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Generated: November 16, 2018

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CLINICAL TRIALS PROFILE FOR LORAZEPAM

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Clinical Trials for Lorazepam

Trial ID Title Status Sponsor Phase Summary
NCT00000441 Drug Therapy for Alcohol Detoxification Completed National Institute on Alcohol Abuse and Alcoholism (NIAAA) Phase 4 This project will provide relevant clinical information for primary care practitioners treating alcohol withdrawal syndrome in outpatient settings. This double-blind, placebo- controlled clinical trial will compare the effectiveness of lorazepam (Ativan) and carbamazepine (Tegretol) in alcoholics who meet the criteria for a diagnosis of uncomplicated alcohol withdrawal syndrome. Participants are randomized to five days of treatment with a 1-week posttreatment followup.
NCT00001725 Studies of Dextromethorphan and Topiramate to Treat Oral and Facial Pain Completed National Institute of Dental and Craniofacial Research (NIDCR) Phase 2 This study will evaluate the safety and effectiveness of two drugs-dextromethorphan and topiramate-in treating orofacial (mouth and face) pain. Dextromethorphan, a commonly used cough suppressant, and topiramate, an anti-seizure medicine, block certain receptors on brain and spinal nerve cells that may cause the cells to produce electrical discharges and pain. Patients 18 years of age and older with oral and facial pain with trigeminal nerve damage and who have had pain daily for at least 3 months may be eligible for this study. Candidates will be screened with a medical history, physical examination, blood tests and psychiatric evaluation. These results will serve as baseline values for participants. Those enrolled in the study will take either dextromethorphan or topiramate in a 2-part study as follows: Dextromethorphan In Part 1, patients will take dextromethorphan and lorazepam (a commonly used anti-anxiety drug) separately in two 6-week periods. (Lorazepam is used in this study as an "active placebo" for comparison with dextromethorphan. An active placebo is a drug that does not work for the problem being studied but whose side effects are like those of the test drug.) They will take dextromethorphan for 4 weeks to determine the maximum tolerated dose (the highest dose that does not cause troubling side effects) and will stay on that dose for the remaining 2 weeks. Then they will repeat this process with lorazepam. Patients who respond to either drug may continue with Part 2 of the study, which compares these two drugs four more times to confirm the response seen in Part 1. In Part 2, the maximum tolerated dose will be determined in a 2-week period and that dose will be continued for another 2 weeks. This procedure will be repeated eight times. Throughout the study, patients will keep a daily pain diary. They will be contacted by telephone 2 to 3 times a week during dose escalation to check for side effects. At the end of each of the two 6-week periods in Part 1 and at the end of each 4-week period in Part 2 of the study, patients will have a 1-hour clinic visit. Participants who live more than a few hours' drive from NIH will have a full telephone follow-up evaluation instead of the clinic visits. Topiramate Patients who receive topiramate will follow a plan similar to that described above for dextromethorphan, with the following exceptions. They will take topiramate and an inactive placebo (a look-alike pill that has no active ingredients) in two separate 12-week periods. Patients' maximum tolerated dose will be determined in the first 8 weeks and they will stay on that dose for the remaining 4 weeks of each period. Patients who respond to the medication in Part 1 may continue with Part 2 to confirm the response. Part 2 consists of six 6-week periods. The first 4 weeks of each will be used to determine the maximum tolerated dose and the patient will remain on that dose for the next 2 weeks. Patients will keep a daily pain diary and will be contacted by phone 2 to 3 times a week while doses are being increased. Patients who complete Part 2 of the topiramate study may participate in another phase of the study that will last for 2 years. Those who continue for this phase will take topiramate for the 2-year period. They will be followed regularly by a study nurse and will come to NIH every 6 months for a follow-up visit.
NCT00004297 Phase III Randomized Study of Diazepam Vs Lorazepam Vs Placebo for Prehospital Treatment of Status Epilepticus Completed University of California, San Francisco Phase 3 OBJECTIVES: I. Compare the efficacy, onset of clinical anticonvulsant activity, and complications of diazepam and lorazepam given intravenously as prehospital therapy to patients in status epilepticus. II. Determine the effect of prehospital therapy on the incidence of status epilepticus at the subsequent emergency department admission. III. Establish whether prehospital therapy alters hospital management of these patients and ultimately affects patient outcome.
NCT00004297 Phase III Randomized Study of Diazepam Vs Lorazepam Vs Placebo for Prehospital Treatment of Status Epilepticus Completed National Institute of Neurological Disorders and Stroke (NINDS) Phase 3 OBJECTIVES: I. Compare the efficacy, onset of clinical anticonvulsant activity, and complications of diazepam and lorazepam given intravenously as prehospital therapy to patients in status epilepticus. II. Determine the effect of prehospital therapy on the incidence of status epilepticus at the subsequent emergency department admission. III. Establish whether prehospital therapy alters hospital management of these patients and ultimately affects patient outcome.
NCT00011297 Comparing Gabapentin and Lorazepam for Treating Alcohol Withdrawal Completed National Institute on Alcohol Abuse and Alcoholism (NIAAA) Phase 2 This study will evaluate a safe and useful medication for outpatient detoxification that is as effective as benzodiazepines in the short-term, and more effective in the protracted withdrawal period. Gabapentin (Neurontin) will be compared to a standard benzodiazepine, lorazepam (Ativan), for its effectiveness in treating alcohol withdrawal.
NCT00029458 Clozapine for Treatment-Resistant Mania Completed National Institute of Mental Health (NIMH) Phase 2 The purpose of this study is to evaluate the safety and effectiveness of clozapine as a treatment for the manic phase of bipolar disorder. A significant proportion of manic patients either do not respond adequately to conventional treatment or cannot tolerate the adverse effects associated with therapeutic doses of these agents. Clozapine may be a safe and effective treatment for mania. However, the efficacy of clozapine as an alternative therapy in treatment-resistant bipolar disorder mania has not been extensively researched. The study will be conducted in three phases. Phase 1 is a screening phase that will take place for 2 to 7 days. Participants will undergo a baseline positron emission tomography (PET) scan of the brain at the end of this period. In Phase 2, participants will be randomly assigned to receive either clozapine or placebo (an inactive pill) for 3 weeks. They may also receive lorazepam for the first 10 days of Phase 2. After 3 weeks, patients treated with clozapine will undergo a second PET scan. During Phase 3, participants who received placebo and did not improve will be offered clozapine for 3 weeks. Those who received clozapine and did not improve will receive other treatment for 3 weeks. At the end of Phase 3, participants who were treated with clozapine will have another PET scan.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Lorazepam

