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Generated: December 13, 2018

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CLINICAL TRIALS PROFILE FOR EXTENDED PHENYTOIN SODIUM

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Clinical Trials for Extended Phenytoin Sodium

Trial ID Title Status Sponsor Phase 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 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 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 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 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.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Extended Phenytoin Sodium

Condition Name

Condition Name for Extended Phenytoin Sodium
Intervention Trials
Optic Neuritis 2
Addiction 1
Head Injuries 1
Nodding Syndrome 1
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Condition MeSH

Condition MeSH for Extended Phenytoin Sodium
Intervention Trials
Multiple Sclerosis 2
Sclerosis 2
Optic Neuritis 2
Neoplasm Metastasis 2
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Clinical Trial Locations for Extended Phenytoin Sodium

Trials by Country

Trials by Country for Extended Phenytoin Sodium
Location Trials
United States 2
United Kingdom 2
Israel 1
Malaysia 1
Brazil 1
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Trials by US State

Trials by US State for Extended Phenytoin Sodium
Location Trials
Georgia 1
North Dakota 1
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Clinical Trial Progress for Extended Phenytoin Sodium

Clinical Trial Phase

Clinical Trial Phase for Extended Phenytoin Sodium
Clinical Trial Phase Trials
Phase 4 1
Phase 3 2
Phase 2/Phase 3 2
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Clinical Trial Status

Clinical Trial Status for Extended Phenytoin Sodium
Clinical Trial Phase Trials
Completed 9
Recruiting 3
Suspended 1
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Clinical Trial Sponsors for Extended Phenytoin Sodium

Sponsor Name

Sponsor Name for Extended Phenytoin Sodium
Sponsor Trials
National Multiple Sclerosis Society 1
Federal University of São Paulo 1
University College London Hospitals 1
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Sponsor Type

Sponsor Type for Extended Phenytoin Sodium
Sponsor Trials
Other 19
Industry 3
NIH 1
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Serving hundreds of leading biopharmaceutical companies globally:

Accenture
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Harvard Business School
McKesson
Johnson and Johnson
Queensland Health
Citi
Moodys
Teva

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