Trial Outcomes & Findings for Ictal and Interictal Inflammatory Markers in Migraine (NCT NCT01138150)
NCT ID: NCT01138150
Last Updated: 2016-10-06
Results Overview
Change in total serum adiponectin after treatment in responders and non responders
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
36 participants
Primary outcome timeframe
30 minutes after treatment, 60 minutes after treatment, 120 minutes after treatment
Results posted on
2016-10-06
Participant Flow
Dates of recruitment - December 9 2010 through January 22, 2013. Types of location - Neurology Headache Clinic, Internal Medicine Clinics, Gynecology clinic; study flyers placed in the medical offices , Johns Hopkins Community Physicians sites, academic institutions and wellness centers.
Participant milestones
| Measure |
Active Drug - Sumatriptan/Naproxen
Participants randomized to sumatriptan/naproxen upon presentation of migraine acute attack
|
Placebo
Participants randomized to placebo upon presentation with acute migraine attack.
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
18
|
|
Overall Study
COMPLETED
|
17
|
17
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Active Drug - Sumatriptan/Naproxen
Participants randomized to sumatriptan/naproxen upon presentation of migraine acute attack
|
Placebo
Participants randomized to placebo upon presentation with acute migraine attack.
|
|---|---|---|
|
Overall Study
blood unable to be processed
|
0
|
1
|
|
Overall Study
Physician Decision
|
1
|
0
|
Baseline Characteristics
Ictal and Interictal Inflammatory Markers in Migraine
Baseline characteristics by cohort
| Measure |
Treximet
n=17 Participants
Participants randomized to active drug Treximet during acute migraine attack.
|
Sugar Pill
n=17 Participants
Participants randomized to placebo (sugar pill) during acute migraine attack.
|
Total
n=34 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
17 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 30 minutes after treatment, 60 minutes after treatment, 120 minutes after treatmentChange in total serum adiponectin after treatment in responders and non responders
Outcome measures
| Measure |
Treatment Responders 30 Minutes After Treatment
n=17 Participants
Treatment responders are defined as those with a reduction of pain from moderate to severe at T0 (before treatment) to none to mild 30 minutes after treatment with Treximet or sugar pill.
|
Treatment Non-Responders 30 Minutes After Treatment
n=17 Participants
Treatment non-responders are defined as those without a reduction of pain from moderate to severe at T0 (before treatment) to none to mild 30 minutes after after treatment with Treximet or sugar pill.
|
Treatment Responders 60 Minutes After Treatment
n=17 Participants
Treatment responders are defined as those with a reduction of pain from moderate to severe at T0 (before treatment) to none to mild 60 minutes after treatment with Treximet or sugar pill.
|
Treatment Non-Responders 60 Minutes After Treatment
n=17 Participants
Treatment non-responders are defined as those without a reduction of pain from moderate to severe at T0 (before treatment) to none to mild 60 minutes after treatment with Treximet or sugar pill.
|
Treatment Responders 120 Minutes After Treatment
n=17 Participants
Treatment responders are defined as those with a reduction of pain from moderate to severe at T0 (before treatment) to none to mild 120 minutes after treatment with Treximet or sugar pill.
|
Treatment Non-Responders
n=17 Participants
Treatment non-responders are defined as those without a reduction of pain from moderate to severe at T0 (before treatment) to none to mild 120 minutes after treatment with Treximet or sugar pill.
|
|---|---|---|---|---|---|---|
|
Change in the Total Serum Adiponectin (T-ADP)
|
-0.96 ug/mL
Interval -1.84 to -0.08
|
0.25 ug/mL
Interval -1.85 to 2.37
|
-0.97 ug/mL
Interval -1.85 to -0.08
|
0.29 ug/mL
Interval -1.88 to 2.46
|
-0.98 ug/mL
Interval -1.88 to -0.08
|
0.24 ug/mL
Interval -1.95 to 2.44
|
SECONDARY outcome
Timeframe: 30 minutes after treatment, 60 minutes after treatment, 120 minutes after treatmentserum HMW-ADP levels after treatment in responders and non responders
Outcome measures
| Measure |
Treatment Responders 30 Minutes After Treatment
n=17 Participants
Treatment responders are defined as those with a reduction of pain from moderate to severe at T0 (before treatment) to none to mild 30 minutes after treatment with Treximet or sugar pill.
|
Treatment Non-Responders 30 Minutes After Treatment
n=17 Participants
Treatment non-responders are defined as those without a reduction of pain from moderate to severe at T0 (before treatment) to none to mild 30 minutes after after treatment with Treximet or sugar pill.
|
Treatment Responders 60 Minutes After Treatment
n=17 Participants
Treatment responders are defined as those with a reduction of pain from moderate to severe at T0 (before treatment) to none to mild 60 minutes after treatment with Treximet or sugar pill.
