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

2020 ◽  
Author(s):  
Manaf AlQahtani ◽  
Abdulkarim Abdulrahman ◽  
Abdulrahman Almadani ◽  
Salman Yousif Alali ◽  
Alaa Mahmood Al Zamrooni ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Standard Therapy ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Severe Disease ◽  
Pilot Trial ◽  
Secondary Outcome ◽  
Open Label ◽  
Phase 3 ◽  
Plasma Therapy

AbstractBackgroundConvalescent plasma (CP) therapy in COVID-19 disease has been suggested to improve clinical outcome in severe disease. This pilot study was designed to inform the design of a definitive phase 3 clinical trial.MethodsThis was a prospective, interventional and randomized open label pilot trial involving 40 patients with COVID-19 who were requiring oxygen therapy and who had radiological evidence of pneumonia. Twenty COVID-19 patients received two 200ml transfusions of convalescent patient CP over 24 hours were compared with 20 patients who received routine care alone. The primary outcome was the requirement for ventilation. The secondary outcomes were white blood cell count, lactate dehydrogenase (LDH), C-reactive protein (CRP), Troponin, Ferritin, D-Dimer, procalcitonin, mortality rate at 28 days.ResultsThe CP group were a higher risk group with higher ferritin levels (p<0.05) though respiratory indices did not differ. The primary outcome measure – ventilation – 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 was 10.5 days in the control against 8.2 days in patients on CP (p=0.81). 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.ConclusionThere were no significant differences in the primary or secondary outcome measures between CP and standard therapy though fewer patients required ventilation and for a shorter period of time. The study showed that CP therapy appears to be safe and it is feasible to perform a definitive phase 3 clinical trial using this study protocol.

scholarly journals Convalescent plasma for hospitalized patients with COVID-19 and the effect of plasma antibodies: a randomized controlled, open-label trial

2021 ◽  
Author(s):  
Philippe Bégin ◽  
Jeannie Callum ◽  
Erin Jamulae Jamula ◽  
Richard Cook ◽  
Nancy M Heddle ◽  
...  
Keyword(s):  
Primary Outcome ◽  
Controlled Trial ◽  
Harmful Effect ◽  
Standard Of Care ◽  
Hospitalized Patients ◽  
Open Label ◽  
Serious Adverse Events ◽  
Randomized Controlled ◽  
Negative Results ◽  
Intent To Treat

The efficacy of convalescent plasma for COVID-19 is unclear. While most randomized controlled trials have shown negative results, uncontrolled studies have suggested that the antibody content may influence patient outcomes. We conducted an open-label, randomized controlled trial of convalescent plasma for adults with COVID-19 receiving oxygen within 12 days of respiratory symptom onset. Patients were allocated 2:1 to 500 mL of convalescent plasma or standard of care. The composite primary outcome was intubation or death by 30 days. The effect of convalescent plasma antibodies on the primary outcome was assessed by logistic regression. The trial was terminated at 78% of planned enrollment after meeting stopping criteria for futility. 940 patients were randomized and 921 patients were included in the intent-to-treat analysis. Intubation or death occurred in 199/614 (32.4%) in the convalescent plasma arm and 86/307 (28.0%) in the standard of care arm; relative risk (RR) 1.16 (95% confidence interval (CI) 0.94-1.43; p=0.18). Patients in the convalescent plasma arm had more serious adverse events (33.4% vs. 26.4%; RR=1.27, 95% CI 1.02-1.57, p=0.034). The antibody content significantly modulated the therapeutic effect of convalescent plasma. In multivariate analysis, each standard log increase in neutralization or antibody-dependent cellular cytotoxicity independently reduced the potential harmful effect of plasma (OR=0.74; 0.57-0.95 and OR=0.66; 0.50-0.87, respectively), while IgG against the full transmembrane Spike protein increased it (OR=1.53, 95% CI 1.14-2.05). Convalescent plasma did not reduce the risk of intubation or death at 30 days among hospitalized patients with COVID-19. Transfusion of convalescent plasma with unfavourable antibody profiles may be associated with worse clinical outcomes compared to standard care.

scholarly journals A Randomized Controlled Trial of Four Precolonoscopy Bowel Cleansing Regimens

