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CompletedNCT00203268Updated Jun 9, 2014Results posted

A Study Examining the Use of a Migraine Medicine in the Treatment of Two Migraine Attacks in Patients Who Have Increased Skin Sensitivity

An interventional study of dihydroergotamine mesylate in Migraine, sponsored by Thomas Jefferson University. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2014-06-09.

Sponsored by Thomas Jefferson University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
13
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

Study summary

This is a research study examining a migraine medicine dihydroergotamine mesylate (DHE-45).It will be used to treat two migraine attacks in subjects who have a history of skin sensitivity associated with their headaches.This skin sensitivity is called cutaneous allodynia (pronounced q-tay-nee-us al-o-din-ee-uh).Cutaneous allodynia is a sensation of pain when a non-noxious stimulus is applied to normal skin. It has been noted in several studies that in subjects with migraine, seventy nine percent of the subjects experienced allodynia on the facial skin on the same side as the headache. It has also been shown that that once allodynia develops, other migraine medicines that would normally be very effective for migraine pain, become much less effective or ineffective. This study will compare the differences,if any, in attacks treated early with this study drug and treated later with the same study drug. It is hoped that that this trial will provide information on the use of DHE-45 in subjects who have cutaneous allodynia. Understanding more about allodynia may help us understand how the pain system works in migraine.

02

Conditions studied

  • Migraine

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Keywords

  • migraine
  • cutaneous allodynia
03

In context

Migraine Disorders

1,528 studies on the registry are indexed under Migraine Disorders; 299 are open to participants now.

This study's enrollment of 13 is below the median of 80 across 1,175 interventional studies indexed under Migraine Disorders.

Browse Migraine Disorders studies →

Lead sponsor

Thomas Jefferson University is the lead sponsor of 384 studies on the registry; 71 are open to participants now.

Of its 44 completed or terminated interventional studies of FDA-regulated products, 20 (45%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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 International Headache Criteria (IHS) (Appendix B) for at least one-year prior to screening
  • Subjects who experience between 3-10 migraine attacks 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 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 come for 2-hour in-clinic treatment of two separate migraine attacks
  • 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

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, Cytochrome P450 3A4 (CYP3A4 enzymes) 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, 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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
13 participants (actual)

Study arms

  • Experimental
    Treatment with dihydroergotamine mesylate (DHE-45)

    Subjects who treated a moderate to severe migraine 2 and 4 hours after the onset of throbbing headache pain

    Drug: dihydroergotamine mesylate

Interventions

  • Drugdihydroergotamine mesylate

    1.0 mg. intramuscularly

    Also known as: DHE-45

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What researchers measure

Primary outcomes

  1. Number of Subjects Reporting Headache Relief at the 2 Hour Post Treatment Assessment. Relief Was Measured as a 2-point Change on a 4-point Scale (0=None, 1=Mild, 2=Moderate, 3=Severe)in Both the Early Treatment and Late Treatment Groups.

    Data was collected at 2 hours post treatment to assess pain level. This assessment was done when subjects treated a migraine early (defined as treatment at 2 hours after onset of throbbing pain)and then late (defined as treatment at 4 hours after onset of throbbing pain). The proportion of subjects reporting headache relief at the 2 hour post treatment assessment was determined for each group and then compared.

    Time frame: 2 hours post treatment and 4 hours post treatment

07

Results

Posted Jun 9, 2014

Participant flow

Early Treatment
Participant flow — Early Treatment
MilestoneTreatment Group
Started13
Completed9
Not completed4
Withdrew: Only treated one headache2
Withdrew: Lost to follow-up1
Withdrew: Withdrawal by subject1
Late Treatment
Participant flow — Late Treatment
MilestoneTreatment Group
Started9
Completed9
Not completed0

Outcome measures

PrimaryNumber of Subjects Reporting Headache Relief at the 2 Hour Post Treatment Assessment. Relief Was Measured as a 2-point Change on a 4-point Scale (0=None, 1=Mild, 2=Moderate, 3=Severe)in Both the Early Treatment and Late Treatment Groups.

Data was collected at 2 hours post treatment to assess pain level. This assessment was done when subjects treated a migraine early (defined as treatment at 2 hours after onset of throbbing pain)and then late (defined as treatment at 4 hours after onset of throbbing pain). The proportion of subjects reporting headache relief at the 2 hour post treatment assessment was determined for each group and then compared.

Time frame:
2 hours post treatment and 4 hours post treatment
Reported as:
Number · participants
Number of Subjects Reporting Headache Relief at the 2 Hour Post Treatment Assessment. Relief Was Measured as a 2-point Change on a 4-point Scale (0=None, 1=Mild, 2=Moderate, 3=Severe)in Both the Early Treatment and Late Treatment Groups.
participantsEarly TreatmentLate Treatment
2 hours post dose65
4 hours post dose67
Statistical analysis
  • Early Treatment vs Late Treatment · clustered survival analysis · p = .3025

Adverse events

Non-serious events are listed at a 3% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Early Treatment—0/13 (0%)3/9 (33.3%)
Late Treatment—0/13 (0%)3/9 (33.3%)
Most frequent other events
Most frequent other events
EventEarly TreatmentLate Treatment
burning at injection siteSkin and subcutaneous tissue disorders3/93/9
muscle spasm, quadricepMusculoskeletal and connective tissue disorders2/92/9
nauseaGastrointestinal disorders2/92/9
Medicinal taste aversionNervous system disorders1/91/9

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Treatment Group
<=18 years0
Between 18 and 65 years13
>=65 years0
Sex: Female, Male
Sex: Female, Male(Participants)Treatment Group
Female13
Male0
Region of Enrollment
Region of Enrollment(participants)Treatment Group
United States13
08

Study locations

1 site
  • Jefferson Headache Center
    Philadelphia, Pennsylvania 19107, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 9, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00203268
Lead sponsor
Thomas Jefferson University
Collaborators
Bausch Health Americas, Inc.
Responsible party
Sponsor
First posted
Sep 20, 2005
Start date
Dec 2003
Primary completion
Mar 2005
Completion
Mar 2005
Results posted
Jun 9, 2014
Last update
Jun 9, 2014

Study contacts

Stephen D Silberstein, MD
principal investigator · Thomas Jefferson University, Jefferson Headache Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2014. You cannot join it, but the record below documents what was studied.

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