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.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Zolpidem in people with Insomnia Disorder, run by Biolab Sanus Farmaceutica.
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 4 inclusion and 11 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 27 Jul 2020. 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 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 Luciano R Pinto Junior, PhD (55.11.973342037, lucianoribeiro48@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference Insomnia Severity Index (ISI) as assessed by questionnaire before treatment and after the treatment (time frame: 28 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 27 Jul 2020.