FC13-11 - Effectiveness of mazindol in children with ADHD : open-label study

2011 ◽  
Vol 26 (S2) ◽  
pp. 1892-1892 ◽  
Author(s):  
E. Konofal ◽  
M. Lecendreux ◽  
F. Kaguelidou ◽  
F. Mentré ◽  
C. Laouenan ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Pulse Rate ◽  
Primary Outcome ◽  
Preliminary Investigation ◽  
Therapeutic Benefit ◽  
Primary Outcome Measure ◽  
Secondary Outcome ◽  
Open Label ◽  
Open Label Study ◽  
Label Study

Mazindol is a central nervous system stimulant, which blocks reuptake of dopamine and norepinephrine. Mazindol (1–6 mg/d) has previously been studied in the treatment of excessive daytime sleepiness with relative therapeutic benefit. Our hypothesis suggests that mazindol may be effective for the treatment of Attention Deficit Hyperactivity Disorder symptoms.Based on clinical assessments after oral administration of mazindol to 24 children (9–12 years) with ADHD (according to DSM-IVTR criteria), this open-label study evaluates the efficacy, safety and tolerability of mazindol (1 mg/d, 7 days). Safety evaluations included routine hematology, electrocardiograms, blood pressure, and pulse rate. Efficacy rating measurements included ADHD-RS score (primary outcome measure), CPRS-R:L, CGI-S and CGI-I (secondary outcome measures). This clinical trial reports data obtained from 21 boys (10 ± 1 years).Based on primary outcome (ADHD-RS), change in ADHD-RS mean total score after one week of mazindol was −24.6 (p < 0.0001) ; greater than a 90% improvement from baseline. Change in CPRS-R:L (80 items) mean total score after one week of mazindol was −55.5 (p < 0.0001); CGI-S after one week of mazindol was -3,02 (p< 0.01). Adverse events were mild to moderate in severity and decreased appetite, weight loss, headache, and abdominal pain were most common (95%).Changes in laboratory values, ECG, blood pressure, pulse rate and body weight were not clinically meaningful. Blood pressure and pulse rate were unchanged (p > 0.05) after one week of treatment.This preliminary investigation suggests that mazindol is still a new well-tolerated and active psychostimulant for the treatment of ADHD in children.

scholarly journals Randomized controlled trial of convalescent plasma therapy against standard therapy in patients with severe COVID-19 disease

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Manaf AlQahtani ◽  
Abdulkarim Abdulrahman ◽  
Abdulrahman Almadani ◽  
Salman Yousif Alali ◽  
Alaa Mahmood Al Zamrooni ◽  
...  
Keyword(s):  
Standard Therapy ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Severe Disease ◽  
Pilot Trial ◽  
Standard Of Care ◽  
Primary Outcome Measure ◽  
Secondary Outcome ◽  
Open Label ◽  
Plasma Therapy

AbstractConvalescent plasma (CP) therapy in COVID-19 disease may improve clinical outcome in severe disease. This pilot study was undertaken to inform feasibility and safety of further definitive studies. This was a prospective, interventional and randomized open label pilot trial in patients with severe COVID-19. Twenty COVID-19 patients received two 200 ml transfusions of convalescent patient CP over 24-h compared with 20 who received standard of care. The primary outcome was the requirement for ventilation (non-invasive or mechanical ventilation). The secondary outcomes were biochemical parameters and mortality at 28 days. The CP group were a higher risk group with higher ferritin levels (p < 0.05) though respiratory indices did not differ. The primary outcome measure was required in 6 controls and 4 patients on CP (risk ratio 0.67, 95% CI 0.22–2.0, p = 0.72); mean time on ventilation (NIV or MV) did not differ. There were no differences in secondary measures at the end of the study. Two patients died in the control and one patient in the CP arm. There were no significant differences in the primary or secondary outcome measures between CP and standard therapy, although a larger definitive study is needed for confirmation. However, the study did show that CP therapy appears to be safe in hospitalized COVID-19 patients with hypoxia.Clinical trials registration NCT04356534: 22/04/2020.

