Trial Outcomes & Findings for A Retrospective Chart Review to Evaluate Diagnosis and Treatment of Chronic Migraine and Headache (NCT NCT01946126)

Results Overview

The presence or absence of prophylactic medications used by the subject for headache/migraine is evaluated through the study period.

Recruitment status

COMPLETED

Target enrollment

459 participants

Primary outcome timeframe

15 Months

Results posted on

2016-03-15

Participant Flow

Participant milestones

Participant milestones
Measure	Chronic Migraine Diagnosis This is a retrospective chart review for patients diagnosed with Chronic Migraine. There is no intervention in this study.	Other Headache Diagnoses This is a retrospective chart review of patients with headache diagnoses other than Chronic Migraine. There is no intervention in this study.
Overall Study STARTED	184	275
Overall Study COMPLETED	184	275
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Retrospective Chart Review to Evaluate Diagnosis and Treatment of Chronic Migraine and Headache

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Chronic Migraine Diagnosis n=184 Participants This is a retrospective chart review for patients diagnosed with Chronic Migraine. There is no intervention in this study.	Other Headache Diagnoses n=275 Participants This is a retrospective chart review of patients with headache diagnoses other than Chronic Migraine. There is no intervention in this study.	Total n=459 Participants Total of all reporting groups
Age, Continuous	45.02 Years STANDARD_DEVIATION 11.54 • n=5 Participants	45.44 Years STANDARD_DEVIATION 11.62 • n=7 Participants	45.3 Years STANDARD_DEVIATION 11.58 • n=5 Participants
Sex/Gender, Customized	NA Participants n=5 Participants	NA Participants n=7 Participants	NA Participants n=5 Participants

PRIMARY outcome

Timeframe: 15 Months

Population: All enrolled subjects

The presence or absence of prophylactic medications used by the subject for headache/migraine is evaluated through the study period.

Outcome measures

Outcome measures
Measure	Chronic Migraine Diagnosis n=184 Participants This is a retrospective chart review for patients diagnosed with Chronic Migraine. There is no intervention in this study.	Other Headache Diagnoses n=275 Participants This is a retrospective chart review of patients with headache diagnoses other than Chronic Migraine. There is no intervention in this study.
Presence or Absence of Prophylactic Medication for Headache/Migraine Presence of Prophylactic Medication	166 Participants	227 Participants
Presence or Absence of Prophylactic Medication for Headache/Migraine Absence of Prophylactic Medication	18 Participants	48 Participants

SECONDARY outcome

Timeframe: 15 Months

Population: All enrolled subjects

The numbers of unique prophylactic medications used by the subjects for headache/migraine are evaluated through the study period.

Outcome measures

Outcome measures
Measure	Chronic Migraine Diagnosis n=184 Participants This is a retrospective chart review for patients diagnosed with Chronic Migraine. There is no intervention in this study.	Other Headache Diagnoses n=275 Participants This is a retrospective chart review of patients with headache diagnoses other than Chronic Migraine. There is no intervention in this study.
Number of Unique Prophylactic Medications for Headache/Migraine Reported	2.7 Medications Standard Deviation 1.49	1.8 Medications Standard Deviation 1.27

SECONDARY outcome

Timeframe: 15 Months

Population: All enrolled subjects

The number of headache days is reported at the visit with the highest number of headaches.

Outcome measures

Outcome measures
Measure	Chronic Migraine Diagnosis n=184 Participants This is a retrospective chart review for patients diagnosed with Chronic Migraine. There is no intervention in this study.	Other Headache Diagnoses n=275 Participants This is a retrospective chart review of patients with headache diagnoses other than Chronic Migraine. There is no intervention in this study.
Number of Days With a Headache Recorded at the Visit With the Highest Number of Headaches	22.0 Headache Days Interval 20.6 to 23.4	19.2 Headache Days Interval 18.2 to 20.2

SECONDARY outcome

Timeframe: 15 Months

Population: All enrolled subjects with data for this outcome measure

The highest number of headache days per month are reported at a qualifying visit per the medical record.

Outcome measures

Outcome measures
Measure	Chronic Migraine Diagnosis n=133 Participants This is a retrospective chart review for patients diagnosed with Chronic Migraine. There is no intervention in this study.	Other Headache Diagnoses n=183 Participants This is a retrospective chart review of patients with headache diagnoses other than Chronic Migraine. There is no intervention in this study.
Highest Number of Headache Days Per Month at a Qualifying Visit	16.28 Days Interval 14.4 to 18.2	14.01 Days Interval 12.6 to 15.4

SECONDARY outcome

Timeframe: 15 Months

Population: All enrolled subjects

The number of visits for headache diagnosis is evaluated through the study period.

Outcome measures

Outcome measures
Measure	Chronic Migraine Diagnosis n=184 Participants This is a retrospective chart review for patients diagnosed with Chronic Migraine. There is no intervention in this study.	Other Headache Diagnoses n=275 Participants This is a retrospective chart review of patients with headache diagnoses other than Chronic Migraine. There is no intervention in this study.
Number of Visits for Headache Diagnosis	4.7 Visits Standard Deviation 2.5	3.5 Visits Standard Deviation 1.63

Adverse Events

Chronic Migraine Diagnosis

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Other Headache Diagnoses

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Vice President Medical Affairs,

Allergan, Inc

Phone: 714-246-4500

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
Publication restrictions are in place

Restriction type: OTHER