|
Treatment Non-Responders 60 Minutes After Treatment
n=17 Participants
Treatment non-responders are defined as those without a reduction of pain from moderate to severe at T0 (before treatment) to none to mild 60 minutes after treatment with Treximet or sugar pill.
|
Treatment Responders 120 Minutes After Treatment
n=17 Participants
Treatment responders are defined as those with a reduction of pain from moderate to severe at T0 (before treatment) to none to mild 120 minutes after treatment with Treximet or sugar pill.
|
Treatment Non-Responders
n=17 Participants
Treatment non-responders are defined as those without a reduction of pain from moderate to severe at T0 (before treatment) to none to mild 120 minutes after treatment with Treximet or sugar pill.
|
|---|---|---|---|---|---|---|
|
High Molecular Weight (HMW)-Adiponectin (ADP)
|
-0.24 ug/mL
Interval -0.47 to -0.01
|
-0.08 ug/mL
Interval -0.76 to 0.61
|
-0.23 ug/mL
Interval -0.46 to -0.01
|
-0.14 ug/mL
Interval -0.79 to 0.52
|
-0.24 ug/mL
Interval -0.91 to 0.44
|
-0.21 ug/mL
Interval -0.44 to 0.01
|
SECONDARY outcome
Timeframe: 30 minutes after treatment, 60 minutes after treatment, 120 minutes after treatmentserum MMW-ADP levels after treatment in responders and non responders
Outcome measures
| Measure |
Treatment Responders 30 Minutes After Treatment
n=17 Participants
Treatment responders are defined as those with a reduction of pain from moderate to severe at T0 (before treatment) to none to mild 30 minutes after treatment with Treximet or sugar pill.
|
Treatment Non-Responders 30 Minutes After Treatment
n=17 Participants
Treatment non-responders are defined as those without a reduction of pain from moderate to severe at T0 (before treatment) to none to mild 30 minutes after after treatment with Treximet or sugar pill.
|
Treatment Responders 60 Minutes After Treatment
n=17 Participants
Treatment responders are defined as those with a reduction of pain from moderate to severe at T0 (before treatment) to none to mild 60 minutes after treatment with Treximet or sugar pill.
|
Treatment Non-Responders 60 Minutes After Treatment
n=17 Participants
Treatment non-responders are defined as those without a reduction of pain from moderate to severe at T0 (before treatment) to none to mild 60 minutes after treatment with Treximet or sugar pill.
|
Treatment Responders 120 Minutes After Treatment
n=17 Participants
Treatment responders are defined as those with a reduction of pain from moderate to severe at T0 (before treatment) to none to mild 120 minutes after treatment with Treximet or sugar pill.
|
Treatment Non-Responders
n=17 Participants
Treatment non-responders are defined as those without a reduction of pain from moderate to severe at T0 (before treatment) to none to mild 120 minutes after treatment with Treximet or sugar pill.
|
|---|---|---|---|---|---|---|
|
Middle Molecular Weight (MMW)-ADP
|
-0.02 ug/mL
Interval -0.25 to 0.22
|
0.02 ug/mL
Interval -0.19 to 0.24
|
-0.03 ug/mL
Interval -0.26 to 0.21
|
-0.02 ug/mL
Interval -0.23 to 0.19
|
0.16 ug/mL
Interval -0.05 to 0.38
|
-0.03 ug/mL
Interval -0.26 to 0.21
|
SECONDARY outcome
Timeframe: 30 minutes after treatment, 60 minutes after treatment, 120 minutes after treatmentserum LMW-ADP levels after treatment in responders and non responders
Outcome measures
| Measure |
Treatment Responders 30 Minutes After Treatment
n=17 Participants
Treatment responders are defined as those with a reduction of pain from moderate to severe at T0 (before treatment) to none to mild 30 minutes after treatment with Treximet or sugar pill.
|
Treatment Non-Responders 30 Minutes After Treatment
n=17 Participants
Treatment non-responders are defined as those without a reduction of pain from moderate to severe at T0 (before treatment) to none to mild 30 minutes after after treatment with Treximet or sugar pill.
|
Treatment Responders 60 Minutes After Treatment
n=17 Participants
Treatment responders are defined as those with a reduction of pain from moderate to severe at T0 (before treatment) to none to mild 60 minutes after treatment with Treximet or sugar pill.
|
Treatment Non-Responders 60 Minutes After Treatment
n=17 Participants
Treatment non-responders are defined as those without a reduction of pain from moderate to severe at T0 (before treatment) to none to mild 60 minutes after treatment with Treximet or sugar pill.
