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Generated: December 14, 2018

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CLINICAL TRIALS PROFILE FOR FLUMAZENIL

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Clinical Trials for Flumazenil

Trial ID Title Status Sponsor Phase Summary
NCT00000246 Rapid Benzodiazepine Detoxification Using Flumazenil - 1 Completed National Institute on Drug Abuse (NIDA) Phase 2 The purpose of this study is to verify the hypothesis that the benzodiazepine antagonist, flumazenil, will reduce acute benzodiazepine withdrawal.
NCT00000246 Rapid Benzodiazepine Detoxification Using Flumazenil - 1 Completed Yale University Phase 2 The purpose of this study is to verify the hypothesis that the benzodiazepine antagonist, flumazenil, will reduce acute benzodiazepine withdrawal.
NCT00176670 A GameBoy as a Distraction Before Surgery in Children Completed University of Medicine and Dentistry of New Jersey Phase 2 Preoperative anxiety is characterized by subjective feelings of tension, apprehension, nervousness and worry. In children, preoperative anxiety is reported to result in postoperative negative psychological effects, including nightmares, separation anxiety, eating problems and increased fear of doctors. Anxiety in children can be expressed in many forms. Many children look scared, become agitated, breathe deeply, tremble, and stop talking or playing and start to cry. They may unexpectedly urinate or may actively attempt to escape from the medical personnel. These reactions reflect the child's fear of separation from the parents, as well as loss of control, unfamiliar routines, instruments and hospital procedures [1]. Previous studies have assessed anxiety in children during the preoperative period and the effects of premedication and parental presence during induction of anesthesia (PPIA) [2]. Midazolam has been proven to reduce preoperative anxiety in children [3]. Side effects related to oral midazolam administered to healthy children are minimal and the drug can be reversed with flumazenil but post operative recovery may be delayed in those children undergoing a short surgical procedure. It is the experience of the investigator that there are some children who have such low levels of anxiety they do not require any intervention Distraction may be particularly helpful in children ages 6-12 as these children may not receive preoperative medication due to their curiosity about the environment. Previous studies regarding distraction therapy have focused on the parent either blowing bubbles or reading to a child [4]. Studies where the child is actively engaged in a distraction activity have not been documented. The purpose of this investigation is to determine whether in the presence of a parent an interactive distraction intervention, i.e. Game Boy which is a hand held video game, is as effective as preoperative Midazolam in reducing preoperative anxiety. This study may help in the search for a low cost and easy to implement method of reducing anxiety for children undergoing surgery.
NCT00262639 Prometa Protocol for Alcohol Dependence Completed Medical University of South Carolina Phase 2/Phase 3 This is a placebo controlled trial (some people receive active and some people receive inactive medication) to evaluate the effectiveness of a new protocol to treat alcohol dependence. Two main medications (plus ancillary non-placebo controlled medications) and their placebos (inactive drugs) will be utilized to treat both alcohol withdrawal, promote abstinence, and reduce drinking over approximately a six-week treatment period. All participants will meet criteria for Alcohol Dependence and be drinking heavily up until 72 hours prior to receiving the first study drug. They will be injected one drug (flumazenil or placebo) over a two day period and receive the second one (gabapentin or placebo) by mouth for 39 days. The main hypothesis is that this protocol will reduce early alcohol withdrawal symptoms and will reduce relapse to drinking and promote abstinence compared to the placebo (inactive) drug group. Secondary outcomes that will be evaluated include reduction in craving, improvement in sleep, brain activity and mood.
NCT00570388 Neurocognitive Functioning Following The PROMETA® Treatment Protocol In Subjects With Alcohol Dependence Unknown status Institute of Addiction Medicine N/A This study will test the safety and efficacy of the PROMETA® Treatment Protocol (which includes the benzodiazepine antagonist flumazenil) in reversing the neurocognitive impairment and this in turn will lead to improved ability to resist alcohol related cues and enhance involvement in psychosocial treatment.
NCT00681720 Positron Emission Tomography (PET) Study With (11C)Flumazenil to Determine Central GABAA Receptor Occupancy of AZD7325 Completed AstraZeneca Phase 1 The study is carried out in order to determine the relationship between the dose of AZD7325 and the blood concentration of AZD7325, and to investigate to which extent AZD7325 binds to the GABAA receptors.
NCT00681746 Positron Emission Tomography (PET) Study With (11C) Flumazenil to Determine Central GABAA Receptor Occupancy of AZD6280 Completed AstraZeneca Phase 1 The study is carried out in order to determine the relationship between the dose of AZD6280 and the blood concentration of AZD6280, and to investigate to which extent AZD6280 binds to GABAA receptors
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Flumazenil

Condition Name

Condition Name for Flumazenil
Intervention Trials
Healthy 3
Anxiety 3
Alcohol Dependence 2
Parkinson Disease 2
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Condition MeSH

Condition MeSH for Flumazenil
Intervention Trials
Alcoholism 3
Parkinson Disease 2
Liver Cirrhosis 1
Compulsive Personality Disorder 1
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Clinical Trial Locations for Flumazenil

Trials by Country

Trials by Country for Flumazenil
Location Trials
United States 15
Israel 2
Sweden 2
Korea, Republic of 2
China 2
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Trials by US State

Trials by US State for Flumazenil
Location Trials
Connecticut 3
Michigan 2
Pennsylvania 2
California 1
Oklahoma 1
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Clinical Trial Progress for Flumazenil

Clinical Trial Phase

Clinical Trial Phase for Flumazenil
Clinical Trial Phase Trials
Phase 4 5
Phase 2/Phase 3 1
Phase 2 3
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Clinical Trial Status

Clinical Trial Status for Flumazenil
Clinical Trial Phase Trials
Completed 14
Recruiting 6
Terminated 2
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Clinical Trial Sponsors for Flumazenil

Sponsor Name

Sponsor Name for Flumazenil
Sponsor Trials
National Institute of Neurological Disorders and Stroke (NINDS) 2
Yale University 2
Coeruleus Ltd. 2
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Sponsor Type

Sponsor Type for Flumazenil
Sponsor Trials
Other 24
Industry 7
NIH 4
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Serving hundreds of leading biopharmaceutical companies globally:

US Department of Justice
Johnson and Johnson
Farmers Insurance
Daiichi Sankyo
Moodys
Cantor Fitzgerald
AstraZeneca
Accenture
Cerilliant

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