scholarly journals Tranexamic acid for intracerebral haemorrhage within 2 hours of onset: protocol of a phase II randomised placebo-controlled double-blind multicentre trial

2021 ◽  
pp. svn-2021-001070
Author(s):  
Nawaf Yassi ◽  
Henry Zhao ◽  
Leonid Churilov ◽  
Bruce C V Campbell ◽  
Teddy Wu ◽  
...  
Keyword(s):  
Tranexamic Acid ◽  
Sample Size ◽  
Phase Ii ◽  
Intracerebral Haemorrhage ◽  
Absolute Difference ◽  
Primary Efficacy ◽  
Double Blind ◽  
Stroke Units ◽  
Primary Efficacy Measure ◽  
Efficacy Measure

RationaleHaematoma growth is common early after intracerebral haemorrhage (ICH), and is a key determinant of outcome. Tranexamic acid, a widely available antifibrinolytic agent with an excellent safety profile, may reduce haematoma growth.Methods and designStopping intracerebral haemorrhage with tranexamic acid for hyperacute onset presentation including mobile stroke units (STOP-MSU) is a phase II double-blind, randomised, placebo-controlled, multicentre, international investigator-led clinical trial, conducted within the estimand statistical framework.HypothesisIn patients with spontaneous ICH, treatment with tranexamic acid within 2 hours of onset will reduce haematoma expansion compared with placebo.Sample size estimatesA sample size of 180 patients (90 in each arm) would be required to detect an absolute difference in the primary outcome of 20% (placebo 39% vs treatment 19%) under a two-tailed significance level of 0.05. An adaptive sample size re-estimation based on the outcomes of 144 patients will allow a possible increase to a prespecified maximum of 326 patients.InterventionParticipants will receive 1 g intravenous tranexamic acid over 10 min, followed by 1 g intravenous tranexamic acid over 8 hours; or matching placebo.Primary efficacy measureThe primary efficacy measure is the proportion of patients with haematoma growth by 24±6 hours, defined as either ≥33% relative increase or ≥6 mL absolute increase in haematoma volume between baseline and follow-up CT scan.DiscussionWe describe the rationale and protocol of STOP-MSU, a phase II trial of tranexamic acid in patients with ICH within 2 hours from onset, based in participating mobile stroke units and emergency departments.

FC03-04 - Lamotrigine treatment of acute alcohol hallucinosis comorbid depersonalizations disorders: A randomimized double-blind, placebo-controlled study

2011 ◽  
Vol 26 (S2) ◽  
pp. 1825-1825 ◽  
Author(s):  
N. Aliyev ◽  
A.A. Aliyev ◽  
Z.N. Aliyev ◽  
A. Aliyev
Keyword(s):  
Controlled Study ◽  
Primary Efficacy ◽  
Efficacy And Safety ◽  
Parallel Study ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Primary Efficacy Measure ◽  
Efficacy Measure ◽  
Alcohol Hallucinosis ◽  
Icd 10

AimsWe compared the efficacy and safety of lamotrigine versus placebo for the treatment of acute alcohol hallucinosis comorbid depersonalization disorders.Methods10 days, randomized, double-blind, parallel study. A total of 40 patients with an ICD-10 diagnosis of acute alcohol hallucinosis comorbid depersonalization disorders were randomized to lamotrigine 300 mg/d (n = 40), or placebo (n = 40). The primary efficacy measure was the PANSS subscale for hallucinosis and Cambridge Depersonalization Scale (CDS).ResultsIamotrigine treated patients demonstrated a statistically significant greater improvement in PANSS subscale for hallucinosis and CDS than placebo-treated patients.ConclusionLamotrigine demonstrated greater efficacy than placebo in treatment of acute hallucinosis comorbid depersonalization disorders and was generally well tolerated.

scholarly journals Tranexamic acid for acute intracerebral haemorrhage growth based on imaging assessment (TRAIGE): a multicentre, randomised, placebo-controlled trial

2021 ◽  
pp. svn-2021-000942
Author(s):  
Jingyi Liu ◽  
Ximing Nie ◽  
Hongqiu Gu ◽  
Qi Zhou ◽  
Haixin Sun ◽  
...  
Keyword(s):  
Placebo Group ◽  
Tranexamic Acid ◽  
Intracerebral Haemorrhage ◽  
Intracranial Haemorrhage ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Intracerebral Haematoma ◽  
Spot Sign ◽  
Double Blind ◽  
Risk Of Death

