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Double-blind Clinical Trial (double-blind + clinical_trial)
Selected AbstractsNefazodone in out-patient treatment of inhaled cocaine dependence: a randomized double-blind placebo-controlled trialADDICTION, Issue 4 2005Sonia Regina Lambert Passos ABSTRACT Aims To assess the efficacy of oral nefazodone in the treatment of cocaine dependence. Design A 10-week randomized double-blind clinical trial was performed. Methods All 210 subjects fulfilled Diagnostic and Statistical Manual version IV (DSM-IV) criteria for cocaine dependence and were assigned randomly to 300 mg/day of oral nefazodone (N) or placebo (P). Self-reported drug use, retention interval in treatment, adherence to prescription and depressive symptoms were assessed by the Hamilton scale. Findings Abstinence from cocaine for 3 weeks or more was achieved by 49.5% (N) and 45.7% (P) (P = 0.58), but 16.2% (N) and 22.9% (P) used other drugs during abstinence. The average interval to resumption of drug use was 33.9 days (N) and 36.1 days (P). Adverse effects were reported by 45.8% (N) and 29.5% (P) (P = 0.01). Treatment for these events was needed more often in N (24.0%) than in P (9.5%) (P < 0.02). Conclusions These results do not support the indication of nefazodone for out-patient treatment of inhaled cocaine dependence with or without other associated drug dependence diagnoses. [source] Comparison of unfractioned and low molecular weight heparin for prophylaxis of coagulopathies in 52 horses with colic: a randomised double-blind clinical trialEQUINE VETERINARY JOURNAL, Issue 5 2003K. FEIGE Summary Reasons for performing study: Unfractioned heparin (UFH) is widely used for prophylaxis of coagulation disorders, especially in colic-affected horses. However, it is accompanied by certain side effects. Objectives: To compare the efficacy and side effects of unfractioned and low molecular weight heparin (LMWH) in horses with colic. Methods: The study was carried out as a randomised, double-blind, controlled clinical trial. Fifty-two horses with colic were treated subcutaneously with either UFH (heparin calcium, 150 iu/kg bwt initially, followed by 125 iu/kg bwt q. 12 h for 3 days and then 100 iu/kg bwt q. 12 h) or LMWH (dalteparin, 50 iu/kg bwt q. 24 h). All horses underwent daily physical examination including assessment of jugular veins, local reaction to heparin injections, haematological evaluation and coagulation profiles over up to 9 days. Results: The type of heparin used did not affect the general behaviour and condition. There were significantly more jugular vein changes in horses treated with UFH. Packed cell volume decreased significantly within the first few days of UFH treatment, but did not change significantly in horses treated with LMWH. Activated partial thromboplastin time (aPTT) and thrombin time (TT) were prolonged in horses treated with UFH but not in those treated with LMWH. Conclusions: It was concluded that, in comparison to UFH, LMWH has markedly fewer side effects in horses. Potential relevance: Therefore, LMWH is recommended for prophylaxis of coagulation disorders in colic patients. [source] Combined therapy of silymarin and desferrioxamine in patients with ,-thalassemia major: a randomized double-blind clinical trialFUNDAMENTAL & CLINICAL PHARMACOLOGY, Issue 3 2009Marjan Gharagozloo Abstract Silymarin, a flavonolignan complex isolated from Silybum marianum, has a strong antioxidant, hepatoprotective, and iron chelating activities. The present study was designed to investigate the therapeutic activity of orally administered silymarin in patients with thalassemia major under conventional iron chelation therapy. A 3-month randomized, double-blind, clinical trial was conducted in 59 ,-thalassemia major patients in two well-matched groups. Patients were randomized to receive a silymarin tablet (140 mg) three times a day plus conventional desferrioxamine therapy. The second group received the same therapy but a placebo tablet instead of silymarin. Clinical laboratory tests were assessed at the beginning and the end of the trial, except for serum ferritin level that was assessed at the middle of the trial as well. Results of this study revealed that the combined therapy was well tolerated and more effective than desferrioxamine in reducing serum ferritin level. Significant improvement in liver alkaline phosphatase and glutathione levels of red blood cells was also observed in silymarin-treated ,-thalassemia patients. However, no significant difference in serum ferritin levels was detected between silymarin and placebo groups after 1.5 and 3 months treatment, probably because of insufficient sample size to detect subtle changes in ferritin