MigraineNCT05177406
Healthcare Costs and Resource Utilization in Aimovig Migraine Patients: a Retrospective Study Using United States Claims Data
An observational study of Migraine, run by Novartis Pharmaceuticals at 1 site in United States.
Trial summary
The proposed study is a retrospective, non-interventional analysis that uses medical and pharmacy claims data in the US from Komodo Health Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Migraine
- What is being tested?
- Aimovig
- How many people
- 1,839 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Aug 2020to 31 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study included the Aimovig migraine patients
Who may be able to join
- General Cohort
- Adult (18 years or older)
- Newly initiating on Aimovig (no other claims during a 180-day wash-in period)
- Had continuous medical and pharmacy benefit eligibility from 180 days pre-index of Aimovig through 180-days post-index
- Primary \& Secondary Objectives Sub-Cohort
- Had 3 consecutive months with a claim for Aimovig (≤15 days gap between days supply and the subsequent claim to be considered consecutive)
Show all 9Show fewer
- Primary \& Secondary Objectives Cost Sensitivity Analyses Sub-Cohorts
- Had continuous medical and pharmacy benefit eligibility from 180 days pre-index of Aimovig through 270-days post-index to permit assessment of cost outcomes (all-cause and migraine-related) during days 91-270 post-index
- Had continuous medical and pharmacy benefit eligibility from 180 days pre-index of Aimovig to the maximum follow-up time post-index with continuous medical and prescription insurance eligibility until the data end date (September 1, 2019)
Who cannot join
- Patients with any claim for another CGRP-targeted medication (Ajovy or Emgality) during entire study period
Trial locations and contacts
1 site in 1 country.
United States1 site
Novartis Investigative Site
East Hanover, New Jersey, 07936-1080
About this study
The proposed study is a retrospective, non-interventional analysis that uses medical and pharmacy claims data in the US from Komodo Health
Read the detailed description
The proposed study is a retrospective, non-interventional analysis that uses medical and pharmacy claims data in the US from Komodo Health.
Study data included adjudicated and paid medical and pharmacy claims in the US between November 1, 2017 and September 1, 2019 provided by Komodo Health.
- Conditions
- Migraine
- Being tested
- Aimovig
- Keywords
- Migraine,, Erenumab,, Aimovig
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AimovigOther
Also called Erenumab
patients newly initiating Aimovig therapy
| Study group | Role | What they receive |
|---|---|---|
| Full cohort | patients newly initiating Aimovig therapy Receives: Other: Aimovig |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in migraine-related medical and prescription costs
Migraine-related costs included: acute and preventive migraine-related prescription costs \& drug administration costs, as well as hospitalizations, emergency room (ER) visits, outpatient visits (including urgent care), provider-office visits, and diagnostic imaging with a primary diagnosis of migraine
Measured: From 180 days pre-index date to 180 days post-index date where index date was defined as first claim for Aimovig between 05/01/18 - 03/01/19
Secondary outcomes (35)
Change in all-cause costs
The outcome was evaluated during the 180-day post-index treatment period compared to the 180-day pre-index treatment period in patients newly initiating Aimovig therapy
Measured: From 180 days pre-index date to 180 days post-index date where index date was defined as first claim for Aimovig between 05/01/18 - 03/01/19
Change in percentage of patients with all-cause hospitalizations or ER visits
The outcome was evaluated during the 180-day post-index treatment period compared to the 180-day pre-index treatment period in patients newly initiating Aimovig therapy
Measured: From 180 days pre-index date to 180 days post-index date where index date was defined as first claim for Aimovig between 05/01/18 - 03/01/19
Change in percentage of patients with migraine-related hospitalizations or ER visits
The outcome was evaluated during the 180-day post-index treatment period compared to the 180-day pre-index treatment period in patients newly initiating Aimovig therapy
Measured: From 180 days pre-index date to 180 days post-index date where index date was defined as first claim for Aimovig between 05/01/18 - 03/01/19
Change in percentage of patients with all-cause outpatient visits
