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Last Updated: March 28, 2024

CLINICAL TRIALS PROFILE FOR PHENYTOIN SODIUM


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All Clinical Trials for phenytoin sodium

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00004817 ↗ Phase III Double Blind Trial of Valproate Sodium for Prophylaxis of Post Traumatic Seizures Completed Harborview Injury Prevention and Research Center Phase 3 1991-02-01 OBJECTIVES: I. Determine whether treating head injured patients with valproate sodium will reduce the risk of developing seizures as a result of the head injury. II. Determine the safety of valproate, the appropriate dose, and the effect valproate may have on the recovery of the brain's ability to compute numbers, solve problems, remember information, and control the movement of limbs after head injury.
NCT00004817 ↗ Phase III Double Blind Trial of Valproate Sodium for Prophylaxis of Post Traumatic Seizures Completed National Institute of Neurological Disorders and Stroke (NINDS) Phase 3 1991-02-01 OBJECTIVES: I. Determine whether treating head injured patients with valproate sodium will reduce the risk of developing seizures as a result of the head injury. II. Determine the safety of valproate, the appropriate dose, and the effect valproate may have on the recovery of the brain's ability to compute numbers, solve problems, remember information, and control the movement of limbs after head injury.
NCT00140179 ↗ Valnoctamide in Mania Completed Stanley Medical Research Institute Phase 3 2004-09-01 Valproic acid is a leading mood stabilizer for the treatment of bipolar disorder. Its well-known teratogenicity limits its use in young women of childbearing age. According to toxicologic studies the teratogenicity of valproate stems from its free carboxylic group. Valnoctamide is an isomer and an analog of valpromide. Unlike valpromide, valnoctamide does not undergo a biotransformation to the corresponding free acid. It is also likely or at least possible that valnoctamide is anti-bipolar. In mice valnoctamide has been shown to be distinctly less teratogenic than valproate. An injection at day 8 of gestation produced only 1% exencephaly (as compared to 0-1% in control mice and 53% in valproate treated mice). The investigators are performing a double-blind controlled trial of valnoctamide as an anti-bipolar drug. If shown to be anti-bipolar, valnoctamide could be an important valproate substitute for young women with bipolar disorder who are at risk of pregnancy. Patients newly admitted to the Beersheva Mental Health Center may participate if they meet Diagnostic and Statistical Manual of Mental Disorders - 4th edition (DSM-IV) criteria for mania or schizoaffective disorder, manic type. Patients admitted to the study are treated with risperidone at doses of the physicians' discretion beginning with 2 mg daily on days 1 and 2. Valnoctamide or placebo is begun at doses of 600 mg per day (200 mg three times daily) and increased to 1200 mg (400 mg three times daily) after four days. Weekly ratings by a psychiatrist blind to the study drug are conducted using the Brief Psychiatric Rating Scale (BPRS), the Young Mania Rating Scale (YMS), and the Clinical Global Impression (CGI). Weekly blood is drawn for drug levels of valnoctamide to be measured by gas chromatography. Each patient receives valnoctamide or placebo for 5 weeks. Low teratogenic mood stabilizers are a high priority for current research.
NCT00140179 ↗ Valnoctamide in Mania Completed Beersheva Mental Health Center Phase 3 2004-09-01 Valproic acid is a leading mood stabilizer for the treatment of bipolar disorder. Its well-known teratogenicity limits its use in young women of childbearing age. According to toxicologic studies the teratogenicity of valproate stems from its free carboxylic group. Valnoctamide is an isomer and an analog of valpromide. Unlike valpromide, valnoctamide does not undergo a biotransformation to the corresponding free acid. It is also likely or at least possible that valnoctamide is anti-bipolar. In mice valnoctamide has been shown to be distinctly less teratogenic than valproate. An injection at day 8 of gestation produced only 1% exencephaly (as compared to 0-1% in control mice and 53% in valproate treated mice). The investigators are performing a double-blind controlled trial of valnoctamide as an anti-bipolar drug. If shown to be anti-bipolar, valnoctamide could be an important valproate substitute for young women with bipolar disorder who are at risk of pregnancy. Patients newly admitted to the Beersheva Mental Health Center may participate if they meet Diagnostic and Statistical Manual of Mental Disorders - 4th edition (DSM-IV) criteria for mania or schizoaffective disorder, manic type. Patients admitted to the study are treated with risperidone at doses of the physicians' discretion beginning with 2 mg daily on days 1 and 2. Valnoctamide or placebo is begun at doses of 600 mg per day (200 mg three times daily) and increased to 1200 mg (400 mg three times daily) after four days. Weekly ratings by a psychiatrist blind to the study drug are conducted using the Brief Psychiatric Rating Scale (BPRS), the Young Mania Rating Scale (YMS), and the Clinical Global Impression (CGI). Weekly blood is drawn for drug levels of valnoctamide to be measured by gas chromatography. Each patient receives valnoctamide or placebo for 5 weeks. Low teratogenic mood stabilizers are a high priority for current research.
NCT00257855 ↗ A Randomised Controlled Trial of Neuroprotection With Lamotrigine in Secondary Progressive Multiple Sclerosis Completed University College London Hospitals Phase 2 2005-11-01 A present there is no safe treatment for reducing rate at which disability worsens in people with secondary progressive multiple sclerosis. Recent research has suggested the possibility that drugs that act by blocking the entry of sodium into nerve cells can protect nerve fibres in the brain and spinal cord. In this trial, the investigators will test whether one such drug, called lamotrigine, can prevent damage to nerve fibres and reduce the rate at which MS worsens. The period of treatment in the trial will run for 2 years.
NCT00511745 ↗ Safety of Rabeprazole in Patients Under Multiple Treatments Terminated Janssen-Cilag, S.A. 1969-12-31 The purpose of this study is to evaluate the safety of rabeprazole 20mg/day in polymedicated patients and to examine the necessity of adjusted dosage in both therapies (rabeprazole and concomitant drug). Proton pump inhibitors (PPI) act in the final step of the gastric secretion. PPI's block ATP-ase H+/K+ in gastric parietals cells. It has been described that inhibition of acid secretion has produced the recovery of the gastroesophageal pathology in a high percentage of the patients resistant to conventional drugs. In this context, the objective of the study is to evaluate the safety of rabeprazole as a concomitant treatment and examine the clinical practice the interaction with drugs whose absorption has gastric pH dependence.
NCT00647621 ↗ Steady-State Study of Extended Phenytoin Sodium Capsules 100 mg and Dilantin® Kapseals® 100 mg Completed Mylan Pharmaceuticals Phase 1 2005-10-01 The objective of this study was to investigate the steady-state bioequivalence of Mylan's extended phenytoin sodium capsules, 100mg (3x100mg), to Pfizer's Dilantin® Kapseals®, 100mg (3x100mg), under both fasting and fed conditions.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for phenytoin sodium