levels between groups. This is the first report showing the beneficial effects of silymarin in thalassemia patients and suggests that silymarin in combination with desferrioxamine can be safely and effectively used in the treatment of iron-loaded patients. [source] Assessing the Therapeutic Use of Lafoensia pacari St. Hil.HELICOBACTER, Issue 3 2006Extract (Mangava-Brava) in the Eradication of Helicobacter pylori: Double-Blind Randomized Clinical Trial Abstract Background:, The eradication of Helicobacter pylori is easily achieved by combining antisecretory agents and antibiotics; however, the cost of these associations is very high for the population of Third World countries, where the prevalence of the infection is even higher and leads to markedly reduced treatment effectiveness. We tested a plant (Lafoensia pacari) that is used in the central region of Brazil. According to previous studies, this plant has high concentrations of ellagic acid, which presents gastric antisecretory and antibacterial actions. Material and Methods:, One hundred dyspeptic, urease-positive patients were randomized to receive 500 mg of methanolic extract of L. pacari (n = 55) or placebo (n = 45), for 14 days, in a double-blind clinical trial. The main variables assessed were the eradication of H. pylori 8 weeks after the intervention and complete symptom relief at the end of the treatment. Results:, The examinations (urease and histology) showed persistence of H. pylori in 100% of participants. Complete symptom relief was experienced by 42.5% of patients (95% CI: 29.4,55.8) in the intervention group and by 21% (95% CI: 8.8,33.1) in the control group, p = .020. The side-effects were minimal and similar in both groups. Conclusions:, The extract of L. pacari as a single agent was not effective to eradicate H. pylori. However, it was well tolerated and many participants reported relief of symptoms. Future studies may test the agent using larger doses and longer periods, in monotherapy or in combination with antibiotics. [source] The use of an intra-oral injection of ketorolac in the treatment of irreversible pulpitisINTERNATIONAL ENDODONTIC JOURNAL, Issue 11 2005A. C. Mellor Abstract Aim, To examine whether an intra-oral injection of a nonsteroidal anti-inflammatory drug (ketorolac), in association with conventional local anaesthetic techniques, would improve the pulp extirpation rate in teeth with irreversible pulpitis. Methodology, A two group double-blind clinical trial was undertaken in the Dental Casualty Department of the University of Manchester School of Dentistry. Patients were randomly allocated to either the test or control group. The test group received an intra-oral injection of ketorolac (30 mg in 1 mL) in the buccal sulcus adjacent to the tooth being treated. After an interval of 15 min, they then received 2.2 mL of 2% lidocaine with 1 : 80 000 epinephrine by buccal infiltration in the maxilla or by inferior dental block in the mandible. The control group received an intra-oral injection of normal saline (1 mL) in the buccal sulcus adjacent to the tooth being treated, followed by the same local anaesthetic regime as the test group after the 15 min interval. Fifteen minutes after the local anaesthetic injections, pulp extirpation was attempted. All patients completed the short-form McGill pain questionnaire prior to treatment and completed identical questionnaires at 6 and 24 h after treatment. Results, The study protocol set the number of patients to be treated at twenty. However, as the study progressed it became apparent that the intra-oral injection of ketorolac caused significant pain to four of the five patients who received it; therefore the study was terminated after ten patients had been treated. The results from the patients treated showed no significant difference in the pulp extirpation rate between the test and control groups. However, patients with higher pain scores at baseline were less likely to have the pulp completely extirpated, irrespective of whether they were in the test or control group. Pain scores for all patients decreased significantly from baseline to 24 h. Conclusion, An intra-oral injection of ketorolac did not improve the pulp extirpation rate in a small group of patients with irreversible pulpitis compared with a placebo. In addition, it was associated with such significant pain on injection that it cannot be recommended as a treatment in this situation. [source] Current Status of Metals as Therapeutic Targets in Alzheimer's DiseaseJOURNAL OF AMERICAN GERIATRICS SOCIETY, Issue 8 2003Anne E. Finefrock MA There is accumulating evidence that interactions between ,-amyloid and copper, iron, and zinc are associated with the pathophysiology of Alzheimer's