Trial Outcomes & Findings for A Study Examining the Use of a Migraine Medicine in the Treatment of Two Migraine Attacks in Patients Who Have Increased Skin Sensitivity (NCT NCT00203268)

NCT ID: NCT00203268

Last Updated: 2014-06-09

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 13 participants
• Primary outcome timeframe: 2 hours post treatment and 4 hours post treatment
• Results posted on: 2014-06-09

Participant Flow

Participant milestones

Measure	Treatment Group Subjects who treated a moderate to severe migraine at 1 hour and at 4 hours after the onset of throbbing pain. Subjects were treated with dihydroergotamine mesylate 1.0 mg. intramuscular (IM). Headache severity was rated by subjects using a 4 point scale : 0=None, 1=mild, 2=moderate, 3=severe
Early Treatment STARTED	13
Early Treatment COMPLETED	9
Early Treatment NOT COMPLETED	4
Late Treatment STARTED	9
Late Treatment COMPLETED	9
Late Treatment NOT COMPLETED	0

Reasons for withdrawal

Measure	Treatment Group Subjects who treated a moderate to severe migraine at 1 hour and at 4 hours after the onset of throbbing pain. Subjects were treated with dihydroergotamine mesylate 1.0 mg. intramuscular (IM). Headache severity was rated by subjects using a 4 point scale : 0=None, 1=mild, 2=moderate, 3=severe
Early Treatment only treated one headache	2
Early Treatment Lost to Follow-up	1
Early Treatment Withdrawal by Subject	1

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Treatment Group n=13 Participants Subjects who treated a moderate to severe migraine 2 hours and 4 hours after the onset of throbbing pain. Subjects were treated with dihydroergotamine mesylate 1.0 mg. IM. Headache severity was rated by subjects using a 4 point scale : 0=None, 1=mild, 2=moderate, 3=severe.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	13 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	13 participants n=5 Participants

PRIMARY outcome

Timeframe: 2 hours post treatment and 4 hours post treatment

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.

Outcome measures

Measure	Early Treatment n=9 Participants Subjects who treated a moderate to severe migraine 2 hours after the onset of throbbing pain. Subjects were treated with dihydroergotamine mesylate 1.0 mg. IM. Headache severity was rated by subjects using a 4 point scale : 0=None, 1=mild, 2=moderate, 3=severe.	Late Treatment n=9 Participants Subjects who treated a moderate to severe migraine 4 hours after the onset of throbbing pain. Subjects were treated with dihydroergotamine mesylate 1.0 mg. IM. Headache severity was rated by subjects using a 4 point scale : 0=None, 1=mild, 2=moderate, 3=severe
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. 2 hours post dose	6 participants	5 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. 4 hours post dose	6 participants	7 participants

Adverse Events

Early Treatment

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Late Treatment

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Early Treatment n=9 participants at risk；n=13 participants at risk Subjects who treated a moderate to severe migraine 2 hours after the onset of throbbing pain. Subjects were treated with dihydroergotamine mesylate 1.0 mg. IM. Headache severity was rated by subjects using a 4 point scale : 0=None, 1=mild, 2=moderate, 3=severe.	Late Treatment n=9 participants at risk；n=13 participants at risk Subjects who treated a moderate to severe migraine 4 hours after the onset of throbbing pain. Subjects were treated with dihydroergotamine mesylate 1.0 mg. IM. Headache severity was rated by subjects using a 4 point scale : 0=None, 1=mild, 2=moderate, 3=severe
Skin and subcutaneous tissue disorders burning at injection site	33.3% 3/9 • Number of events 3	33.3% 3/9 • Number of events 3
Musculoskeletal and connective tissue disorders muscle spasm, quadricep	22.2% 2/9 • Number of events 2	22.2% 2/9 • Number of events 2
Gastrointestinal disorders nausea	22.2% 2/9 • Number of events 2	22.2% 2/9 • Number of events 2
Nervous system disorders Medicinal taste aversion	11.1% 1/9 • Number of events 1	11.1% 1/9 • Number of events 1

Additional Information

Stephen D. Silberstein, MD

Thomas Jefferson University

Phone: 215-955-2243

Email: Stephen.Silberstein@Jefferson.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place