Neuromyelitis optica relapses: Race and rate, immunosuppression and impairment.

Objective: Neuromyelitis optica (NMO) is a rare antibody-mediated CNS disease characterised by disabling relapses leading to high morbidity and mortality. Understanding relapse activity and severity is important for treatment decisions and clinical trial design. We assessed (1) whether clinical and demographic factors associate with different relapse rates and (2) the relative impact of immunosuppressive treatments on relapse rates and on attack-related residual disability.

Challenges and opportunities in designing clinical trials for neuromyelitis optica.

Current management of neuromyelitis optica (NMO) is noncurative and only partially effective. Immunosuppressive or immunomodulatory agents are the mainstays of maintenance treatment. Safer, better-tolerated, and proven effective treatments are needed.

Home time is extended in patients with ischemic stroke who receive thrombolytic therapy: a validation study of home time as an outcome measure.

Background And Purpose: "Home time" (HT) refers to the number of days over the first 90 after stroke onset that a patient spends residing in their own home or a relative's home versus any institutional care. It is an accessible and objective parameter, free from subjective bias, with potential as an outcome measure in acute stroke trials. We sought to validate HT and assess treatment responsiveness using independent data.

Ancrod in acute ischemic stroke: results of 500 subjects beginning treatment within 6 hours of stroke onset in the ancrod stroke program.

Background And Purpose: Previous studies of multiple-day dosing with the defibrinogenating agent, ancrod, in acute ischemic stroke yielded conflicting results but suggested that a brief dosing regimen might improve efficacy and safety. The Ancrod Stroke Program was designed to test this concept in subjects beginning ancrod or placebo within 6 hours of the onset of acute ischemic stroke.

Methods: Five hundred subjects with acute ischemic stroke who could begin receiving study material within 6 hours of symptom onset were infused intravenously with either ancrod (0.

Hyperfibrinogenemia and functional outcome from acute ischemic stroke.

Background And Purpose: Epidemiological studies have found strong correlations between elevated plasma fibrinogen levels and both ischemic stroke incidence and stroke mortality. Little is known about the influence of fibrinogen levels on functional stroke outcome.

Methods: Placebo data from the Stroke Treatment with Ancrod Trial (STAT) and European Stroke Treatment with Ancrod Trial (ESTAT) were analyzed.

Ancrod for acute ischemic stroke: a new dosing regimen derived from analysis of prior ancrod stroke studies.

Background: Ancrod, a fibrinogen-reducing agent, has been evaluated as treatment beginning within 3 or 6 hours of onset of acute ischemic stroke with inconsistent results. The data sets from these studies provide an opportunity to determine whether ancrod-related variables are associated with efficacy and safety.

Objective: This post hoc analysis of data from the Stroke Treatment with Ancrod Trial (STAT) analyzed ancrod-related variables as potential determinants of efficacy or safety.

NXY-059 for the treatment of acute stroke: pooled analysis of the SAINT I and II Trials.

Background And Purpose: In animal models of acute ischemic stroke (AIS), the free radical-trapping agent NXY-059 showed promise as a neuroprotectant. SAINT I and II were randomized, placebo-controlled, double-blind trials to investigate the efficacy of NXY-059 in patients with AIS.

Methods: Patients with AIS received an infusion of intravenous NXY-059 or placebo within 6 hours from the onset of stroke symptoms.

NXY-059 for the treatment of acute ischemic stroke.

Background: The free-radical-trapping agent NXY-059 showed promise as a neuroprotectant in the Stroke-Acute Ischemic NXY Treatment I (SAINT I) trial, reducing disability when given to patients who had acute ischemic stroke. We sought confirmation of efficacy in a second, larger trial.

Methods: We enrolled 3306 patients with acute ischemic stroke in a randomized, double-blind trial to receive a 72-hour infusion of intravenous NXY-059 or placebo within 6 hours after the onset of stroke symptoms.

Efficacy of zolmitriptan nasal spray in adolescent migraine.

Objective: The goal was to evaluate the efficacy and tolerability of zolmitriptan nasal spray in the treatment of adolescent migraine.

Methods: The "Double-Diamond" study used a novel, single-blind, "placebo challenge" in a multicenter, randomized, double-blind, placebo-controlled, 2-way, 2-attack, crossover design. A total of 248 US adolescent patients (12-17 years of age) with an established diagnosis of migraine, with or without aura, were enrolled.

Safety and tolerability of NXY-059 for acute intracerebral hemorrhage: the CHANT Trial.

Background And Purpose: NXY-059 is a free radical-trapping neuroprotectant developed for use in acute ischemic stroke. To facilitate prompt administration of treatment, potentially before neuroimaging, we investigated the safety of NXY-059 in patients with intracerebral hemorrhage (ICH).

Methods: We randomized 607 patients within 6 hours of acute ICH to receive 2270 mg intravenous NXY-059 over 1 hour and then up to 960 mg/h over 71 hours, or matching placebo, in addition to standard care.

