Trial Outcomes & Findings for Study of the Molecular Genetics of Menstrual Migraine (NCT NCT00904150)
NCT ID: NCT00904150
Last Updated: 2014-02-24
Results Overview
PR PROGINS
Recruitment status
COMPLETED
Target enrollment
585 participants
Primary outcome timeframe
6 years
Results posted on
2014-02-24
Participant Flow
Participant milestones
| Measure |
1 Menstrual Migraine
Caucasian women with a current or past history of menstrual migraine (MM = pure menstrual migraine or menstrually-related migraine) attending the City of London Migraine Clinic
|
2 No Migraine
Caucasian women with no personal history of migraine
|
|---|---|---|
|
Saliva Samples (DNA)
STARTED
|
285
|
300
|
|
Saliva Samples (DNA)
COMPLETED
|
282
|
155
|
|
Saliva Samples (DNA)
NOT COMPLETED
|
3
|
145
|
|
Blood Samples (RNA): Follicular Phase
STARTED
|
37
|
32
|
|
Blood Samples (RNA): Follicular Phase
COMPLETED
|
37
|
32
|
|
Blood Samples (RNA): Follicular Phase
NOT COMPLETED
|
0
|
0
|
|
Blood Samples (RNA): Luteal Phase
STARTED
|
34
|
30
|
|
Blood Samples (RNA): Luteal Phase
COMPLETED
|
34
|
30
|
|
Blood Samples (RNA): Luteal Phase
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
1 Menstrual Migraine
Caucasian women with a current or past history of menstrual migraine (MM = pure menstrual migraine or menstrually-related migraine) attending the City of London Migraine Clinic
|
2 No Migraine
Caucasian women with no personal history of migraine
|
|---|---|---|
|
Saliva Samples (DNA)
saliva samples not suitable for assay
|
3
|
0
|
|
Saliva Samples (DNA)
Australian samples of different genotype
|
0
|
145
|
Baseline Characteristics
Study of the Molecular Genetics of Menstrual Migraine
Baseline characteristics by cohort
| Measure |
1 Menstrual Migraine
n=285 Participants
Caucasian women with a current or past history of menstrual migraine (MM = pure menstrual migraine or menstrually-related migraine) attending the City of London Migraine Clinic
|
2 No Migraine
n=300 Participants
Caucasian women with no personal history of migraine
|
Total
n=585 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
285 Participants
n=99 Participants
|
300 Participants
n=107 Participants
|
585 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
285 Participants
n=99 Participants
|
300 Participants
n=107 Participants
|
585 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United Kingdom
|
285 participants
n=99 Participants
|
155 participants
n=107 Participants
|
440 participants
n=206 Participants
|
|
Region of Enrollment
Australia
|
0 participants
n=99 Participants
|
145 participants
n=107 Participants
|
145 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 6 yearsPopulation: Not all samples were suitable for analysis for each outcome measure
PR PROGINS
Outcome measures
| Measure |
1 Menstrual Migraine
n=280 Participants
Caucasian women with a current or past history of menstrual migraine (MM = pure menstrual migraine or menstrually-related migraine) attending the City of London Migraine Clinic
|
2 No Migraine
n=153 Participants
Caucasian women with no personal history of migraine
|
|---|---|---|
|
Progesterone Receptor Gene Polymorphism PROGINS in Women With Menstrual Migraine and Women Without Migraine
No PROGINS insert
|
208 participants
|
112 participants
|
|
Progesterone Receptor Gene Polymorphism PROGINS in Women With Menstrual Migraine and Women Without Migraine
Heterozygote
|
64 participants
|
39 participants
|
|
Progesterone Receptor Gene Polymorphism PROGINS in Women With Menstrual Migraine and Women Without Migraine
Homozygote
|
8 participants
|
2 participants
|
PRIMARY outcome
Timeframe: 6 yearsPopulation: Not all samples were suitable for analysis for each outcome measure
ESR1 G594A
Outcome measures
| Measure |
1 Menstrual Migraine
n=280 Participants
Caucasian women with a current or past history of menstrual migraine (MM = pure menstrual migraine or menstrually-related migraine) attending the City of London Migraine Clinic
|
2 No Migraine
n=150 Participants
Caucasian women with no personal history of migraine
|
|---|---|---|
|
Estrogen Receptor 1 G594a Polymorphism in Women With Menstrual Migraine and Women Without Migraine
Genotype GG
|
196 participants
|
101 participants
|
|
Estrogen Receptor 1 G594a Polymorphism in Women With Menstrual Migraine and Women Without Migraine
Genotype GA
|
76 participants
|
43 participants
|
|
Estrogen Receptor 1 G594a Polymorphism in Women With Menstrual Migraine and Women Without Migraine
Genotype AA
|
8 participants
|
6 participants
|
PRIMARY outcome
Timeframe: 6 yearsPopulation: Not all samples were suitable for analysis for each outcome measure
ESR1 C325G
Outcome measures
| Measure |
1 Menstrual Migraine
n=280 Participants
Caucasian women with a current or past history of menstrual migraine (MM = pure menstrual migraine or menstrually-related migraine) attending the City of London Migraine Clinic
|
2 No Migraine
n=154 Participants
Caucasian women with no personal history of migraine
|
|---|---|---|
|
Estrogen Receptor 1 C325G Polymorphism in Women With Menstrual Migraine and Women Without Migraine
Genotype GG
|
16 participants
|
7 participants
|
|
Estrogen Receptor 1 C325G Polymorphism in Women With Menstrual Migraine and Women Without Migraine
Genotype CC
|
155 participants
|
96 participants
|
|
Estrogen Receptor 1 C325G Polymorphism in Women With Menstrual Migraine and Women Without Migraine
Genotype CG
|
109 participants
