– New clinical trial data highlight potential of an evoked migraine model to test potential efficacy for investigational products intended to treat acute migraine   –

– Collaboration between MAC Clinical Research and Trevena, Inc. intended to aid the advancement of novel, anti-migraine medications –

SAN FRANCISCO, June 28, 2018 (GLOBE NEWSWIRE) -- MAC Clinical Research, plc (Manchester, UK), announced today the presentation of results from a clinical trial evaluating an evoked migraine model at the 60th Annual Scientific Meeting of the American Headache Society taking place in San Francisco CA from June 27 - July 1, 2018. The study, performed in collaboration with scientists from Trevena, Inc. (Chesterbrook, PA) showed that migraine could be reproducibly evoked and treated in otherwise healthy migraine patients, potentially enabling more efficient testing of investigational products for signals of efficacy.

This trial was a randomized, 4-period, crossover design in 20 otherwise healthy subjects with a diagnosis of migraine without aura. The primary objectives of the study were to assess the ability of glyceryl trinitrate (GTN) to induce migraine-like headaches in migraineurs and to evaluate the within-subject reproducibility of migrainous headaches upon repeated exposure to GTN. Secondary objectives were to determine the effects of GTN on headache latency and to assess the utility of 5-HT agonists to treat GTN delayed headache.

Results of the study indicate that GTN headache induction was well-tolerated, with few adverse events and patients willing to return for multiple exposures.  A delayed headache was induced more frequently following GTN than placebo, with a delayed headache present on two or more exposures in 75% of patients receiving GTN compared to zero patients receiving placebo. The delayed headache was rapidly and effectively treated with standard-of-care 5-HT agonists.  The delayed headache was morphologically similar to the patients’ spontaneous migraine attack, as judged by comparison by a migraine expert and the patients’ self-reported experience.

“This study suggests that delayed headache following glyceryl trinitrate exposure in migraineurs is a reasonable surrogate for spontaneous migraine attacks,” said John Connell, Ph.D., Chief Scientific Officer at MAC Clinical Research.  “These headaches were well-tolerated, reproducible, migrainous in character, and treatable.  This technique could be used to rapidly assess putative efficacy of novel compounds under development for the treatment of migraine.”

Presentation details:

Poster PS107LB
Title: The reproducibility of glyceryl trinitrate (GTN) at inducing migraine-like attacks in migraine patients
Time: 1:00 – 2:15pm PDT
Location: Exhibit and Poster Hall, Marriott Marquis San Francisco, San Francisco CA

About MAC Clinical Research

MAC Clinical Research is the UK's largest independently-owned clinical trials site management organisation.  The organisation is committed to the recruitment and conduct of clinical trials through fully owned Dedicated Research Sites.  MAC was the first memory assessment centre based in Europe, and now conducts research for sponsors over an ever expanding group of therapeutic areas. MAC has an extensive range of clinical research capabilities to accommodate the most complex Phase 1 trials at a MHRA Accredited Phase 1 Unit through Phase IV trials across a network of late phase Dedicated Research Sites.  Recent studies cover a range of therapeutic areas including CNS diseases (Depression, anxiety, Alzheimer's Disease and multiple sclerosis), analgesia (acute and chronic pain), dermatology (psoriasis and eczema), rheumatology (fibromyalgia and arthritis), endocrinological diseases (Type 1 and Tyoe 2 diabetes), anxiety and insomnia. For more information, please see https://www.macplc.com/

Contact:

John Connell, Ph.D.
Chief Scientific Officer
MAC Clinical Research
Johnconnell@macplc.com
+44 7799115400