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
  Purpose

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 Intervention Phase
Healthy
Drug: Flumazenil
Drug: Placebo
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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)

Resource links provided by NLM:


Further study details as provided by Coeruleus Ltd.:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 20
Study Start Date: May 2010
Study Completion Date: October 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01071889

Locations
Israel
Rambam Medical Center
Haifa, Israel
Sponsors and Collaborators
Coeruleus Ltd.
  More Information

No publications provided

Responsible Party: Dr Medy Wiener/ CEO, Coeruleus Ltd.
ClinicalTrials.gov Identifier: NCT01071889     History of Changes
Other Study ID Numbers: 0076-10-RMB
Study First Received: February 17, 2010
Last Updated: November 14, 2010
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Coeruleus Ltd.:
Healthy Volunteers

Additional relevant MeSH terms:
Flumazenil
Hypnotics and Sedatives
Brotizolam
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Antidotes
Protective Agents
Central Nervous System Depressants
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 22, 2014