Clinical Trial Information
Clinical trials are research studies that include volunteers to address specific health issues. These studies may be designed to learn more about a specific disorder, identify the causative gene, discover new therapies, or improve existing treatments. By participating in clinical trials, patients can be more involved in their own health care and potentially gain access to the newest treatments before they become widely available. Participation in clinical trials is also an important way to help others affected with a similar disease. Volunteer participation increases the body of information available to find out more about the causes, special features of the disorder and the most effective treatments for these rare diseases.
Clinical trials are a critical method by which therapies for neurological illnesses are advanced. Many neurological trials in the United States are greatly hampered by insufficient recruitment of subjects, and thus, awareness of trials by patients and providers is a major contributor to recruitment. Therefore, the WSNS attempts to increase provider awareness of clinical trials by posting them on its website. There will be no fee for posting a clinical trial.
Trials proposed for listing on the website must also meet the following standards:
- Submitted in the format of trialscurrently listed on the WSNS web site
- WSNS member submitting the trial as study contact (rather than an institutional representative)
- Up-to-date notification of changes in study status by WSNS member posting the study. Studies will be reviewed by WSNS staff every 6 month to ensure active status
- Approval by an accepted local or national Institutional Review Board (IRB)
- Active recruitment of study subjects
- Study is listed on http://www.clinicaltrials.gov
- WSNS Web Trials subcommittee review and approval completed.
Please submit information for posting to admin@washingtonneurology.org.
An Open Label, Multicenter, Safety and Pharmacokinetic Study of YKP3089 (cenobamate) as Adjunctive Therapy in Subjects With Partial Onset Seizures. ClinicalTrials.gov Identifier: NCT NCT02535091
Inclusion Criteria:
• Ages 18-70 years
• Partial-onset seizures and require additional AED therapy despite having been treated with at least one AED within approximately the last 2 years.
• Currently on stable antiepileptic treatment regimen:
• Subject must have been receiving stable doses of 1 to 3 AEDs for at least 3 weeks prior to Visit 2
• Vagus nerve stimulator (VNS) will not be counted as an AED, but parameters must remain stable for > 4 weeks prior to baseline. The VNS must have been implanted at least 5 months prior to Visit 1.
Exclusion Criteria:
• History of any serious drug-induced hypersensitivity reaction (including but not limited to Stevens Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms) or any drug-related rash requiring hospitalization.
• History of any drug-induced rash or hypersensitivity reaction.
• History of a first degree relative with a serious cutaneous drug-induced adverse reaction.
• Subjects taking phenytoin must not be taking phenobarbital or primidone; subjects taking phenobarbital must not be taking phenytoin or primidone
Location:
David Vossler, MD, Krista Kawaguchi, MD & Carole Burton RN, Rainier Clinical Research Center, Inc. Renton, Washington, United States, 98057. Phone 1 425-251-1720
(Posted 10/04/16)
Study of Perampanel as Adjunctive Treatment for Inadequately Controlled Seizures Associated With Lennox-Gastaut Syndrome. ClinicalTrials.gov Identifier: NCT02834793
Inclusion Criteria:
• Participants must have a diagnosis of Lennox-Gastaut Syndrome (LGS) as evidenced by:
• more than one type of generalized seizure, including drop seizures (atonic, tonic, or myoclonic) for at least 6 months before Visit 1;
• an EEG reporting diagnostic criteria for LGS at some point in their history (abnormal background activity accompanied by slow, spike, and wave pattern <2.5 Hz).
• At least 2 years old at the time of consent.
• Have been <11 years old at the onset of LGS.
• At least 2 drop seizures per week in the 4-week Baseline Period preceding randomization.
• Receiving 1 to 3 concomitant AEDs at a stable dose for at least 30 days before Visit 1 (vagal nerve stimulation (VNS) and ketogenic diet do not count as AEDs).
Exclusion Criteria:
• Presence of progressive neurological disease
• Presence of drop seizure clusters where individual seizures cannot be reliably counted (seizure clusters are defined as ≥2 drop seizures with <5 minutes between any 2 consecutive seizures)
• Prior treatment with perampanel with discontinuation due to safety issues (related to perampanel)
• Prior treatment with perampanel must have been discontinued at least 30 days before Visit 1
• Evidence of clinically significant disease (eg, cardiac, respiratory, gastrointestinal, renal disease, hepatic disease) that in the opinion of the investigator(s) could affect the participant’s safety or study conduct
• Scheduled for epilepsy-related surgery or any other form of surgery during the projected course of the study
• Ketogenic diet and VNS, unless stable and ongoing, for at least 30 days before Visit 1
Location:
David Vossler, MD and Carole Burton RN, Rainier Clinical Research Center, Inc.
Renton, Washington, United States, 98057. Phone 1 425-251-1720
(Posted 10/06/16)
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
Summary:
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)
DISEASE CHARACTERISTICS:
• 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)<
PATIENT CHARACTERISTICS:
• 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<
PRIOR CONCURRENT THERAPY:
• No prior chemotherapy or radiation therapy for lymphoma<
• No history of organ transplantation or ongoing immunosuppressant therapy<
• No concurrent palliative radiotherapy<
Contact:
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
Posted (01/26/16)
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
Location:
David Vossler, MD and Carole Burton RN, Rainier Clinical Research Center, Inc.
Renton, Washington, United States, 98057. Phone 1 425-251-1720
Posted (01/26/16)
A Randomized, Double-blind, Placebo-controlled, Parallel Group, Multi-center Trial of Pregabalin as Adjunctive Therapy in Pediatric and Adult Subjects With Primary Generalized Tonic Clonic Seizures – Protocol A0081105. ClinicalTrials.gov Identifier: NCT01747915
Inclusion Criteria:
- Ages 12 to 65 years
- Primary Generalized Tonic-Clonic (PGTC) seizures
- Must have at least 1 PGTC seizure in the 8 weeks prior to screening
- Must have a minimum of 3 PGTC seizures during the 8-week baseline phase and at least 1 PGTC in each 4-week period of the baseline phase
- Currently receiving adequate and stable dosage of 1 – 3 anti-epileptic treatments (stable within 28 days of screening)
- Signed informed consent and assent if a minor
- Ability to comply with daily seizure and dosing diary requirements and all study procedures
Exclusion Criteria:
- A current diagnosis of febrile seizures, or seizures related to an ongoing acute medical illness
- Focal seizures (simple partial, complex partial, or partial becoming secondarily generalized)
- Status Epilepticus within 1 year prior to screening
- Lennox-Gastaut syndrome, infantile spasms, Benign Epilepsy with Centrotemporal Spikes (BECTS) and Dravet syndrome
- Seizures related to drugs, alcohol, or acute medical illness
- Any change in anti-epileptic treatment regimen (type of medication or dose; VNS alteration) within 28 days of the screening visit or during the baseline phase
- Progressive or potentially progressive structural CNS lesion or a progressive encephalopathy.
- Progressive inborn errors of metabolism.
Location:
United States, Washington
David Vossler, MD, Kevin Joseph, DO and Carole Burton RN, Rainier Clinical Research Center, Inc.
Renton, Washington, United States, 98057. Phone 1 425-251-1720 (Posted 07/02/13)
High-Dose Methotrexate and Liposomal Cytarabine in Treating Patients With Central Nervous System (CNS) Metastases From Breast Cancer
This study is currently recruiting participants. Learn more. Verified by Fred Hutchinson Cancer Research Center, February 2010. Posted (03/17/10)