scholarly journals MP121THE EFFECT OF CILNIDIPINE ON INTRADIALYTIC BLOOD PRESSURE IN INTRADIALYTIC HYPERTENSIVE PATIENTS: A MULTICENTER, PROSPECTIVE, RANDOMIZED, OPEN-LABEL STUDY

2017 ◽  
Vol 32 (suppl_3) ◽  
pp. iii472-iii472 ◽  
Author(s):  
Takayasu Ito ◽  
Naoki Fujimoto ◽  
Eiji Ishikawa ◽  
Kaoru Dohi ◽  
Michiyo Kiyohara ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Open Label ◽  
Open Label Study ◽  
Label Study ◽  
Hypertensive Patients

scholarly journals Effectiveness, Safety and Obedience of Dienogest and Leuprolide Acetate in Postlaparoscopic Endometriosis Patients

2020 ◽  
pp. 44-51
Author(s):  
Joko P. Purwanto ◽  
Yusuf Effendi ◽  
Heriyadi Manan ◽  
Theodorus
Keyword(s):  
Blood Pressure ◽  
Side Effects ◽  
Safety Profile ◽  
Pulse Frequency ◽  
Leuprolide Acetate ◽  
Therapeutic Effectiveness ◽  
Open Label ◽  
Open Label Study ◽  
Label Study ◽  
Vas Scores

Abstract Objective: Comparing therapeutic effectiveness, safety profile, and adherence between Dienogest and postoperative Leuprolide Acetate in women with endometriosis who underwent laparoscopy. Methods: This study was a randomized clinical trial comparing the open label study to compare the effectiveness of therapy, safety profile, and obedience between postoperative dienogest and leuprolide acetate in women with endometriosis who underwent laparoscopy. Result: From the statistical test it was found that there was effectiveness of dienogest after 4 weeks of therapy (p = 0.004), after 8 weeks of therapy (p = 0.004) and after 12 weeks of therapy (p = 0.004). In the leuprolide acetate group it was also found that there was effectiveness of administration after 4 weeks of therapy (p = 0.004), after 8 weeks of therapy (p = 0.004) and after 12 weeks of therapy (p = 0.003). There was no difference in systolic blood pressure (p = 0.481), diastolic blood pressure (p = 1,000) and pulse frequency (p = 0.125) breath frequency (p = 1,000) and temperature (p = 0.236) between patients who received dienogest and leuprolide acetate. From the statistical analysis it was found that there were no differences in side effects in patients who received dienogest and leuprolide acetate (p = 0.238). Conclusion: There was no difference in therapeutic effectiveness, and the safety profile assessed by side effects as well as obedience of postoperative Dienogest and Leuprolide Acetate in endometriosis women undergoing Laparoscopy because in both groups there was a decrease in VAS scores from week to week. Key Word: Dienogest, Leuprolide Acetate, Endometriosis, Post-Laparoscopy, Therapy   Abstrak Tujuan: Membandingkan efektivitas terapi, profil keamanan, dan kepatuhan antara Dienogest dengan Leuprolid Asetat pascaoperatif pada wanita endometriosis yang menjalani Lapararoskopi. Metode: Penelitian ini merupakan uji klinik acak berpembanding dengan open label study untuk membandingkan efektivitas terapi, profil keamanan, dan kepatuhan antara dienogest dan leuprolid asetat pascaoperatif pada wanita endometriosis yang menjalani lapararoskopi. Hasil: Dari uji statistik didapatkan hasil terdapat efektivitas pemberian dienogest setelah 4 minggu terapi (p = 0,004), setelah 8 minggu terapi (p = 0,004) dan setelah 12 minggu terapi (p = 0,004). Pada kelompok leuprolid asetat juga didapatkan hasil terdapat efektivitas pemberian setelah 4 minggu terapi (p = 0,004), setelah 8 minggu terapi (p = 0,004) dan setelah 12 minggu terapi (p = 0,003).  Tidak terdapat perbedaan tekanan darah sistolik (p = 0,481), tekanan darah diastolik (p = 1,000) dan frekuensi nadi (p = 0,125) frekuensi napas (p = 1,000) dan suhu (p = 0,236) antara pasien yang mendapatkan dienogest dan leuprolid asetat. Dari analisa statistik didapatkan hasil tidak terdapat perbedaan efek samping pada pasien yang mendapatkan dienogest dan leuprolid asetat (p = 0,238). Kesimpulan: Tidak terdapat perbedaan efektivitas terapi, dan profil keamanan yang dinilai dari efek samping serta kepatuhan Dienogest dan Leuprolid Asetat pascaoperatif pada wanita endometriosis yang menjalani Lapararoskopi karena pada kedua kelompok terdapat penurunan VAS skor dari minggu ke minggu.  