The outcome was evaluated during the 180-day post-index treatment period compared to the 180-day pre-index treatment period in patients newly initiating Aimovig therapy
Measured: From 180 days pre-index date to 180 days post-index date where index date was defined as first claim for Aimovig between 05/01/18 - 03/01/19
Change in percentage of patients with migraine-related outpatient visits
The outcome was evaluated during the 180-day post-index treatment period compared to the 180-day pre-index treatment period in patients newly initiating Aimovig therapy
Measured: From 180 days pre-index date to 180 days post-index date where index date was defined as first claim for Aimovig between 05/01/18 - 03/01/19
Change in percentage of patients with all-cause provider-office visits
The outcome was evaluated during the 180-day post-index treatment period compared to the 180-day pre-index treatment period in patients newly initiating Aimovig therapy
Measured: From 180 days pre-index date to 180 days post-index date where index date was defined as first claim for Aimovig between 05/01/18 - 03/01/19
Change in percentage of patients with migraine-related provider-office visits
The outcome was evaluated during the 180-day post-index treatment period compared to the 180-day pre-index treatment period in patients newly initiating Aimovig therapy
Measured: From 180 days pre-index date to 180 days post-index date where index date was defined as first claim for Aimovig between 05/01/18 - 03/01/19
Change in percentage of patients with all-cause neurologist office visits
The outcome was evaluated during the 180-day post-index treatment period compared to the 180-day pre-index treatment period in patients newly initiating Aimovig therapy
Measured: From 180 days pre-index date to 180 days post-index date where index date was defined as first claim for Aimovig between 05/01/18 - 03/01/19
Change in percentage of patients with migraine-related neurologist visits
The outcome was evaluated during the 180-day post-index treatment period compared to the 180-day pre-index treatment period in patients newly initiating Aimovig therapy
Measured: From 180 days pre-index date to 180 days post-index date where index date was defined as first claim for Aimovig between 05/01/18 - 03/01/19
Change in percentage of patients with all-cause pain specialist office visits
The outcome was evaluated during the 180-day post-index treatment period compared to the 180-day pre-index treatment period in patients newly initiating Aimovig therapy
Measured: From 180 days pre-index date to 180 days post-index date where index date was defined as first claim for Aimovig between 05/01/18 - 03/01/19
Change in percentage of patients with migraine-related pain specialist office visits
The outcome was evaluated during the 180-day post-index treatment period compared to the 180-day pre-index treatment period in patients newly initiating Aimovig therapy
Measured: From 180 days pre-index date to 180 days post-index date where index date was defined as first claim for Aimovig between 05/01/18 - 03/01/19
Change in percentage of patients with all-cause physical therapy visits
The outcome was evaluated during the 180-day post-index treatment period compared to the 180-day pre-index treatment period in patients newly initiating Aimovig therapy
Measured: From 180 days pre-index date to 180 days post-index date where index date was defined as first claim for Aimovig between 05/01/18 - 03/01/19
Change in percentage of patients with migraine-related physical therapy visits
The outcome was evaluated during the 180-day post-index treatment period compared to the 180-day pre-index treatment period in patients newly initiating Aimovig therapy
Measured: From 180 days pre-index date to 180 days post-index date where index date was defined as first claim for Aimovig between 05/01/18 - 03/01/19
Change in percentage of patients with all-cause psychiatrist/psychologist visits
The outcome was evaluated during the 180-day post-index treatment period compared to the 180-day pre-index treatment period in patients newly initiating Aimovig therapy
Measured: From 180 days pre-index date to 180 days post-index date where index date was defined as first claim for Aimovig between 05/01/18 - 03/01/19
Change in percentage of patients with anxiety-related psychiatrist/psychologist visits
The outcome was evaluated during the 180-day post-index treatment period compared to the 180-day pre-index treatment period in patients newly initiating Aimovig therapy
Measured: From 180 days pre-index date to 180 days post-index date where index date was defined as first claim for Aimovig between 05/01/18 - 03/01/19
