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

NCT01946126 | Completed Results

• 1 other identifier: GMA-BTX-CM-13-592
• Study Type: observational
• Target: 459
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a retrospective chart review in patients diagnosed with headache or migraine to evaluate treatment patterns and diagnosis.

Conditions

Migraine Disorders; Headache

Outcome Measures

Primary Outcomes (1)

• Presence or Absence of Prophylactic Medication for Headache/Migraine

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

  15 Months

Secondary Outcomes (4)

• Number of Unique Prophylactic Medications for Headache/Migraine Reported

  15 Months

• Number of Days With a Headache Recorded at the Visit With the Highest Number of Headaches

  15 Months

• Highest Number of Headache Days Per Month at a Qualifying Visit

  15 Months

• Number of Visits for Headache Diagnosis

  15 Months

Study Arms (2)

Chronic Migraine Diagnosis

This is a retrospective chart review for patients diagnosed with Chronic Migraine. There is no intervention in this study.

Other: No Intervention

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.

Other: No Intervention

Interventions

No Intervention OTHER

There is no intervention in this study.

Chronic Migraine Diagnosis; Other Headache Diagnoses

Eligibility Criteria

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

Study Population

Patients with a diagnosis of chronic migraine or other diagnosis of migraine or headache.

You may qualify if:

• Diagnosis of chronic migraine or other diagnosis of migraine or headache for a minimum of 15 months
• Eight (8) headache days per month for at least 1 of the preceding 15 months

You may not qualify if:

• Not currently diagnosed with chronic migraine, headache or migraine
• History of receiving botulinum toxin injections for the treatment of chronic migraine.

Sponsors & Collaborators

• Allergan: lead

Study Sites (1)

Unknown Facility

Raleigh, North Carolina, United States

Location

MeSH Terms

Conditions

Migraine Disorders; Headache

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Vice President Medical Affairs,
• Organization: Allergan, Inc

clinicaltrials@allergan.com

714-246-4500

Study Officials

• Medical Director

  Allergan

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2013
• First Posted: September 19, 2013
• Study Start: March 1, 2014
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: March 15, 2016
• Results First Posted: March 15, 2016

Record last verified: 2016-02

Locations

US (1)