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Last Updated: November 24, 2020

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CLINICAL TRIALS PROFILE FOR SOMA COMPOUND

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505(b)(2) Clinical Trials for Soma Compound

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 NCT00009542 Effects of Kava on the Body's Elimination of Caffeine and Dextromethorphan Completed National Institutes of Health Clinical Center (CC) Phase 4 2001-01-01 This study will examine how kava-a widely used herbal remedy-may affect the body's elimination of other medicines. Many people take kava to reduce anxiety or cause sedation. Since this product is considered a food supplement and not a drug, it is not subject to the rigorous pre-market testing required for prescription and over-the-counter (OTC) drugs. As a result, information has not been collected on possible interactions between kava and other medications. This study will look at how kava affects the elimination of caffeine-a compound commonly found in chocolate, coffee, tea and soft drinks-and dextromethorphan-an OTC cough suppressant. Normal healthy volunteers 21 years of age or older may be eligible for this 30-day study. Candidates will provide a medical history and undergo a physical examination and routine blood tests. Women of childbearing age will have a urine pregnancy test. Study participants will not drink alcoholic beverages or take any medications (except those given in the study) for 2 weeks prior to the study and throughout its duration. In addition, they will abstain from caffeine, grapefruit and grapefruit juice and charbroiled foods for at least 72 hours before and throughout each study day that urine is collected. On day 1 of the study, study subjects will take one dose each of caffeine and dextromethorphan at 4:00 P.M.. They will empty their bladder before the dosing and then collect all their urine after the dosing for the rest of the day and including the next mornings first urine. They will bring the urine samples to the Clinical Center when the collection is complete. This procedure will be repeated 1 week later (study day 8). After the second urine collection is completed, subjects will take 200 milligrams of kava 3 times a day for 21 days. On study day 29 (after 21 days of kava), subjects will repeat the dextromethorphan and caffeine dosing and urine collection described above, while continuing to take kava. Subjects will have an electroencephalograph (EEG) done before starting kava and again at the end of kava (study day 30). For this procedure, several electrodes (metal cups attached to wires) are secured to the scalp with a glue-like substance. A conductive gel fills the space between the electrode and the scalp to ensure good contact. The electrodes will remain in place for about 2 hours and then removed. The subject lies quietly on a bed during the EEG recording. Participation in the study will end with another physical examination and blood tests following the second EEG and urine collection.
OTC NCT00214877 Methylene Blue for Cognitive Dysfunction in Bipolar Disorder Completed Stanley Medical Research Institute Phase 3 2003-11-01 While many bipolar patients treated with mood stabilizing medications experience improvement in their symptoms, some continue to have ongoing difficulties with concentration and memory. The purpose of this study is to look at whether these symptoms can be improved by adding the compound methylene blue to the treatment plan of patients who are already taking lamotrigine. Methylene blue is an available 'over the counter medication' in Canada. It has been studied in the long-term treatment of mood symptoms in bipolar disorder. Several clinical studies done in bipolar disorder report that methylene blue has had positive effects on both cognition and mood. It is important to do further research in this area as we know that, for patients who continue to have ongoing cognitive difficulties, there is no recognized standard of care for bipolar patients who experience these type of deficits.
OTC NCT00214877 Methylene Blue for Cognitive Dysfunction in Bipolar Disorder Completed Nova Scotia Health Authority Phase 3 2003-11-01 While many bipolar patients treated with mood stabilizing medications experience improvement in their symptoms, some continue to have ongoing difficulties with concentration and memory. The purpose of this study is to look at whether these symptoms can be improved by adding the compound methylene blue to the treatment plan of patients who are already taking lamotrigine. Methylene blue is an available 'over the counter medication' in Canada. It has been studied in the long-term treatment of mood symptoms in bipolar disorder. Several clinical studies done in bipolar disorder report that methylene blue has had positive effects on both cognition and mood. It is important to do further research in this area as we know that, for patients who continue to have ongoing cognitive difficulties, there is no recognized standard of care for bipolar patients who experience these type of deficits.
OTC NCT00322127 An Evaluation of Safety and Efficacy of Escalating Doses of AMD3100 to Mobilize CD34+ Cells in Healthy Volunteers Completed National Heart, Lung, and Blood Institute (NHLBI) Phase 1 2006-05-01 This study will determine how safely and well people can tolerate AMD3100 at larger than normal doses to mobilize CD34+ cells, (stem cells). AMD3100 is a new drug designed to mobilize stem cells for transplantation in cancer patients. It pushes those cells into the circulation, making it easier to collect them, and it temporarily increases the number of stem cells in a person's blood. Patients ages 18 to 50 in good health and who are not pregnant or breastfeeding may be eligible for this study. They will undergo the following tests and procedures: - History and physical examination - Review of medications, including those prescribed and over-the-counter, as well as nutritional supplements - Blood tests for liver, kidneys, and other functions; and for infections including hepatitis and AIDS - Pregnancy test - Electrocardiogram On the day they receive AMD3100, patients will be admitted to the Clinical Center. They will receive two doses, injected under the skin, at intervals separated by 14 to 90 days. Dose levels are 240 and 320 micrograms/kg and 400 and 480 micrograms/kg. For 24 hours following the first AMD3100 administration, blood will be collected periodically through a plastic tube at amounts dependent on doses of AMD3100 given. If patients receive one of the two highest doses, their heart rhythm will be monitored continuously during the hospital stay. From 7 to 10 days following administration of AMD3100, patients will give blood samples to monitor the effects. The second dose of AMD3100 will be given 14 to 90 days after the first one. Patients will return to the Clinical Center for the same procedures as done previously, but the dose of the drug will be higher. Risks involve side effects of AMD3100. In previous studies, patients who received the drug experienced a temporary increase in white blood cell counts. Serious side effects have included abnormally low platelet clot, abnormal heart rhythm, and low blood pressure. Patients will be carefully monitored for such effects.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Soma Compound