scholarly journals An open-label study to assess safety, tolerability, and effectiveness of dextromethorphan/quinidine for pseudobulbar affect in dementia: PRISM II results

CNS Spectrums ◽  
2015 ◽  
Vol 21 (6) ◽  
pp. 450-459 ◽  
Author(s):  
Rachelle S. Doody ◽  
Stephen D’Amico ◽  
Andrew J. Cutler ◽  
Charles S. Davis ◽  
Paul Shin ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Adverse Events ◽  
Primary Outcome ◽  
Open Label ◽  
Open Label Study ◽  
Label Study ◽  
Pseudobulbar Affect ◽  
Secondary Outcomes ◽  
Global Impression Of Change ◽  
Lateral Sclerosis

BackgroundDextromethorphan (DM)/quinidine (Q) is an approved treatment for pseudobulbar affect (PBA) based on trials in amyotrophic lateral sclerosis or multiple sclerosis. PRISM II evaluated DM/Q effectiveness and tolerability for PBA secondary to dementia, stroke, or traumatic brain injury; dementia cohort results are reported.MethodsThis was an open-label, multicenter, 90 day trial; patients received DM/Q 20/10 mg twice daily. Primary outcome was change in Center for Neurologic Study–Lability Scale (CNS-LS) score. Secondary outcomes included PBA episode count and Clinical and Patient/Caregiver Global Impression of Change scores with respect to PBA (CGI-C/PGI-C).Results134 patients were treated. CNS-LS improved by a mean (SD) of 7.2 (6.0) points at Day 90/Endpoint (P<.001) vs. baseline. PBA episodes were reduced 67.7% (P<.001) vs. baseline; global measures showed 77.5% CGI-C and 76.5% PGI-C “much”/”very much” improved. Adverse events included headache (7.5%), urinary tract infection (4.5%), and diarrhea (3.7%); few patients dropped out for adverse events (10.4%).ConclusionsDM/Q significantly reduced PBA symptoms in patients with dementia; reported adverse events were consistent with the known safety profile of DM/Q.Trial Registrationclinicaltrials.gov identifier: NCT01799941.

scholarly journals Effects of simvastatin on blood pressure in hypercholesterolemic patients: An open-label study in patients with hypertension or normotension

2004 ◽  
Vol 65 (3) ◽  
pp. 239-254 ◽  
Author(s):  
Adriana Branchi ◽  
Anna Maria Fiorenza ◽  
Adriana Torri ◽  
Cristina Berra ◽  
Emanuela Colombo ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Open Label ◽  
Open Label Study ◽  
Label Study

scholarly journals Randomized controlled trial of sulforaphane and metabolite discovery in children with Autism Spectrum Disorder

2021 ◽  
Vol 12 (1) ◽  
Author(s):  
Andrew W. Zimmerman ◽  
Kanwaljit Singh ◽  
Susan L. Connors ◽  
Hua Liu ◽  
Anita A. Panjwani ◽  
...  
Keyword(s):  
Autism Spectrum Disorder ◽  
Primary Outcome ◽  
Outcome Measure ◽  
Primary Outcome Measure ◽  
Autism Spectrum ◽  
Secondary Outcome ◽  
Clinical Effects ◽  
Open Label ◽  
Children With Asd ◽  
Open Label Phase