disease (AD). A significant dyshomeostasis of copper, iron, and zinc has been detected, and the mismanagement of these metals induces ,-amyloid precipitation and neurotoxicity. Chelating agents offer a potential therapeutic solution to the neurotoxicity induced by copper and iron dyshomeostasis. Currently, the copper and zinc chelating agent clioquinol represents a potential therapeutic route that may not only inhibit ,-amyloid neurotoxicity, but may also reverse the accumulation of neocortical ,-amyloid. A Phase II double-blind clinical trial of clioquinol with B12 supplementation will be published soon, and the results are promising. This article summarizes the role of transition metals in amyloidgenesis and reviews the potential promise of chelation therapy as a treatment for AD. [source] Randomized, placebo-controlled, double-blind clinical trial evaluating the treatment of plantar fasciitis with an extracoporeal shockwave therapy (ESWT) device: A North American confirmatory studyJOURNAL OF ORTHOPAEDIC RESEARCH, Issue 2 2006Patricia Kudo Abstract Despite numerous publications and clinical trials, the results of treatment of recalcitrant chronic plantar fasciitis with extracorporeal shockwave therapy (ESWT) still remain equivocal as to whether or not this treatment provides relief from the pain associated with this condition. The objective of this study was to determine whether extracorporeal shock wave therapy can safely and effectively relieve the pain associated with chronic plantar fasciitis compared to placebo treatment, as demonstrated by pain with walking in the morning. This was set in a multicenter, randomized, placebo-controlled, double-blind, confirmatory clinical study undertaken in four outpatient orthopedic clinics. The patients, 114 adult subjects with chronic plantar fasciitis, recalcitrant to conservative therapies for at least 6 months, were randomized to two groups. Treatment consisted of approximately 3,800 total shock waves (±10) reaching an approximated total energy delivery of 1,300 mJ/mm2 (ED+) in a single session versus placebo treatment. This study demonstrated a statistically significant difference between treatment groups in the change from baseline to 3 months in the primary efficacy outcome of pain during the first few minutes of walking measured by a visual analog scale. There was also a statistically significant difference between treatments in the number of participants whose changes in Visual Analog Scale scores met the study definition of success at both 6 weeks and 3 months posttreatment; and between treatment groups in the change from baseline to 3 months posttreatment in the Roles and Maudsley Score. The results of this study confirm that ESWT administered with the Dornier Epos Ultra is a safe and effective treatment for recalcitrant plantar fasciitis. © 2005 Orthopaedic Research Society. Published by Wiley Periodicals, Inc. J Orthop Res [source] Efficacy and safety of recombinant human soluble thrombomodulin (ART-123) in disseminated intravascular coagulation: results of a phase III, randomized, double-blind clinical trialJOURNAL OF THROMBOSIS AND HAEMOSTASIS, Issue 1 2007H. SAITO Summary.,Background: Soluble thrombomodulin is a promising therapeutic natural anticoagulant that is comparable to antithrombin, tissue factor pathway inhibitor and activated protein C. Objectives: We conducted a multicenter, double-blind, randomized, parallel-group trial to compare the efficacy and safety of recombinant human soluble thrombomodulin (ART-123) to those of low-dose heparin for the treatment of disseminated intravascular coagulation (DIC) associated with hematologic malignancy or infection. Methods: DIC patients (n = 234) were assigned to receive ART-123 (0.06 mg kg,1 for 30 min, once daily) or heparin sodium (8 U kg,1 h,1 for 24 h) for 6 days, using a double-dummy method. The primary efficacy endpoint was DIC resolution rate. The secondary endpoints included clinical course of bleeding symptoms and mortality rate at 28 days. Results: DIC was resolved in 66.1% of the ART-123 group, as compared with 49.9% of the heparin group [difference 16.2%; 95% confidence interval (CI) 3.3,29.1]. Patients in the ART-123 group also showed more marked improvement in clinical course of bleeding symptoms (P = 0.0271). The incidence of bleeding-related adverse events up to 7 days after the start of infusion was lower in the ART-123 group than in the heparin group (43.1% vs. 56.5%, P = 0.0487). Conclusions: When compared with heparin therapy, ART-123 therapy more significantly improves DIC and alleviates bleeding symptoms in DIC patients. [source] Co-administration of salbutamol and fluticasone for emergency treatment of children with moderate