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00000628 A Pharmacokinetic Study of L-697,661 Alone and in Combination With Zidovudine Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 1 1969-12-31 Part 1: To study the potential safety and pharmacokinetic (blood level) effects of zidovudine (AZT) on L-697,661; to obtain additional pharmacokinetic information in humans with L-697,661; to study the effect of L-697,661 on hepatic enzyme induction. Part 2: To begin a study of the antiviral activity of L-697,661. L-697,661 is a newly identified compound that inhibits HIV replication (reproduction and growth) in cell culture. It works together with AZT against HIV.
NCT00000628 A Pharmacokinetic Study of L-697,661 Alone and in Combination With Zidovudine Completed Merck Sharp & Dohme Corp. Phase 1 1969-12-31 Part 1: To study the potential safety and pharmacokinetic (blood level) effects of zidovudine (AZT) on L-697,661; to obtain additional pharmacokinetic information in humans with L-697,661; to study the effect of L-697,661 on hepatic enzyme induction. Part 2: To begin a study of the antiviral activity of L-697,661. L-697,661 is a newly identified compound that inhibits HIV replication (reproduction and growth) in cell culture. It works together with AZT against HIV.
NCT00000675 A Phase I Study of the Safety and Pharmacokinetics of Recombinant Human CD4 Immunoglobulin (rCd4-IgG) Administered by Intravenous Bolus in Patients With AIDS and AIDS Related Complex Completed Genentech, Inc. Phase 1 1969-12-31 To study the safety and pharmacokinetics (blood levels) of recombinant human CD4 immunoglobulin (rCd4-IgG) in patients with AIDS or AIDS related complex (ARC) who have failed or declined therapy with zidovudine (AZT). An additional goal of the study is to obtain a preliminary indication of the antiviral effects of Cd4-IgG in patients with AIDS or ARC. Other approaches in addition to existing treatment of HIV infection need to be evaluated. One approach may be to block HIV infection by interrupting the assembly of the virus within the cell or the budding of virus from the membrane of the infected cell. In addition, blocking the attachment of HIV to its cellular receptor may offer another point of attack. HIV binds to the CD4 receptor on the target T4 lymphocyte and the envelope glycoprotein of the virus (gp120) is capable of high affinity binding to CD4. Any agent that prevents the attachment of gp120 to the CD4 receptor should be able to block virus transmission and spread. Recently, scientists have succeeded in producing highly purified recombinant soluble human CD4. Recombinant CD4 is capable of binding to HIV envelope protein (gp120) and inhibiting HIV infectivity in test tube studies. Potential therapeutic benefit in patients with HIV infection could be derived from either or both of these biologic effects. In order to extend the length of time that rCD4 stays in the body, the compound has been modified by combining it with a human immunoglobulin of the IgG1 class (IgG).
NCT00000675 A Phase I Study of the Safety and Pharmacokinetics of Recombinant Human CD4 Immunoglobulin (rCd4-IgG) Administered by Intravenous Bolus in Patients With AIDS and AIDS Related Complex Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 1 1969-12-31 To study the safety and pharmacokinetics (blood levels) of recombinant human CD4 immunoglobulin (rCd4-IgG) in patients with AIDS or AIDS related complex (ARC) who have failed or declined therapy with zidovudine (AZT). An additional goal of the study is to obtain a preliminary indication of the antiviral effects of Cd4-IgG in patients with AIDS or ARC. Other approaches in addition to existing treatment of HIV infection need to be evaluated. One approach may be to block HIV infection by interrupting the assembly of the virus within the cell or the budding of virus from the membrane of the infected cell. In addition, blocking the attachment of HIV to its cellular receptor may offer another point of attack. HIV binds to the CD4 receptor on the target T4 lymphocyte and the envelope glycoprotein of the virus (gp120) is capable of high affinity binding to CD4. Any agent that prevents the attachment of gp120 to the CD4 receptor should be able to block virus transmission and spread. Recently, scientists have succeeded in producing highly purified recombinant soluble human CD4. Recombinant CD4 is capable of binding to HIV envelope protein (gp120) and inhibiting HIV infectivity in test tube studies. Potential therapeutic benefit in patients with HIV infection could be derived from either or both of these biologic effects. In order to extend the length of time that rCD4 stays in the body, the compound has been modified by combining it with a human immunoglobulin of the IgG1 class (IgG).
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Soma Compound

