EHMTI-0026. Neuroprolotherapy and acupuncture for clinical trial of acute and chronic migraine treatment

Background The Phase 3 REsearch Evaluating Migraine Prophylaxis Therapy (PREEMPT) trials demonstrated efficacy/tolerability of onabotulinumtoxinA for headache prevention in adults with chronic migraine. This post hoc analysis assessed time of onset of onabotulinumtoxinA after the first treatment in total and responder populations and consistency weekly through five treatment cycles. Methods In the 24-week, double-blind, placebo-controlled phase of PREEMPT, individuals were randomized 1:1 to onabotulinumtoxinA (155-195 U) or placebo every 12 weeks for two cycles. The primary pooled efficacy variable was change in headache days per 28 days at week 24. We assessed change in headache and migraine/probable migraine (hereafter migraine) days/week compared with baseline week 4. Results Baseline mean (SD) headache days/week (week 4 of baseline) for onabotulinumtoxinA (n = 688) and placebo (n = 696) were similar (4.8 [1.6] vs. 4.8 [1.6] days/week, respectively), as were migraine days/week (4.6 [1.7] vs. 4.6 [1.7] days/week). The effect of onabotulinumtoxinA on change in headache and migraine days/week was significantly greater than placebo at week 1, persisting from week 3 after the first treatment (−1.6 [2.2] vs. −1.1 [2.2] headache days/week [ p < 0.001] and −1.6 [2.2] vs. −1.1 [2.2] migraine days/week [ p < 0.001]). Headache and migraine days decreased in onabotulinumtoxinA responders beginning 1 week after treatment 1. Conclusions Treatment with onabotulinumtoxinA is associated with significant reductions in headache and migraine days/week at week 1, persisting after week 3, compared with placebo. Combined with earlier reports showing onabotulinumtoxinA treatment results in a persistent and progressive reduction in headache days over 56 weeks, it is suggested peak benefit may require multiple treatments. Trial registration number ClinicalTrials.gov: NCT00156910 and NCT00168428.

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Early and sustained effect of onabotulinumtoxinA for chronic migraine treatment: Analysis of preempt data

Toxicon ◽

10.1016/j.toxicon.2018.11.060 ◽

2018 ◽

Vol 156 ◽

pp. S23-S24

Author(s):

David W. Dodick ◽

Stephen D. Silberstein ◽

Richard B. Lipton ◽

Ronald E. DeGryse ◽

Aubrey Manack Adams ◽

...

Keyword(s):

Chronic Migraine ◽

Migraine Treatment ◽

Sustained Effect ◽

Treatment Analysis

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Cognitive behavioral therapy for chronic migraine

European Psychiatry ◽

10.1016/j.eurpsy.2017.01.626 ◽

2017 ◽

Vol 41 (S1) ◽

pp. s500-s500 ◽

Cited By ~ 1

Author(s):

O. Onur ◽

D.H. Ertem ◽

D. Uludüz ◽

Ç. Karşıdağ

Keyword(s):

Chronic Migraine ◽

Psychological Treatment ◽

Treatment Options ◽

Depression Scale ◽

Migraine Treatment ◽

Hamilton Depression Scale ◽

Post Traumatic Stress ◽

Current Standard ◽

Significant Difference ◽

Hamilton Anxiety

AimAlthough current standard treatment for migraine headache is medication, high levels of psychological comorbidity has led to migraine influencing by cognitive, emotional and environmental factors, as well as biological. Viewing migraine in a biopsychosocial framework introduces the possible utilisation of psychological treatment options, such as cognitive behavioural therapy (CBT). The aim of this study was to evaluate the efficacy of CBT for chronic migraine.MethodologyThirty-five participants diagnosed as chronic migraine were recruited from Headache Clinic. According to inclusion criteria 14 participants, underwent bi-weekly lasting 30 minutes CBT sessions for 6 months, were administered Hamilton Anxiety Scale, Hamilton Depression Scale, Visual Analog Scale (VAS) and the Migraine Disability Assessment Scale (MİDAS) before and after CBT.FindingsNine of the participants were female and 5 male. Mean age of group was 34.35 ± 8.17. Duration of illness was 13.07 ± 7.18 and 12 of participants had the history of a psychiatry illness whose diagnoses were depression (7), anxiety disorder (4) and post-traumatic stress disorder (1). Nine of the patients had prophylactic migraine treatment. There were statistically significant difference in Hamilton Depression scores between before CBT (29.07 ± 7.74) and after CBT (14.21 ± 7.7); in Hamilton Anxiety scores before CBT (26.8 ± 11.7) and after CBT (11.7 ± 2.6); in VAS scores before CBT (8.07± 0.91) and after CBT (3.71 ± 1.32); in frequency of migraine attacks between before CBT (10.85 ± 3.50 day) and after CBT (4.92 ± 2.70 day) and in MİDAS before CBT (55.5 ± 20.4) and after CBT (20.12 ± 16.6) (P < 0.05).ConclusionCBT might reduce the severity of symptoms in migraine patients especially with the comorbidity of psychiatric illness.Disclosure of interestThe authors have not supplied their declaration of competing interest.

