Diazepam Clinical Trial

Open-label, Study of Safety and Tolerability of Chronic Intermittent Usage of Diazepam Nasal Spray in Epilepsy Patients With Cluster Seizures – Protocol DZNS-EP-1025.

ClinicalTrials.gov Identifier: NCT02316847

Inclusion Criteria:
•    Diagnosis of drug-resistant epilepsy
•    Patients who experience multiple episodes of acute repetitive seizures requiring at least one concomitant antiepileptic drug (AED)
•    Occurrence of at least 3 seizure clusters within the past 12 months, including at least one cluster in the 4 months prior to the Screening Visit
•    A caregiver must consent to participate together with the subject for purposes of observation and data collection
•    The caregiver must be present when the investigational product is administered
•    Screening body weight between 26 to 111 kg, inclusive

Exclusion Criteria:
•    Female subject who is pregnant, breastfeeding, or planning to become pregnant
•    Presence or history of any abnormality or illness that may affect the absorption, distribution, metabolism or elimination of diazepam
•    Known allergy or hypersensitivity to diazepam, related drugs, or any of the formulation components
•    Positive screening test for ethanol or other drugs of abuse
•    Unable to receive medications intranasally

David Vossler, MD and Carole Burton RN, Rainier Clinical Research Center, Inc.
Renton, Washington, United States, 98057. Phone 1 425-251-1720

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Lacosamide Clinical Trial

A Double-blind, Randomized, Placebo-controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of Lacosamide as Adjunctive Therapy for Uncontrolled Primary Generalized Tonic-Clonic Seizures in Subjects With Idiopathic Generalized Epilepsy – Protocol SP0982.

ClinicalTrials.gov Identifier: NCT02408523

Inclusion Criteria:
•    Idiopathic generalized epilepsy (IGE) – primary generalized tonic-clonic seizures (PGTCS)
•    Age ≥4 years
•    ≥ 3 PGTCS during the 16-week Combined Baseline (12-week Historical Baseline plus 4-week Prospective Baseline)
•    No imaging evidence of a lesion likely to be associated with partial-onset seizures
•    Stable dose regimen of 1 – 2 non-benzodiazepine marketed anti-epileptic drugs (AEDs) OR 1 – 3 AEDs (with at least 1 AED identified as a benzodiazepine) for at least 28 days prior to Visit 1 with or without additional concurrent stable vagus nerve stimulation (VNS)
•    An electroencephalogram (EEG) report consistent with IGE (eg, generalized ≥ 3Hz epileptiform discharges and a normal EEG background)
Exclusion Criteria:
•    History of partial onset seizures or EEG findings indicating partial onset seizures
•    Symptomatic generalized epilepsy, e.g. Lennox-Gastaut Syndrome
•    Lifetime history of suicide attempt, or suicidal ideation in past 6 months
•    Use of felbamate or vigabatrin within last 6 months
•    Subject is on a ketogenic diet

David Vossler, MD and Carole Burton RN, Rainier Clinical Research Center, Inc.
Renton, Washington, United States, 98057. Phone 1 425-251-1720

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Lymphoma Clinical Trial

Combination Chemotherapy w w/o Auto Transplant for Central Nervous System B-Cell Lymphoma (CALGB 51101)
A Randomized Phase II Trial of Myeloablative Versus Non-Myeloablative Consolidation Chemotherapy for Newly Diagnosed Primary CNS B-cell Lymphoma

Clinical Trials.gov # NCT01511562

RATIONALE: Giving chemotherapy before an autologous stem cell transplant stops the growth of cancer cells by stopping them from dividing or killing them. After treatment, stem cells are collected from the patient’s blood and stored. More chemotherapy or radiation therapy is given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy.
PURPOSE: This randomized phase II trial studies how well combination chemotherapy given together with autologous stem cell transplant works compared to combination chemotherapy alone in treating patients with central nervous system B-cell lymphoma.
Eligibility Criteria (must meet the following to participate in this study)
•         Diagnosis of primary central nervous system (CNS) diffuse large B-cell lymphoma confirmed by one of the following:
o    Brain biopsy or resection<<
o    Cerebrospinal fluid<<
o    Vitreous fluid<<
•         No evidence or history of non-Hodgkin lymphoma (NHL) outside of CNS<
•         No isolated ocular lymphoma or isolated leptomeningeal lymphoma<
•         At least one measurable, contrast-enhancing brain lesion (≥ 1 cm in length)<
•         Karnofsky performance status ≥ 30% (≥ 50% for patients ages 60-70 years)<
•         Adequate cardiac function (left ventricular ejection fraction [LVEF] ≥ 50%) and pulmonary function (corrected diffusion capacity of carbon monoxide [DLCO] ≥ 60% predicted)<
•         Pregnant or nursing patients may not be enrolled; women of childbearing potential must have a negative serum or urine pregnancy test 10-14 days prior to registration; in addition, women and men of childbearing potential must commit to use an effective form of contraception throughout their participation in this study due to the teratogenic potential of the therapy utilized in this trial; appropriate methods of birth control include abstinence, oral contraceptives, implantable hormonal contraceptives, or double barrier method (diaphragm plus condom)<
•         Negative human immunodeficiency virus (HIV) serology<
•         Negative hepatitis B virus (HBV) and hepatitis C virus (HCV) serology (unless HBV antibody [HBsAb]-positive patient has recently received HBV vaccine, in this case HBcAb should be negative)<
•         Absolute neutrophil count (ANC) ≥ 1500/mcL<
•         Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2 times upper limit of normal (ULN)<
•         Total bilirubin ≤ 3 mg/dL<
•         Creatinine clearance ≥ 50 mL/min<
•         Platelet count ≥ 100,000/mcL<
•         No prior chemotherapy or radiation therapy for lymphoma<
•         No history of organ transplantation or ongoing immunosuppressant therapy<
•         No concurrent palliative radiotherapy<
Investigator: Maciej M. Mrugala, MD
Research Coordinator: Alisa Claeys. Phone 206-616-4925
University of Washington Medical Center, Seattle, WA 98195
Seattle Cancer Care Alliance, Seattle, WA 98109

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