Condition Name

Condition Name for Soma Compound
Intervention Trials
Healthy 71
Schizophrenia 40
Breast Cancer 22
HIV Infections 21
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Condition MeSH

Condition MeSH for Soma Compound
Intervention Trials
Diabetes Mellitus 43
Schizophrenia 42
Syndrome 37
Disease 36
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Clinical Trial Locations for Soma Compound

Trials by Country

Trials by Country for Soma Compound
Location Trials
China 204
Italy 83
Australia 80
France 59
India 53
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Trials by US State

Trials by US State for Soma Compound
Location Trials
California 159
New York 133
Texas 120
Florida 113
Maryland 109
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Clinical Trial Progress for Soma Compound

Clinical Trial Phase

Clinical Trial Phase for Soma Compound
Clinical Trial Phase Trials
Phase 4 141
Phase 3 135
Phase 2/Phase 3 46
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Clinical Trial Status

Clinical Trial Status for Soma Compound
Clinical Trial Phase Trials
Completed 680
Recruiting 263
Not yet recruiting 181
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Clinical Trial Sponsors for Soma Compound

Sponsor Name

Sponsor Name for Soma Compound
Sponsor Trials
GlaxoSmithKline 74
Pfizer 60
National Cancer Institute (NCI) 43
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Sponsor Type

Sponsor Type for Soma Compound
Sponsor Trials
Other 1258
Industry 782
NIH 161
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