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Effect of PACAP38/VIP on Migraineurs Measured by Magnetic Resonance

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ClinicalTrials.gov Identifier: NCT01471990
Recruitment Status : Completed
First Posted : November 16, 2011
Last Update Posted : August 29, 2012
Sponsor:
Collaborators:
Bispebjerg Hospital
University Hospital, Gentofte, Copenhagen
Lundbeck Foundation
Cool Sorption Foundation of 1988
Information provided by (Responsible Party):
Faisal Mohammad Amin, Glostrup University Hospital, Copenhagen

Tracking Information
First Submitted Date  ICMJE November 9, 2011
First Posted Date  ICMJE November 16, 2011
Last Update Posted Date August 29, 2012
Study Start Date  ICMJE May 2011
Actual Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 10, 2011)
Comparison between PACAP38 and VIP induced changes in intracranial artery circumference before and after infusions [ Time Frame: Baseline, 20 minutes, 2 hours and 5 hours ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01471990 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 10, 2011)
  • Headache scores [ Time Frame: 24 hours ]
    hospital and post hospital phase
  • Comparison between PACAP38 and VIP induced changes in BOLD response [ Time Frame: 5 hours ]
  • Change in intracranial artery circumference before and after injection of sumatriptan [ Time Frame: 5 hours ]
  • Comparison between PACAP38 and VIP induced changes in brain structure [ Time Frame: 5 hours ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of PACAP38/VIP on Migraineurs Measured by Magnetic Resonance
Official Title  ICMJE The Effect of PACAP38 and VIP on Migraine Patients Assessed by a 3-Tesla MR Scanner
Brief Summary

The purpose of this study is to examine and compare the effect of pituitary adenylate cyclase-activating polypeptide-38 (PACAP38) and vasoactive intestinal polypeptide (VIP) on intracranial arteries and neuronal activity in patients with migraine without aura using a high resolution magnetic resonance imaging (MRI), including MR angiography (MRA) and functional MRI (fMRI).

MRA will be used to detect changes in intracranial artery circumferences before and after PACAP38 and VIP.

fMRI will be used oo detect changes in blood-oxygenation-level-dependent-signal (BOLD-signal).

PACAP38 but not VIP induces migraine like attacks in migraine patients. The migraine specific drug sumatriptan will be given to relieve pain and the effect will also be registered using MRA and fMRI.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Condition  ICMJE Migraine Without Aura
Intervention  ICMJE
  • Drug: Pituitary Adenylate Cyclase-Activating Polypeptide-38
    10 pmol/kg/min over 20 mins
  • Drug: Vasoactive Intestinal Peptide
    8 pmol/kg/min over 20 mins
Study Arms  ICMJE
  • Active Comparator: PACAP38
    Intervention: Drug: Pituitary Adenylate Cyclase-Activating Polypeptide-38
  • Active Comparator: VIP
    Intervention: Drug: Vasoactive Intestinal Peptide
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 28, 2012)
24
Original Estimated Enrollment  ICMJE
 (submitted: November 10, 2011)
18
Actual Study Completion Date  ICMJE June 2012
Actual Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy migraine patient without aura
  • Age 18-40
  • Weight 50-100 kg
  • Fertile women must use safe contraceptives

Exclusion Criteria:

  • Tension type headache more than 5 days per month
  • Other primary headaches
  • Daily use of medication except contraceptives
  • Drug taken within 4 times the half life for the specific drug except contraceptives
  • Pregnant or lactating women
  • Exposure to radiation within the last year
  • Hypotension or hypertension
  • Cardiovascular or cerebrovascular disease
  • Mental illness or substance abuse
  • Other significant conditions determined by the examining doctor
  • Contraindications to MRI scan
  • Headache within the last 48 hours before start of trial
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01471990
Other Study ID Numbers  ICMJE H-1-2011-023
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Faisal Mohammad Amin, Glostrup University Hospital, Copenhagen
Study Sponsor  ICMJE Glostrup University Hospital, Copenhagen
Collaborators  ICMJE
  • Bispebjerg Hospital
  • University Hospital, Gentofte, Copenhagen
  • Lundbeck Foundation
  • Cool Sorption Foundation of 1988
Investigators  ICMJE
Principal Investigator: Faisal Amin, M.D. Danish Headache Centre and Department of Neurology, Glostrup Hospital, Faculty of Health Sciences, University of Copenhagen
PRS Account Glostrup University Hospital, Copenhagen
Verification Date August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP