Trial Outcomes & Findings for A Retrospective Study to Evaluate the Effectiveness and Benefit of onabotulinumtoxinA in Patients With Chronic Migraines (NCT NCT01749410)

Results Overview

The mean number of headache days was counted as the number of headache days occurring during the 30 day period ending with treatment cycle 7. Each treatment cycle was administered approximately every 12 weeks.

Recruitment status

COMPLETED

Target enrollment

33 participants

Primary outcome timeframe

Treatment Cycle 7 (approximately 1.5 years)

Results posted on

2015-09-10

Participant Flow

Participant milestones

Participant milestones
Measure	All Participants Previous treatment with onabotulinumtoxinA for Chronic Migraine based on retrospective medical record review.
Overall Study STARTED	33
Overall Study COMPLETED	33
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Retrospective Study to Evaluate the Effectiveness and Benefit of onabotulinumtoxinA in Patients With Chronic Migraines

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Participants n=33 Participants Previous treatment with onabotulinumtoxinA for Chronic Migraine based on retrospective medical record review.
Age, Continuous	43.97 Years STANDARD_DEVIATION 11.07 • n=5 Participants
Sex: Female, Male Female	29 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants

PRIMARY outcome

Timeframe: Treatment Cycle 7 (approximately 1.5 years)

Population: All subjects who satisfied the inclusion and exclusion criteria

The mean number of headache days was counted as the number of headache days occurring during the 30 day period ending with treatment cycle 7. Each treatment cycle was administered approximately every 12 weeks.

Outcome measures

Outcome measures
Measure	All Participants n=33 Participants Previous treatment with onabotulinumtoxinA for Chronic Migraine based on retrospective medical record review.
Change From Baseline in the Number of Headache Days Baseline	19.08 Days Standard Deviation 5.76
Change From Baseline in the Number of Headache Days Change from Baseline at Cycle 7 (approx 1.5 years)	6.25 Days Standard Deviation 6.76

Adverse Events

All Participants

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	All Participants n=33 participants at risk Previous treatment with onabotulinumtoxinA for Chronic Migraine based on retrospective medical record review.
Eye disorders Eyelid Ptosis	6.1% 2/33
Musculoskeletal and connective tissue disorders Muscular Weakness	6.1% 2/33

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