Patients with adult-onset epileptic seizures and diagnosed ischemic stroke.

Hyperhomocysteinemia, Thrombotic, Cbs-Related

Ischemic Stroke

Epilepsy

To investigate the incidence of MTHFR deficiency in patients with adult-onset epileptic seizures and diagnosed ischemic stroke

Methylenetetrahydrofolate reductase (MTHFR) deficiency

Zeynep Orhon

Istanbul MU Goztepe Training and Research Hospital

Methylenetetrahydrofolate Reductase Deficiency in Ischemic Stroke

Investigation the Incidence of Methylenetetrahydrofolate Reductase Deficiency in Ischemic Cerebrovascular Diseases Presenting With Epileptic Seizures in Adults

The incidence of methylenetetrahydrofolate reductase (MTHFR) deficiency in ischemic stroke

Zeynep Nur Orhon

Principal Investigator

Istanbul Medeniyet University

Subjects receive only one injection of NeoSTX in saline on the back of one calf (test side). Subjects receive NeoSTX in saline in subsequent dose escalation levels: 5mcg, 10mcg, 15mcg, 20mcg, 30mcg, and 40mcg NeoSTX.

Subjects receive only one injection of NeoSTX in combination with 0.2% bupivacaine on the back of one calf (test side). Subjects receive NeoSTX in bupivacaine in subsequent dose escalation levels: 5 mcg, 10 mcg, 15 mcg, 20 mcg, 30 mcg, and 40 mcg NeoSTX.

Subjects receive one injection of NeoSTX in bupivacaine 0.2% with epinephrine 5 mcg/ml on the back of one calf (test side). Subjects receive NeoSTX in bupivacaine 0.2% with epinephrine 5 mcg/ml in doses of 10 mcg or 30 mcg of NeoSTX.

Subjects receive one injection of saline on the back of one calf (test side).

Safety of Neosaxitoxin in Healthy Volunteers

NeoSTX will be administered in sequential dose cohorts. Each subject receives one injection with bupivacaine 0.2% alone on one side (control). On the other side they receive NeoSTX in saline (test). Subjects receive NeoSTX in saline in subsequent dose escalation levels: 5 mcg, 10 mcg, 15 mcg, 20 mcg, 30 mcg, and 40 mcg of NeoSTX.

Neosaxitoxin in saline

NeoSTX will be administered in sequential dose cohorts. Each subject receives one injection with bupivacaine 0.2% on one side (control). On the other side they receive NeoSTX with 0.2% bupivacaine. Subjects receive NeoSTX in 0.2% bupivacaine in subsequent dose escalation levels: 5 mcg, 10 mcg, 15 mcg, 20 mcg, 30 mcg, and 40 mcg of NeoSTX.

NeoSTX + bupivacaine 0.2%

Each subject receives one injection with bupivacaine 0.2% on one side (control). On the other side they receive NeoSTX in 0.2% bupivacaine with epinephrine 5 mcg/ml. Subjects receive NeoSTX in 0.2% bupivacaine with epinephrine 5 mcg/ml in doses of 10 mcg or 30 mcg of NeoSTX.

NeoSTX + bupivacaine 0.2% + epinephrine 5mcg/ml

Each subject receives one injection with bupivacaine 0.2% alone on one side. On the other side they receive saline placebo.

Saline placebo

Boston Children's Hospital

Safety Study of Long-Acting Local Anesthetic

Neosaxitoxin (NeoSTX) Alone and in Combination With Bupivacaine as Prolonged Duration Local Anesthetics: A Phase I Investigator-initiated Dose Escalation Study

measured by noninvasive quantitative sensory testing (QST)

Charles Berde

Chief, Division of Pain Medicine (Department of Anesthesiology, Perioperative, and Pain Medicine)

Bone Marrow Transplantation

Sickle Cell Disease

Conduct a pilot trial using a transplant protocol, in which the standard busulfan, cyclophosphamide and anti-thymocyte globulin conditioning regimen is modified by adding fludarabine, a highly immunosuppressive agent, in order to determine the feasibility of reducing the total dose of cyclophosphamide from its present standard of 200 mg/kg to 90 mg/kg and of busulfan from its present standard of 12.8 mg/kg (IV) to 6.4 mg/kg, using a four step dose de-escalation schema.

fludarabine

University of Alabama-Birmingham

Children's National Medical Center

All Children's Research Institute Inc.

Children's Healthcare of Atlanta

Tulane University

Wayne State University

University of Mississippi Medical Center

Montefiore Medical Center

University of North Carolina at Chapel Hill

University of Texas Southwestern

Sickle Cell Disease Conditioning for Bone Marrow Transplant

Toward a Less Toxic Yet Highly Effective Conditioning Regimen in Allogeneic Hematopoietic Stem Cell Transplantation for Children and Adolescents With Severe Sickle Cell Disease: A Pilot Study

infertility/seizures

Methylenetetrahydrofolate Reductase Deficiency in Ischemic Stroke

Safety Study of Long-Acting Local Anesthetic

Sickle Cell Disease Conditioning for Bone Marrow Transplant

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