Biolab Zolpidem Orodispersible 1.0 mg, 1.75 mg and 3.5 mg to Treat Maintenance Insomnia Disorder.

NCT03885141 | Unknown Phase 2

• 1 other identifier: ZOLP_18_01
• Study Type: interventional
• Target: 366
• Locations: 0 countries
• Sites: N/A

Brief 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 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

Keywords

Insomnia; Zolpidem

Outcome Measures

Primary Outcomes (1)

• 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.

  28 days

Secondary Outcomes (3)

• Total Sleep Time (polysomnography parameter)

  1 day

• Sleep Efficiency (polysomnography parameter)

  1 day

• Sleep Latency (polysomnography parameter)

  1 day

Study Arms (6)

Men - Placebo

PLACEBO COMPARATOR

Men - Placebo, 1 tablet if a wake up occurs

Drug: Zolpidem

Men - Zolpidem 1.75 mg

EXPERIMENTAL

Men - Zolpidem 1.75 mg, 1 tablet if a wake up occurs

Drug: Zolpidem

Men - Zolpidem 3.5 mg

EXPERIMENTAL

Men - Zolpidem 3.5 mg, 1 tablet if a wake up occurs

Drug: Zolpidem

Women - Placebo

PLACEBO COMPARATOR

Women - Placebo, 1 tablet if a wake up occurs

Drug: Zolpidem

Women - Zolpidem 1.0 mg

EXPERIMENTAL

Women - Zolpidem 1.0 mg, 1 tablet if a wake up occurs

Drug: Zolpidem

Women - Zolpidem 1.75 mg

EXPERIMENTAL

Women - Zolpidem 1.75 mg, 1 tablet if a wake up occurs

Drug: Zolpidem

Interventions

Zolpidem DRUG

Zolpidem or Placebo if there is a wake up during the night

Men - Placebo; Men - Zolpidem 1.75 mg; Men - Zolpidem 3.5 mg; Women - Placebo; Women - Zolpidem 1.0 mg; Women - Zolpidem 1.75 mg

Eligibility Criteria

• Age: 18 Years - 64 Years
• Gender Eligibility Details: Men: Placebo or Zolpidem 1.75 mg or Zolpidem 3.5 mg Women: Placebo or Zolpidem 1.0 mg or Zolpidem 1.75 mg
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.
• History of chemical dependence or alcohol abuse.
• Any significant neurological and psychiatric disease or laboratory findings present, unless adequately controlled with medication allowed in the protocol.
• 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.

Sponsors & Collaborators

• Biolab Sanus Farmaceutica: lead

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Zolpidem

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Luciano R Pinto Junior, PhD

CONTACT

55.11.973342037; lucianoribeiro48@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Placebo
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 14, 2019
• First Posted: March 21, 2019
• Study Start: March 1, 2021
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: July 27, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share