2011 ◽  
Vol 25 (12) ◽  
pp. 657-662 ◽  
Author(s):  
Dina Kao ◽  
Eoin Lalor ◽  
Gurpal Sandha ◽  
Richard N Fedorak ◽  
Bloeme van der Knoop ◽  
...  
Keyword(s):  
Bowel Preparation ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Short Interval ◽  
Primary Outcome Measure ◽  
Secondary Outcome ◽  
Bowel Cleansing ◽  
The Mean ◽  
Clinically Significant ◽  
The Ideal

BACKGROUND: The ideal bowel cleansing regimen for colonoscopy has yet to be determined.OBJECTIVE: To compare the cleansing efficacy, and patient tolerability and safety of four bowel preparation regimens.METHODS: A total of 834 patients undergoing outpatient colonoscopy were randomly assigned to one of four regimens: 4 L polyethylene glycol (PEG); 2 L PEG + 20 mg bisacodyl; 90 mL of sodium phosphate (NaP); or two sachets of a commercially available bowel cleansing solution (PSMC) + 300 mL of magnesium citrate (M). The primary outcome measure was cleansing efficacy, which was scored by blinded endoscopists using the Ottawa Bowel Preparation Scale. Secondary outcome measures were bowel preparation quality according to time of colonoscopy, and patient tolerability and safety.RESULTS: The mean total cleansing score was significantly worse in the NaP group compared with the other three groups (P<0.0001). The mean cleansing scores were worse in patients who underwent morning versus afternoon colonoscopy, a finding that was consistent in all four groups. PSMC + M was the best tolerated regimen. No clinically significant mean changes in creatinine or electrolyte levels were identified, although a significantly higher proportion of patients in the NaP group developed hypokelemia (P<0.0001).CONCLUSIONS: 2 L PEG + 20 mg bisacodyl, or PSMC + M was as efficacious as 4 L PEG and superior to NaP for bowel cleansing. A short interval between the completion of bowel preparation and the start of colonoscopy (ie, ‘runway time’), irrespective of bowel preparation regimen, appeared to be a more important predictor of bowel cleanliness than the cathartic agents used.

Results of the first interim assessment of rEECur, an international randomized controlled trial of chemotherapy for the treatment of recurrent and primary refractory Ewing sarcoma.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 11007-11007 ◽  
Author(s):  
Martin G. McCabe ◽  
Veronica Moroz ◽  
Maria Khan ◽  
Uta Dirksen ◽  
Abigail Evans ◽  
...  
Keyword(s):  
Primary Outcome ◽  
Outcome Measure ◽  
Controlled Trial ◽  
Objective Response ◽  
Pairwise Comparison ◽  
Standard Of Care ◽  
Primary Outcome Measure ◽  
The Other ◽  
High Dose ◽  
Interim Assessment

11007 Background: 5-year survival of RR-ES is about 15%. Several chemotherapy regimens are used, but without robust evidence. rEECur, the first randomised controlled trial in this setting, is defining a standard of care, balancing efficacy and toxicity. Methods: Patients aged 4 to 50 with RR-ES and fit to receive chemotherapy were randomised 2, 3 or 4 ways between topotecan & cyclophosphamide (TC), irinotecan & temolozomide (IT), gemcitabine & docetaxel (GD) or high-dose ifosfamide (IFOS). Primary outcome measure was objective response (OR) after 4 cycles by RECIST 1.1. Secondary outcomes included PFS, OS and toxicity. A probability-based Bayesian approach was used. The first interim assessment to determine which arm should be closed occurred when 50 evaluable patients had been recruited to 3 arms and evaluated for the primary outcome measure. Results: 242 patients (89% RECIST-evaluable) recruited between 18/12/14 and 21/06/18 were randomised to TC (n=75), IT (71), GD (66) and IFOS (30). Median age was 21 years (range 4 to 49). Patients had: refractory ES (20%), 1st recurrence (63%), >1st recurrence (17%); initial primary disease arose in bone in 60%; disease progression sites were primary site (17%), pleuropulmonary (29%) or other metastatic (54%). Median follow up was 11.3 months. Outcomes in the GD arm were: response rate 11.5% (95% CI: 4.4 to 23%), median PFS 3.0 months (95% CI: 1.6 to 8.0), median OS 13.7 months (95% CI: 10.1 to 23.9). The table shows, for each pairwise comparison of GD with the other arms (randomly labelled A, B, C to maintain blinding of open arms), the probabilities given the observed data that OR, PFS and OS were better for GD than for each other arm (RR: relative risk, HR: hazard ratio). For OR and PFS, all comparisons favoured the other arms. There were fewer grade 3/4 adverse events with GD than with the other arms pooled (58% v. 74%). Conclusions: rEECur has shown that GD is a less effective treatment than TC, IT or IFOS in reducing tumour burden or prolonging PFS in RR-ES. Recruitment continues to the remaining arms. Clinical trial information: ISRCTN36453794. [Table: see text]

scholarly journals Efficacy of nature-based therapy for individuals with stress-related illnesses: randomised controlled trial

