Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 38 of 231 for:    CALCITONIN SALMON

CGRP Induced Migraine Attacks in Patients With High and Low Genetic Load

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01924052
Recruitment Status : Completed
First Posted : August 16, 2013
Last Update Posted : August 16, 2013
Sponsor:
Information provided by (Responsible Party):
Song Guo, Danish Headache Center

Brief Summary:
The investigators hypothesized that migraine without patients with many genetic loci associated with migraine (high genetic load) would be more sensitive and get provoked more migraine attacks by calcitonin gene-related peptide (CGRP) compared to patients with few genetic loci associated with migraine (low genetic load).

Condition or disease Intervention/treatment Phase
Migraine Without Aura Drug: CGRP Not Applicable

Detailed Description:

Migraine is a very prevalent neurological disorder with a strong genetic factor. The common forms of migraine have a multifactorial and polygenic pattern of inheritance and genetics research is crucial for a deeper understanding of migraine mechanisms. Recently, 12 genetic loci have been identified to be associated with migraine with (MA) and without aura (MA) in four large genome-wide association studies (GWAS). The functional consequences of these genetic loci in humans are yet unknown.

Calcitonin gene-related peptide (CGRP) is a neuropeptide which plays a crucial role in the pathophysiology of migraine and is present in migraine relevant structures. CGRP can induce migraine attacks in MO patients via an adenosine monophosphate (cAMP) dependent pathway and CGRP antagonism is efficient in the treatment of migraine attacks. Also, a recent study has showed that intracellular accumulation of cAMP is crucial for the induction of migraine attacks. However, CGRP does not cause migraine attacks in familial hemiplegic migraine (FHM), an autosomal dominant subtype of MA.

The phenotype of the migraine inducing effects of CGRP might therefore be linked to some of the 12 genetic susceptibility loci that have been identified. One of the genetic loci (rs13208321) is located in a gene (FHL5) that is associated with the regulation of cAMP-responsive elements.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Official Title: CGRP Induced Migraine Attacks in Patients With High and Low Genetic Load
Study Start Date : June 2013
Actual Primary Completion Date : August 2013
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Migraine patients with high genetic load
CGRP intravenous infusion 1.5 microgram/min for 20 min
Drug: CGRP
Calcitonin-gene-related-peptide (CGRP)
Other Name: calcitonin-gene-related peptide

Active Comparator: Migraine patients with low genetic load
CGRP intravenous infusion 1.5 microgram/min for 20 min
Drug: CGRP
Calcitonin-gene-related-peptide (CGRP)
Other Name: calcitonin-gene-related peptide




Primary Outcome Measures :
  1. CGRP induced migraine attacks in patients with high and low genetic load [ Time Frame: Change from baseline in headache intensity at 12 hours after the start of infusion of CGRP ]
    The difference in incidence of migraine-like attacks between patients with high genetic load and patients with low genetic load using verbal rating scale (VRS).


Secondary Outcome Measures :
  1. CGRP induced migraine attacks in patients with high and low genetic load [ Time Frame: Change from baseline in headache intensity at 12 hours after the start of infusion of CGRP ]
    The difference in area under the curve (AUC) for headache intensity scores (0-12 hours)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

- Migraine without aura patients genotyped for the 12 newly idetified gene variants associated with migraine.

Exclusion Criteria:

  • Other primary headache
  • A history of cerebrovascular disease and other CNS- disease
  • A history suggesting ischaemic heart disease
  • Serious somatic and mental disease
  • Hypo- or hypertension
  • Abuse of alcohol or medicine (opioid analgesics).
  • Pregnant or breastfeeding women.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01924052


Sponsors and Collaborators
Danish Headache Center
Investigators
Layout table for investigator information
Principal Investigator: Song Guo, MD Danish Headache Center & Department of Neurology

Layout table for additonal information
Responsible Party: Song Guo, MD, Danish Headache Center
ClinicalTrials.gov Identifier: NCT01924052     History of Changes
Other Study ID Numbers: H-2-2011-141
First Posted: August 16, 2013    Key Record Dates
Last Update Posted: August 16, 2013
Last Verified: August 2013
Additional relevant MeSH terms:
Layout table for MeSH terms
Calcitonin
Calcitonin Gene-Related Peptide
Katacalcin
Migraine Disorders
Migraine without Aura
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Bone Density Conservation Agents
Vasodilator Agents