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

This study has been completed.
Sponsor:
Information provided by:
Coeruleus Ltd.
ClinicalTrials.gov Identifier:
NCT01071889
First received: February 17, 2010
Last updated: November 14, 2010
Last verified: June 2010

February 17, 2010
November 14, 2010
May 2010
September 2010   (final data collection date for primary outcome measure)
Safety of single dose administration of sublingual Flumazenil 0.4 mg as a reversal drug for the hypnotic effect of sleep/ hypnotic drugs [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01071889 on ClinicalTrials.gov Archive Site
Efficacy of single dose administration of sublingual Flumazenil 0.4 mg as a reversal drug for the hypnotic effect of sleep/ hypnotic drugs [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Safety and the Efficacy of a Sublingual Administration of Flumazenil to Reverse the Effect of Hypnotic Drugs in Healthy Adults
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)

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.

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Healthy
  • 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
  • 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
    Interventions:
    • Drug: Flumazenil
    • Drug: Placebo
  • 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.
    Interventions:
    • Drug: Flumazenil
    • Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
October 2010
September 2010   (final data collection date for primary outcome measure)

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).

  3. Body mass index ≥ 18.5 and < 32 kg/m2.
  4. 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.
  5. Subject is in good health as determined by a medical history, physical examination and ECG.
  6. 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.
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Israel
 
NCT01071889
0076-10-RMB
No
Dr Medy Wiener/ CEO, Coeruleus Ltd.
Coeruleus Ltd.
Not Provided
Not Provided
Coeruleus Ltd.
June 2010

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