Safety and efficacy of LY2951742, a monoclonal antibody to calcitonin gene-related peptide, for the prevention of migraine: a phase 2, randomised, double-blind, placebo-controlled study

What Was Tested

The paper reports a study of CGRP (Calcitonin Gene-Related Peptide) in the context of migraine, published as a randomized controlled trial.

Who Took Part

PubMed indexes the participants as teenagers, young adults, adults, middle-aged adults and older adults, both men and women.

Patients aged 18-65 years with four to 14 migraine headache days per month were randomly assigned (1:1) to LY2951742 or placebo by a computerised randomisation scheme.

Safety was assessed over 24 weeks, including the 12-week treatment period and the subsequent 12 weeks after study drug administration.

How the Study Was Run

The design is described as randomized, double-blind and placebo-controlled.

Because people in this CGRP (Calcitonin Gene-Related Peptide) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

As a double-blind CGRP (Calcitonin Gene-Related Peptide) study, the assignments were hidden from both participants and investigators until the end.

Some participants received a placebo instead of CGRP (Calcitonin Gene-Related Peptide), giving a reference point.

The methods mention a period of 24 weeks.

The researchers did a randomised, double-blind, placebo-controlled, phase 2 proof-of-concept study at 35 centres in the USA.

The primary endpoint was the mean change in number of migraine headache days per 28-day period assessed at 9-12 weeks.

Patients and treating investigators were masked to treatment allocation.

Analyses were by intention to treat.

A mixed-effects model of repeated measures was used, including patient baseline value, treatment, visit, and treatment-by-visit interaction as fixed effects, and patients as random effects.

What Was Measured

Safety measures were analysed according to the treatment received.

Topics PubMed links to this paper include Antibodies, Monoclonal, Humanized, Calcitonin Gene-Related Peptide and Migraine Disorders.

What This Means in Plain Language

The paper is a randomized, double-blind and placebo-controlled study of CGRP (Calcitonin Gene-Related Peptide) in people with migraine over 24 weeks.

Results are reported in around 6 sentences of the abstract; we leave them to the paper itself rather than summarise them.

The publication is from 2014 (The Lancet. Neurology), a journal based in England.

More context: the CGRP (Calcitonin Gene-Related Peptide) compound page, Migraine research.