Change in percentage of patients with depression-related psychiatrist/psychologist visits
The outcome was evaluated during the 180-day post-index treatment period compared to the 180-day pre-index treatment period in patients newly initiating Aimovig therapy
Measured: From 180 days pre-index date to 180 days post-index date where index date was defined as first claim for Aimovig between 05/01/18 - 03/01/19
Change in percentage of patients with any 30-day adjusted prescription for other preventive migraine medications
The outcome was evaluated during the 180-day post-index treatment period compared to the 180-day pre-index treatment period in patients newly initiating Aimovig therapy
Measured: From 180 days pre-index date to 180 days post-index date where index date was defined as first claim for Aimovig between 05/01/18 - 03/01/19
Change in percentage of patients with any prescriptions for acute migraine medications
The outcome was evaluated during the 180-day post-index treatment period compared to the 180-day pre-index treatment period in patients newly initiating Aimovig therapy
Measured: From 180 days pre-index date to 180 days post-index date where index date was defined as first claim for Aimovig between 05/01/18 - 03/01/19
Change in number of all-cause hospitalizations or ER visits
The outcome was evaluated during the 180-day post-index treatment period compared to the 180-day pre-index treatment period in patients newly initiating Aimovig therapy
Measured: From 180 days pre-index date to 180 days post-index date where index date was defined as first claim for Aimovig between 05/01/18 - 03/01/19
Change in number of migraine-related hospitalizations or ER visits
The outcome was evaluated during the 180-day post-index treatment period compared to the 180-day pre-index treatment period in patients newly initiating Aimovig therapy
Measured: From 180 days pre-index date to 180 days post-index date where index date was defined as first claim for Aimovig between 05/01/18 - 03/01/19
Change in number of all-cause outpatient visits
The outcome was evaluated during the 180-day post-index treatment period compared to the 180-day pre-index treatment period in patients newly initiating Aimovig therapy
Measured: From 180 days pre-index date to 180 days post-index date where index date was defined as first claim for Aimovig between 05/01/18 - 03/01/19
Change in number of migraine-related outpatient visits
The outcome was evaluated during the 180-day post-index treatment period compared to the 180-day pre-index treatment period in patients newly initiating Aimovig therapy
Measured: From 180 days pre-index date to 180 days post-index date where index date was defined as first claim for Aimovig between 05/01/18 - 03/01/19
Change in number of all-cause provider-office visits
The outcome was evaluated during the 180-day post-index treatment period compared to the 180-day pre-index treatment period in patients newly initiating Aimovig therapy
Measured: From 180 days pre-index date to 180 days post-index date where index date was defined as first claim for Aimovig between 05/01/18 - 03/01/19
Change in number of migraine-related provider-office visits
The outcome was evaluated during the 180-day post-index treatment period compared to the 180-day pre-index treatment period in patients newly initiating Aimovig therapy
Measured: From 180 days pre-index date to 180 days post-index date where index date was defined as first claim for Aimovig between 05/01/18 - 03/01/19
Change in number of all-cause neurologist office visits
The outcome was evaluated during the 180-day post-index treatment period compared to the 180-day pre-index treatment period in patients newly initiating Aimovig therapy
Measured: From 180 days pre-index date to 180 days post-index date where index date was defined as first claim for Aimovig between 05/01/18 - 03/01/19
Change in number of migraine-related neurologist visits
The outcome was evaluated during the 180-day post-index treatment period compared to the 180-day pre-index treatment period in patients newly initiating Aimovig therapy
Measured: From 180 days pre-index date to 180 days post-index date where index date was defined as first claim for Aimovig between 05/01/18 - 03/01/19
Change in number of all-cause pain specialist office visits
The outcome was evaluated during the 180-day post-index treatment period compared to the 180-day pre-index treatment period in patients newly initiating Aimovig therapy
Measured: From 180 days pre-index date to 180 days post-index date where index date was defined as first claim for Aimovig between 05/01/18 - 03/01/19
