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A Research Study Examining Migranal and Skin Sensitivity in Subjects With Migraine

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ClinicalTrials.gov Identifier: NCT00335777
Recruitment Status : Completed
First Posted : June 12, 2006
Results First Posted : October 14, 2011
Last Update Posted : April 16, 2014
Sponsor:
Information provided by (Responsible Party):
Thomas Jefferson University

Brief Summary:

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 or disease Intervention/treatment Phase
Migraine Drug: Migranal nasal spray Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (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
Study Start Date : August 2006
Actual Primary Completion Date : December 2008
Actual Study Completion Date : April 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache Migraine

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Number of Subjects Who Were Pain Free at 2 Hours Post Treatment With Study Drug. [ Time Frame: 2 hours post treatment with study medication ]
    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 :
  1. 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 ]
  2. 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 ]
  3. Subjects Historical Response to Triptan Therapy and Ergot Therapies [ Time Frame: baseline ]
  4. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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 (International Headache Society) 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 (CYP3A4 enzyme) 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 (dihydroergotamine) 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

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): NCT00335777


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

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Responsible Party: Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT00335777     History of Changes
Other Study ID Numbers: SDS/MIG-CA/ 01
First Posted: June 12, 2006    Key Record Dates
Results First Posted: October 14, 2011
Last Update Posted: April 16, 2014
Last Verified: March 2014

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