InsomniaPhase 2TINANCT07420816
Efficacy and Safety of APSTZD in the Treatment of Insomnia Disorder
A Phase 2 study testing APSTZD 1, APSTZD 2 and APSTZD 3 in people with Insomnia and Insomnia Chronic, run by Apsen Farmaceutica S.A. at 1 site in Brazil.
Trial summary
The purpose of this study is to evaluate the efficacy of APSTZD compared to one active drug and placebo in insomnia treatment. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Insomnia, Insomnia Chronic
- What is being tested?
- APSTZD 1, APSTZD 2 and APSTZD 3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 222 participants
- Where
- 1 siteBrazil
- Study dates
- 5 Aug 2026to Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- Participants aged between 18 and 64 years;
- Participants diagnosed with insomnia disorder according to the criteria defined by the DSM-V (1) and who report sleep maintenance disorder;
- Participants who agree not to use alcoholic beverages during the entire treatment period (6 weeks).
Who cannot join
- Participants with known hypersensitivity to the active ingredients used during the trial or who have exhibited complex sleep behavior after using them;
- Participants with a history of alcohol, substance, or illicit drug abuse disorder in the last 2 years;
- Women who are pregnant or breastfeeding, as well as women who have a positive result on a pregnancy test (β-hCG) during the screening period of the trial;
- Participants diagnosed with severe liver failure;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
UNIFAG - Casa Nossa Senhora da PAZ -ASF
Bragança Paulista, São Paulo, 12916-900
Rafaella Santos Dantas Beltrame, +55(35)98833-9715, rafaellasantosdantas@gmail.com
About this study
Official title: Phase II Randomized, Multicenter, Double-blind, Doubledummy, Parallel Clinical Trial to Evaluate the Efficacy and Safety of APSTZD in the Treatment of Insomnia Disorder
The purpose of this study is to evaluate the efficacy of APSTZD compared to one active drug and placebo in insomnia treatment.
- Conditions
- Insomnia, Insomnia Chronic
- Being tested
- APSTZD 1, APSTZD 2, APSTZD 3, APSTZD 4, Stilnox CR®
- 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.
APSTZD 1Drug
APSTZD + placebo test 2 + placebo test 3 + placebo test 4 + comparator placebo 1
APSTZD 2Drug
APSTZD + placebo test 1 + placebo test 3 + placebo test 4 + comparator placebo 1
APSTZD 3Drug
APSTZD + placebo test 1 + placebo test 2 + placebo test 4 + comparator placebo 1
APSTZD 4Drug
APSTZD + placebo test 1 + placebo test 2 + placebo test 3 + comparator placebo 1
Stilnox CR®Drug
Stilnox CR® + placebo test 1 + placebo test 2 + placebo test 3 + placebo test 4
PlaceboDrug
placebo test 1 + placebo test 2 + placebo test 3 + placebo test 4 + comparator 1
| Study group | Role | What they receive |
|---|---|---|
| APSTZD 1 | Experimental | 5 oral tablets, once a day, before bedtime, for 6 weeks. Receives: Drug: APSTZD 1 |
| APSTZD 2 | Experimental | 5 oral tablets, once a day, before bedtime, for 6 weeks. Receives: Drug: APSTZD 2 |
| APSTZD 3 | Experimental | 5 oral tablets, once a day, before bedtime, for 6 weeks. Receives: Drug: APSTZD 3 |
| APSTZD 4 | Experimental | 5 oral tablets, once a day, before bedtime, for 6 weeks. Receives: Drug: APSTZD 4 |
| Stilnox CR® | Active comparator | 5 oral tablets, once a day, before bedtime, for 6 weeks. Receives: Drug: Stilnox CR® |
| Placebo | Placebo comparator | 5 oral tablets, once a day, before bedtime, for 6 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in WASO 6h (Wake After Sleep Onset) assessed by polysomnography
Measured: Change from baseline after 2 weeks of treatment
Secondary outcomes (1)
Adverse events incidence and classification
Measured: Through study completion, up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2026
- Study start5 Aug 2026
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
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.