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Eptinezumab for prevention of chronic migraine: A randomized phase 2b clinical trial

Cephalalgia ◽

10.1177/0333102419858355 ◽

2019 ◽

Vol 39 (9) ◽

pp. 1075-1085 ◽

Cited By ~ 26

Author(s):

David W Dodick ◽

Richard B Lipton ◽

Stephen Silberstein ◽

Peter J Goadsby ◽

David Biondi ◽

...

Keyword(s):

Clinical Trial ◽

Chronic Migraine ◽

Development Program ◽

Calcitonin Gene Related Peptide ◽

Electronic Diary ◽

Phase 3 ◽

Pivotal Phase ◽

Double Blind ◽

Related Peptide ◽

Calcitonin Gene

Background Calcitonin gene-related peptide plays an important role in migraine pathophysiology. We evaluated eptinezumab, an intravenous (IV) anti-calcitonin gene-related peptide monoclonal antibody, for the prevention of chronic migraine. Objective To determine the safety, tolerability, and effectiveness of four dose levels of eptinezumab and to inform the phase 3 development program. Methods This was a phase 2b, parallel-group, double-blind, randomized, placebo-controlled, dose-ranging clinical trial. Men and women (N = 616) aged 18–55 years were included if they had a diagnosis of chronic migraine, with onset at age ≤35 years and history of chronic migraine ≥1 year. During the 28-day screening period, patients must have had ≥15 headache days, including ≥8 migraine days, with ≥5 migraine attacks as recorded in the electronic diary. Patients were assigned in a 1:1:1:1:1 ratio to eptinezumab 300, 100, 30, 10 mg or placebo, administered as a single IV infusion. The primary endpoint was the percentage of patients with a ≥75% decrease in monthly migraine days over weeks 1–12 compared with the 28-day screening period. Results The ≥75% migraine responder rates over weeks 1–12 for eptinezumab 300, 100, 30, and 10 mg were 33.3%, 31.4%, 28.2%, and 26.8%, respectively, versus 20.7% for placebo ( p = 0.033, 0.072, 0.201, 0.294 vs. placebo). Secondary efficacy endpoints (e.g. ≥50% responder rate, change from baseline in frequency of migraine/headache days, and percentage of severe migraines) had results favoring the three higher eptinezumab doses versus placebo. Eptinezumab was well tolerated and adverse event rates were similar to placebo. Conclusions The results of this trial demonstrate that eptinezumab appears effective and well-tolerated for the preventive treatment of chronic migraine and justifies the conduct of pivotal phase 3 trials for migraine prevention. Trial Registration ClinicalTrials.gov identifier: NCT02275117.

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Cambia® (Diclofenac Potassium for Oral Solution) in the Management of Acute Migraine

US Neurology ◽

10.17925/usn.2011.07.02.139 ◽

2011 ◽

Vol 07 (02) ◽

pp. 139 ◽

Cited By ~ 3

Author(s):

Kevin Kahn ◽

Keyword(s):

Clinical Trial ◽

Real World ◽

Clinical Trial Data ◽

Oral Solution ◽

Comparable Efficacy ◽

Migraine Treatment ◽

The Past ◽

The Us ◽

Clinical Trial Results ◽

Favorable Side Effect Profile

Migraine is a prevalent and disabling disorder involving central and peripheral neurologic processes that generate inflammatory mediated pain. Cambia® (diclofenac potassium for oral solution), a novel patented form of the anti-inflammatory medication diclofenac potassium, has been approved by the US Food and Drug Administration for the acute treatment of migraine. Clinical trial data have demonstrated that this formulation offers a four-fold decrease in time of onset of relief compared with conventional diclofenac, which has comparable efficacy to triptan medication. It has also proven effective in a real-world setting. Over the past few years, it has been established that migraine treatment that is administered early may prevent central sensitization and improve treatment outcomes. Given the importance of early intervention in migraine treatment, this medication offers rapid, convenient, and effective relief with a favorable side-effect profile. This review describes migraine pathophysiology, treatment rationale, clinical trial results, and real-world experience with the use of this new medication.