acute asthma,PEDIATRIC ALLERGY AND IMMUNOLOGY, Issue 7 2005Elizabeth Estrada-Reyes This study aimed to compare the efficacy of nebulized therapy with salbutamol alone or in combination with fluticasone. In a randomized, double-blind clinical trial, 150 children with moderate acute asthma were randomly assigned to receive by nebulizations either (i) three doses of salbutamol 30 ,l/kg per dose, each dose administered every 15 min, (ii) three doses of salbutamol plus two doses of fluticasone 500 ,g/dose at 15 and 30 min after first dose of salbutamol, or (iii) three doses of salbutamol/fluticasone 500 ,g/dose, each combined dose administered every 15 min. Pulse oxymetry (SaO2), peak expiratory flow (PEF) and Wood et al. (Am J Dis Child, 123, 1972, 123) clinical scale were evaluated at baseline, 15, 30, 45, 60, 90 and 120 min after the first nebulization. Patients in the three groups significantly improved since 15 min after the first nebulization. We did not observe differences in the recovery of SaO2 and PEF among the three groups of treatment (p > 0.10). In group 3, children showed better clinical response at 120 min than the other two groups (p < 0.05). No significant adverse effects were observed with any treatment. To summarize, in children with acute moderate asthma, nebulized salbutamol at an accumulated dose of 90 ,l/kg plus fluticasone at an accumulated dose of 1500 ,g produced better clinical relief after 2 h. However, similar PEF and SaO2 responses were observed with salbutamol alone or in combination with different doses of fluticasone. [source] Addition of clonidine and fentanyl: comparison between three different regional anesthetic techniques in circumcisionPEDIATRIC ANESTHESIA, Issue 11 2005ZOUHER A NAJA MD Summary Background :,Several techniques have been used for alleviating postcircumcision pain with regional anesthetics being more effective than systemic opioids. Our aim was to compare the effectiveness of dorsal penile block, ring block (RB) and dorsal penile block associated with RB in reducing postcircumcision pain in children. Methods :,We conducted a prospective randomized double-blind clinical trial on 100 boys aged between 1 month and 5 years undergoing elective circumcision. Each 20 ml of local anesthetic mixture contained 9 ml lidocaine 1% without epinephrine, 9 ml bupivacaine 0.5%, 1 ml fentanyl (50 ,g·ml,1) and 1 ml clonidine (75 ,g·ml,1). They were allocated to one of three groups: 33 boys were given a RB with 1,1.5 ml (group 1), 32 had a dorsal penile block with 1.5,4 ml (group 2) and 35 had a combined ring and dorsal penile block with 2.5,5 ml of anesthetic mixture based on the child's age. Results :,Ninety-one children (91%) completed the clinical trial (three failed blocks and six follow-up losses). The groups were similar with regard to age, weight, height, duration of surgery and hemodynamic status. The average pain scores were significantly higher with a RB compared with the other two groups (P < 0.05) for the first postoperative day. RB children and dorsal penile block children consumed significantly more analgesics for the first six postoperative hours (P < 0.05). The surgeon's satisfaction was significantly higher with the ring + dorsal penile block group (100%) compared with the other two groups (P = 0.032). Conclusion :,Dorsal penile block plus RB technique is superior to dorsal penile block alone and RB alone in reducing postcircumcision pain in children. [source] The efficacy of Silybum marianum (L.) Gaertn. (silymarin) in the treatment of type II diabetes: a randomized, double-blind, placebo-controlled, clinical trialPHYTOTHERAPY RESEARCH, Issue 12 2006H. Fallah Huseini Abstract Oxidative stresses are increasingly implicated in the pathogenesis of diabetic complications which may either cause direct pancreatic , -cell damage or lead to metabolic abnormalities that can induce or aggravate diabetes. The valuable effect of antioxidant nutrients on the glycemic control of diabetic patients has been reported in experimental and clinical studies. The present study was designed to investigate the effects of the herbal medicine, Silybum marianum seed extract (silymarin), which is known to have antioxidant properties on the glycemic profile in diabetic patients. A 4-month randomized double-blind clinical trial was conducted in 51 type II diabetic patients in two well-matched groups. The first group (n = 25) received a silymarin (200 mg) tablet 3 times a day plus conventional therapy. The second group (n = 26) received the same therapy but a placebo tablet instead of silymarin. The patients were visited monthly and glycosylated hemoglobin (HbA1c), fasting blood glucose (FBS), insulin, total cholesterol, LDL and HDL, triglyceride, SGOT