Abstract Background Sulforaphane (SF), an isothiocyanate in broccoli, has potential benefits relevant to autism spectrum disorder (ASD) through its effects on several metabolic and immunologic pathways. Previous clinical trials of oral SF demonstrated positive clinical effects on behavior in young men and changes in urinary metabolomics in children with ASD. Methods We conducted a 15-week randomized parallel double-blind placebo-controlled clinical trial with 15-week open-label treatment and 6-week no-treatment extensions in 57 children, ages 3–12 years, with ASD over 36 weeks. Twenty-eight were assigned SF and 29 received placebo (PL). Clinical effects, safety and tolerability of SF were measured as were biomarkers to elucidate mechanisms of action of SF in ASD. Results Data from 22 children taking SF and 23 on PL were analyzed. Treatment effects on the primary outcome measure, the Ohio Autism Clinical Impressions Scale (OACIS), in the general level of autism were not significant between SF and PL groups at 7 and 15 weeks. The effect sizes on the OACIS were non-statistically significant but positive, suggesting a possible trend toward greater improvement in those on treatment with SF (Cohen’s d 0.21; 95% CI − 0.46, 0.88 and 0.10; 95% CI − 0.52, 0.72, respectively). Both groups improved in all subscales when on SF during the open-label phase. Caregiver ratings on secondary outcome measures improved significantly on the Aberrant Behavior Checklist (ABC) at 15 weeks (Cohen’s d − 0.96; 95% CI − 1.73, − 0.15), but not on the Social Responsiveness Scale-2 (SRS-2). Ratings on the ABC and SRS-2 improved with a non-randomized analysis of the length of exposure to SF, compared to the pre-treatment baseline (p < 0.001). There were significant changes with SF compared to PL in biomarkers of glutathione redox status, mitochondrial respiration, inflammatory markers and heat shock proteins. Clinical laboratory studies confirmed product safety. SF was very well tolerated and side effects of treatment, none serious, included rare insomnia, irritability and intolerance of the taste and smell. Limitations The sample size was limited to 45 children with ASD and we did not impute missing data. We were unable to document significant changes in clinical assessments during clinical visits in those taking SF compared to PL. The clinical results were confounded by placebo effects during the open-label phase. Conclusions SF led to small yet non-statistically significant changes in the total and all subscale scores of the primary outcome measure, while for secondary outcome measures, caregivers’ assessments of children taking SF showed statistically significant improvements compared to those taking PL on the ABC but not the SRS-2. Clinical effects of SF were less notable in children compared to our previous trial of a SF-rich preparation in young men with ASD. Several of the effects of SF on biomarkers correlated to clinical improvements. SF was very well tolerated and safe and effective based on our secondary clinical measures. Trial registration: This study was prospectively registered at clinicaltrials.gov (NCT02561481) on September 28, 2015. Funding was provided by the U.S. Department of Defense.

scholarly journals Finasteride monotherapy maintains stable lower urinary tract symptoms in men with benign prostatic hyperplasia following cessation of alpha blockers

2013 ◽  
Vol 2 (1) ◽  
pp. 16 ◽  
Author(s):  
J. Curtis Nickel ◽  
Jack Barkin ◽  
Caroline Koch ◽  
Charles Dupont ◽  
Mostafa Elhilali
Keyword(s):  
Lower Urinary Tract ◽  
Primary Outcome ◽  
Outcome Measure ◽  
Response Rate ◽  
Primary Outcome Measure ◽  
Prostatic Hyperplasia ◽  
Open Label ◽  
Open Label Study ◽  
Urinary Tract Symptoms ◽  
Lower Urinary

Objective: Our Canadian multicentre open-label study sought to evaluate, inpatients with moderate/severe lower urinary symptoms (LUTS) secondary tobenign prostatic hyperplasia, the effect on symptoms of 9 months of monotherapywith finasteride 5 mg following 9 months of combination treatment (finasteridewith an α-blocker) as quantified according to the International ProstateSymptom Score (IPSS).Methods: The primary outcome measure for efficacy was the maintenance ofIPSS response after cessation of the α-blocker. Subjects were treated with acombination of finasteride and an α-blocker for 9 months and then with finasteridealone for 3 or 9 months.Results: Results showed that the IPSS scores after 3 months of monotherapy werewithin the criteria for equivalence to those after 9 months of combination therapy.Symptom control equivalence was also found after 9 months of monotherapy.The IPSS response rate was also similar for combination and monotherapy.The safety profile was similar and as expected with these medications.Conclusion: Control of LUTS associated with BPH thus appears to be maintainedfor at least 9 months with finasteride alone, following a 9-month course of combinationtherapy with finasteride and an α-blocker, with similar safety profiles.

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