2018 ◽  
Vol 213 (1) ◽  
pp. 404-411 ◽  
Author(s):  
Ulrika Karlsson Stigsdotter ◽  
Sus Sola Corazon ◽  
Ulrik Sidenius ◽  
Patrik Karlsson Nyed ◽  
Helmer Bøving Larsen ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Well Being ◽  
Behavioural Therapy ◽  
Primary Outcome Measure ◽  
Secondary Outcome ◽  
Significant Difference ◽  
Increasing Demand ◽  
Randomised Controlled

BackgroundStress-related illnesses are a major threat to public health, and there is increasing demand for validated treatments.AimsTo test the efficacy of nature-based therapy (NBT) for patients with stress-related illnesses.MethodRandomised controlled trial (ClinicalTrials.gov ID NCT01849718) comparing Nacadia® NBT (NNBT) with the cognitive–behavioural therapy known as Specialised Treatment for Severe Bodily Distress Syndromes (STreSS). In total, 84 participants were randomly allocated to one of the two treatments. The primary outcome measure was the mean aggregate score on the Psychological General Well-Being Index (PGWBI).ResultsBoth treatments resulted in a significant increase in the PGWBI (primary outcome) and a decrease in burnout (the Shirom–Melamed Burnout Questionnaire, secondary outcome), which were both sustained 12 months later. No significant difference in efficacy was found between NNBT and STreSS for primary outcome and secondary outcomes.ConclusionsThe study showed no statistical evidence of a difference between NNBT and STreSS for treating patients with stress-related illnesses.Declaration of interestNone.

scholarly journals Efficacy of Convalescent Plasma Therapy compared to Fresh Frozen Plasma in Severely ill COVID-19 Patients: A Pilot Randomized Controlled Trial

2020 ◽  
Author(s):  
Meenu Bajpai ◽  
Suresh Kumar ◽  
Ashish Maheshwari ◽  
Karan Chhabra ◽  
Pratibha kale ◽  
...  
Keyword(s):  
Virus Disease ◽  
Controlled Trial ◽  
Pilot Trial ◽  
Fresh Frozen Plasma ◽  
Rapid Improvement ◽  
Open Label ◽  
Plasma Therapy ◽  
Link Type ◽  
Fresh Frozen ◽  
Frozen Plasma

AbstractBackgroundThe role of convalescent plasma (COPLA) for the treatment of severely ill Corona Virus Disease-2019 is under investigation. We compared the efficacy and safety of convalescent plasma with fresh frozen plasma (FFP) in severe COVID-19 patients.Methods and findingsThis was an open-label, single-centre phase II RCT on 29 patients with severe COVID-19 from India. One group received COPLA with standard medical care (SMC) (n=14), and another group received FFP with SMC (n=15). A total of 29 patients were randomized in the two treatment groups. Eleven out of 14 (78.5%) patients remained free of ventilation at day seven in the intervention arm while the proportion was 14 out of 15 (93.3 %) in the control arm (p= 0.258). The median reductions in RR per min at 48-hours in COPLA-group and FFP group were -6.5 and -3 respectively [p=0.004] and at day seven were -14.5 and -10 respectively (p=0.008). The median improvements in percentage O2 saturation at 48-hours were 6.5 and 2 respectively [p=0.001] and at day seven were 10 and 7.5 respectively (p=0.026). In the COPLA-group, the median improvement in PaO2/FiO2 was significantly superior to FFP at 48-hours [41.94 and 231.15, p=0.009], and also at day-7 [5.55 and 77.01 p<0.001]. We did not find significant differences in hospitalization duration between the groups (0.08).ConclusionCOPLA therapy resulted in rapid improvement in respiratory parameters and shortened time to clinical recovery, although no significant reduction in mortality was observed in this pilot trial. We need larger trials to draw conclusive evidence on the use of Convalescent plasma in COVID-19. This trial is registered with ClinicalTrial.gov (identifier: NCT04346446).

