NCT02074163 - ASIS for Botox in Chronic Migraine | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

January 31, 2016

Primary Completion Date

June 30, 2016

Study Completion Date

June 30, 2017

Conditions

Chronic Migraine More than15 Days Per Month, and Lasting 4 Hours a Day or Longer.

Interventions

DRUG

Gadolinium

Gadolinium .1cc/ diluted with .9ccNS intramuscularly with ASIS Device for 30 patients. Total cumulative Persistent % of Gadolinium intramuscularly on MRI at 6 hrs, 12 hrs, and 24 hrs.

DRUG

Gadolinium

Relative Prolongation Ability Score or total Persistent % of Gadolinium subdermally over total Persistent % of Gadolinium intramuscularly on MRI.

DRUG

Efficacy of Botox intramuscularly at Week 6

Efficacy of Botox (onabotulinumtoxinA) intramuscularly at Week 6, in terms of Change in frequency of headache days, and Change in hrs of HA on HA days.

DRUG

Efficacy of Botox intramuscularly at Week 12

Efficacy of Botox (onabotulinumtoxinA) intramuscularly at Week 12, in terms of Change in frequency of headache days, and Change in hrs of HA on HA days.

DRUG

Efficacy of Botox intramuscularly at Week 18

Efficacy of Botox (onabotulinumtoxinA) intramuscularly at Week 18, in terms of Change in frequency of headache days, and Change in hrs of HA on HA days.

DRUG

Efficacy of Botox intramuscularly at Week 24,

Efficacy of Botox (onabotulinumtoxinA) intramuscularly at Week 24, in terms of Change in frequency of headache days, and Change in hrs of HA on HA days.

DRUG

Efficacy of Botox intramuscularly at Week 30

Efficacy of Botox (onabotulinumtoxinA) intramuscularly at Week 30, in terms of Change in frequency of headache days, and Change in hrs of HA on HA days.

DRUG

Efficacy of Botox subdermally at Week 6

Efficacy of Botox (onabotulinumtoxinA) subdermally at Week 6, in terms of Change in frequency of headache days, and Change in hrs of HA on HA days.

DRUG

Efficacy of Botox subdermally at Week 12

Efficacy of Botox (onabotulinumtoxinA) subdermally at Week 12, in terms of Change in frequency of headache days, and Change in hrs of HA on HA days.

DRUG

Efficacy of Botox subdermally at Week 18

Efficacy of Botox (onabotulinumtoxinA) subdermally at Week 18, in terms of Change in frequency of headache days, and Change in hrs of HA on HA days.

DRUG

Efficacy of Botox subdermally at Week 24

Efficacy of Botox (onabotulinumtoxinA) subdermally at Week 24, in terms of Change in frequency of headache days, and Change in hrs of HA on HA days.

DRUG

Efficacy of Botox subdermally at Week 30

Efficacy of Botox (onabotulinumtoxinA) subdermally at Week 30, in terms of Change in frequency of headache days, and Change in hrs of HA on HA days.

DRUG

Adverse Reactions of Botox intramuscularly

Adverse Reactions of Botox (onabotulinumtoxinA) intramuscularly at Week 30, in number of Headache Migraine, Facial paresis, Eyelid ptosis, Bronchitis, Neck pain Musculoskeletal stiffness, Muscular weakness Myalgia, Musculoskeletal pain, Muscle spasms, Injection site pain, and Hypertension.

DRUG

Adverse Reactions of Botox subdermally

Adverse Reactions of Botox (onabotulinumtoxinA) subdermally at Week 30, in number of Headache Migraine, Facial paresis, Eyelid ptosis, Bronchitis, Neck pain Musculoskeletal stiffness, Muscular weakness Myalgia, Musculoskeletal pain, Muscle spasms, Injection site pain, and Hypertension.

Trial Locations (1)

92683

Automatic Subdermal Injector System, Inc, Westminster