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Efficacy and safety of acupuncture in Chronic MIGraine - a multicentre, randomised, controlled clinical trial

http://isrctn.org/> ◽

10.1186/isrctn52683557 ◽

2013 ◽

Author(s):

Hans-Christoph Diener

Keyword(s):

Clinical Trial ◽

Chronic Migraine ◽

Controlled Clinical Trial ◽

Efficacy And Safety ◽

Randomised Controlled Clinical Trial ◽

Randomised Controlled

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The Scientific Basis of Medication Choice in Symptomatic Migraine Treatment

Canadian Journal of Neurological Sciences / Journal Canadien des Sciences Neurologiques ◽

10.1017/s0317167100000159 ◽

1999 ◽

Vol 26 (3) ◽

pp. 20-26 ◽

Cited By ~ 25

Author(s):

Peter J. Goadsby

Keyword(s):

Clinical Trial ◽

Pain Relief ◽

Placebo Response ◽

Acute Attack ◽

Controlled Clinical Trial ◽

Migraine Treatment ◽

Number Needed To Treat ◽

Acute Migraine ◽

End Point ◽

Therapeutic Gain

ABSTRACT:With the rapid advances in the treatment of acute attacks of migraine in the last few years and a number of new treatments, has come the practical clinical problem of comparing emerging acute attack therapies alone and with regard to current treatments. Acute migraine therapies can usefully be regarded as non-specific and specific, from the perspective of migraine, since some medicines, such as aspirin or paracetamol, are used to treat pain more broadly. In this review I will compare both non-specific and specific compounds. To some extent the introduction into trial then clinical use of sumatriptan, the first of the 5HT1B/1D agonists or triptans, brought new standards in both clinical trial design, and execution and clinical outcome. Thus sumatriptan has become the de facto gold standard and will be thus employed here. To be practical the discussion of the new triptans will be limited to those available widely, naratriptan, rizatriptan and zolmitriptan. There are two broad issues when comparing treatments: what end-point should be considered and then, how can different compounds be compared with respect to that end-point. In terms of end-points those used here relate to pain relief because they have been collected robustly in the clinical studies and, fortunately, rapid pain relief is what patients questioned in population-based studies rate highest in an acute attack medicine. Headache pain has been rated on a scale of nil, mild, moderate and severe and success rated as either a response, nil or mild pain, or headache free, nil pain, at two or four hours. The ideal comparison of the triptans would be a randomized controlled clinical trial directly comparing the medicines in each case. Given that these are not available for all the compounds and the well characterised placebo response in acute migraine studies, summary measures have been developed to express the differences between compounds to try and adjust for the varying placebo effect. The two most widely used are the therapeutic gain, response on active medication minus response on placebo, and the number-needed-to-treat (NNT). The NNT is the reciprocal of the therapeutic gain as a proportion. The strengths and weaknesses of this approach will be discussed, including the importance of the calculation of confidence intervals. It can be concluded that our current instruments are rather blunt and patient preference needs much greater study.

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Randomized, proof-of-principle clinical trial of active transcranial magnetic stimulation in chronic migraine

Cephalalgia ◽

10.1177/0333102413515340 ◽

2013 ◽

Vol 34 (6) ◽

pp. 464-472 ◽

Cited By ~ 61

Author(s):

Adriana B Conforto ◽

Edson Amaro ◽

André L Gonçalves ◽

Juliane PP Mercante ◽

Vera Z Guendler ◽

...

Keyword(s):

Clinical Trial ◽

Transcranial Magnetic Stimulation ◽

Chronic Migraine ◽

High Frequency ◽

Magnetic Stimulation ◽

Sham Group ◽

Repetitive Transcranial Magnetic Stimulation ◽

Placebo Response ◽

Double Blind ◽

Proof Of Principle

Background High-frequency repetitive transcranial magnetic stimulation of the left dorsolateral prefrontal cortex (rTMS-DLPFC) is an effective treatment for depression. Preliminary studies indicated beneficial effects of rTMS-DLPFC on pain relief in patients treated for depression, and in patients with chronic migraine. Methods In this randomized, double-blind, parallel-group, single-center, proof-of-principle clinical trial, we tested the hypothesis that 23 sessions of active rTMS-DLPFC delivered over eight weeks would be feasible, safe and superior to sham rTMS to decrease the number of headache days in 18 patients with chronic migraine without severe depression. Per-protocol analysis was performed. Results rTMS-DLPFC applied over eight weeks was feasible and safe in patients with chronic migraine. Contrary to our primary hypothesis, the number of headache days decreased significantly more in the sham group than in the group treated with active rTMS-DLPFC at eight weeks. Average decrease in headache days was >50% in the sham group, indicating a powerful placebo response. Pain intensity improved in both groups to a similar extent. Conclusions Positive results of M1 stimulation in other studies, and the absence of significant benefits of active high-frequency rTMS of the DLPFC in the present study, point to M1 as a more promising target than the DLPFC, for larger trials of noninvasive brain stimulation in patients with chronic migraine.

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