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Safety and Efficacy of Zolpidem in the Long-Term Treatment of Insomnia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05456152
Recruitment Status : Not yet recruiting
First Posted : July 13, 2022
Last Update Posted : August 9, 2022
Sponsor:
Information provided by (Responsible Party):
EMS

Tracking Information
First Submitted Date  ICMJE July 8, 2022
First Posted Date  ICMJE July 13, 2022
Last Update Posted Date August 9, 2022
Estimated Study Start Date  ICMJE June 2023
Estimated Primary Completion Date January 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 8, 2022)
To assess the safety profile of sublingual zolpidem during the long-term insomnia treatment. [ Time Frame: 60 days. ]
The safety profile will be assessed considering the number and percentage of each adverse event.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 5, 2022)
  • To evaluate daytime sleepiness in the next morning. [ Time Frame: 60 days. ]
    The daytime sleepiness will be assessed using the Epworth Sleepiness Scale (ESS). The scale has a score from 0 to 24 and a score more than 10 is considered as excessive daytime sleepiness.
  • To assess the adverse events during 7 days after the last dose administration. [ Time Frame: 7 days. ]
    The safety profile will be assessed considering the number and percentage of each adverse event occurred 7 days after the last dose administration.
  • To assess the number of adverse events in different periods of the clinical trial. [ Time Frame: 60 days. ]
    The safety profile will be assessed considering the number of adverse events during the first 30 days and from 31 to 60 days of treatment.
  • To assess the number of participants with adverse events in different periods of the clinical trial. [ Time Frame: 60 days. ]
    The safety profile will be assessed considering the number of adverse events during the first 30 days and from 31 to 60 days of treatment.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 8, 2022)
  • To evaluate daytime sleepiness in the next morning. [ Time Frame: 60 days. ]
    The daytime sleepiness will be assessed using the Epworth Sleepiness Scale.
  • To assess the adverse events during 7 days after the last dose administration. [ Time Frame: 7 days. ]
    The safety profile will be assessed considering the number and percentage of each adverse event occurred 7 days after the last dose administration.
  • To assess the number of adverse events in different periods of the clinical trial. [ Time Frame: 60 days. ]
    The safety profile will be assessed considering the number of adverse events during the first 30 days and from 31 to 60 days of treatment.
  • To assess the number of participants with adverse events in different periods of the clinical trial. [ Time Frame: 60 days. ]
    The safety profile will be assessed considering the number of adverse events during the first 30 days and from 31 to 60 days of treatment.
Current Other Pre-specified Outcome Measures
 (submitted: July 8, 2022)
  • To assess the efficacy of sublingual zolpidem in the sleep induction. [ Time Frame: 60 days. ]
    The efficacy will be evaluated considering any change in the Latency to Persistent Sleep parameter (LPS) after 60 days of treatment in comparison to the baseline measure.
  • To assess the efficacy of sublingual zolpidem in the improvement of sleep quality. [ Time Frame: 60 days. ]
    The efficacy will be evaluated considering any change in the Sleep Efficiency parameter (SE) after 60 days of treatment in comparison to the baseline measure.
  • To assess the efficacy of sublingual zolpidem in the improvement of time awake before onset. [ Time Frame: 60 days. ]
    The efficacy will be evaluated considering any change in the Wake After Sleep Onset parameter (WASO) after 60 days of treatment in comparison to the baseline measure.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of Zolpidem in the Long-Term Treatment of Insomnia
Official Title  ICMJE National, Multicenter, Open, Single-arm, Phase III Clinical Trial to Evaluate the Safety and Efficacy of Zolpidem in the Long-Term Treatment of Insomnia.
Brief Summary The purpose of this study is to evaluate the safety and efficacy of sublingual zolpidem during the long-term treatment of insomnia.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Chronic Insomnia
Intervention  ICMJE Drug: Sublingual Tablet
Sublingual zolpidem - 1 sublingual tablet 30 minutes before bed time.
Study Arms  ICMJE Experimental: Sublingual zolpidem
1 sublingual tablet (5mg) 30 minutes before bed time during 60 days.
Intervention: Drug: Sublingual Tablet
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: July 8, 2022)
358
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2025
Estimated Primary Completion Date January 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Ability to confirm voluntary participation and agree to all trial purposes by signing and dating the informed consent forms;
  • Age between 18 to 64 years;
  • Participants diagnosed with chronic insomnia defined by difficulty in initiating or maintaining sleep in the last 3 months for at least 3 nights a week according to DSM-V criteria and confirmed by polysomnography;
  • Participants with difficulty in initiating or maintaining sleep parameters.

Exclusion Criteria:

  • Participants with clinical or laboratory diagnose of non-treated hypothyroidism or hyperthyroidism, kidney or liver failure;
  • Known hypersensitivity to any of the formula compounds;
  • Participants with other sleep disorders according to the International Classification Sleep Disorders (3rd edition), example: sleep-relate breathing disorders, circadian rhythm sleep-wake disorders, parasomnias (including history of sleep-walking after hypnotic use) and sleep related movement disorders;
  • Participants using sedatives or hypnotic medications;
  • Participants with current diagnosis of depression or anxiety according to the Diagnostic and Statistical Manual of Mental Disorders;
  • Participants with history of drug and alcohol abuse in the past 2 years;
  • Participants with current smoking habits during the night period;
  • Participants who treated insomnia in the last 3 months;
  • Participants who are pregnant, breastfeeding or planning to get pregnant or female participants with the potential to become pregnant who are not using a reliable method of contraception;
  • Any clinical and laboratory findings that, in the judgment of the investigator, may interfere with the safety of research participants;
  • Participants with current or medical history of cancer in the last 5 years;
  • Participants who participated in other research protocol in the last 12 months, unless the investigator judges that there may be a direct benefit to it.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 64 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Alexandra F.D. Alves, MSc +551938878917 pesquisa.clinica@ncfarma.com.br
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05456152
Other Study ID Numbers  ICMJE EMS0222- SERENA
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party EMS
Original Responsible Party Same as current
Current Study Sponsor  ICMJE EMS
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account EMS
Verification Date August 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP