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Last Updated: August 10, 2020

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CLINICAL TRIALS PROFILE FOR DOPAMINE HYDROCHLORIDE IN DEXTROSE 5%

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505(b)(2) Clinical Trials for Dopamine Hydrochloride In Dextrose 5%

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
OTC NCT00405912 St. John's Wort for Tobacco Cessation Completed National Cancer Institute (NCI) Phase 2 2005-09-01 After a steady decline for the last 50 years, the prevalence of tobacco use in the United States has reached a plateau of approximately 23%. Currently available treatments among adults are expensive and not efficacious for all tobacco users. New pharmacologic agents need to be developed and tested to achieve the Healthy People 2010 goal of less than a 12% adult tobacco use prevalence. Bupropion, an FDA approved agent for tobacco cessation, acts by inhibiting central synaptosomal reuptake of dopamine and norepinephrine. A widely used herbal antidepressant, St. John's Wort (SJW), shares a similar mechanism of action and is effective for treating mild to moderate depression. SJW is well tolerated, available over the counter, and is significantly less expensive than the established treatments for tobacco dependence. To date, no prospective clinical trial evaluating the efficacy of SJW for the treatment of tobacco use has been published. We propose to evaluate the efficacy of SJW for increasing tobacco abstinence and decreasing nicotine withdrawal symptoms in a randomized, double-blind, placebo-controlled, three-arm, parallel group, dose-ranging clinical trial. Participants (N=120) will be randomly assigned to one of the three groups and will receive a twelve-week course of SJW 900 mg per day, 1800 mg per day, or a matching placebo. This study is anticipated to provide the data needed to develop a larger randomized controlled clinical trial submitted through the R01 funding mechanism.
OTC NCT00405912 St. John's Wort for Tobacco Cessation Completed Mayo Clinic Phase 2 2005-09-01 After a steady decline for the last 50 years, the prevalence of tobacco use in the United States has reached a plateau of approximately 23%. Currently available treatments among adults are expensive and not efficacious for all tobacco users. New pharmacologic agents need to be developed and tested to achieve the Healthy People 2010 goal of less than a 12% adult tobacco use prevalence. Bupropion, an FDA approved agent for tobacco cessation, acts by inhibiting central synaptosomal reuptake of dopamine and norepinephrine. A widely used herbal antidepressant, St. John's Wort (SJW), shares a similar mechanism of action and is effective for treating mild to moderate depression. SJW is well tolerated, available over the counter, and is significantly less expensive than the established treatments for tobacco dependence. To date, no prospective clinical trial evaluating the efficacy of SJW for the treatment of tobacco use has been published. We propose to evaluate the efficacy of SJW for increasing tobacco abstinence and decreasing nicotine withdrawal symptoms in a randomized, double-blind, placebo-controlled, three-arm, parallel group, dose-ranging clinical trial. Participants (N=120) will be randomly assigned to one of the three groups and will receive a twelve-week course of SJW 900 mg per day, 1800 mg per day, or a matching placebo. This study is anticipated to provide the data needed to develop a larger randomized controlled clinical trial submitted through the R01 funding mechanism.
New Formulation NCT00640159 Tolerability and Efficacy of Switch From Oral Selegiline to Orally Disintegrating Selegiline (Zelapar) in Patients With Parkinson's Disease Completed Baylor College of Medicine Phase 4 2007-01-01 Parkinson's disease (PD) is a progressive neurodegenerative disease. Symptomatic therapy is primarily aimed at restoring dopamine function in the brain. Oral selegiline in conjunction with L-dopa has been a mainstay of therapy for PD patients experiencing motor fluctuations for many years. The mechanisms accounting for selegiline's beneficial adjunctive action in the treatment of PD are not fully understood. Inhibition of monoamine oxidase (MAO) type B (MAO-B) activity is generally considered to be of primary importance. Oral selegiline has low bio-availability and is typically dosed BID, for a total of 5-10 mg daily. Recently, the FDA approved a new orally disintegration tablet (ODT) formulation of selegiline, called ZelaparTM. This new formulation utilizes Zydis technology to dissolve in the mouth, with absorption through the oral mucosa, thereby largely bypassing the gut and avoiding first pass hepatic metabolism. This allows more active drug to be delivered at a lower dose. Consequently, Zelapar is dosed once-daily, up to 2.5 mg per day. There are no empirical data indicating whether the use of the new approved formulation of selegiline ODT (Zelapar) is superior or preferred by patients compared to traditional oral selegiline. It is believed that clinical efficacy will be preserved or enhanced, by delivering more active drug, with improved patient preference for the ODT formulation due to the once-daily dosing . The effectiveness of orally disintegrating selegiline as an adjunct to carbidopa/levodopa in the treatment of PD was established in a multicenter randomized placebo-controlled trial (n=140; 94 received orally disintegrating selegiline, 46 received placebo) of three months' duration. Patients randomized to orally disintegrating selegiline received a daily dose of 1.25 mg for the first 6 weeks and a daily dose of 2.5 mg for the last 6 weeks. Patients were all treated with levodopa and could additionally have been on dopamine agonists, anticholinergics, amantadine, or any combination of these during the trial. At 12 weeks, orally disintegrating selegiline-treated patients had an average of 2.2 hours per day less "OFF" time compared to baseline. Placebo treated patients had 0.6 hours per day less "OFF" time compared to baseline. These differences were significant (p < 0.001). Adverse events were very similar between drug and placebo.
OTC NCT00722124 S-Adenosyl-L-Methionine (SAMe) for Smoking Abstinence Completed Pharmavite Phase 2/Phase 3 2008-09-01 Cigarette smoking is of great public health importance and is the single most important preventable cause of morbidity, mortality and excess health care costs in the United States. After a steady decline for the last 50 years, the prevalence of tobacco use in the United States has reached a plateau of approximately 21%. Currently available treatments among adults are not efficacious for all tobacco users. New pharmacologic agents thus need to be continually developed and tested. The release of dopamine in the nucleus accumbens is one of the key components of the pleasurable and rewarding effects of nicotine. Drugs that increase monoamine neurotransmitter availability (particularly dopamine and norepinephrine) are likely to increase the reward function and thus ameliorate withdrawal symptoms. S-Adenosyl-L-Methionine (SAMe), the primary methyl donor for the central nervous system (CNS), donates methyl groups towards presynaptic synthesis of CNS monoamine neurotransmitters. By facilitating the synthesis of dopamine and norepinephrine in the brain, SAMe is likely to ameliorate the symptoms of nicotine withdrawal, thus improving tobacco abstinence rates in smokers who are trying to stop smoking. SAMe is well tolerated and is available over-the-counter. To date, no prospective clinical trial evaluating the efficacy of SAMe for the treatment of tobacco dependence has been published. We propose to evaluate the efficacy of SAMe for increasing smoking abstinence and decreasing nicotine withdrawal symptoms in a randomized, blinded, placebo-controlled, three-arm, parallel-group, dose-ranging phase II clinical trial. Participants (N=120) will be randomly assigned to one of the three groups, and will receive an 8-week course of SAMe 800-mg per day, 1600-mg per day, or a matching placebo. This study is anticipated to provide the data needed to develop a larger randomized controlled clinical trial submitted through the R01 funding mechanism, if the results appear promising.
OTC NCT00722124 S-Adenosyl-L-Methionine (SAMe) for Smoking Abstinence Completed Mayo Clinic Phase 2/Phase 3 2008-09-01 Cigarette smoking is of great public health importance and is the single most important preventable cause of morbidity, mortality and excess health care costs in the United States. After a steady decline for the last 50 years, the prevalence of tobacco use in the United States has reached a plateau of approximately 21%. Currently available treatments among adults are not efficacious for all tobacco users. New pharmacologic agents thus need to be continually developed and tested. The release of dopamine in the nucleus accumbens is one of the key components of the pleasurable and rewarding effects of nicotine. Drugs that increase monoamine neurotransmitter availability (particularly dopamine and norepinephrine) are likely to increase the reward function and thus ameliorate withdrawal symptoms. S-Adenosyl-L-Methionine (SAMe), the primary methyl donor for the central nervous system (CNS), donates methyl groups towards presynaptic synthesis of CNS monoamine neurotransmitters. By facilitating the synthesis of dopamine and norepinephrine in the brain, SAMe is likely to ameliorate the symptoms of nicotine withdrawal, thus improving tobacco abstinence rates in smokers who are trying to stop smoking. SAMe is well tolerated and is available over-the-counter. To date, no prospective clinical trial evaluating the efficacy of SAMe for the treatment of tobacco dependence has been published. We propose to evaluate the efficacy of SAMe for increasing smoking abstinence and decreasing nicotine withdrawal symptoms in a randomized, blinded, placebo-controlled, three-arm, parallel-group, dose-ranging phase II clinical trial. Participants (N=120) will be randomly assigned to one of the three groups, and will receive an 8-week course of SAMe 800-mg per day, 1600-mg per day, or a matching placebo. This study is anticipated to provide the data needed to develop a larger randomized controlled clinical trial submitted through the R01 funding mechanism, if the results appear promising.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Dopamine Hydrochloride In Dextrose 5%

