Topics

A Functional MRI Study on Erenumab Treatment Effects in Episodic Migraine Patients

2019-06-12 01:37:20 | BioPortfolio

Summary

The purpose of this study is to investigate the effects of erenumab on central sensitization and brain networks connectivity of migraine patients

Description

This is a randomized, double blind, placebo-controlled trial with a 2-sequence, 2-period, 2-treatment crossover design. The study population will consist of adult male and female subjects with a documented history of episodic migraine (4 to 14 baseline migraine days), who have failed at least 2 previous migraine prophylactic treatment for lack of efficacy or tolerability. After a run-in phase of 4 weeks, patients will be randomized, according to a 1:1 ratio, to a 24 weeks of treatment, as follow:

- Sequence 1: A/B

- Sequence 2: B/A where: A=monthly subcutaneous erenumab 140 mg for 12 weeks; B=monthly subcutaneous masked placebo for 12 weeks

Study Design

Conditions

Migraine Disorders

Intervention

erenumab, placebo

Location

Presidio Ospedaliero San Nicola e Filippo
Avezzano
Italy

Status

Not yet recruiting

Source

Novartis

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-06-12T01:37:20-0400

Clinical Trials [977 Associated Clinical Trials listed on BioPortfolio]

A Controlled Trial of Erenumab in Migraine Prevention

Study is a phase 3 confirmatory trial intended to assess the efficacy and safety of erenumab for prevention of migraine in Japanese subjects with episodic migraine (EM) and chronic migrain...

Efficacy and Safety of Erenumab in Pediatric Subjects With Episodic Migraine

This study will evaluate the efficacy and safety of erenumab in migraine prevention in children (6 to

Efficacy and Safety of Erenumab in Pediatric Subjects With Chronic Migraine

This study will evaluate the efficacy and safety of erenumab in migraine prevention in children (6 to

Study of Efficacy and Safety of Erenumab in Adult Chronic Migraine Patients

The purpose of this study is to evaluate the efficacy and safety of erenumab in patients with chronic migraine in Asian population.

Effect of Erenumab-aooe on Disability and Work Productivity in Employed Subjects With Episodic Migraine.

To evaluate the effect of erenumab compared to placebo on disability in employed subjects with episodic migraine (EM) who have previously failed 1 or more migraine preventive treatments.

PubMed Articles [6429 Associated PubMed Articles listed on BioPortfolio]

Erenumab safety and efficacy in migraine: A systematic review and meta-analysis of randomized clinical trials.

Erenumab is a new medicine recently approved in the United States of America for the preventive treatment of migraine among adults. We aimed to conduct a meta-analysis and evaluation of the efficacy a...

The spectrum of response to erenumab in patients with chronic migraine and subgroup analysis of patients achieving ≥50%, ≥75%, and 100% response.

To assess the efficacy of erenumab across the spectrum of response thresholds (≥50%, ≥75%, 100%) based on monthly migraine days (MMD) reduction in patients with chronic migraine from a 12-week, ra...

The treatment efficacy of galcanezumab for migraine: A meta-analysis of randomized controlled trials.

The treatment efficacy of galcanezumab for migraine remained controversial. We conducted a systematic review and meta-analysis to explore the influence of galcanezumab versus placebo on the treatment ...

The influence of allergic rhinoconjunctivitis on migraine disability in children.

Migraine is a common condition in the pediatric population and causes a significant impact on the quality of life. Atopic disorders are some of the migraine comorbidities. We hypothesized that allergi...

Efficacy, Tolerability, and Safety of DFN-15 (Celecoxib Oral Solution, 25 mg/mL) in the Acute Treatment of Episodic Migraine: A Randomized, Double-Blind, Placebo-Controlled Study.

The objective of this study was to evaluate the efficacy, tolerability, and safety of 120 mg DFN-15 vs placebo for the acute treatment of migraine.

Medical and Biotech [MESH] Definitions

A class of disabling primary headache disorders, characterized by recurrent unilateral pulsatile headaches. The two major subtypes are common migraine (without aura) and classic migraine (with aura or neurological symptoms). (International Classification of Headache Disorders, 2nd ed. Cephalalgia 2004: suppl 1)

A subtype of migraine disorder, characterized by recurrent attacks of reversible neurological symptoms (aura) that precede or accompany the headache. Aura may include a combination of sensory disturbances, such as blurred VISION; HALLUCINATIONS; VERTIGO; NUMBNESS; and difficulty in concentrating and speaking. Aura is usually followed by features of the COMMON MIGRAINE, such as PHOTOPHOBIA; PHONOPHOBIA; and NAUSEA. (International Classification of Headache Disorders, 2nd ed. Cephalalgia 2004: suppl 1)

Abnormal sensitivity to light. This may occur as a manifestation of EYE DISEASES; MIGRAINE; SUBARACHNOID HEMORRHAGE; MENINGITIS; and other disorders. Photophobia may also occur in association with DEPRESSION and other MENTAL DISORDERS.

Serotonin antagonist used against MIGRAINE DISORDERS and vascular headaches.

A 9,10alpha-dihydro derivative of ERGOTAMINE. It is used as a vasoconstrictor, specifically for the therapy of MIGRAINE DISORDERS.

More From BioPortfolio on "A Functional MRI Study on Erenumab Treatment Effects in Episodic Migraine Patients"

Quick Search

Relevant Topics

Neurology - Central Nervous System (CNS)
Alzheimer's Disease Anesthesia Anxiety Disorders Autism Bipolar Disorders Dementia Epilepsy Multiple Sclerosis (MS) Neurology Pain Parkinson's Disease Sleep Disorders Neurology is the branch of me...

The Top 100 Pharmaceutical Companies
Top 10 biotech and pharmaceutical companies worldwide based on market value in 2015 2015 ranking of the global top 10 biotech and pharmaceutical companies based on revenue (in billion U.S. dollars) Johnson & Johnson, U.S. 74...


Searches Linking to this Trial