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| Name | Class |
|---|---|
| National Multiple Sclerosis Society | OTHER |
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Duavee is a hormone receptor modulator that has been approved for the treatment of menopausal symptoms in menopausal women. The goal of this 8-week randomized, double blind, placebo controlled pilot study, is to determine whether this medication alleviates menopausal symptoms in women with MS. The investigators will secondarily determine whether addressing menopausal symptoms ameliorates MS symptoms and, on MRIs, is not triggering worsening inflammation.
Menopause in MS. Multiple sclerosis (MS) affects 3 times more women than men, and before age 50 in about 90% cases, i.e. prior to menopause. There is broad evidence for hormonal regulation of MS in animal models and in clinical cohorts. Around menopause, many clinical patients report symptom worsening associated with hot flashes, sleep disturbance or mood changes. Additionally, individuals at MS may be at increased risk of developing osteoporosis. Longer-term, an age-related decline in gonadal steroids might represent one sex-specific influence on the known age-related increases in disability and conversion to progressive course, which is marked by accelerated brain volume loss and neurodegeneration. Recent data suggest that MS disease severity may worsen after menopause.
In the current study, 24 women with MS and who are experiencing bothersome menopause symptoms will be enrolled and randomized to receive either 8 weeks of Duavee or 8 weeks of placebo. Visits will be: eligibility, baseline, and 2 month visit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Duavee | Experimental | 1 Tablet of 0.45mg conjugated estrogens/20 mg bazedoxifene daily for 8 weeks |
|
| Placebo | Placebo Comparator | Placebo pill daily for 8 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tissue Selective Estrogen Complex | Drug | Once-daily dosing of Duavee for 8 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Hot Flash Related Daily Interference Scale (HFRDIS) Score | The interference of vasomotor symptoms (VMS) with daily life will be assessed using the HFRDIS. Scores range from 0 to 100; higher scores indicate greater interference of hot flashes with daily life. | Baseline and 8 weeks |
| Change in Number of Participants Who Experienced a Reduction in Hot Flashes Per 24 Hours From Baseline to 8 Weeks | The number of daily vasomotor symptoms (VMS) will be collected in the form of hot flashes per 24 hours. The average hot flashes per day will be determined at 2 week intervals (baseline, 2 weeks, 4 weeks, and 8 weeks). The number of women experiencing reduction in hot flashes at week 8 compared to baseline will be counted; when baseline data is unavailable 1-2 week on study data will be used. | Baseline and 8 weeks |
| Change in Average Hot Flashes Per Day From Baseline to 8 Weeks | The number of daily vasomotor symptoms (VMS) will be collected in the form of hot flashes per 24 hours. The average hot flashes per day will be determined at 2 week intervals (baseline, 2 weeks, 4 weeks, and 8 weeks). The average reduction in hot flashes per day over the course of the trial will be determined from the difference between 8 week and baseline frequency (by randomization group, treatment or placebo). When baseline data is not available, the 2 weeks on study data will be used as 'baseline'. Differences <0 indicate reduction in hot flash frequency over the course of the trial. | Baseline and 8 weeks |
| Number of Participants Reporting Side Effects on the Treatment Satisfaction Questionnaire for Medication (TSQM) | The primary measure will be the percentage of subjects reporting side effects (yes or no) on the Satisfaction Questionnaire for Medication (TSQM). The TSQM is used to assess patients' satisfaction with medication, providing scores on four scales - side effects, effectiveness, convenience and global satisfaction. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the MS Quality of Life 54 (MSQOL-54) | MS Quality of Life 54 (MSQOL-54) composite scores provide a patient reported quality of life score assessing physical QOL and mental QOL. A sub-scale of this assessment also assesses energy QOL. These will be measured at baseline and end of study (8 weeks). These scores fall within the range of 0 to 100; higher scores indicate better QOL within that domain or sub-scale. |
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Inclusion Criteria:
MS considerations:
Exclusion Criteria:
History of any of the following, as determined by clinician review of the potential participant's medical history:
MS considerations:
MRI considerations:
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| Name | Affiliation | Role |
|---|---|---|
