Trial Outcomes & Findings for Investigation of Efficacy and Safety of Botulinum Toxin A (Botox-Allergan Inc) in Migraine Headaches (NCT NCT00660192)

Results Overview

Number of days of decreased pain (2 grades or more) on Visual Analog scale. VAS ranges from 0-10, with 0 being no pain, and 10 being worst pain.

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

25 participants

Primary outcome timeframe

4 weeks

Results posted on

2016-03-14

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo Subjects randomized to placebo ho receive injections of 2cc's to 3cc's of saline solution. into muscle of the scalp and neck.	Botox Subjects randomized to receive 200-300units of onobotulinumtoxinA by injections into the scalp and neck muscles
Overall Study STARTED	12	13
Overall Study COMPLETED	10	10
Overall Study NOT COMPLETED	2	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Subjects randomized to placebo ho receive injections of 2cc's to 3cc's of saline solution. into muscle of the scalp and neck.	Botox Subjects randomized to receive 200-300units of onobotulinumtoxinA by injections into the scalp and neck muscles
Overall Study Lost to Follow-up	2	3

Baseline Characteristics

Investigation of Efficacy and Safety of Botulinum Toxin A (Botox-Allergan Inc) in Migraine Headaches

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=12 Participants	Botox n=13 Participants	Total n=25 Participants Total of all reporting groups
Age, Continuous	59 years n=5 Participants	61 years n=7 Participants	60 years n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	7 Participants n=7 Participants	13 Participants n=5 Participants
Pain	8.1 units on a scale n=5 Participants	8.3 units on a scale n=7 Participants	8.24 units on a scale n=5 Participants

PRIMARY outcome

Timeframe: 4 weeks

Number of days of decreased pain (2 grades or more) on Visual Analog scale. VAS ranges from 0-10, with 0 being no pain, and 10 being worst pain.

Outcome measures

Outcome measures
Measure	Placebo n=10 Participants Inactive Saline	Botullinum Toxin n=10 Participants Subjects injected with 100-200 units of botox depending on body and neck size
Mean Number of Days of Decrease in Pain Level Using VAS	1.20 days Standard Deviation 5.63	8.67 days Standard Deviation 8.18

SECONDARY outcome

Timeframe: 4 weeks

Number of Patients whose Patient global impression of change (PGIC) moderately or much improved- The PGIC is a 7 point scale that requires the clinician to assess how much the patient's pain has improved or worsened relative to a baseline state at the beginning of the intervention. and rated as: No change (or condition has gotten worse) (1) Almost the same, hardly any change at all (2) A little better, but no noticeable change (3) Somewhat better, but the change has not made any real difference (4) Moderately better, and a slight but noticeable change (5) Better and a definite improvement that has made a real and worthwhile difference (6) A great deal better and a considerable improvement that has made all the difference (7)improved This outcome is number of patients who chose a 6 or above on the PGIC 6 weeks after treatment.

Outcome measures

Outcome measures
Measure	Placebo n=10 Participants Inactive Saline	Botullinum Toxin n=10 Participants Subjects injected with 100-200 units of botox depending on body and neck size
Number of Participants Satisfied With Treatment	9 participants	3 participants

Adverse Events

Saline

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Botox

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Saline n=12 participants at risk	Botox n=13 participants at risk
Skin and subcutaneous tissue disorders Pain at injection site	0.00% 0/12 • 6 weeks	7.7% 1/13 • Number of events 1 • 6 weeks
Infections and infestations Cold symptoms	0.00% 0/12 • 6 weeks	7.7% 1/13 • Number of events 1 • 6 weeks

Additional Information

Baman,Jabbari M.D. Porfessor of Neurology

Yale School of Medicine

Phone: 203-737-2464

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place