|
Treatment Responders 120 Minutes After Treatment
n=17 Participants
Treatment responders are defined as those with a reduction of pain from moderate to severe at T0 (before treatment) to none to mild 120 minutes after treatment with Treximet or sugar pill.
|
Treatment Non-Responders
n=17 Participants
Treatment non-responders are defined as those without a reduction of pain from moderate to severe at T0 (before treatment) to none to mild 120 minutes after treatment with Treximet or sugar pill.
|
|---|---|---|---|---|---|---|
|
Low Molecular Weight (LMW)-ADP
|
0.32 ug/mL
Interval 0.03 to 0.6
|
-0.43 ug/mL
Interval -0.75 to -0.11
|
0.15 ug/mL
Interval -0.13 to 0.42
|
-0.25 ug/mL
Interval -0.57 to 0.06
|
-0.45 ug/mL
Interval -0.77 to -0.14
|
0.11 ug/mL
Interval -0.17 to 0.39
|
SECONDARY outcome
Timeframe: 30 minutes, 60 minutes, 120 minutes after treatmentserum HMW:T-ADP levels after treatment in responders and non responders
Outcome measures
| Measure |
Treatment Responders 30 Minutes After Treatment
n=17 Participants
Treatment responders are defined as those with a reduction of pain from moderate to severe at T0 (before treatment) to none to mild 30 minutes after treatment with Treximet or sugar pill.
|
Treatment Non-Responders 30 Minutes After Treatment
n=17 Participants
Treatment non-responders are defined as those without a reduction of pain from moderate to severe at T0 (before treatment) to none to mild 30 minutes after after treatment with Treximet or sugar pill.
|
Treatment Responders 60 Minutes After Treatment
n=17 Participants
Treatment responders are defined as those with a reduction of pain from moderate to severe at T0 (before treatment) to none to mild 60 minutes after treatment with Treximet or sugar pill.
|
Treatment Non-Responders 60 Minutes After Treatment
n=17 Participants
Treatment non-responders are defined as those without a reduction of pain from moderate to severe at T0 (before treatment) to none to mild 60 minutes after treatment with Treximet or sugar pill.
|
Treatment Responders 120 Minutes After Treatment
n=17 Participants
Treatment responders are defined as those with a reduction of pain from moderate to severe at T0 (before treatment) to none to mild 120 minutes after treatment with Treximet or sugar pill.
|
Treatment Non-Responders
n=17 Participants
Treatment non-responders are defined as those without a reduction of pain from moderate to severe at T0 (before treatment) to none to mild 120 minutes after treatment with Treximet or sugar pill.
|
|---|---|---|---|---|---|---|
|
High Molecular Weight (HMW): T-ADP
|
-0.04 ratio
Interval -0.07 to -0.01
|
0.01 ratio
Interval -0.03 to 0.06
|
-0.02 ratio
Interval -0.06 to 0.01
|
0.01 ratio
Interval -0.04 to 0.05
|
0.01 ratio
Interval -0.05 to 0.05
|
-0.02 ratio
Interval -0.05 to 0.02
|
SECONDARY outcome
Timeframe: 30 minutes after treatment, 60 minutes after treatment, 120 minutes after treatmentserum LMW:T-ADP levels after treatment in responders and non responders
Outcome measures
| Measure |
Treatment Responders 30 Minutes After Treatment
n=17 Participants
Treatment responders are defined as those with a reduction of pain from moderate to severe at T0 (before treatment) to none to mild 30 minutes after treatment with Treximet or sugar pill.
|
Treatment Non-Responders 30 Minutes After Treatment
n=17 Participants
Treatment non-responders are defined as those without a reduction of pain from moderate to severe at T0 (before treatment) to none to mild 30 minutes after after treatment with Treximet or sugar pill.
|
Treatment Responders 60 Minutes After Treatment
n=17 Participants
Treatment responders are defined as those with a reduction of pain from moderate to severe at T0 (before treatment) to none to mild 60 minutes after treatment with Treximet or sugar pill.
|
Treatment Non-Responders 60 Minutes After Treatment
n=17 Participants
Treatment non-responders are defined as those without a reduction of pain from moderate to severe at T0 (before treatment) to none to mild 60 minutes after treatment with Treximet or sugar pill.
|
Treatment Responders 120 Minutes After Treatment
n=17 Participants
Treatment responders are defined as those with a reduction of pain from moderate to severe at T0 (before treatment) to none to mild 120 minutes after treatment with Treximet or sugar pill.
|
Treatment Non-Responders
n=17 Participants
Treatment non-responders are defined as those without a reduction of pain from moderate to severe at T0 (before treatment) to none to mild 120 minutes after treatment with Treximet or sugar pill.