Change in number of migraine-related pain specialist office visits
The outcome was evaluated during the 180-day post-index treatment period compared to the 180-day pre-index treatment period in patients newly initiating Aimovig therapy
Measured: From 180 days pre-index date to 180 days post-index date where index date was defined as first claim for Aimovig between 05/01/18 - 03/01/19
Change in number of all-cause physical therapy visits
The outcome was evaluated during the 180-day post-index treatment period compared to the 180-day pre-index treatment period in patients newly initiating Aimovig therapy
Measured: From 180 days pre-index date to 180 days post-index date where index date was defined as first claim for Aimovig between 05/01/18 - 03/01/19
Change in number of migraine-related physical therapy visits
The outcome was evaluated during the 180-day post-index treatment period compared to the 180-day pre-index treatment period in patients newly initiating Aimovig therapy
Measured: From 180 days pre-index date to 180 days post-index date where index date was defined as first claim for Aimovig between 05/01/18 - 03/01/19
Change in number of all-cause psychiatrist/psychologist visits
The outcome was evaluated during the 180-day post-index treatment period compared to the 180-day pre-index treatment period in patients newly initiating Aimovig therapy
Measured: From 180 days pre-index date to 180 days post-index date where index date was defined as first claim for Aimovig between 05/01/18 - 03/01/19
Change in number of anxiety-related psychiatrist/psychologist visits
The outcome was evaluated during the 180-day post-index treatment period compared to the 180-day pre-index treatment period in patients newly initiating Aimovig therapy
Measured: From 180 days pre-index date to 180 days post-index date where index date was defined as first claim for Aimovig between 05/01/18 - 03/01/19
Change in number of depression-related psychiatrist/psychologist visits
The outcome was evaluated during the 180-day post-index treatment period compared to the 180-day pre-index treatment period in patients newly initiating Aimovig therapy
Measured: From 180 days pre-index date to 180 days post-index date where index date was defined as first claim for Aimovig between 05/01/18 - 03/01/19
Change in the number of 30-day adjusted prescriptions for other preventive migraine medications
Other preventive migraine medications included anticonvulsants, antidepressants, Botox, beta blockers, calcium channel blockers, renin-angiotensin system antagonists. The outcome was evaluated during the 180-day post-index treatment period compared to the 180-day pre-index treatment period in patients newly initiating Aimovig therapy
Measured: From 180 days pre-index date to 180 days post-index date where index date was defined as first claim for Aimovig between 05/01/18 - 03/01/19
Change in the number of prescriptions for acute migraine medications
Acute migraine medications included ergots, prescription NSAIDs, opioids, and triptans. The outcome was evaluated during the 180-day post-index treatment period compared to the 180-day pre-index treatment period in patients newly initiating Aimovig therapy
Measured: From 180 days pre-index date to 180 days post-index date where index date was defined as first claim for Aimovig between 05/01/18 - 03/01/19
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2022
- Study start31 Aug 2020
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,839 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05177406
- Sponsor's protocol ID
- CAMG334A2029
- Status last verified
- Dec 2021
- First submitted
- 15 Dec 2021
- Last updated
- 4 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healthcare Costs and Resource Utilization in Aimovig Migraine Patients: a Retrospective Study Using United States Claims Data
- ClinicalTrials.gov ID
- NCT05177406
- Acronym / sponsor ID
- CAMG334A2029
- Conditions
- Migraine
- Keywords
- Migraine,, Erenumab,, Aimovig
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,839 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 31 Aug 2020 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 4 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The proposed study is a retrospective, non-interventional analysis that uses medical and pharmacy claims data in the US from Komodo Health
Detailed description
The proposed study is a retrospective, non-interventional analysis that uses medical and pharmacy claims data in the US from Komodo Health.
