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Safety and the Efficacy of a Sublingual Administration of Flumazenil to Reverse the Effect of Hypnotic Drugs in Healthy Adults

Sponsor
Coeruleus Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT01071889
Collaborator
(none)
10
Enrollment
1
Location
2
Arms
38
Duration (Months)
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the safety and effectiveness of treatment with sublingual (s/l) Flumazenil in healthy volunteers as reversing the effect of the sleep/hypnotic drugs. This study is designed to collect short-term safety and tolerability data.

In addition, the psychomotor/ cognitive and behavioral effects of Flumazenil will be assessed to monitor the degree and the duration of action in a single use of Flumazenil.

Condition or Disease Intervention/Treatment Phase
Phase 1/Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
10 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Double-blind, Randomized, Placebo and Active Controlled Study to Assess the Safety and the Efficacy of a Sublingual Administration of Flumazenil to Reverse the Effect of Hypnotic Drugs in Healthy Adults(Zolpidem or Brotizolam)
Study Start Date :
May 1, 2010
Actual Primary Completion Date :
Aug 1, 2012
Actual Study Completion Date :
Jul 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Other: Brotizolam

Treatment response will be evaluated for each treatment arm. Good Response (GR) - is considered as an improvement of 30% in efficacy parameters of Flumazenil treatment in comparison to placebo

Drug: Flumazenil
Flumazenil- 0.4 mg per 100 µl in a sublingual spray administration
Other Names:
  • Romzicon,
  • Anexate®,
  • BRN 4763661,
  • Flumazenilo (Spanish),
  • Flumazenilum (Latin),
  • Flumazepil
  • Lanexat®,
  • Mazicon®,
  • Ro 151788,
  • Ro-15-1788,
  • Romazicon®,
  • UNII-40P7XK9392

    • Drug: Placebo
    Placebo - only excipients with no API
    Other: Zolpidem

    Treatment response will be evaluated for each treatment arm. Good Response (GR) - is considered as an improvement of 30% in efficacy parameters of Flumazenil treatment in comparison to placebo.

    Drug: Flumazenil
    Flumazenil- 0.4 mg per 100 µl in a sublingual spray administration
    Other Names:
  • Romzicon,
  • Anexate®,
  • BRN 4763661,
  • Flumazenilo (Spanish),
  • Flumazenilum (Latin),
  • Flumazepil
  • Lanexat®,
  • Mazicon®,
  • Ro 151788,
  • Ro-15-1788,
  • Romazicon®,
  • UNII-40P7XK9392

    • Drug: Placebo
    Placebo - only excipients with no API

    Outcome Measures

    Primary Outcome Measures

    1. Safety of single dose administration of sublingual Flumazenil 0.4 mg as a reversal drug for the hypnotic effect of sleep/ hypnotic drugs [6 months]

    Secondary Outcome Measures

    1. Efficacy of single dose administration of sublingual Flumazenil 0.4 mg as a reversal drug for the hypnotic effect of sleep/ hypnotic drugs [6 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    1. The subject understood and voluntarily signed an informed consent form prior to any study-mandated procedure.

    2. Male or female aged 18-65 at screening. Women of childbearing potential must have a negative pregnancy test at the screening visit and use a reliable method of contraception during the entire study duration (e.g.

    Contraceptive pill; Intra-uterine device; Contraceptive injection (prolonged-release gestagen); Subdermal implantation;Vaginal ring or Transdermal patch).

    1. Body mass index ≥ 18.5 and < 32 kg/m2.

    2. Normal sleep habits, i.e. usual self-reported total sleep time > 6 h; usual self-reported time to fall asleep < 30 min; usual bedtime between 10:30 pm and 01:00 am.

    3. Subject is in good health as determined by a medical history, physical examination and ECG.

    4. Negative any use of illicit drug, alcohol (ethanol), stimulants.

    Exclusion Criteria:

    1. Any use of medications within 1 month prior to screening visit, except for contraceptive pills.

    2. Any sleep associated complains.

    3. Previous exposure to Benzodiazepines and/or non-Benzodiazepine hypnotic drugs within 3 months prior to study initiation.

    4. History of Epilepsy and or anti-epileptic drugs.

    5. Excessive caffeine consumption (≥ 500 mg per day).

    6. Pregnancy or breast feeding.

    7. Night shift workers within 1 month prior to the screening visit.

    8. Clinically relevant ECG abnormalities.

    9. History of alcohol or drug abuse within 3 years prior to the screening visit.

    10. Cognitive Behavioral Therapy (CBT) started within 1 month prior to the screening visit.

    11. Known hypersensitivity to drugs of the same class as the study treatment, or any excipients of the drug formulation.

    12. Treatment with another investigational drug within 1 month prior to the screening visit.

    13. History of severe head injury.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Rambam Medical Center Haifa Israel

    Sponsors and Collaborators

    • Coeruleus Ltd.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Coeruleus Ltd.
    ClinicalTrials.gov Identifier:
    NCT01071889
    Other Study ID Numbers:
    • 0076-10-RMB
    First Posted:
    Feb 19, 2010
    Last Update Posted:
    Jan 30, 2015
    Last Verified:
    Jan 1, 2015
    Keywords provided by Coeruleus Ltd.
    Healthy Volunteers
    Additional relevant MeSH terms:
    Flumazenil

    Study Results

    No Results Posted as of Jan 30, 2015