BackgroundStudies show tranexamic acid can reduce the risk of death and early neurological deterioration after intracranial haemorrhage. We aimed to assess whether tranexamic acid reduces haematoma expansion and improves outcome in intracerebral haemorrhage patients susceptible to haemorrhage expansion.MethodsWe did a prospective, double-blind, randomised, placebo-controlled trial at 10 stroke centres in China. Acute supratentorial intracerebral haemorrhage patients were eligible if they had indication of haemorrhage expansion on admission imaging (eg, spot sign, black hole sign or blend sign), and were treatable within 8 hours of symptom onset. Patients were randomly assigned (1:1) to receive either tranexamic acid or a matching placebo. The primary outcome was intracerebral haematoma growth (>33% relative or >6 mL absolute) at 24 hours. Clinical outcomes were assessed at 90 days.ResultsOf the 171 included patients, 124 (72.5%) were male, and the mean age was 55.9±11.6 years. 89 patients received tranexamic acid and 82 received placebo. The primary outcome did not differ significantly between the groups: 36 (40.4%) patients in the tranexamic acid group and 34 (41.5%) patients in the placebo group had intracranial haemorrhage growth (OR 0.96, 95% CI 0.52 to 1.77, p=0.89). The proportion of death was lower in the tranexamic acid treatment group than placebo group (8.1% vs 10.0%), but there were no significant differences in secondary outcomes including absolute intracranial haemorrhage growth, death and dependency.ConclusionsAmong patients susceptible to haemorrhage expansion treated within 8 hours of stroke onset, tranexamic acid did not significantly prevent intracerebral haemorrhage growth. Larger studies are needed to assess safety and efficacy of tranexamic acid in intracerebral haemorrhage patients.

scholarly journals Does tranexamic acid lead to changes in MRI measures of brain tissue health in patients with spontaneous intracerebral haemorrhage? Protocol for a MRI substudy nested within the double-blind randomised controlled TICH-2 trial

BMJ Open ◽  
2018 ◽  
Vol 8 (2) ◽  
pp. e019930 ◽  
Author(s):  
Rob A Dineen ◽  
Stefan Pszczolkowski ◽  
Katie Flaherty ◽  
Zhe K Law ◽  
Paul S Morgan ◽  
...  
Keyword(s):  
Tranexamic Acid ◽  
Intracerebral Haemorrhage ◽  
Lesion Volume ◽  
Imaging Data ◽  
Double Blind ◽  
Link Type ◽  
Diffusion Weighted ◽  
Primary Hypothesis ◽  
Randomised Controlled ◽  
Spontaneous Intracerebral Haemorrhage

ObjectivesTo test whether administration of the antifibrinolytic drug tranexamic acid (TXA) in patients with spontaneous intracerebral haemorrhage (SICH) leads to increased prevalence of diffusion-weighted MRI-defined hyperintense ischaemic lesions (primary hypothesis) or reduced perihaematomal oedema volume, perihaematomal diffusion restriction and residual MRI-defined SICH-related tissue damage (secondary hypotheses).DesignMRI substudy nested within the double-blind randomised controlled Tranexamic Acid for Hyperacute Primary Intracerebral Haemorrhage (TICH)-2 trial (ISRCTN93732214).SettingInternational multicentre hospital-based study.ParticipantsEligible adults consented and randomised in the TICH-2 trial who were also able to undergo MRI scanning. To address the primary hypothesis, a sample size of n=280 will allow detection of a 10% relative increase in prevalence of diffusion-weighted imaging (DWI) hyperintense lesions in the TXA group with 5% significance, 80% power and 5% imaging data rejection.InterventionsTICH-2 MRI substudy participants will undergo MRI scanning using a standardised protocol at day ~5 and day ~90 after randomisation. Clinical assessments, randomisation to TXA or placebo and participant follow-up will be performed as per the TICH-2 trial protocol.ConclusionThe TICH-2 MRI substudy will test whether TXA increases the incidence of new DWI-defined ischaemic lesions or reduces perihaematomal oedema or final ICH lesion volume in the context of SICH.Ethics and disseminationThe TICH-2 trial obtained ethical approval from East Midlands - Nottingham 2 Research Ethics Committee (12/EM/0369) and an amendment to allow the TICH-2 MRI sub study was approved in April 2015 (amendment number SA02/15). All findings will be published in peer-reviewed journals. The primary outcome results will also be presented at a relevant scientific meeting.Trial registration numberISRCTN93732214; Pre-results.

scholarly journals Frovatriptan for the Acute Treatment of Migraine

2011 ◽  
Vol 6 (4) ◽  
pp. 262 ◽  
Author(s):  
Peer Tfelt Hansen ◽  
Keyword(s):  
Acute Treatment ◽  
Randomised Controlled Trials ◽  
Primary Efficacy ◽  
Primary Efficacy Measure ◽  
First Choice ◽  
Headache Relief ◽  
Efficacy Measure ◽  
The Mean ◽  
Randomised Controlled ◽  
Severe Migraine

