28 research outputs found
Fenfluramine for Treatment-Resistant Seizures in Patients With Dravet Syndrome Receiving Stiripentol-Inclusive Regimens A Randomized Clinical Trial
IMPORTANCE Fenfluramine treatment may reduce monthly convulsive seizure frequency in
patients with Dravet syndrome who have poor seizure control with their current
stiripentol-containing antiepileptic drug regimens.
OBJECTIVE To determine whether fenfluramine reduced monthly convulsive seizure
frequency relative to placebo in patients with Dravet syndrome who were taking
stiripentol-inclusive regimens.
DESIGN, SETTING, AND PARTICIPANTS This double-blind, placebo-controlled, parallel-group
randomized clinical trial was conducted in multiple centers. Eligible patients were children
aged 2 to 18 years with a confirmed clinical diagnosis of Dravet syndrome who were receiving
stable, stiripentol-inclusive antiepileptic drug regimens.
INTERVENTIONS Patients with 6 or more convulsive seizures during the 6-week baseline
period were randomly assigned to receive fenfluramine, 0.4 mg/kg/d (maximum, 17 mg/d),
or a placebo. After titration (3 weeks), patients’ assigned dosages were maintained for
12 additional weeks. Caregivers recorded seizures via a daily electronic diary.
MAIN OUTCOMES AND MEASURES The primary efficacy end point was the change in mean
monthly convulsive seizure frequency between fenfluramine and placebo during the
combined titration and maintenance periods relative to baseline.
RESULTS A total of 115 eligible patients were identified; of these, 87 patients (mean [SD], age
9.1 [4.8] years; 50 male patients [57%]; mean baseline frequency of seizures, approximately
25 convulsive seizures per month) were enrolled and randomized to fenfluramine,
0.4 mg/kg/d (n = 43) or placebo (n = 44). Patients treated with fenfluramine achieved a
54.0% (95% CI, 35.6%-67.2%; P < .001) greater reduction in mean monthly convulsive
seizure frequency than those receiving the placebo. With fenfluramine, 54% of patients
demonstrated a clinically meaningful (50%) reduction in monthly convulsive seizure
frequency vs 5% with placebo (P < .001). The median (range) longest seizure-free interval
was 22 (3.0-105.0) days with fenfluramine and 13 (1.0-40.0) days with placebo (P = .004).
The most common adverse events were decreased appetite (19 patients taking fenfluramine
[44%] vs 5 taking placebo [11%]), fatigue (11 [26%] vs 2 [5%]), diarrhea (10 [23%] vs 3 [7%]),
and pyrexia (11 [26%] vs 4 [9%]). Cardiac monitoring demonstrated no clinical or
echocardiographic evidence of valvular heart disease or pulmonary arterial hypertension.
CONCLUSIONS AND RELEVANCE Fenfluramine demonstrated significant improvements in
monthly convulsive seizure frequency in patients with Dravet syndrome whose conditions
were insufficiently controlled with stiripentol-inclusive antiepileptic drug regimens.
Fenfluramine was generally well tolerated. Fenfluramine may represent a new treatment
option for Dravet syndrome.
TRIAL REGISTRATION ClinicalTrials.gov identifier: NCT0292689
Flector Tissugel : efficacité et tolérance dans le traitement des microtraumatismes sportifs. Données d'une étude contrôlée conduite aux Etats-Unis
Efficacité (contre l'inflammation et la douleur) et tolérance d'un traitement local, Flector Tissugel, dispositif bio-adhésif imprégné de diclofénac épolamine, appliqué directement au niveau de la lésion traumatique douloureuse (entorse, foulure ou contusion)
Somatosensory conflicts in complex regional pain syndrome type 1 and fibromyalgia syndrome
The somatosensory system is an integral component of the motor control system that facilitates the recognition of location and experience of peripheral stimuli, as well as body part position and differentiation. In chronic pain, this system may be disrupted by alterations in peripheral and cortical processing. Clinical symptoms that accompany such changes can be difficult for patients to describe and health care practitioners to comprehend. Patients with chronic pain conditions such as complex regional pain syndrome or fibromyalgia typically describe a diverse range of somatosensory changes. This article describes how sensory information processing can become disturbed in fibromyalgia syndrome and complex regional pain syndrome and how symptoms can potentially be explained by the mechanisms that generate them. © 2009 Springer Science+Business Media, LLC
Fenfluramine for Treatment-Resistant Seizures in Patients With Dravet Syndrome Receiving Stiripentol-Inclusive Regimens A Randomized Clinical Trial
IMPORTANCE Fenfluramine treatment may reduce monthly convulsive seizure frequency in
patients with Dravet syndrome who have poor seizure control with their current
stiripentol-containing antiepileptic drug regimens.
OBJECTIVE To determine whether fenfluramine reduced monthly convulsive seizure
frequency relative to placebo in patients with Dravet syndrome who were taking
stiripentol-inclusive regimens.
DESIGN, SETTING, AND PARTICIPANTS This double-blind, placebo-controlled, parallel-group
randomized clinical trial was conducted in multiple centers. Eligible patients were children
aged 2 to 18 years with a confirmed clinical diagnosis of Dravet syndrome who were receiving
stable, stiripentol-inclusive antiepileptic drug regimens.
INTERVENTIONS Patients with 6 or more convulsive seizures during the 6-week baseline
period were randomly assigned to receive fenfluramine, 0.4 mg/kg/d (maximum, 17 mg/d),
or a placebo. After titration (3 weeks), patients’ assigned dosages were maintained for
12 additional weeks. Caregivers recorded seizures via a daily electronic diary.
MAIN OUTCOMES AND MEASURES The primary efficacy end point was the change in mean
monthly convulsive seizure frequency between fenfluramine and placebo during the
combined titration and maintenance periods relative to baseline.
RESULTS A total of 115 eligible patients were identified; of these, 87 patients (mean [SD], age
9.1 [4.8] years; 50 male patients [57%]; mean baseline frequency of seizures, approximately
25 convulsive seizures per month) were enrolled and randomized to fenfluramine,
0.4 mg/kg/d (n = 43) or placebo (n = 44). Patients treated with fenfluramine achieved a
54.0% (95% CI, 35.6%-67.2%; P < .001) greater reduction in mean monthly convulsive
seizure frequency than those receiving the placebo. With fenfluramine, 54% of patients
demonstrated a clinically meaningful (50%) reduction in monthly convulsive seizure
frequency vs 5% with placebo (P < .001). The median (range) longest seizure-free interval
was 22 (3.0-105.0) days with fenfluramine and 13 (1.0-40.0) days with placebo (P = .004).
The most common adverse events were decreased appetite (19 patients taking fenfluramine
[44%] vs 5 taking placebo [11%]), fatigue (11 [26%] vs 2 [5%]), diarrhea (10 [23%] vs 3 [7%]),
and pyrexia (11 [26%] vs 4 [9%]). Cardiac monitoring demonstrated no clinical or
echocardiographic evidence of valvular heart disease or pulmonary arterial hypertension.
CONCLUSIONS AND RELEVANCE Fenfluramine demonstrated significant improvements in
monthly convulsive seizure frequency in patients with Dravet syndrome whose conditions
were insufficiently controlled with stiripentol-inclusive antiepileptic drug regimens.
Fenfluramine was generally well tolerated. Fenfluramine may represent a new treatment
option for Dravet syndrome.
TRIAL REGISTRATION ClinicalTrials.gov identifier: NCT0292689