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Trial of Comprehensive Migraine Intervention

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ClinicalTrials.gov Identifier: NCT01071317
Recruitment Status : Completed
First Posted : February 19, 2010
Results First Posted : July 26, 2018
Last Update Posted : August 31, 2018
Sponsor:
Information provided by (Responsible Party):
Benjamin W. Friedman, MD, Montefiore Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Prevention
Condition Migraine
Interventions Drug: Naproxen
Drug: Sumatriptan
Behavioral: Migraine education
Behavioral: Reenforcement of diagnosis
Other: Typical care
Enrollment 50
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Comprehensive Care Typical Care
Hide Arm/Group Description

Reinforcement of diagnosis, education, medications, and referral

Naproxen: Naproxen 500mg PO bid prn headache

Sumatriptan: 100mg po q day prn headache

Migraine education: Educational program available through NIH/ national library of medicine/ X-plain

Reenforcement of diagnosis: Patient told he/s he has migraine headache and how the headache meets migraine criteria

Usual care

Typical care: Care to be determined by attending physician

Period Title: Overall Study
Started 25 25
Completed 23 23
Not Completed 2 2
Reason Not Completed
Lost to Follow-up             2             2
Arm/Group Title Comprehensive Care Typical Care Total
Hide Arm/Group Description

Reinforcement of diagnosis, education, medications, and referral

Naproxen: Naproxen 500mg PO bid prn headache

Sumatriptan: 100mg po q day prn headache

Migraine education: Educational program available through NIH/ national library of medicine/ X-plain

Reenforcement of diagnosis: Patient told he/s he has migraine headache and how the headache meets migraine criteria

Usual care

Typical care: Care to be determined by attending physician

Total of all reporting groups
Overall Number of Baseline Participants 25 25 50
Hide Baseline Analysis Population Description
Patients who enrolled and were randomized
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 25 participants 25 participants 50 participants
33  (9) 35  (9) 34  (9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 25 participants 50 participants
Female
23
  92.0%
20
  80.0%
43
  86.0%
Male
2
   8.0%
5
  20.0%
7
  14.0%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 25 participants 25 participants 50 participants
25 25 50
Pre-existing migraine-related functional impairment as measured by the MIDAS scale   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Units on a scale
Number Analyzed 25 participants 25 participants 50 participants
10
(7 to 18)
13
(9 to 31)
12
(9 to 25)
[1]
Measure Description: The Migraine Disability Assessment (MIDAS) Test is a brief, self-administered questionnaire designed to quantify headache-related disability over a 3 month period. It is a 5-question instrument used to determine the severity of the underlying migraine disorder. Each question is scored from 0 to 90; the total minimum and total maximum scores are 0 and 450 respectively. A total score of 0 indicates no impairment. A total score greater than 20 indicates severe migraine related functional impairment.
1.Primary Outcome
Title Migraine Functional Impairment as Measured by Score on the Headache Impact Test 6 (HIT6) Scale
Time Frame 1 month after study enrollment
Hide Outcome Measure Data
Hide Analysis Population Description
2 patients in each group were lost-to-followup
Arm/Group Title Comprehensive Care Typical Care
Hide Arm/Group Description:

Reinforcement of diagnosis, education, medications, and referral

Naproxen: Naproxen 500mg PO bid prn headache

Sumatriptan: 100mg po q day prn headache

Migraine education: Educational program available through NIH/ national library of medicine/ X-plain

Reenforcement of diagnosis: Patient told he/s he has migraine headache and how the headache meets migraine criteria

Usual care

Typical care: Care to be determined by attending physician

Overall Number of Participants Analyzed 23 23
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
59
(53 to 65)
56
(51 to 62)
2.Secondary Outcome
Title Number of Participants Who Report Satisfaction With Treatment, as Measured by a Three Item Likert Scale
Hide Description Participants could report that they were completely satisfied, mostly satisfied or unsatisfied. Reported here are the number who were unsatisfied.
Time Frame 1 month after study enrollment
Hide Outcome Measure Data
Hide Analysis Population Description
2 patients in each group were lost to followup. One patient in the Typical Care group did not answer the question
Arm/Group Title Comprehensive Care Typical Care
Hide Arm/Group Description:

