Full Text View
Tabular View
Study Results
Related Studies
A Research Study Examining Migranal and Skin Sensitivity in Subjects With Migraine
This study has been completed.

First Received on June 9, 2006.   Last Updated on September 12, 2011   History of Changes
Sponsor: Thomas Jefferson University
Information provided by (Responsible Party): Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT00335777
  Purpose

This is a research study looking at Migranal (study drug) in the treatment of two migraine attacks in patients who have a history of cutaneous allodynia (pronounced q-tay-nee-us al-o-din-ee-a). Cutaneous allodynia is an increased skin sensitivity experienced during a headache. It has been noted in several studies that in patients with migraine, seventy nine percent of the patients experienced allodynia on the facial skin on the same side as the headache. Understanding more about allodynia may help us understand how the pain system works in migraine.

This study will compare the differences, if any, in attacks treated early with study drug (at 1-hour from onset) and attacks treated later (at 4-hours). You will be asked to treat one attack early and one attack late for this study. If the first attack you treat is early (at 1 hour following onset of throbbing pain) then the second attack you treat should be late (at 4 hours following onset of throbbing pain).

It is hoped that this study will provide information on the use of Migranal in subjects who have cutaneous allodynia. The results from this study may be used in the development of larger clinical trials. The study drug is a medication that is taken in the form of nasal spray.


Condition Intervention Phase
Migraine
 Drug: Migranal nasal spray
 Phase IV

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label Pilot Trial To Collect And Evaluate Data On The Use Of Migranal® In The Treatment Of Two Acute Migraine Attacks Associated With Cutaneous Allodynia

Resource links provided by NLM:

Genetics Home Reference related topics: familial hemiplegic migraine
MedlinePlus related topics: Headache Migraine
Drug Information available for: Dihydroergotamine Dihydroergotamine mesylate
U.S. FDA Resources

Further study details as provided by Thomas Jefferson University:

Primary Outcome Measures:
  • Number of Subjects Who Were Pain Free at 2 Hours Post Treatment With Study Drug. [ Time Frame: 2 hours post treatment with study medication ] [ Designated as safety issue: No ]
    Number of subjects who were pain free at 2 hours after treatment with study medication when they treated a migraine early (defined as treatment within 1 hour of onset of throbbing pain) compared to the number of subjects who were pain free at 2 hours after treatment with study medication when they treated late (defined as 4 hours after onset of throbbing pain). "Pain free" is defined as a subject rating of zero on a 4 point pain scale; (0=None, 1=mild, 2= moderate, 3=severe).


Secondary Outcome Measures:
  • Allodynia Assessments as Performed at Pre-dosing, 15 Minutes, 30 Minutes, 1 Hour, 1 ½ Hours, 2 Hours, 4 Hours, 8 Hours and 24 Hours Post-dosing for Each Attack Treated Per Subject. Post-dosing Assessments Begin After the Entire 4mg. Dose Has Been Adminis [ Time Frame: baseline, 15 minutes, 30 min., 1 hr., 1.5 hr, 2 hr, 4 hr, 8 hr, 24 hr ] [ Designated as safety issue: No ]
  • Pain and Associated Symptoms Assessments as Measured at Pre-dose, 15 Minutes, 30 Minutes, 1 Hour, 1 ½ Hours, 2 Hours, 4 Hours, 8 Hours and 24 Hours Post-dosing for Each Attack Treated Per Subject. Post-dosing Assessments Begin After the Entire 4mg. Dose [ Time Frame: baseline, 15 min, 30 min, 1 hr, 1.5 hr, 2 hr, 4 hr. 8 hr, 24 hr ] [ Designated as safety issue: No ]
  • Subjects Historical Response to Triptan Therapy and Ergot Therapies [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • Use of Rescue Therapy for Each Attack Treated Per Subject [ Time Frame: number subjects using rescue used between 2 and 24 hrs after study drug ] [ Designated as safety issue: No ]

