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:
Coeruleus Ltd.
Information provided by:
Coeruleus Ltd.
ClinicalTrials.gov Identifier:
NCT01071889
First received: February 17, 2010
Last updated: November 14, 2010
Last verified: June 2010
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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:
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:
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:
- The subject understood and voluntarily signed an informed consent form prior to any study-mandated procedure.
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).
- Body mass index ≥ 18.5 and < 32 kg/m2.
- 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.
- Subject is in good health as determined by a medical history, physical examination and ECG.
- Negative any use of illicit drug, alcohol (ethanol), stimulants.
Exclusion Criteria:
- Any use of medications within 1 month prior to screening visit, except for contraceptive pills.
- Any sleep associated complains.
- Previous exposure to Benzodiazepines and/or non-Benzodiazepine hypnotic drugs within 3 months prior to study initiation.
- History of Epilepsy and or anti-epileptic drugs.
- Excessive caffeine consumption (≥ 500 mg per day).
- Pregnancy or breast feeding.
- Night shift workers within 1 month prior to the screening visit.
- Clinically relevant ECG abnormalities.
- History of alcohol or drug abuse within 3 years prior to the screening visit.
- Cognitive Behavioral Therapy (CBT) started within 1 month prior to the screening visit.
- Known hypersensitivity to drugs of the same class as the study treatment, or any excipients of the drug formulation.
- Treatment with another investigational drug within 1 month prior to the screening visit.
- History of severe head injury.
Contacts and Locations 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 May 23, 2013