Frovatriptan 2.5 mg has been investigated for the treatment of moderate or severe migraine attacks in six placebo-controlled, randomised controlled trials (RCTs). The mean headache relief (a decrease from moderate or severe to none or mild) was 43 % after frovatriptan and 24 % after placebo. The mean therapeutic gain (active minus placebo) was 19 % (95 % confidence interval 16–22 %). In one large comparative RCT, sumatriptan 100 mg was superior to frovatriptan 2.5 mg for headache relief at two hours (47 versus 37 %). In three cross-over RCTs in which the patients treated migraine attacks as early as possible, frovatriptan 2.5 mg was quite similar to zolmitriptan 2.5 mg, rizatriptan 10 mg and almotriptan 12.5 mg for preference – the primary efficacy measure. It is concluded that frovatriptan is not the triptan of first choice in established moderate to severe migraine attacks (based on systematic reviews and one comparative RCT). However, if the patients can treat their migraine attacks at the start of an attack (and are not triptan-resistant), then frovatriptan is a reasonable treatment choice among the triptans.

scholarly journals Agomelatine or placebo as adjunctive therapy to a mood stabiliser in bipolar I depression: Randomised double-blind placebo-controlled trial

2016 ◽  
Vol 208 (1) ◽  
pp. 78-86 ◽  
Author(s):  
Lakshmi N. Yatham ◽  
Eduard Vieta ◽  
Guy M. Goodwin ◽  
Michel Bourin ◽  
Christian de Bodinat ◽  
...  
Keyword(s):  
Adjunctive Therapy ◽  
Rating Scale ◽  
Bipolar Depression ◽  
Controlled Trial ◽  
Acute Therapy ◽  
Double Blind ◽  
Continuation Therapy ◽  
Primary Efficacy Measure ◽  
Scale Scores ◽  
Efficacy Measure

BackgroundAdjunctive antidepressant therapy is commonly used to treat acute bipolar depression but few studies have examined this strategy.AimsTo examine the efficacy of agomelatine v. placebo as adjuncts to lithium or valproate in bipolar depression.MethodPatients who were currently depressed despite taking lithium or valproate for at least 6 weeks were randomised to treatment with agomelatine (n = 172) or placebo (n = 172) for 8 weeks of acute therapy and 44 weeks of continuation therapy (trial registration: ISRCTN28588282).ResultsNo significant differences in improvement of depressive symptoms were observed between the two groups either at 8 weeks or 52 weeks on the primary efficacy measure of change in Montgomery–Åsberg Depression Rating Scale scores from baseline to end-point. Adverse events including switches into mania/hypomania were low and similar in both groups.ConclusionsAgomelatine adjunctive therapy was not superior to placebo adjunctive therapy for acute bipolar depression.

scholarly journals Anti-pruritic effect of nemolizumab in hemodialysis patients with uremic pruritus: a phase II, randomized, double-blind, placebo-controlled clinical study

2021 ◽  
Author(s):  
Eriko Kinugasa ◽  
Ken Igawa ◽  
Hisaki Shimada ◽  
Morihiro Kondo ◽  
Satoshi Funakoshi ◽  
...  
Keyword(s):  
Phase Ii ◽  
Reference Group ◽  
Hemodialysis Patients ◽  
Least Square ◽  
Controlled Study ◽  
Primary Efficacy ◽  
Double Blind ◽  
Clinical Trial Registration ◽  
Uremic Pruritus ◽  
The Absolute

Abstract Background The pathophysiology of uremic pruritus (UP), which is characterized by systemic and intractable itching, remains unclear. As interleukin (IL)-31 may be involved, we conducted a phase II, randomized, controlled study to evaluate nemolizumab (anti-IL-31 receptor A antibody) in Japanese hemodialysis patients with UP. Methods Patients were randomly assigned (1:1:1:1:1) to one of four double-blind groups (receiving a single subcutaneous injection of nemolizumab 0.125, 0.5, or 2.0 mg/kg, or placebo on Day 1) or an open-label reference group (receiving oral nalfurafine hydrochloride 2.5–5 μg once daily for 12 weeks). The primary endpoint was the difference in the absolute change in pruritus visual analog scale (VAS) at Week 4 between placebo and each nemolizumab group. Results The primary efficacy endpoint was not met. The mean change from baseline with all three nemolizumab doses at Week 1, and with 0.5 mg/kg at Week 4, was greater than with placebo. Least square mean differences (95% confidence intervals) in the absolute changes between the placebo arm and each nemolizumab arm were − 2.4 (− 19.7, 14.9) for 0.125 mg/kg, − 8.7 (− 26.6, 9.2) for 0.5 mg/kg, and 0.4 (− 17.0, 17.8) for 2.0 mg/kg. Secondary efficacy parameters including the Shiratori severity score and 5-D itch score failed to show between-group differences. Patients with higher serum IL-31 levels at screening tended to have greater pruritus VAS reductions following nemolizumab treatment. Conclusions In this phase II study in patients with UP, the primary efficacy parameter was not met. Nemolizumab was generally well tolerated with no clinically significant safety concerns. Clinical trial registration JAPIC: JapicCTI-152961, https://www.clinicaltrials.jp/cti-user/trial/ShowDirect.jsp?japicId=JapicCTI-152961.