Study data included adjudicated and paid medical and pharmacy claims in the US between November 1, 2017 and September 1, 2019 provided by Komodo Health.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Full cohort | – | Other: Aimovigpatients newly initiating Aimovig therapy |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study included the Aimovig migraine patients
Key inclusion criteria (9 listed)
- General Cohort
- Adult (18 years or older)
- Newly initiating on Aimovig (no other claims during a 180-day wash-in period)
- Had continuous medical and pharmacy benefit eligibility from 180 days pre-index of Aimovig through 180-days post-index
- Primary \& Secondary Objectives Sub-Cohort
Key exclusion criteria (1 listed)
- Patients with any claim for another CGRP-targeted medication (Ajovy or Emgality) during entire study period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AimovigAlso: Erenumabpatients newly initiating Aimovig therapy | Other | Full cohort |
Primary outcome
Change in migraine-related medical and prescription costs
Time frame: From 180 days pre-index date to 180 days post-index date where index date was defined as first claim for Aimovig between 05/01/18 - 03/01/19
Migraine-related costs included: acute and preventive migraine-related prescription costs \& drug administration costs, as well as hospitalizations, emergency room (ER) visits, outpatient visits (including urgent care), provider-office visits, and diagnostic imaging with a primary diagnosis of migraine
35 secondary outcomes
Change in all-cause costs
Time frame: From 180 days pre-index date to 180 days post-index date where index date was defined as first claim for Aimovig between 05/01/18 - 03/01/19
Change in percentage of patients with all-cause hospitalizations or ER visits
Time frame: From 180 days pre-index date to 180 days post-index date where index date was defined as first claim for Aimovig between 05/01/18 - 03/01/19
Change in percentage of patients with migraine-related hospitalizations or ER visits
Time frame: From 180 days pre-index date to 180 days post-index date where index date was defined as first claim for Aimovig between 05/01/18 - 03/01/19
Change in percentage of patients with all-cause outpatient visits
Time frame: From 180 days pre-index date to 180 days post-index date where index date was defined as first claim for Aimovig between 05/01/18 - 03/01/19
Change in percentage of patients with migraine-related outpatient visits
Time frame: From 180 days pre-index date to 180 days post-index date where index date was defined as first claim for Aimovig between 05/01/18 - 03/01/19
Change in percentage of patients with all-cause provider-office visits
Time frame: From 180 days pre-index date to 180 days post-index date where index date was defined as first claim for Aimovig between 05/01/18 - 03/01/19
Change in percentage of patients with migraine-related provider-office visits
Time frame: From 180 days pre-index date to 180 days post-index date where index date was defined as first claim for Aimovig between 05/01/18 - 03/01/19
Change in percentage of patients with all-cause neurologist office visits
Time frame: From 180 days pre-index date to 180 days post-index date where index date was defined as first claim for Aimovig between 05/01/18 - 03/01/19
Change in percentage of patients with migraine-related neurologist visits
Time frame: From 180 days pre-index date to 180 days post-index date where index date was defined as first claim for Aimovig between 05/01/18 - 03/01/19
Change in percentage of patients with all-cause pain specialist office visits
Time frame: From 180 days pre-index date to 180 days post-index date where index date was defined as first claim for Aimovig between 05/01/18 - 03/01/19
Change in percentage of patients with migraine-related pain specialist office visits
Time frame: From 180 days pre-index date to 180 days post-index date where index date was defined as first claim for Aimovig between 05/01/18 - 03/01/19
Change in percentage of patients with all-cause physical therapy visits
Time frame: From 180 days pre-index date to 180 days post-index date where index date was defined as first claim for Aimovig between 05/01/18 - 03/01/19
Change in percentage of patients with migraine-related physical therapy visits
Time frame: From 180 days pre-index date to 180 days post-index date where index date was defined as first claim for Aimovig between 05/01/18 - 03/01/19
Change in percentage of patients with all-cause psychiatrist/psychologist visits
Time frame: From 180 days pre-index date to 180 days post-index date where index date was defined as first claim for Aimovig between 05/01/18 - 03/01/19
Change in percentage of patients with anxiety-related psychiatrist/psychologist visits
Time frame: From 180 days pre-index date to 180 days post-index date where index date was defined as first claim for Aimovig between 05/01/18 - 03/01/19