- 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
- 222 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Apsen Farmaceutica S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07420816
- Sponsor's protocol ID
- APS002/2024
- Acronym
- TINA
- Status last verified
- Aug 2026
- First submitted
- 6 Feb 2026
- Last updated
- 21 Aug 2026
- 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 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Randomized, Multicenter, Double-blind, Doubledummy, Parallel Clinical Trial to Evaluate the Efficacy and Safety of APSTZD in the Treatment of Insomnia Disorder
- ClinicalTrials.gov ID
- NCT07420816
- Acronym / sponsor ID
- TINA / APS002/2024
- Conditions
- Insomnia, Insomnia Chronic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 222 participants (estimated)
- Lead sponsor
- Apsen Farmaceutica S.A.Industry (pharma, biotech, devices)
- Study start
- 5 Aug 2026 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 19 Feb 2026 (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 of APSTZD compared to one active drug and placebo in insomnia treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| APSTZD 1 | Experimental | Drug: APSTZD 15 oral tablets, once a day, before bedtime, for 6 weeks. |
| APSTZD 2 | Experimental | Drug: APSTZD 25 oral tablets, once a day, before bedtime, for 6 weeks. |
| APSTZD 3 | Experimental | Drug: APSTZD 35 oral tablets, once a day, before bedtime, for 6 weeks. |
| APSTZD 4 | Experimental | Drug: APSTZD 45 oral tablets, once a day, before bedtime, for 6 weeks. |
| Stilnox CR® | Active comparator | Drug: Stilnox CR®5 oral tablets, once a day, before bedtime, for 6 weeks. |
| Placebo | Placebo comparator | Drug: Placebo5 oral tablets, once a day, before bedtime, for 6 weeks. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Participants aged between 18 and 64 years;
- Participants diagnosed with insomnia disorder according to the criteria defined by the DSM-V (1) and who report sleep maintenance disorder;
- Participants who agree not to use alcoholic beverages during the entire treatment period (6 weeks).
Key exclusion criteria (4 listed)
- Participants with known hypersensitivity to the active ingredients used during the trial or who have exhibited complex sleep behavior after using them;
- Participants with a history of alcohol, substance, or illicit drug abuse disorder in the last 2 years;
- Women who are pregnant or breastfeeding, as well as women who have a positive result on a pregnancy test (β-hCG) during the screening period of the trial;
- Participants diagnosed with severe liver failure;
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 |
|---|---|---|
| APSTZD 1APSTZD + placebo test 2 + placebo test 3 + placebo test 4 + comparator placebo 1 | Drug | APSTZD 1 |
| APSTZD 2APSTZD + placebo test 1 + placebo test 3 + placebo test 4 + comparator placebo 1 | Drug | APSTZD 2 |
| APSTZD 3APSTZD + placebo test 1 + placebo test 2 + placebo test 4 + comparator placebo 1 | Drug | APSTZD 3 |
| APSTZD 4APSTZD + placebo test 1 + placebo test 2 + placebo test 3 + comparator placebo 1 | Drug | APSTZD 4 |
| Stilnox CR®Stilnox CR® + placebo test 1 + placebo test 2 + placebo test 3 + placebo test 4 | Drug | Stilnox CR® |
| Placeboplacebo test 1 + placebo test 2 + placebo test 3 + placebo test 4 + comparator 1 | Drug | Placebo |
Primary outcome
Reduction in WASO 6h (Wake After Sleep Onset) assessed by polysomnography
Time frame: Change from baseline after 2 weeks of treatment
1 secondary outcome
Adverse events incidence and classification
Time frame: Through study completion, up to 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing APSTZD 1, APSTZD 2 and APSTZD 3 in people with Insomnia and Insomnia Chronic, run by Apsen Farmaceutica S.A. at 1 site 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 4 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: looking for participants now, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bianca Zanetti (+55115641-2305, bianca.zanetti@apsen.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in WASO 6h (Wake After Sleep Onset) assessed by polysomnography (time frame: Change from baseline after 2 weeks of treatment). 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 21 Aug 2026.