| Riley M Bove, MD | Assistant Professor of Clinical Neurology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Francisco | San Francisco | California | 94158 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26447063 | Background | Bove R, Healy BC, Musallam A, Glanz BI, De Jager PL, Chitnis T. Exploration of changes in disability after menopause in a longitudinal multiple sclerosis cohort. Mult Scler. 2016 Jun;22(7):935-43. doi: 10.1177/1352458515606211. Epub 2015 Oct 7. | |
| 24101131 | Background | Bove R, Chitnis T, Houtchens M. Menopause in multiple sclerosis: therapeutic considerations. J Neurol. 2014 Jul;261(7):1257-68. doi: 10.1007/s00415-013-7131-8. Epub 2013 Oct 8. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Duavee | 1 Tablet of 0.45mg conjugated estrogens/20 mg bazedoxifene daily for 8 weeks Tissue Selective Estrogen Complex: Once-daily dosing of Duavee for 8 weeks. |
| FG001 | Placebo | Placebo pill daily for 8 weeks. Placebo: Once-daily dosing of placebo for 8 weeks |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Duavee | 1 Tablet of 0.45mg conjugated estrogens/20 mg bazedoxifene daily for 8 weeks Tissue Selective Estrogen Complex: Once-daily dosing of Duavee for 8 weeks. |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Hot Flash Related Daily Interference Scale (HFRDIS) Score | The interference of vasomotor symptoms (VMS) with daily life will be assessed using the HFRDIS. Scores range from 0 to 100; higher scores indicate greater interference of hot flashes with daily life. | Data for this measure available only for 21 participants, due to missing data. | Posted | Median | Inter-Quartile Range | score on a scale | Baseline and 8 weeks |
|
8 weeks, from start of study medication (at baseline visit) to end of study visit.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Duavee | 1 Tablet of 0.45mg conjugated estrogens/20 mg bazedoxifene daily for 8 weeks Tissue Selective Estrogen Complex: Once-daily dosing of Duavee for 8 weeks. |
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Planned low sample size and our pre-specified power calculation allowed 80% power to observe a greater mean change in the treatment than in the control arm but did not provide sufficient power to assess statistical significance in this pilot study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Riley Bove | University of California, San Francisco | 415-595-2795 | riley.bove@ucsf.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 29, 2016 | Apr 24, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 19, 2019 | Apr 24, 2020 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D019584 | Hot Flashes |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| Placebo | Drug | Once-daily dosing of placebo for 8 weeks |
|
| Change in the Expanded Disability Status Scale (EDSS) | EDSS total score is a metric used for quantifying disability in MS and monitoring changes in the level of disability over time. The EDSS will be assessed by a the trial neurologist at baseline and end of study (8 weeks). The score range is 0 to 10; higher scores indicate greater disability. All analyses were performed according to the intention-to-treat principle (primary) then the per-protocol principle. | Baseline and 8 weeks |
| Baseline and 8 weeks |
| Change in the Bladder Control Scale (BLCS) | Bladder function will be assessed using the BLCS. Patient reported scores will be collected at baseline and at the end of study (8 weeks); scores fall within the range of 0 to 12. Higher scores indicate worse bladder function. | Baseline and 8 weeks |
| Change in the Multiple Sclerosis Rating Scale (MSRS) | Patient reported disability will be measured by the MSRS at baseline and end of study (8 weeks). Scores range of 0 to 32; higher scores indicate worse patient reported disability. | Baseline and 8 weeks |
| Change in the Multiple Sclerosis Neuropsychological Questionnaire (MSNQ) | Cognitive function will be assessed by the MSNQ at baseline and end of study (8 weeks). Scores range 0 to 60 (scores >27 indicate cognitive impairment). | Baseline and 8 weeks |
| Change in the Symbol Digit Modalities Test (SDMT) Raw Score | SDMT is a screening instrument commonly used in clinical and research settings to assess cognitive dysfunction in MS. The SDMT will be administered at baseline and end of study (8 weeks). The final raw score is the correct number responses completed in 90 seconds and scores range between 0 and 110; higher scores indicate better performance. | Baseline and 8 weeks |
| Change in SDMT Z-score | Regression-based norms for the SDMT were used to convert participants' raw scores at baseline and end of study (8 weeks) to demographically adjusted Z-scores, correcting for the effects of age, gender, and education. Scores are normalized so that 0 represents the mean, scores above 0 fall above the mean and are associated with greater performance on the SDMT. Scores below 0 fall below the mean and are associated with poorer performance on the SDMT. | Baseline and 8 weeks |
| Change in Letter Number Sequencing (LNS) Performance | The LNS is administered to asses working memory and processing speed at baseline and end of study (8 weeks). The score range is 0 to 21; higher scores indicate better performance on this test. | Baseline and 8 weeks |