A randomized, double-blind, placebo-controlled trial of memantine in a behaviorally enriched sample of patients with moderate-to-severe Alzheimer's disease

2013 ◽  
Vol 25 (6) ◽  
pp. 919-927 ◽  
Author(s):  
Nathan Herrmann ◽  
Serge Gauthier ◽  
Neli Boneva ◽  
Ole Michael Lemming
Keyword(s):  
Alzheimer’S Disease ◽  
Alzheimer's Disease ◽  
Outcome Measures ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Neuropsychiatric Symptoms ◽  
Primary Outcome Measure ◽  
Community Dwelling ◽  
Secondary Outcome ◽  
Double Blind

ABSTRACTBackground: Agitation and aggression in Alzheimer's disease (AD) are amongst the most serious of neuropsychiatric symptoms, and contribute to poor outcomes and worse quality of life. Previous studies have suggested a benefit for memantine on agitation and aggression, but none have examined its efficacy in community-dwelling patients with significant agitation and aggression at baseline, utilizing these behaviors as a primary outcome measure.Methods: Patients with moderate-to-severe AD with Neuropsychiatric Inventory (NPI) total score ≥13 and NPI agitation/aggression score ≥1 were randomized to placebo or 20-mg memantine in a double-blind, 24-week trial. Co-primary outcome measures were behavior, measured by total NPI score, and cognition, using the Severe Impairment Battery (SIB). Secondary outcome measures included global assessment, function and other measures of behavior. This trial was registered as Clinicaltrials.gov: NCT00857649.Results: A total of 369 patients (average age = 75, average MMSE = 12) were randomized to placebo or memantine. The study was prematurely terminated due to recruitment problems. There were no statistically significant differences between memantine and placebo in mean change from baseline in NPI, SIB, or any of the secondary outcome measures. Behavior improved in both groups (total NPI change scores −3.90 ± 1.24 for memantine and −5.13 ± 1.23 for placebo). Memantine was generally well tolerated and patient retention in both treatment arms was good.Conclusions: The study failed to show the superiority of memantine in this sample of patients with moderate-to-severe AD with significant baseline agitation and aggression. Methodological limitations could have contributed to these results.

scholarly journals An open label, randomised controlled trial of rifapentine versus rifampicin based short course regimens for the treatment of latent tuberculosis in England: the HALT LTBI pilot study

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
J. Surey ◽  
H. R. Stagg ◽  
T. A. Yates ◽  
M. Lipman ◽  
P. J. White ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Pilot Trial ◽  
Latent Tuberculosis ◽  
Standard Of Care ◽  
Treatment Completion ◽  
Current Treatment ◽  
Open Label ◽  
Latent Tb Infection ◽  
Randomised Controlled ◽  
Urine Testing

Abstract Background Ending the global tuberculosis (TB) epidemic requires a focus on treating individuals with latent TB infection (LTBI) to prevent future cases. Promising trials of shorter regimens have shown them to be effective as preventative TB treatment, however there is a paucity of data on self-administered treatment completion rates. This pilot trial assessed treatment completion, adherence, safety and the feasibility of treating LTBI in the UK using a weekly rifapentine and isoniazid regimen versus daily rifampicin and isoniazid, both self-administered for 12 weeks. Methods An open label, randomised, multi-site pilot trial was conducted in London, UK, between March 2015 and January 2017. Adults between 16 and 65 years with LTBI at two TB clinics who were eligible for and agreed to preventative therapy were consented and randomised 1:1 to receive either a weekly combination of rifapentine/isoniazid (‘intervention’) or a daily combination of rifampicin/isoniazid (‘standard’), with both regimens taken for twelve weeks; treatment was self-administered in both arms. The primary outcome, completion of treatment, was self-reported, defined as taking more than 90% of prescribed doses and corroborated by pill counts and urine testing. Adverse events were recorded. Results Fifty-two patients were successfully enrolled. In the intervention arm 21 of 27 patients completed treatment (77.8, 95% confidence interval [CI] 57.7–91.4), compared with 19 of 25 (76.0%, CI 54.9–90.6) in the standard of care arm. There was a similar adverse effect profile between the two arms. Conclusion In this pilot trial, treatment completion was comparable between the weekly rifapentine/isoniazid and the daily rifampicin/isoniazid regimens. Additionally, the adverse event profile was similar between the two arms. We conclude that it is safe and feasible to undertake a fully powered trial to determine whether self-administered weekly treatment is superior/non-inferior compared to current treatment. Trial registration The trial was funded by the NIHR, UK and registered with ISRCTN (26/02/2013-No.04379941).

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.

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.

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