|
51 participants
|
PRIMARY outcome
Timeframe: 6 yearsPopulation: Matched pairs of follicular and luteal samples Not all samples were suitable for analysis for each outcome measure
PgR and ESR
Outcome measures
| Measure |
1 Menstrual Migraine
n=30 Participants
Caucasian women with a current or past history of menstrual migraine (MM = pure menstrual migraine or menstrually-related migraine) attending the City of London Migraine Clinic
|
2 No Migraine
n=29 Participants
Caucasian women with no personal history of migraine
|
|---|---|---|
|
Menstrual Cycle Expression of PGR and ESR in Women With Menstrual Migraine and Women Without Migraine
ESR expression in follicular phase
|
15.98 number of genes expressed
Standard Deviation NA
Data not reported
|
16.73 number of genes expressed
Standard Deviation NA
Data not reported
|
|
Menstrual Cycle Expression of PGR and ESR in Women With Menstrual Migraine and Women Without Migraine
PGR expression in luteal phase
|
8.95 number of genes expressed
Standard Deviation NA
Data not reported
|
8.69 number of genes expressed
Standard Deviation NA
Data not reported
|
|
Menstrual Cycle Expression of PGR and ESR in Women With Menstrual Migraine and Women Without Migraine
ESR expression in luteal phase
|
16.58 number of genes expressed
Standard Deviation NA
Data not reported
|
15.62 number of genes expressed
Standard Deviation NA
Data not reported
|
|
Menstrual Cycle Expression of PGR and ESR in Women With Menstrual Migraine and Women Without Migraine
PGR expression in follicular phase
|
9.62 number of genes expressed
Standard Deviation NA
Data not reported
|
9.80 number of genes expressed
Standard Deviation NA
Data not reported
|
SECONDARY outcome
Timeframe: 6 yearsPopulation: Not all samples were suitable for analysis for each outcome measure
TNF
Outcome measures
| Measure |
1 Menstrual Migraine
n=190 Participants
Caucasian women with a current or past history of menstrual migraine (MM = pure menstrual migraine or menstrually-related migraine) attending the City of London Migraine Clinic
|
2 No Migraine
n=54 Participants
Caucasian women with no personal history of migraine
|
|---|---|---|
|
Tumour Necrosis Factor Genotype in Women With Menstrual Migraine and Women Without Migraine
Genotype GG
|
1 participants
|
2 participants
|
|
Tumour Necrosis Factor Genotype in Women With Menstrual Migraine and Women Without Migraine
Genotype GA
|
40 participants
|
20 participants
|
|
Tumour Necrosis Factor Genotype in Women With Menstrual Migraine and Women Without Migraine
Genotype AA
|
149 participants
|
32 participants
|
SECONDARY outcome
Timeframe: 6 yearsPopulation: Not all samples were suitable for analysis for each outcome measure
SYNE1
Outcome measures
| Measure |
1 Menstrual Migraine
n=215 Participants
Caucasian women with a current or past history of menstrual migraine (MM = pure menstrual migraine or menstrually-related migraine) attending the City of London Migraine Clinic
|
2 No Migraine
n=119 Participants
Caucasian women with no personal history of migraine
|
|---|---|---|
|
SYNE1 Genotype in Women With Menstrual Migraine and Women Without Migraine
Genotype GG
|
89 participants
|
40 participants
|
|
SYNE1 Genotype in Women With Menstrual Migraine and Women Without Migraine
Genotype TT
|
24 participants
|
25 participants
|
|
SYNE1 Genotype in Women With Menstrual Migraine and Women Without Migraine
Genotype TG
|
102 participants
|
54 participants
|
SECONDARY outcome
Timeframe: 6 yearsPopulation: Matched luteal and follicular phase samples Not all samples were suitable for analysis for each outcome measure
TNF and SYNE1
Outcome measures
| Measure |
1 Menstrual Migraine
n=29 Participants
Caucasian women with a current or past history of menstrual migraine (MM = pure menstrual migraine or menstrually-related migraine) attending the City of London Migraine Clinic
|
2 No Migraine
n=29 Participants
Caucasian women with no personal history of migraine
|
|---|---|---|
|
Menstrual Cycle Expression of TNF and SYNE1 in Women With Menstrual Migraine and Women Without Migraine
TNF expression in follicular phase
|
17.16 number of genes expressed
Standard Deviation NA
Not reported
|
17.33 number of genes expressed
Standard Deviation NA
Not reported
|
|
Menstrual Cycle Expression of TNF and SYNE1 in Women With Menstrual Migraine and Women Without Migraine
TNF expression in luteal phase
|
16.24 number of genes expressed
Standard Deviation NA
Not reported
|
16.96 number of genes expressed
Standard Deviation NA
Not reported
|
|
Menstrual Cycle Expression of TNF and SYNE1 in Women With Menstrual Migraine and Women Without Migraine
SYNE1 expression in follicular phase
|
21.56 number of genes expressed
Standard Deviation NA
Not reported
|
20.68 number of genes expressed
Standard Deviation NA
Not reported
|
|
Menstrual Cycle Expression of TNF and SYNE1 in Women With Menstrual Migraine and Women Without Migraine
SYNE1 expression in luteal phase
|
20.01 number of genes expressed
Standard Deviation NA
Not reported
|
20.06 number of genes expressed
Standard Deviation NA
Not reported
|
Adverse Events
1 Menstrual Migraine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
2 No Migraine
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
Professor Anne MacGregor
Centre for Neuroscience and Trauma, Queen Mary, University of London
Phone: +44 7774 868628
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place