Change in percentage of patients with depression-related psychiatrist/psychologist visits
Time frame: From 180 days pre-index date to 180 days post-index date where index date was defined as first claim for Aimovig between 05/01/18 - 03/01/19
Change in percentage of patients with any 30-day adjusted prescription for other preventive migraine medications
Time frame: From 180 days pre-index date to 180 days post-index date where index date was defined as first claim for Aimovig between 05/01/18 - 03/01/19
Change in percentage of patients with any prescriptions for acute migraine medications
Time frame: From 180 days pre-index date to 180 days post-index date where index date was defined as first claim for Aimovig between 05/01/18 - 03/01/19
Change in number of all-cause hospitalizations or ER visits
Time frame: From 180 days pre-index date to 180 days post-index date where index date was defined as first claim for Aimovig between 05/01/18 - 03/01/19
Change in number of migraine-related hospitalizations or ER visits
Time frame: From 180 days pre-index date to 180 days post-index date where index date was defined as first claim for Aimovig between 05/01/18 - 03/01/19
Change in number of all-cause outpatient visits
Time frame: From 180 days pre-index date to 180 days post-index date where index date was defined as first claim for Aimovig between 05/01/18 - 03/01/19
Change in number of migraine-related outpatient visits
Time frame: From 180 days pre-index date to 180 days post-index date where index date was defined as first claim for Aimovig between 05/01/18 - 03/01/19
Change in number of all-cause provider-office visits
Time frame: From 180 days pre-index date to 180 days post-index date where index date was defined as first claim for Aimovig between 05/01/18 - 03/01/19
Change in number of migraine-related provider-office visits
Time frame: From 180 days pre-index date to 180 days post-index date where index date was defined as first claim for Aimovig between 05/01/18 - 03/01/19
Change in number of all-cause neurologist office visits
Time frame: From 180 days pre-index date to 180 days post-index date where index date was defined as first claim for Aimovig between 05/01/18 - 03/01/19
Change in number of migraine-related neurologist visits
Time frame: From 180 days pre-index date to 180 days post-index date where index date was defined as first claim for Aimovig between 05/01/18 - 03/01/19
Change in number of all-cause pain specialist office visits
Time frame: From 180 days pre-index date to 180 days post-index date where index date was defined as first claim for Aimovig between 05/01/18 - 03/01/19
Change in number of migraine-related pain specialist office visits
Time frame: From 180 days pre-index date to 180 days post-index date where index date was defined as first claim for Aimovig between 05/01/18 - 03/01/19
Change in number of all-cause physical therapy visits
Time frame: From 180 days pre-index date to 180 days post-index date where index date was defined as first claim for Aimovig between 05/01/18 - 03/01/19
Change in number of migraine-related physical therapy visits
Time frame: From 180 days pre-index date to 180 days post-index date where index date was defined as first claim for Aimovig between 05/01/18 - 03/01/19
Change in number of all-cause psychiatrist/psychologist visits
Time frame: From 180 days pre-index date to 180 days post-index date where index date was defined as first claim for Aimovig between 05/01/18 - 03/01/19
Change in number of anxiety-related psychiatrist/psychologist visits
Time frame: From 180 days pre-index date to 180 days post-index date where index date was defined as first claim for Aimovig between 05/01/18 - 03/01/19
Change in number of depression-related psychiatrist/psychologist visits
Time frame: From 180 days pre-index date to 180 days post-index date where index date was defined as first claim for Aimovig between 05/01/18 - 03/01/19
Change in the number of 30-day adjusted prescriptions for other preventive migraine medications
Time frame: From 180 days pre-index date to 180 days post-index date where index date was defined as first claim for Aimovig between 05/01/18 - 03/01/19
Change in the number of prescriptions for acute migraine medications
Time frame: From 180 days pre-index date to 180 days post-index date where index date was defined as first claim for Aimovig between 05/01/18 - 03/01/19
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Migraine, run by Novartis Pharmaceuticals at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in migraine-related medical and prescription costs (time frame: From 180 days pre-index date to 180 days post-index date where index date was defined as first claim for Aimovig between 05/01/18 - 03/01/19). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2022.