Efficacy and Tolerability of Lasmiditan, an Oral 5-HT1F Receptor Agonist, for the Acute Treatment of Migraine: A Phase 3 Randomized, Placebo-Controlled, Double-Blind Study

2018 ◽  
Author(s):  
Peter Goadsby ◽  
Linda Wietecha ◽  
Ellen Dennehy ◽  
Bernice Kuca ◽  
Michael Case ◽  
...  
Keyword(s):  
Acute Treatment ◽  
Receptor Agonist ◽  
Blind Study ◽  
Double Blind Study ◽  
Phase 3 ◽  
Double Blind

OnabotulinumtoxinA for Treatment of Moderate-to-Severe Horizontal Lines and Glabellar Lines from the Subject's Perspective: Patient-Reported Satisfaction and Impact Outcomes from a Phase 3 Double-Blind Study

2017 ◽  
Vol 1 ◽  
pp. s82
Author(s):  
Steven Dayan ◽  
Patricia Ogilvie ◽  
Alexander Z Rivkin ◽  
Steven G Yoelin ◽  
Julie K Garcia ◽  
...  
Keyword(s):  
Blind Study ◽  
Double Blind Study ◽  
Phase 3 ◽  
Double Blind ◽  
Patient Reported

Abstract Not Available Disclosures: Study supported by Allergan.

scholarly journals Intravenous chlorpromazine in the acute treatment of episodic tension-type headache: a randomized, placebo controlled, double-blind study

2002 ◽  
Vol 60 (3A) ◽  
pp. 537-541 ◽  
Author(s):  
Marcelo Eduardo Bigal ◽  
Carlos Alberto Bordini ◽  
José Geraldo Speciali
Keyword(s):  
Acute Treatment ◽  
Tension Type Headache ◽  
Blind Study ◽  
Number Needed To Treat ◽  
Double Blind Study ◽  
Emergency Rooms ◽  
Double Blind ◽  
Therapeutic Gain ◽  
Type Headache ◽  
To Receive

Acute headache is a very frequent symptom, responsible for a significant percentage of caseload at primary care units and emergency rooms. Chlorpromazine is easily available in such settings. The aim of this study is to conduct a randomized, placebo-controlled, double-blind study to assess the efficacy of chlorpromazine on the acute treatment of episodic tension-type headache. We randomized 30 patients to receive placebo (10 ml of saline intravenous injections) and 30 patients to receive 0.1 mg/Kg chlorpromazine intravenously. We used 7 parameters of analgesic evaluation. Patients receiving chlorpromazine showed a statistically significant improvement (p < 0.05 and p < 0.01) of pain compared to placebo, far up to 30 minutes after the drug administration. The therapeutic gain was 36.7% in 30 minutes and 56.6 % in 60 minutes. The number needed to treat (NNT, the reciprocal or the therapeutic gain) was 2.7 in 30 minutes and 1.8 in 60 minutes. There were reductions in the recurrence and in the use of rescue medication in the chlorpromazine group. We can conclude that intravenous chlorpromazine is an effective drug to relief the pain in tension-type headache.

ClarIDHy: A phase 3, multicenter, randomized, double-blind study of AG-120 vs placebo in patients with an advanced cholangiocarcinoma with an IDH1 mutation.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. TPS4142-TPS4142 ◽  
Author(s):  
Maeve Aine Lowery ◽  
Ghassan K. Abou-Alfa ◽  
Juan W. Valle ◽  
Robin Kate Kelley ◽  
Lipika Goyal ◽  
...  
Keyword(s):  
Disease Progression ◽  
Phase 1 ◽  
Data Monitoring Committee ◽  
Blind Study ◽  
Clinical Activity ◽  
Double Blind Study ◽  
Phase 3 ◽  
Isocitrate Dehydrogenase 1 ◽  
Double Blind ◽  
Eortc Qlq

TPS4142 Background: Advanced cholangiocarcinoma (CC) is a life-threatening disease for which there are limited therapeutic options. Mutations in isocitrate dehydrogenase 1 (mIDH1) occur in up to 25% of intrahepatic CC cases. mIDH1 lead to epigenetic and genetic changes that promote oncogenesis via production of the oncometabolite, D-2-hydroxyglutarate (2-HG). AG-120 is a first-in-class oral inhibitor of the mIDH1 enzyme, and is being tested in a phase 1 study that enrolled 73 patients (pts) with mIDH1 CC who had received a median of 2 prior therapies (range 1–5). AG-120 has demonstrated a favorable safety profile and clinical activity in this study. Among the 72 efficacy evaluable pts (≥1 post-baseline response assessment or discontinued prematurely), 6% (n = 4) had a confirmed partial response and 56% (n = 40) had stable disease. Progression-free survival (PFS) rate at 6 months was 40% as of Dec 16, 2016. The 500 mg once daily (QD) dose of AG-120 was selected for the ongoing phase 3 study in mIDH1 CC described here. Methods: ClarIDHy is a global, phase 3, multicenter, double-blind study randomizing 186 pts with mIDH1 CC in a 2:1 ratio to AG-120 (500 mg QD) or matched placebo (NCT02989857). Key eligibility criteria: nonresectable or metastatic CC; documented mIDH1 based on central laboratory testing; ECOG 0–1; measurable disease (RECIST v1.1); documented disease progression following ≤2 prior systemic therapies in the advanced setting, including at least 1 gemcitabine- or 5-fluorouracil-containing regimen; and no prior mIDH inhibitor therapy. Crossover from the placebo arm to the AG-120 arm will be permitted. The primary endpoint is PFS as assessed by an independent review. Secondary endpoints include safety, tolerability, overall response rate, overall survival, pharmacokinetic and pharmacodynamic analyses on plasma, and quality of life as assessed by the EORTC QLQ-C30, EORTC QLQ-BIL21, and EQ-5D-5L instruments. An independent data monitoring committee will monitor the data throughout the study. The ClarIDHy study is currently activated at participating sites in the US and will be activated in centers throughout Europe and in South Korea. Clinical trial information: NCT02989857.

Effectiveness of Oral Diclofenac in the Acute Treatment of Common Migraine Attacks: A Double-Blind Study Versus Placebo

Cephalalgia ◽  
1991 ◽  
Vol 11 (2) ◽  
pp. 59-63 ◽  
Author(s):  
Hélène Massiou ◽  
Dominique Serrurier ◽  
Odile Lasserre ◽  
Marie-Germaine Bousser
Keyword(s):  
Clinical Relevance ◽  
Acute Treatment ◽  
Migraine Without Aura ◽  
International Headache Society ◽  
Blind Study ◽  
Drug Intake ◽  
Double Blind Study ◽  
Double Blind ◽  
The One

In a multicentre double-blind cross-over trial, oral diclofenac at a dose of 50 mg to 100 mg was compared to placebo in the acute treatment of migraine attacks. A hundred and seven patients suffering from migraine without aura were included, and 91 were analysed for efficacy; they had to treat four successive attacks-two with diclofenac and two with placebo. Diclofenac was significantly more effective than placebo ( p < 0.05) on the main judgement parameter, which was the number of attacks aborted within 2 h of drug intake, as well as on the following secondary parameters: the necessity for an escape medication and the evaluation of global efficacy. Diclofenac was well tolerated. This trial demonstrates the efficacy of diclofenac in the acute treatment of migraine attacks. It confirms the good clinical relevance of the main judgement parameter chosen, which is the one recommended by the International Headache Society, but appears to be a severe one in terms of successes.

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