Condition Name

Condition Name for Lorazepam
Intervention Trials
Status Epilepticus 11
Bipolar Disorder 10
Schizophrenia 10
Healthy 7
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Condition MeSH

Condition MeSH for Lorazepam
Intervention Trials
Disease 17
Anxiety Disorders 14
Status Epilepticus 13
Bipolar Disorder 13
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Clinical Trial Locations for Lorazepam

Trials by Country

Trials by Country for Lorazepam
Location Trials
United States 184
Japan 16
Netherlands 10
France 6
Taiwan 6
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Trials by US State

Trials by US State for Lorazepam
Location Trials
California 20
Ohio 15
Texas 14
New York 14
Maryland 12
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Clinical Trial Progress for Lorazepam

Clinical Trial Phase

Clinical Trial Phase for Lorazepam
Clinical Trial Phase Trials
Phase 4 36
Phase 3 25
Phase 2/Phase 3 5
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Clinical Trial Status

Clinical Trial Status for Lorazepam
Clinical Trial Phase Trials
Completed 90
Recruiting 17
Unknown status 15
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Clinical Trial Sponsors for Lorazepam

Sponsor Name

Sponsor Name for Lorazepam
Sponsor Trials
National Institute of Mental Health (NIMH) 11
Pfizer 7
National Cancer Institute (NCI) 6
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Sponsor Type

Sponsor Type for Lorazepam
Sponsor Trials
Other 175
Industry 50
NIH 31
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