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

NCT00335777 | Completed Phase 4 Results

• 1 other identifier: SDS/MIG-CA/ 01
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Migraine

Outcome Measures

Primary Outcomes (1)

• Number of Subjects Who Were Pain Free at 2 Hours Post Treatment With Study Drug.

  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).

  2 hours post treatment with study medication

Secondary Outcomes (1)

• Number of Subjects Who Had Pain Relief at 2 Hours Post Treatment With Study Drug.

  2 hours post treatment with study medication

Study Arms (2)

Migranal treatment first treatment phase

EXPERIMENTAL

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 at 1 hour

Migranal second treatment phase

EXPERIMENTAL

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 at 4 hour

Interventions

Migranal nasal spray at 1 hour DRUG

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.

Also known as: Dihydroergotamine (DHE)

Migranal treatment first treatment phase

Migranal nasal spray at 4 hour DRUG

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.

Also known as: Dihydroergotamine (DHE)

Migranal second treatment phase

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Thomas Jefferson University: lead

Study Sites (1)

Jefferson Headache Center

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Migraine Disorders

Interventions

Dihydroergotamine

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Ergotamines; Ergot Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Stephen D. Silberstein, MD
• Organization: Jefferson Headache Center

stephen.silberstein@jefferson.edu

215-955-2243

Study Officials

• Stephen D. Silberstein, M.D.

  Jefferson Headache Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2006
• First Posted: June 12, 2006
• Study Start: August 1, 2006
• Primary Completion: December 1, 2008
• Study Completion: April 1, 2009
• Last Updated: March 11, 2022
• Results First Posted: October 14, 2011

Record last verified: 2022-02

Locations

US (1)