scholarly journals Adjunctive zonisamide therapy in the long-term treatment of children with partial epilepsy: Results of an open-label extension study of a phase III, randomized, double-blind, placebo-controlled trial

Epilepsia ◽  
2014 ◽  
Vol 55 (4) ◽  
pp. 568-578 ◽  
Author(s):  
Renzo Guerrini ◽  
Anna Rosati ◽  
Kate Bradshaw ◽  
Luigi Giorgi
Keyword(s):  
Controlled Trial ◽  
Term Treatment ◽  
Partial Epilepsy ◽  
Phase Iii ◽  
Open Label ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Long Term Treatment ◽  
Open Label Extension

scholarly journals Long-term safety and effectiveness of lurasidone in schizophrenia: a 22-month, open-label extension study

CNS Spectrums ◽  
2016 ◽  
Vol 21 (5) ◽  
pp. 393-402 ◽  
Author(s):  
Christoph U. Correll ◽  
Josephine Cucchiaro ◽  
Robert Silva ◽  
Jay Hsu ◽  
Andrei Pikalov ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Term Treatment ◽  
Extension Study ◽  
Open Label ◽  
Double Blind ◽  
Syndrome Scale ◽  
Long Term Treatment ◽  
Open Label Extension ◽  
The Mean

ObjectiveTo evaluate the safety and effectiveness of lurasidone in the long-term treatment of patients with schizophrenia.MethodsPatients who completed a 6-week, double-blind (DB), placebo-controlled trial continued in a 22-month, open-label (OL) study during which they received once-daily, flexible-doses of lurasidone, 40–120 mg. Change in the Positive and Negative Syndrome Scale (PANSS) was analyzed using both observed case (OC) and last observation carried forward (LOCF) analyses.ResultsOf the 251 patients who entered the OL extension, 51.4% completed 6 months, 36.7% completed 12 months, and 26.7% completed 22 months of OL treatment. Treatment with lurasidone was associated with a mean change from DB baseline, in weight of +0.4 kg at Month 12 (n=99), and +0.8 kg at Month 24 (n=67; OC analyses). Median change from DB baseline to Month 12 and Month 24, respectively, was -1.0 and -9.0 mg/dL for total cholesterol; 0.0 and -1.0 mg/dL for LDL; +1.0 and -11.0 mg/dL for triglycerides; and 0.0 and +0.1/% for HbA1c (OC analyses). The mean PANSS total score was 96.5 at DB baseline and 69.5 at OL baseline. The mean change from DB baseline in the PANSS total score at Month 24 was -43.6 (OC) and -28.4 (LOCF). Thirty-seven patients (14.7%) discontinued due to an adverse event (AE) during OL treatment. Three AEs occurred in ≥10% of patients: schizophrenia (12.4%), akathisia (10.8%), and somnolence (10.8%); and 19.2% reported at least one movement disorder–related AE. Discontinuations due to AEs occurred in 14.8% of patients.ConclusionsIn this 22-month, open-label extension study, treatment with lurasidone was associated with minimal effects on weight, glucose, lipids, and prolactin. Patients demonstrated sustained improvement in the PANSS total score for up to 24 months of lurasidone treatment.

scholarly journals Long-term treatment of Cushing’s disease with pasireotide: 5-year results from an open-label extension study of a Phase III trial

Endocrine ◽  
2017 ◽  
Vol 57 (1) ◽  
pp. 156-165 ◽  
Author(s):  
S. Petersenn ◽  
L. R. Salgado ◽  
J. Schopohl ◽  
L. Portocarrero-Ortiz ◽  
G. Arnaldi ◽  
...  
Keyword(s):  
Cushing’S Disease ◽  
Term Treatment ◽  
Phase Iii ◽  
Cushing's Disease ◽  
Extension Study ◽  
Open Label ◽  
Phase Iii Trial ◽  
Long Term Treatment ◽  
Open Label Extension

scholarly journals A randomized, double‐blind, placebo‐controlled trial to evaluate the efficacy, safety, and tolerability of long‐term treatment with prucalopride

2015 ◽  
Vol 27 (6) ◽  
pp. 805-815 ◽  
Author(s):  
H. Piessevaux ◽  
E. Corazziari ◽  
E. Rey ◽  
M. Simren ◽  
A. Wiechowska‐Kozlowska ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Term Treatment ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Long Term Treatment

Antiaggregatory Effects of Picotamide in Long-Term Treatment: A 2-Year, Double-Blind Placebo-Controlled Trial

1997 ◽  
Vol 2 (4) ◽  
pp. 292-295 ◽  
Author(s):  
Manlio Cocozza ◽  
Massimo Milani ◽  
Tommaso Picano ◽  
Ugo Oliviero ◽  
Nicola Russo ◽  
...  
Keyword(s):  
Platelet Aggregation ◽  
Ex Vivo ◽  
Controlled Trial ◽  
Term Treatment ◽  
Significant Inhibition ◽  
Diabetic Patients ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Long Term Treatment

