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Generated: December 13, 2018

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CLINICAL TRIALS PROFILE FOR PRIMIDONE

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Clinical Trials for Primidone

Trial ID Title Status Sponsor Phase Summary
NCT00006025 Temozolomide Plus Irinotecan in Treating Patients With Recurrent Malignant Glioma Completed National Cancer Institute (NCI) Phase 1/Phase 2 RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase I/II trial to study the effectiveness of temozolomide plus irinotecan in treating patients who have recurrent malignant glioma.
NCT00006025 Temozolomide Plus Irinotecan in Treating Patients With Recurrent Malignant Glioma Completed North American Brain Tumor Consortium Phase 1/Phase 2 RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase I/II trial to study the effectiveness of temozolomide plus irinotecan in treating patients who have recurrent malignant glioma.
NCT00006773 Bortezomib in Treating Patients With Recurrent Glioma Terminated National Cancer Institute (NCI) Phase 1 Phase I trial to study the effectiveness of bortezomib in treating patients who have recurrent glioma. Bortezomib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth
NCT00068770 Celecoxib in Patients With Newly Diagnosed GBM Who Are Receiving Anticonvulsant Drugs and Undergoing RT Terminated National Cancer Institute (NCI) Phase 2 RATIONALE: Celecoxib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. It is not yet known whether the effectiveness of celecoxib in treating glioblastoma multiforme is decreased in patients who are receiving anticonvulsant drugs and undergoing radiation therapy. PURPOSE: Phase II trial to study the effectiveness of celecoxib in treating patients who are receiving anticonvulsant drugs and undergoing radiation therapy for newly diagnosed glioblastoma multiforme.
NCT00068770 Celecoxib in Patients With Newly Diagnosed GBM Who Are Receiving Anticonvulsant Drugs and Undergoing RT Terminated Sidney Kimmel Comprehensive Cancer Center Phase 2 RATIONALE: Celecoxib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. It is not yet known whether the effectiveness of celecoxib in treating glioblastoma multiforme is decreased in patients who are receiving anticonvulsant drugs and undergoing radiation therapy. PURPOSE: Phase II trial to study the effectiveness of celecoxib in treating patients who are receiving anticonvulsant drugs and undergoing radiation therapy for newly diagnosed glioblastoma multiforme.
NCT00102596 Clinical Trial Characterizing the Bioavailability of 1-Octanol in Adults With Ethanol-responsive Essential Tremor Completed National Institute of Neurological Disorders and Stroke (NINDS) Phase 2 OVERVIEW Essential tremor (ET) is a common movement disorder affecting 0.4% of the general population and up to 14% of people 65 years and older. Response to medications such as beta blockers and primidone may be of benefit, but are often accompanied by intolerable side effects. Response to ethanol, on the other hand, has a roughly 80% chance of significant tremor reduction, though daily use of this as a treatment has potentially serious medical, social, and legal consequences. The leading hypothesis for ET pathophysiology is an unmasking of spontaneous oscillations originating in neurons of the inferior olive. Both ethanol and 1-octanol have been shown to reduce these spontaneous oscillations in an animal model of ET; however, 1-octanol does this at a dose much lower than that leading to intoxication, suggesting in may be useful in the treatment of essential tremor. Our initial studies with 1-octanol have shown it to be safe at dosages up to 64mg/kg without signs of intoxication, while at the same time showing benefit. OBJECTIVE We plan to evaluate the efficacy of different 1-octanol formulations in humans based on accelerometry and spirography. We will also evaluate drug and metabolite bioavailabilities using a high performance liquid chromatography (HPLC) detection method from plasma and urine samples. STUDY POPULATION We will study adult subjects with ethanol-responsive Essential Tremor (ET). DESIGN This study is designed as a two-phase unblinded inpatient study of adults with ET receiving weight-adjusted oral dosages of 2 different formulations of 1-octanol in a crossover fashion. Phase I of the study is designed to develop an octanol detection assay using HPLC. Four subjects will receive daily escalating dosages (1-32 mg/kg) of a single 1-octanol formulation followed by a crossover trial of both formulations at a dosage of 64 mg/kg. Phase II will study 20 subjects receiving one of the two formulations at 64 mg/kg on inpatient day 1 followed by a 24 hour period of close monitoring. The second formulation will be given on day 3 and the patient will again undergo close monitoring for 24 hours. OUTCOME MEASURES The primary outcome measures for the study will be efficacy based on tremor ratings from accelerometry and spirography. Secondary outcome measures will be the determination of bioavailability, pharmacodynamic and pharmacokinetic profiles of octanol #61864 and octanol #68751 and their metabolites.
NCT00236496 A Comparison of the Efficacy and Safety of Topiramate Versus Placebo in Treating Tremor of Unknown Cause. Completed Ortho-McNeil Neurologics, Inc. Phase 3 The purpose of this study is to assess the safety and effectiveness of topiramate as compared to placebo in treating patients with tremor of unknown cause.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Primidone

Condition Name

Condition Name for Primidone
Intervention Trials
Seizures 5
Epilepsy 5
Epilepsies, Partial 5
Essential Tremor 4
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Condition MeSH

Condition MeSH for Primidone
Intervention Trials
Tremor 6
Essential Tremor 5
Seizures 5
Epilepsy 5
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Clinical Trial Locations for Primidone

Trials by Country

Trials by Country for Primidone
Location Trials
United States 23
Hungary 2
China 1
India 1
France 1
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Trials by US State

Trials by US State for Primidone
Location Trials
Maryland 4
Pennsylvania 3
North Carolina 3
New York 2
Massachusetts 2
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Clinical Trial Progress for Primidone

Clinical Trial Phase

Clinical Trial Phase for Primidone
Clinical Trial Phase Trials
Phase 4 2
Phase 3 4
Phase 2 11
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Clinical Trial Status

Clinical Trial Status for Primidone
Clinical Trial Phase Trials
Completed 14
Withdrawn 2
Not yet recruiting 2
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Clinical Trial Sponsors for Primidone

Sponsor Name

Sponsor Name for Primidone
Sponsor Trials
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. 6
National Cancer Institute (NCI) 4
Duke University 2
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Sponsor Type

Sponsor Type for Primidone
Sponsor Trials
Industry 13
Other 13
NIH 5
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Serving hundreds of leading biopharmaceutical companies globally:

Boehringer Ingelheim
Farmers Insurance
UBS
US Department of Justice
McKinsey
Express Scripts
Julphar
Daiichi Sankyo
Mallinckrodt

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