The Spot Sign and Tranexamic Acid on Preventing ICH Growth – AUStralasia Trial (STOP-AUST): Protocol of a Phase II Randomized, Placebo-Controlled, Double-Blind, Multicenter Trial

2013 ◽  
Vol 9 (4) ◽  
pp. 519-524 ◽  
Author(s):  
Atte Meretoja ◽  
Leonid Churilov ◽  
Bruce C. V. Campbell ◽  
Richard I. Aviv ◽  
Nawaf Yassi ◽  
...  
Keyword(s):  
Tranexamic Acid ◽  
Phase Ii ◽  
Multicenter Trial ◽  
Spot Sign ◽  
Double Blind

scholarly journals Olanzapine for the treatment of borderline personality disorder: variable dose 12-week randomised double-blind placebo-controlled study

2008 ◽  
Vol 193 (6) ◽  
pp. 485-492 ◽  
Author(s):  
S. Charles Schulz ◽  
Mary C. Zanarini ◽  
Anthony Bateman ◽  
Martin Bohus ◽  
Holland C. Detke ◽  
...  
Keyword(s):  
Borderline Personality Disorder ◽  
Personality Disorder ◽  
Rating Scale ◽  
Borderline Personality ◽  
Controlled Study ◽  
Double Blind ◽  
Point Change ◽  
End Point ◽  
Primary Efficacy Measure ◽  
Efficacy Measure

BackgroundDespite the prevalence and clinical significance of borderline personality disorder, its treatment remains understudied.AimsTo evaluate treatment with variably dosed olanzapine in individuals with borderline personality disorder.MethodIn this 12-week randomised, double-blind trial, individuals received olanzapine (2.5–20 mg/day; n=155) or placebo (n=159) (trial registry: NCT00091650). The primary efficacy measure was baseline to end-point change on the Zanarini Rating Scale for Borderline Personality Disorder (ZAN–BPD) using last-observation-carried-forward methodology.ResultsBoth olanzapine and placebo groups showed significant improvements but did not differ in magnitude at end-point (76.56 v. 76.25, P=0.661). Response rates (50% reduction in ZAN–BPD) were 64.7% with olanzapine and 53.5% with placebo (P=0.062); however, time to response was significantly shorter for olanzapine (P=0.022). Weight gain was significantly greater (2.86 v. 70.35 kg, P50.001), with higher incidence of treatment-emergent abnormal high levels of prolactin for the olanzapine group.ConclusionsIndividuals treated with olanzapine and placebo showed significant but not statistically different improvements on overall symptoms of borderline personality disorder. The types of adverse events observed with olanzapine treatment appeared similar to those observed previously in adult populations.

scholarly journals A RANDOMIZED CONTROLLED TRIAL OF CURCUMIN AND DICLOFENAC COMBINATION IN KNEE OSTEOARTHRITIS

2019 ◽  
pp. 111-114 ◽  
Author(s):  
DHANESHWAR SHEP ◽  
CHITRA KHANWELKAR ◽  
PRAKASHCHANDRA GADE ◽  
SATYANAND KARAD
Keyword(s):  
Knee Osteoarthritis ◽  
Controlled Trial ◽  
Primary Efficacy ◽  
Inclusion Criteria ◽  
Knee Oa ◽  
Randomized Controlled ◽  
Primary Efficacy Measure ◽  
Efficacy Measure ◽  
Laboratory Investigations ◽  
To Receive

Objective: The objective of the study was to evaluate pain relief and safety of the combination of curcumin and diclofenac versus diclofenac alone in the treatment of knee osteoarthritis (OA). Methods: 140 patients of knee OA meeting inclusion criteria were randomized to receive either curcumin 500 mg with diclofenac 50 mg twice daily or diclofenac 50 mg tablet al. one twice daily for 28 d. Patients were assessed at baseline, Day 14 and Day 28. Primary efficacy measure was severity of pain (VisualAnalogue Scale) at day 14 and day 28. Safety after treatment was evaluated by recording side effects and laboratory investigations. Results: Patients receiving curcumin plus diclofenac showed significantly superior improvement in severity of pain at each study visit (p<0.001) when compared to diclofenac. Adverse effects were significantly less in the curcumin plus diclofenac group (p<0.001). Conclusion: Combination of curcumin and diclofenac showed a significant improvement in pain on the basis of VAS when compared to diclofenac which may be due to the synergistic effect between curcumin and diclofenac

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