Additional outcomes and subgroup analyses of NXY-059 for acute ischemic stroke in the SAINT I trial.

Background And Purpose: NXY-059 is a free radical-trapping neuroprotectant demonstrated to reduce disability from ischemic stroke. We conducted analyses on additional end points and sensitivity analyses to confirm our findings.

Methods: We randomized 1722 patients with acute ischemic stroke to a 72-hour infusion of placebo or intravenous NXY-059 within 6 hours of stroke onset.

NXY-059 for acute ischemic stroke.

Background: NXY-059 is a free-radical-trapping agent that is neuroprotective in animal models of stroke. We tested whether it would reduce disability in humans after acute ischemic stroke.

Methods: We conducted a randomized, double-blind, placebo-controlled trial involving 1722 patients with acute ischemic stroke who were randomly assigned to receive a 72-hour infusion of placebo or intravenous NXY-059 within 6 hours after the onset of the stroke.

Zolmitriptan oral tablet in migraine treatment: high placebo responses in adolescents.

Objective: The objective of this randomized, double-blind, placebo-controlled study was to evaluate the efficacy and tolerability of the zolmitriptan conventional tablet at three different doses for the treatment of a single migraine attack in adolescents.

Background: Preliminary data from an open-label study suggested that the zolmitriptan conventional tablet could be effective in the treatment of acute migraine in adolescent patients.

Methods: Migraine patients aged 12 to 17 years (n = 850) were randomized to receive zolmitriptan 2.

Chronic daily headache in children and adolescents presenting to tertiary headache clinics.

Background: Adults with chronic daily headache often describe a transformation from episodic migraine and partial retention of migrainous features. Although chronic daily headache has not been investigated as carefully in the pediatric population, one study showed a predominance of coexisting daily headache and episodic migraine, without a clear history of transformation.

Objective: To identify the clinical features of chronic daily headache in children and adolescents, to evaluate the efficacy of current headache classification criteria, and to compare the features of coexistent daily and episodic headaches so as to determine whether they represent separate syndromes or different stages in the "transformation" process.

Chronic nonprogressive headaches in children and adolescents.

Chronic nonprogressive headaches (CNPHA) are common in children and increase in frequency in adolescents. Features are usually, but not always, distinct from those of migraine. CNPHA have also been called chronic daily headaches, tension-type headaches, muscle contraction headaches, and psychogenic headaches.

Preventive therapy in pediatric migraine.

Preventive therapy for migraine headache includes identification of migraine precipitants, possible adjustments in lifestyle, appropriate management of acute headache, and, when necessary, the use of pharmacologic agents. There are no well-controlled clinical trials with sufficient patient numbers to support the use of any agent in the prevention of migraine headache in children. Data on the use of amitriptyline and divalproex sodium in open-label studies suggest that these agents may be efficacious.

Multicenter prospective evaluation of proposed pediatric migraine revisions to the IHS criteria. Pediatric Headache Committee of the American Association for the Study of Headache.

Eighty-eight children and adolescents were prospectively evaluated at eight specialty clinics comparing the diagnostic criteria of the International Headache Society (IHS) and the proposed revised (IHS-R) classification to the clinical diagnosis. The proposed revisions to the IHS classification for pediatric migraine include: duration-1 hour to 48 hours; location--bifrontal/bitemporal or unilateral; and symptoms--to include photophobia or phonophobia. A comparison of the diagnostic rates of pediatric migraine with and without aura of the total sample revealed IHS (66%) versus IHS-R (93%) and comparison of a subset of those patients less than 12 years of age (n = 39) revealed IHS (49%) versus IHS-R (87%).

Neurologic history and examination results and their relationship to human immunodeficiency virus type 1 serostatus in hemophilic subjects: results from the hemophilia growth and development study.

In a prospective study of the growth and neuropsychologic function of hemophilic subjects, 333 boys, median age of 12.3 years, had baseline neurologic examinations. The study population included 207 individuals (62%) who were seropositive for human immunodeficiency virus type 1 (HIV-1).

Cerebral glycogenosis, alpha particle type: morphologic and biochemical observations in an infant.

A 3-month-old infant with congenital hypotonia suffering from an unusual form of glycogenosis is reported. The most striking neuropathologic findings were vacuolation of neuropile and glycogen accumulation, especially in the cerebral cortex and cerebellar molecular layer. Ultrastructurally, glycogen accumulation was present mainly in neurites and astrocytic processes, and mostly appeared as rosettes (alpha glycogen particles).

Weaver syndrome: the changing phenotype in an adult.

We report on a 25-year-old woman who was diagnosed with Weaver syndrome after reevaluation because of the family's concern regarding recurrence risk for mental retardation in offspring of the woman's brother. The diagnosis was suggested on the basis of postnatal growth excess, camptodactyly, and developmental delay, but with a somewhat atypical facial appearance. When childhood photographs were reviewed, her facial characteristics were more consistent with those of Weaver syndrome in early childhood, but became less obvious with age.