Reinforcement of diagnosis, education, medications, and referral

Naproxen: Naproxen 500mg PO bid prn headache

Sumatriptan: 100mg po q day prn headache

Migraine education: Educational program available through NIH/ national library of medicine/ X-plain

Reenforcement of diagnosis: Patient told he/s he has migraine headache and how the headache meets migraine criteria

Usual care

Typical care: Care to be determined by attending physician

Overall Number of Participants Analyzed 23 22
Measure Type: Count of Participants
Unit of Measure: Participants
4
  17.4%
4
  18.2%
3.Secondary Outcome
Title Number of Participants Who Report They Are Comfortable With Disease Management, as Measured by a Three-item Likert Scale
Hide Description Participants were asked to describe themselves as very comfortable, somewhat comfortable, or uncomfortable. Reported here are those who were very comfortable
Time Frame 1 month after study enrollment
Hide Outcome Measure Data
Hide Analysis Population Description
Two patients in each arm were lost-to-follow-up. One patient in Typical Care did not answer this question.
Arm/Group Title Comprehensive Care Typical Care
Hide Arm/Group Description:

Reinforcement of diagnosis, education, medications, and referral

Naproxen: Naproxen 500mg PO bid prn headache

Sumatriptan: 100mg po q day prn headache

Migraine education: Educational program available through NIH/ national library of medicine/ X-plain

Reenforcement of diagnosis: Patient told he/s he has migraine headache and how the headache meets migraine criteria

Usual care

Typical care: Care to be determined by attending physician

Overall Number of Participants Analyzed 23 22
Measure Type: Count of Participants
Unit of Measure: Participants
10
  43.5%
6
  27.3%
4.Secondary Outcome
Title Number of Participants Who Returned to the Emergency Department for Management of Headache
Hide Description We report the number of patient who returned to the emergency department for management of headache
Time Frame 1 month after study enrollment
Hide Outcome Measure Data
Hide Analysis Population Description
Two patients in each arm were lost to followup.
Arm/Group Title Comprehensive Care Typical Care
Hide Arm/Group Description:

Reinforcement of diagnosis, education, medications, and referral

Naproxen: Naproxen 500mg PO bid prn headache

Sumatriptan: 100mg po q day prn headache

Migraine education: Educational program available through NIH/ national library of medicine/ X-plain

Reenforcement of diagnosis: Patient told he/s he has migraine headache and how the headache meets migraine criteria

Usual care

Typical care: Care to be determined by attending physician

Overall Number of Participants Analyzed 23 23
Measure Type: Count of Participants
Unit of Measure: Participants
1
   4.3%
3
  13.0%
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Comprehensive Care Typical Care
Hide Arm/Group Description

Reinforcement of diagnosis, education, medications, and referral

Naproxen: Naproxen 500mg PO bid prn headache

Sumatriptan: 100mg po q day prn headache

Migraine education: Educational program available through HIH/ national library of medicine/ X-plain

Reenforcement of diagnosis: Patient told he/s he has migraine headache and how the headache meets migraine criteria

Usual care

Typical care: Care to be determined by attending physician

All-Cause Mortality
Comprehensive Care Typical Care
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Comprehensive Care Typical Care
Affected / at Risk (%) Affected / at Risk (%)
Total   0/25 (0.00%)   0/25 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Comprehensive Care Typical Care
Affected / at Risk (%) Affected / at Risk (%)
Total   0/25 (0.00%)   0/25 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Benjamin W. Friedman, MD
Organization: Montefiore Health
Phone: 718-920-6626
Responsible Party: Benjamin W. Friedman, MD, Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT01071317     History of Changes
Other Study ID Numbers: 09-08-248
First Submitted: February 17, 2010
First Posted: February 19, 2010
Results First Submitted: April 15, 2018
Results First Posted: July 26, 2018
Last Update Posted: August 31, 2018