| Number of Participants With New or Enhancing Lesions on MRI | To verify that CE+BZA does not yield any marked changes in inflammatory activity, a randomized subset of 12 participants will undergo MRI at baseline and end of study (8 weeks) to evaluate for new T2 lesions and new gadolinium enhancing lesions. | 8 weeks |
| Number of Missed Doses | The number of missed doses will be assed at the end of study visit. | 8 weeks |
| 25787049 | Background | Bove R, Healy BC, Secor E, Vaughan T, Katic B, Chitnis T, Wicks P, De Jager PL. Patients report worse MS symptoms after menopause: findings from an online cohort. Mult Scler Relat Disord. 2015 Jan;4(1):18-24. doi: 10.1016/j.msard.2014.11.009. Epub 2014 Dec 9. |
| 19031437 | Background | Bebo BF Jr, Dehghani B, Foster S, Kurniawan A, Lopez FJ, Sherman LS. Treatment with selective estrogen receptor modulators regulates myelin specific T-cells and suppresses experimental autoimmune encephalomyelitis. Glia. 2009 May;57(7):777-90. doi: 10.1002/glia.20805. |
| 16837880 | Background | Boccardi M, Ghidoni R, Govoni S, Testa C, Benussi L, Bonetti M, Binetti G, Frisoni GB. Effects of hormone therapy on brain morphology of healthy postmenopausal women: a Voxel-based morphometry study. Menopause. 2006 Jul-Aug;13(4):584-91. doi: 10.1097/01.gme.0000196811.88505.10. |
| 24336141 | Background | Bove R, Secor E, Chibnik LB, Barnes LL, Schneider JA, Bennett DA, De Jager PL. Age at surgical menopause influences cognitive decline and Alzheimer pathology in older women. Neurology. 2014 Jan 21;82(3):222-9. doi: 10.1212/WNL.0000000000000033. Epub 2013 Dec 11. |
| 22367731 | Background | North American Menopause Society. The 2012 hormone therapy position statement of: The North American Menopause Society. Menopause. 2012 Mar;19(3):257-71. doi: 10.1097/gme.0b013e31824b970a. |
| 26140279 | Background | Pozzilli C, De Giglio L, Barletta VT, Marinelli F, Angelis FD, Gallo V, Pagano VA, Marini S, Piattella MC, Tomassini V, Pantano P. Oral contraceptives combined with interferon beta in multiple sclerosis. Neurol Neuroimmunol Neuroinflamm. 2015 Jun 18;2(4):e120. doi: 10.1212/NXI.0000000000000120. eCollection 2015 Aug. |
| 26621682 | Background | Voskuhl RR, Wang H, Wu TC, Sicotte NL, Nakamura K, Kurth F, Itoh N, Bardens J, Bernard JT, Corboy JR, Cross AH, Dhib-Jalbut S, Ford CC, Frohman EM, Giesser B, Jacobs D, Kasper LH, Lynch S, Parry G, Racke MK, Reder AT, Rose J, Wingerchuk DM, MacKenzie-Graham AJ, Arnold DL, Tseng CH, Elashoff R. Estriol combined with glatiramer acetate for women with relapsing-remitting multiple sclerosis: a randomised, placebo-controlled, phase 2 trial. Lancet Neurol. 2016 Jan;15(1):35-46. doi: 10.1016/S1474-4422(15)00322-1. Epub 2015 Nov 29. |
| 37715710 | Derived | Morales-Rodriguez D, Anderson A, Nylander A, Hsu S, Singh J, Rowles W, Walsh CM, Braley TJ, Bove R. Well-being at midlife: Correlates of mental health in ambulatory menopausal women with multiple sclerosis. Mult Scler. 2023 Oct;29(11-12):1493-1502. doi: 10.1177/13524585231197056. Epub 2023 Sep 16. |
| Death |
|
Placebo pill daily for 8 weeks.
Placebo: Once-daily dosing of placebo for 8 weeks
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Disease Modifying Therapy (DMT) | Count of Participants | Participants |
|
| Expanded Disability Status Scale Score | Scale of 0 to 10 (higher scores indicate greater disability). | Median | Inter-Quartile Range | units on a scale |
|
| Timed 25 Foot Walk | N=16 with available data. | Mean | Standard Deviation | seconds |
|
| Symbol Digit Modalities (SDMT) Raw Score | The Symbol Digit Modalities Test (SDMT) is a screening instrument commonly used in clinical and research settings to assess cognitive dysfunction in MS. The final score is the correct number responses completed in 90 seconds and scores range between 0 and 110; higher scores indicate better performance. | Median | Inter-Quartile Range | number of correct responses |
|
| SDMT (z-score) | Regression-based norms for the SDMT were used to convert participants' raw scores to demographically adjusted Z-scores, correcting for the effects of age, gender, and education. Scores are normalized so that 0 represents the mean, scores above 0 fall above the mean and are associated with greater performance on the SDMT. Scores below 0 fall below the mean and are associated with poorer performance on the SDMT | Median | Inter-Quartile Range | z-score |
|
| Letter Number Sequencing (LNS) | The Letter Number Sequencing (LNS) is administered to asses working memory and processing speed. The score range is 0 to 21; higher scores indicate better performance on this test. | Median | Inter-Quartile Range | number of correct responses |
|
| Multiple Sclerosis Quality of Life 54 (MSQOL-54) | Score range 0 to 100 for each sub-scale (mental, physical, energy); higher scores indicate better quality of life within that domain. | N=20 with available data. | Median | Inter-Quartile Range | units on a scale |
|