The ex vivo antiaggregatory activity of picotamide, a dual antithromboxane agent, was assessed to find whether it was maintained in long-term treatment. In a double-blind, placebo-controlled 2-year study, 50 type 2 diabetic patients (35 men and 15 women; mean age 66 ± 5 years) were enrolled and randomly given picotamide, 300 mg t.i.d. or the corresponding placebo. Platelet aggregation studies were performed at baseline and after 1, 3, 6, 12, 18 and 24 months. Compliance to the treatment was assessed by pill count at each visit. Forty-nine patients concluded the study. Starting from month 1, compared with placebo, picotamide-treated patients showed a significant inhibition of agonist-induced (ADP, arachidonic acid and collagen) platelet aggregation (–41%). The antiaggregatory effect was maintained throughout the study. At month 24, in the picotamide group, platelet aggregation was significantly lower compared with placebo (–30%). After 24 months of treatment, 20 out of 23 (86%) picotamide-treated patients showed a significant inhibition of platelet aggregation, whereas the remaining three patients had a normal platelet response. During the study, 12 patients suffered from thrombotic events of death: nine in the placebo group and three in the picotamide group, respectively. It was concluded that picotamide maintains its antiaggregatory effect, in long-term treatment, in more than 85% of patients.

Long-term treatment with probiotics in primary care patients with irritable bowel syndrome – a randomised, double-blind, placebo controlled trial

2013 ◽  
Vol 48 (10) ◽  
pp. 1127-1135 ◽  
Author(s):  
Luise Mølenberg Begtrup ◽  
Ove B Schaffalitzky de Muckadell ◽  
Jens Kjeldsen ◽  
René dePont Christensen ◽  
Dorte Ejg Jarbøl
Keyword(s):  
Primary Care ◽  
Irritable Bowel Syndrome ◽  
Controlled Trial ◽  
Term Treatment ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Long Term Treatment ◽  
Primary Care Patients ◽  
Irritable Bowel

scholarly journals Secukinumab for Long-Term Treatment of Psoriatic Arthritis: A Two-Year Followup From a Phase III, Randomized, Double-Blind Placebo-Controlled Study

2017 ◽  
Vol 69 (3) ◽  
pp. 347-355 ◽  
Author(s):  
Arthur Kavanaugh ◽  
Philip J. Mease ◽  
Andreas M. Reimold ◽  
Hasan Tahir ◽  
Jürgen Rech ◽  
...  
Keyword(s):  
Psoriatic Arthritis ◽  
Term Treatment ◽  
Phase Iii ◽  
Controlled Study ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Long Term Treatment

Long-Term, Open-Label Extension Study of Guanfacine Extended Release in Children and Adolescents with ADHD

CNS Spectrums ◽  
2008 ◽  
Vol 13 (12) ◽  
pp. 1047-1055 ◽  
Author(s):  
Joseph Biederman ◽  
Raun D. Melmed ◽  
Anil Patel ◽  
Keith McBurnett ◽  
Jessica Donahue ◽  
...  
Keyword(s):  
Adverse Events ◽  
Extended Release ◽  
Rating Scale ◽  
Multicenter Trial ◽  
Term Treatment ◽  
Open Label ◽  
Double Blind ◽  
Long Term Treatment ◽  
Open Label Extension

ABSTRACTIntroduction:Guanfacine is a noradrenergic agonist that is believed to improve symptoms of attention-deficit/hyperactivity disorder (ADHD) through selective actions at α2A-adrenoceptors in the prefrontal cortex. A recent double-blind, multicenter trial supports the efficacy and safety of guanfacine extended release (GXR) for pediatric ADHD. This long-term, open-label extension was conducted to study the safety profile and effectiveness of GXR for up to 2 years.Methods:Subjects were 240 children 6–17 years of age with a diagnosis of ADHD who participated in the preceding randomized trial. GXR was initiated at 2 mg/day and titrated as needed in 1-mg increments to a maximum of 4 mg/day to achieve optimal clinical response.Results:The most common adverse events were somnolence (30.4%), headache (26.3%), fatigue (14.2%), and sedation (13.3%). Somnolence, sedation, and fatigue were usually transient. Cardiovascular-related adverse events were uncommon, although small reductions in mean blood pressure and pulse rate were evident at monthly visits. ADHD Rating Scale, Version IV, total and subscale scores improved significantly from baseline to endpoint for all dose groups (P<.001 for all comparisons, intent-to-treat population).Conclusion:Long-term treatment with GXR was generally safe for up to 24 months of treatment, and effectiveness was maintained over this treatment period.

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