|
|---|---|---|---|---|---|---|
|
Low Molecular Weight (LMW):Total (T)-ADP
|
0.04 ratio
Interval 0.01 to 0.07
|
-0.04 ratio
Interval -0.07 to -0.01
|
-0.01 ratio
Interval -0.05 to 0.02
|
0.02 ratio
Interval -0.02 to 0.05
|
-0.04 ratio
Interval -0.07 to -0.01
|
0.01 ratio
Interval -0.02 to 0.05
|
SECONDARY outcome
Timeframe: 30 minutes after treatment, 60 minutes after treatment, 120 minutes after treatmentserum leptin levels after treatment in responders and non responders
Outcome measures
| Measure |
Treatment Responders 30 Minutes After Treatment
n=17 Participants
Treatment responders are defined as those with a reduction of pain from moderate to severe at T0 (before treatment) to none to mild 30 minutes after treatment with Treximet or sugar pill.
|
Treatment Non-Responders 30 Minutes After Treatment
n=17 Participants
Treatment non-responders are defined as those without a reduction of pain from moderate to severe at T0 (before treatment) to none to mild 30 minutes after after treatment with Treximet or sugar pill.
|
Treatment Responders 60 Minutes After Treatment
n=17 Participants
Treatment responders are defined as those with a reduction of pain from moderate to severe at T0 (before treatment) to none to mild 60 minutes after treatment with Treximet or sugar pill.
|
Treatment Non-Responders 60 Minutes After Treatment
n=17 Participants
Treatment non-responders are defined as those without a reduction of pain from moderate to severe at T0 (before treatment) to none to mild 60 minutes after treatment with Treximet or sugar pill.
|
Treatment Responders 120 Minutes After Treatment
n=17 Participants
Treatment responders are defined as those with a reduction of pain from moderate to severe at T0 (before treatment) to none to mild 120 minutes after treatment with Treximet or sugar pill.
|
Treatment Non-Responders
n=17 Participants
Treatment non-responders are defined as those without a reduction of pain from moderate to severe at T0 (before treatment) to none to mild 120 minutes after treatment with Treximet or sugar pill.
|
|---|---|---|---|---|---|---|
|
Leptin
|
0.71 ug/mL
Interval -1.55 to 2.97
|
0.89 ug/mL
Interval -0.93 to 2.71
|
0.28 ug/mL
Interval -1.93 to 2.5
|
0.84 ug/mL
Interval -0.91 to 2.59
|
1.00 ug/mL
Interval -0.8 to 2.8
|
0.02 ug/mL
Interval -2.21 to 2.24
|
SECONDARY outcome
Timeframe: 30 minutes after treatment, 60 minutes after treatment, 120 minutes after treatmentserum resistin levels after treatment in responders and non responders
Outcome measures
| Measure |
Treatment Responders 30 Minutes After Treatment
n=17 Participants
Treatment responders are defined as those with a reduction of pain from moderate to severe at T0 (before treatment) to none to mild 30 minutes after treatment with Treximet or sugar pill.
|
Treatment Non-Responders 30 Minutes After Treatment
n=17 Participants
Treatment non-responders are defined as those without a reduction of pain from moderate to severe at T0 (before treatment) to none to mild 30 minutes after after treatment with Treximet or sugar pill.
|
Treatment Responders 60 Minutes After Treatment
n=17 Participants
Treatment responders are defined as those with a reduction of pain from moderate to severe at T0 (before treatment) to none to mild 60 minutes after treatment with Treximet or sugar pill.
|
Treatment Non-Responders 60 Minutes After Treatment
n=17 Participants
Treatment non-responders are defined as those without a reduction of pain from moderate to severe at T0 (before treatment) to none to mild 60 minutes after treatment with Treximet or sugar pill.
|
Treatment Responders 120 Minutes After Treatment
n=17 Participants
Treatment responders are defined as those with a reduction of pain from moderate to severe at T0 (before treatment) to none to mild 120 minutes after treatment with Treximet or sugar pill.
|
Treatment Non-Responders
n=17 Participants
Treatment non-responders are defined as those without a reduction of pain from moderate to severe at T0 (before treatment) to none to mild 120 minutes after treatment with Treximet or sugar pill.
|
|---|---|---|---|---|---|---|
|
Resistin
|
-0.95 ug/mL
Interval -1.83 to -0.07
|
-0.97 ug/mL
Interval -3.95 to 2.0
|
-1 ug/mL
Interval -1.86 to -0.14
|
-0.88 ug/mL
Interval -3.75 to 1.98
|
-1.36 ug/mL
Interval -4.3 to 1.59
|
-0.79 ug/mL
Interval -1.65 to 0.08
|
Adverse Events
Treximet
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sugar Pill
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Lee Peterlin
The Johns Hopkins University School of Medicine
Phone: 410-550-5452
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place