Trial Outcomes & Findings for Pilot Study of BOTOX for Migraine Headaches (NCT NCT00850421)

Results Overview

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

35 participants

Primary outcome timeframe

190 days

Results posted on

2018-09-26

Participant Flow

Participant milestones

Participant milestones
Measure	Botulinum Toxin Type A
Overall Study STARTED	35
Overall Study COMPLETED	18
Overall Study NOT COMPLETED	17

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pilot Study of BOTOX for Migraine Headaches

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Botulinum Toxin Type A n=35 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	35 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	29 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants

PRIMARY outcome

Timeframe: 190 days

Population: Mid-enrollment statistical review determined study should not continue, due to recently published BOTOX efficacy data and study design deficits. Not possible to summarize as PI left the institution and did not provide location of the data

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 190 days

Population: Mid-enrollment statistical review determined study should not continue, due to recently published BOTOX efficacy data and study design deficits. Not possible to summarize as PI left the institution and did not provide location of the data

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 190 days

Population: Mid-enrollment statistical review determined study should not continue, due to recently published BOTOX efficacy data and study design deficits. Not possible to summarize as PI left the institution and did not provide location of the data

Outcome measures

Outcome data not reported

Adverse Events

Botulinum Toxin Type A

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Botulinum Toxin Type A n=35 participants at risk
Infections and infestations Sore throat	5.7% 2/35
Musculoskeletal and connective tissue disorders Soreness, posterior neck	5.7% 2/35
Renal and urinary disorders Urinary tract infection	5.7% 2/35

Additional Information

Park Nicollet Institute

Phone: 952-993-3123

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place