Enrollment: 64
Study Start Date: August 2006
Study Completion Date: April 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Migranal treatment first treatment phase
All subjects were asked to treat one headache at 1 hour (early) and one headache at 4 hours after onset of throbbing (late). Dose of nasal spray constant for both time points. The subject could determine the order in which they could treat the headaches (early (first treatment phase) then late (second treatment phase), or late (first treatment phase) then early (second treatment phase).
 Drug: Migranal nasal spray
Migranal® 4 mg. will be self administered by each subject in the following manner: one spray in each nostril, wait 15 minutes then follow with one spray in each nostril. This will deliver the desired 4 mg. dose.
Experimental: Migranal second treatment phase
All subjects were asked to treat one headache at 1 hour (early) and one headache at 4 hours after onset of throbbing (late). Dose of nasal spray constant for both time points. The subject could determine the order in which they could treat the headaches (early (first treatment phase) then late (second treatment phase), or late (first treatment phase) then early (second treatment phase).
 Drug: Migranal nasal spray
Migranal® 4 mg. will be self administered by each subject in the following manner: one spray in each nostril, wait 15 minutes then follow with one spray in each nostril. This will deliver the desired 4 mg. dose.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and female subjects between the ages of 18 and 65, inclusive
  • Subjects diagnosed with episodic migraine, with or without aura according to IHS criteria (Appendix B) for at least one-year prior to screening
  • Subjects who experience between 3-10 migraine attacks (inclusive) per month (during the previous 6 months) with no more than 15 days of headache per month.
  • Subjects who report their migraine pain quality as pulsating/ throbbing.
  • Subject experiences episodic migraine associated with cutaneous allodynia, as determined by the Cutaneous Allodynia screening tool and investigator.
  • Subject is using or agrees to use for the duration of participation a medically acceptable form of contraception (as determined by investigator), if female of child-bearing potential
  • Subjects who are able to understand and comply with all study procedures.
  • Subject provides written informed consent prior to any screening procedures being conducted

Exclusion Criteria:

  • Pregnant and/or lactating women
  • Subjects who, in the investigators opinion, have a history or have evidence of a medical or psychiatric condition that would expose them to an increased risk of a significant adverse event or would interfere with the assessments of efficacy and tolerability during this trial
  • Subjects with an abnormal ECG that, in the investigators opinion, would expose them to increased risk of adverse events or interfere with study drug and/or analysis of efficacy/tolerability
  • Subjects currently using, or expecting to use during the trial, CYP 3A4 inhibitors (such as protease inhibitors and macrolide antibiotics)
  • Subjects with severely impaired hepatic or renal function, as determined by the investigator
  • Subjects who have participated in an investigational drug trial in the 30 days prior to the screening visit
  • Subjects who currently have or have a history of basilar or hemiplegic migraine
  • Subjects who have previously shown hypersensitivity to ergot alkaloids
  • Subjects who have a history of non-response to DHE-45 or Migranal®, as determined by investigator
  • Subjects with uncontrolled hypertension
  • Subjects who currently have or who have a history of ischemia and/or vasospastic coronary artery disease
  • Subjects who, in the investigators opinion, have significant risk factors of coronary artery disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00335777

Locations
United States, Pennsylvania
Jefferson Headache Center
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Thomas Jefferson University
Investigators
Principal Investigator: Stephen D. Silberstein, M.D. Jefferson Headache Center
  More Information

No publications provided

Responsible Party: Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT00335777     History of Changes
Other Study ID Numbers: SDS/MIG-CA/ 01
Study First Received: June 9, 2006
Results First Received: October 26, 2010
Last Updated: September 12, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Dihydroergotamine
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
 Pharmacologic Actions
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Vasoconstrictor Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on February 09, 2012



Contact Help Desk
Lister Hill National Center for Biomedical Communications,  U.S. National Library of Medicine,
U.S. National Institutes of Health,  U.S. Department of Health & Human Services,
USA.gov,  Copyright,  Privacy,  Accessibility,  Freedom of Information Act

U.S. National Institutes of Health U.S. National Library of Medicine U.S. Department of Health & Human Services