and SGPT levels were determined at the beginning and the end of the study. The results showed a significant decrease in HbA1c, FBS, total cholesterol, LDL, triglyceride SGOT and SGPT levels in silymarin treated patients compared with placebo as well as with values at the beginning of the study in each group. In conclusion, silymarin treatment in type II diabetic patients for 4 months has a beneficial effect on improving the glycemic profile. Copyright © 2006 John Wiley & Sons, Ltd. [source] Utility of Crossover Designs in Clinical Trials: Efficacy of Desipramine vs.THE AMERICAN JOURNAL ON ADDICTIONS, Issue 2 2002Placebo in Opioid-Dependent Cocaine Abusers The utility of the crossover design in substance abuse research was examined in a 26-week, double-blind clinical trial that evaluated the efficacy of desipramine (0 or 150 mg/day) in 109 male and female cocaine- and opiate-dependent patients maintained on buprenorphine (12 mg/day) or methadone (65 mg/day). After being stabilized on buprenorphine or methadone (weeks 1,2), half of the patients were randomly assigned to receive desipramine for the first half of the trial and placebo for the second, with the order reversed for the second half. Analyses using hierarchical linear models (HLM) indicated that desipramine reduced the use of opiates only when administered at the start (rather than the middle) of the trial, whereas cocaine use was reduced when desipramine was introduced at either time. [source] Role of Albumin Coating of Tympanostomy Tubes: Long-Term Clinical EvaluationTHE LARYNGOSCOPE, Issue 12 2007Teemu J. Kinnari MD Abstract Objective: Our previous work has shown that albumin coating of tympanostomy tubes prevented adhesion of proteins or bacteria on the tube surface in vitro and in a 9-month prospective follow-up study. This study was continued until all tubes were extruded. Study Design: A prospective, clinical trial. Methods: The randomized, double-blind clinical trial had 149 patients. The randomization was revealed after the follow-up period of 9 months. The number of tube sequelae in ears with human serum albumin (HSA)-coated titanium tympanostomy tubes was compared with the contralateral ears with uncoated, otherwise identical titanium tubes. The follow-up continued until all tubes were extruded, followed by evaluation of each tympanostomized patient. Results: No significant difference between the two tube types emerged after the 9-month follow-up. Among the patients younger than 2 years, one of the three typical bacteria causing acute otitis media (AOM), Streptococcus pneumoniae, Haemophilus influenzae, or Moraxella catarrhalis, was found in 45% of all bacterial cultures taken during AOM. However, among patients older than 2, one of these bacteria appeared in 17% of all the bacterial cultures and in 8% of cultures taken during the summer. Conclusions: After the first 9 follow-up months, no difference was found in the sequelae related to uncoated and HSA-coated tubes. The typical bacteria causing AOM were found less frequently among patients older than 2 years. A profile of tympanostomy patients in Finland will be given. [source] Evaluation of Omeprazole in the Treatment of Reflux Laryngitis: A Prospective, Placebo-Controlled, Randomized, Double-Blind Study,THE LARYNGOSCOPE, Issue 12 2001J. Pieter Noordzij MD Abstract Objectives Proton-pump inhibitors are often recommended in the treatment of laryngitis secondary to gastric reflux. Despite prospective treatment studies reporting high efficacy, only one previous report has been placebo-controlled and blinded. The objective of this study was to determine the efficacy of omeprazole in treating proven reflux laryngitis. Study Design Prospective, placebo-controlled, randomized, double-blind clinical trial. Methods Fifty-three patients with one or more reflux laryngitis symptoms were recruited to undergo 24-hour dual-channel pH probe testing. Thirty patients with more than four episodes of laryngopharyngeal reflux were enrolled. By random assignment, 15 patients received 40 mg omeprazole twice a day and the other 15 received placebo for a period of 2 months. Symptoms (hoarseness, throat pain, lump in throat sensation, throat clearing, cough, excessive phlegm, dysphagia, odynophagia, and heartburn) and endoscopic laryngeal signs (erythema, edema, and mucus accumulation) were recorded initially, at 1 month, and 2 months. Results In general, most symptom scores improved over time for both the omeprazole and placebo groups. Hoarseness, when patients begin with low hoarseness symptom scores, and throat clearing improved significantly more in patients on omeprazole than in those on placebo during the 2-month study. Throat pain, lump in throat sensation, excessive