Condition Name

Condition Name for phenytoin sodium
Intervention Trials
Healthy 2
Optic Neuritis 2
Gastric Ulcer 1
Overuse Headache Medication 1
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Condition MeSH

Condition MeSH for phenytoin sodium
Intervention Trials
Sclerosis 2
Optic Neuritis 2
Seizures 2
Neoplasm Metastasis 2
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Clinical Trial Locations for phenytoin sodium

Trials by Country

Trials by Country for phenytoin sodium
Location Trials
United States 4
United Kingdom 2
China 1
Uganda 1
Iran, Islamic Republic of 1
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Trials by US State

Trials by US State for phenytoin sodium
Location Trials
New York 1
Georgia 1
California 1
North Dakota 1
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Clinical Trial Progress for phenytoin sodium

Clinical Trial Phase

Clinical Trial Phase for phenytoin sodium
Clinical Trial Phase Trials
Phase 4 3
Phase 3 4
Phase 2/Phase 3 2
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Clinical Trial Status

Clinical Trial Status for phenytoin sodium
Clinical Trial Phase Trials
Completed 11
Unknown status 3
Not yet recruiting 2
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Clinical Trial Sponsors for phenytoin sodium

Sponsor Name

Sponsor Name for phenytoin sodium
Sponsor Trials
Tehran University of Medical Sciences 1
Stanley Medical Research Institute 1
Ministry of Health, Uganda 1
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Sponsor Type

Sponsor Type for phenytoin sodium
Sponsor Trials
Other 27
Industry 5
NIH 1
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