Phase 4
Completed N=36
Ictal and Interictal Inflammatory Markers in Migraine
Source: ClinicalTrials.gov NCT01138150 ↗Enrolled (actual)
36
Serious AEs
0.0%
Results posted
Oct 2016
Primary outcomePrimary: Change in the Total Serum Adiponectin (T-ADP) — -0.96; 0.25; -0.97; 0.29 ug/mL
Summary
The purpose of this study is to evaluate blood levels of several proteins that may be altered in the inflammation associated with migraine headaches. These blood levels will be evaluated in individuals during an acute migraine attack and compared to their levels when pain free. The investigators study hypothesis is that the pro inflammatory proteins in the blood will be greater than the levels of these proteins when evaluated during a pain free period.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in the Total Serum Adiponectin (T-ADP) |
-0.96; 0.25; -0.97; 0.29; -0.98; 0.24 | — |
| SECONDARY High Molecular Weight (HMW)-Adiponectin (ADP) |
-0.24; -0.08; -0.23; -0.14; -0.24; -0.21 | — |
| SECONDARY Middle Molecular Weight (MMW)-ADP |
-0.02; 0.02; -0.03; -0.02; 0.16; -0.03 | — |
| SECONDARY Low Molecular Weight (LMW)-ADP |
0.32; -0.43; 0.15; -0.25; -0.45; 0.11 | — |
| SECONDARY High Molecular Weight (HMW): T-ADP |
-0.04; 0.01; -0.02; 0.01; 0.01; -0.02 | — |
| SECONDARY Low Molecular Weight (LMW):Total (T)-ADP |
0.04; -0.04; -0.01; 0.02; -0.04; 0.01 | — |
| SECONDARY Leptin |
0.71; 0.89; 0.28; 0.84; 1.00; 0.02 | — |
| SECONDARY Resistin |
-0.95; -0.97; -1; -0.88; -1.36; -0.79 | — |
Eligibility Criteria
Inclusion Criteria
- Age greater than 18 years of age, migraine
Exclusion Criteria
- Pregnant or breast-feeding women, presence of cardiovascular or cerebrovascular disorders as well as any known inflammatory, infectious, metabolic, thyroid, renal, cardiovascular or gastrointestinal diseases
Data sourced from ClinicalTrials.gov (NCT01138150). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.