phlegm, difficulty swallowing, pain with swallowing, and heartburn showed improvement in both treatment arms, signifying the possibility of a placebo effect. Endoscopic laryngeal signs did not change significantly over the course of the study for either treatment group. Conclusions A placebo effect appears to exist in the treatment of reflux laryngitis. However, hoarseness, when initially scored low, and throat clearing resulting from reflux laryngitis are effectively treated by omeprazole. [source] Subjective effects of Lepidium meyenii (Maca) extract on well-being and sexual performances in patients with mild erectile dysfunction: a randomised, double-blind clinical trialANDROLOGIA, Issue 2 2009T. Zenico Summary Lepidium meyenii (Maca) is a cultivated root belonging to the brassica family used in the Andean region for its supposed aphrodisiac properties. We carried out a double-blind clinical trial on 50 Caucasian men affected by mild erectile dysfunction (ED), randomised to treatment with Maca dry extract, 2400 mg, or placebo. The treatment effect on ED and subjective well-being was tested administrating before and after 12 weeks the International Index of Erectile Function (IIEF-5) and the Satisfaction Profile (SAT-P). After 12 weeks of treatment, both Maca- and placebo-treated patients experienced a significant increase in IIEF-5 score (P < 0.05 for both). However, patients taking Maca experienced a more significant increase than those taking placebo (1.6 ± 1.1 versus 0.5 ± 0.6, P < 0.001). Both Maca- and placebo-treated subjects experienced a significant improvement in psychological performance-related SAT-P score, but the Maca group higher than that of placebo group (+9 ± 6 versus +6 ± 5, P < 0.05). However, only Maca-treated patients experienced a significant improvement in physical and social performance-related SAT-P score compared with the baseline (+7 ± 6 and +7 ± 6, both P < 0.05). In conclusion, our data support a small but significant effect of Maca supplementation on subjective perception of general and sexual well-being in adult patients with mild ED. [source] Oral Glucose Solution as Pain Relief in Newborns: Results of a Clinical TrialBIRTH, Issue 2 2010Ben Dilen RN Abstract:, Background:,It was long believed that newborns could not experience pain. As it is now documented that newborns have all the necessary systems to perceive pain, pain management can no longer be ignored. The objective of this study is to investigate which concentration of glucose is most effective in reducing pain for venipuncture in the newborn. Methods:,This double-blind clinical trial of 304 newborns was conducted on a maternity and neonatal ward (neonatal medium intensive care unit). During at least 1 month, one of the four selected solutions (10, 20, 30% glucose, and placebo) was administered orally, 2 minutes before the venipuncture was performed. The pain from the skin puncture was scored using a validated pain scale (the "Leuven Pain Scale"). Results:,This study showed a significantly lower average pain score in the 30 percent glucose group (3.99) when compared with the placebo group (8.43). The average pain scores in the 20 percent glucose group (5.26) and the 10 percent glucose group (5.92) were also significantly lower than those in the placebo group. Conclusion:,Oral administration of 2 mL of 30 percent glucose 2 minutes before the venipuncture provides the most effective pain reduction in newborns. (BIRTH 37:2 June 2010) [source] Long-term safety and efficacy of zonisamide in patients with refractory partial-onset epilepsyACTA NEUROLOGICA SCANDINAVICA, Issue 2 2008S. J. Wroe Objectives,,, To investigate whether zonisamide remains effective and well tolerated in the treatment of refractory partial epilepsy during long-term treatment and with flexible dosing in clinical practice. Materials and methods,,, Patients with refractory partial epilepsy who completed a fixed-dose, randomized, double-blind clinical trial were recruited in an open-label extension study with adjustment of zonisamide and other antiepileptic drug dosage according to the treating physician's usual clinical practice. Results,,, An intention-to-treat analysis of 317 patients showed that zonisamide was well tolerated with a predictable safety profile. Patient retention rates at 1, 2 and 3 years were 65.3%, 44.5% and 28.8%, respectively. Zonisamide treatment was associated with a maintained reduction in seizure frequency, with some patients achieving prolonged periods of seizure freedom. Conclusions,,, Flexible dosing with zonisamide demonstrated a good safety profile and sustained efficacy in the long-term adjunctive treatment of refractory partial epilepsy. [source] | |||||||||||||||||||