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00000276 Dopamine Reuptake Inhibitors of Cocaine Abuse - 1 Terminated National Institute on Drug Abuse (NIDA) Phase 1 1994-09-01 The purpose of this study is to evaluate dopamine reuptake inhibitors for cocaine abuse.
NCT00000276 Dopamine Reuptake Inhibitors of Cocaine Abuse - 1 Terminated VA Connecticut Healthcare System Phase 1 1994-09-01 The purpose of this study is to evaluate dopamine reuptake inhibitors for cocaine abuse.
NCT00000276 Dopamine Reuptake Inhibitors of Cocaine Abuse - 1 Terminated Yale University Phase 1 1994-09-01 The purpose of this study is to evaluate dopamine reuptake inhibitors for cocaine abuse.
NCT00000309 Serotonin/Dopamine Antagonism of Cocaine Effect: 1 - 1 Terminated National Institute on Drug Abuse (NIDA) Phase 2 1994-08-01 The purpose of this study is to evaluate use of risperidone with cocaine abusers. Study measures incorporate an appropriate integration of behavioral and neurobiological indices.
NCT00000309 Serotonin/Dopamine Antagonism of Cocaine Effect: 1 - 1 Terminated VA Boston Healthcare System Phase 2 1994-08-01 The purpose of this study is to evaluate use of risperidone with cocaine abusers. Study measures incorporate an appropriate integration of behavioral and neurobiological indices.
NCT00000309 Serotonin/Dopamine Antagonism of Cocaine Effect: 1 - 1 Terminated Butler Hospital Phase 2 1994-08-01 The purpose of this study is to evaluate use of risperidone with cocaine abusers. Study measures incorporate an appropriate integration of behavioral and neurobiological indices.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Dopamine Hydrochloride In Dextrose 5%

Condition Name

Condition Name for Dopamine Hydrochloride In Dextrose 5%
Intervention Trials
Schizophrenia 94
Parkinson's Disease 66
Parkinson Disease 60
Schizoaffective Disorder 28
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Condition MeSH

Condition MeSH for Dopamine Hydrochloride In Dextrose 5%
Intervention Trials
Parkinson Disease 152
Schizophrenia 100
Disease 71
Depression 53
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Clinical Trial Locations for Dopamine Hydrochloride In Dextrose 5%

Trials by Country

Trials by Country for Dopamine Hydrochloride In Dextrose 5%
Location Trials
United States 824
Canada 70
Germany 55
France 49
United Kingdom 33
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Trials by US State

Trials by US State for Dopamine Hydrochloride In Dextrose 5%
Location Trials
New York 74
California 69
Maryland 65
Massachusetts 48
Connecticut 45
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Clinical Trial Progress for Dopamine Hydrochloride In Dextrose 5%

Clinical Trial Phase

Clinical Trial Phase for Dopamine Hydrochloride In Dextrose 5%
Clinical Trial Phase Trials
Phase 4 170
Phase 3 114
Phase 2/Phase 3 32
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Clinical Trial Status

Clinical Trial Status for Dopamine Hydrochloride In Dextrose 5%
Clinical Trial Phase Trials
Completed 414
Recruiting 168
Not yet recruiting 111
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Clinical Trial Sponsors for Dopamine Hydrochloride In Dextrose 5%

Sponsor Name

Sponsor Name for Dopamine Hydrochloride In Dextrose 5%
Sponsor Trials
National Institute on Drug Abuse (NIDA) 60
National Institute of Mental Health (NIMH) 36
Yale University 27
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Sponsor Type

Sponsor Type for Dopamine Hydrochloride In Dextrose 5%
Sponsor Trials
Other 1056
Industry 193
NIH 172
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