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

• ClinicalTrials.gov Identifier: NCT02158221
• Recruitment Status: Completed
• First Posted: June 6, 2014
• Last Update Posted: February 10, 2015
• Sponsor: Danish Headache Center
• Information provided by (Responsible Party): Song Guo, Danish Headache Center

Tracking Information

• First Submitted Date: June 5, 2014
• First Posted Date: June 6, 2014
• Last Update Posted Date: February 10, 2015
• Study Start Date: June 2014
• Actual Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 5, 2014)

Incidence of migraine attacks induced by PACAP 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 PACAP ]

The difference in incidence of migraine-like attacks after PACAP between patients with and without high genetic load and patients with low genetic load using verbal rating scale (VRS).

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: June 5, 2014)

Incidence of headache induced by PACAP 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 PACAP ]

The difference in area under the curve (AUC) for headache intensity scores (0-12 hours) after infusion of PACAP

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: PACAP Induced Migraine Attacks in Patients With High and Low Genetic Load
• Official Title: PACAP Induced Migraine Attacks in Patients With High and Low Genetic Load
• 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 PACAP compared to patients with few genetic loci associated with migraine (low genetic load).

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 this genetic variant in humans are yet unknown.

PACAP is a neuropeptide which plays a crucial role in the pathophysiology of migraine and is present in migraine relevant structures. PACAP can induce migraine attacks in MO patients via an adenosine monophosphate (cAMP) dependent pathway. Also, a recent study has showed that intracellular accumulation of cAMP is crucial for the induction of migraine attacks.

The phenotype of the migraine inducing effects of PACAP might therefore be linked to some of the 12 genetic susceptibility loci that have been identified.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Outcomes Assessor)
• Condition: Migraine Without Aura

Intervention

Drug: PACAP

Pituitary adenylate cyclase-activating polypeptide (PACAP)

Other Name: Pituitary adenylate cyclase-activating polypeptide

Study Arms

• Active Comparator: Migraine patients with high genetic load
  PACAP intravenous infusion 1.5 microgram/min for 20 min
  Intervention: Drug: PACAP
• Active Comparator: Migraine patients with low genetic load
  PACAP intravenous infusion 1.5 microgram/min for 20 min
  Intervention: Drug: PACAP

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: June 5, 2014): 32
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: December 2014
• Actual Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Denmark

Administrative Information

• NCT Number: NCT02158221
• Other Study ID Numbers: H-2-2013-043
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Song Guo, Danish Headache Center
• Original Responsible Party: Same as current
• Current Study Sponsor: Danish Headache Center
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Danish Headache Center
• Verification Date: February 2015