| Multiple Sclerosis Rating Scale Composite Score | Score range of 0 to 32 (higher scores indicate worse patient reported disability). | N=20 with available data. | Median | Inter-Quartile Range | units on a scale |
|
| Multiple Sclerosis Neuropsychological Questionnaire | Score range 0 to 60 (scores >27 indicate cognitive impairment). | N=20 with available data. | Median | Inter-Quartile Range | units on a scale |
|
| Bladder Control Score | Score range of 0 to 12 (higher scores indicate greater bladder dysfunction). | N=20 with available data. | Median | Inter-Quartile Range | units on a scale |
|
| Hot Flashes (per 24 hours) | Median calculated from 2 weeks of daily hot flash diaries. | N=19 with available data. | Median | Inter-Quartile Range | hot flashes/day |
|
| Hot Flash Related Daily Interference Scale | Score range 0 to 100 (higher scores indicate greater interference of hot flashes with daily life). | N=16 with available data. | Median | Inter-Quartile Range | units on a scale |
|
| Insomnia Severity Index | Score range of 0 to 28 (0-7 indicates no clinically significant insomnia, 8-14 indicates sub-threshold insomnia, 15-21 indicates clinical insomnia of moderate severity, and 22-28 indicates severe clinical insomnia). | N=9 with available data. | Median | Inter-Quartile Range | units on a scale |
|
|
|
| Primary | Change in Number of Participants Who Experienced a Reduction in Hot Flashes Per 24 Hours From Baseline to 8 Weeks | The number of daily vasomotor symptoms (VMS) will be collected in the form of hot flashes per 24 hours. The average hot flashes per day will be determined at 2 week intervals (baseline, 2 weeks, 4 weeks, and 8 weeks). The number of women experiencing reduction in hot flashes at week 8 compared to baseline will be counted; when baseline data is unavailable 1-2 week on study data will be used. | Data for this measure available only for 18 participants, due to missing data; in 3 cases, weeks 1-2 of on- study data was used when baseline was unavailable. | Posted | Count of Participants | Participants | Baseline and 8 weeks |
|
|
|
| Primary | Change in Average Hot Flashes Per Day From Baseline to 8 Weeks | The number of daily vasomotor symptoms (VMS) will be collected in the form of hot flashes per 24 hours. The average hot flashes per day will be determined at 2 week intervals (baseline, 2 weeks, 4 weeks, and 8 weeks). The average reduction in hot flashes per day over the course of the trial will be determined from the difference between 8 week and baseline frequency (by randomization group, treatment or placebo). When baseline data is not available, the 2 weeks on study data will be used as 'baseline'. Differences <0 indicate reduction in hot flash frequency over the course of the trial. | Data for this measure available only for 21 participants, due to missing data; in 3 cases, weeks 1-2 of on- study data was used when baseline was unavailable. | Posted | Median | Inter-Quartile Range | hot flashes/day | Baseline and 8 weeks |
|
|
|
| Primary | Number of Participants Reporting Side Effects on the Treatment Satisfaction Questionnaire for Medication (TSQM) | The primary measure will be the percentage of subjects reporting side effects (yes or no) on the Satisfaction Questionnaire for Medication (TSQM). The TSQM is used to assess patients' satisfaction with medication, providing scores on four scales - side effects, effectiveness, convenience and global satisfaction. | Data for this measure available only for 16 participants, due to missing data. | Posted | Count of Participants | Participants | 8 weeks |
|
|
|
| Primary | Change in the Expanded Disability Status Scale (EDSS) | EDSS total score is a metric used for quantifying disability in MS and monitoring changes in the level of disability over time. The EDSS will be assessed by a the trial neurologist at baseline and end of study (8 weeks). The score range is 0 to 10; higher scores indicate greater disability. All analyses were performed according to the intention-to-treat principle (primary) then the per-protocol principle. | Data for this measure available only for 22 participants, due to missing data. | Posted | Median | Inter-Quartile Range | units on a scale | Baseline and 8 weeks |
|
|
|
| Secondary | Change in the MS Quality of Life 54 (MSQOL-54) | MS Quality of Life 54 (MSQOL-54) composite scores provide a patient reported quality of life score assessing physical QOL and mental QOL. A sub-scale of this assessment also assesses energy QOL. These will be measured at baseline and end of study (8 weeks). These scores fall within the range of 0 to 100; higher scores indicate better QOL within that domain or sub-scale. | Data for this measure available only for 16 participants, due to missing data. | Posted | Median | Inter-Quartile Range | units on a scale | Baseline and 8 weeks |
|
|
|
| Secondary | Change in the Bladder Control Scale (BLCS) | Bladder function will be assessed using the BLCS. Patient reported scores will be collected at baseline and at the end of study (8 weeks); scores fall within the range of 0 to 12. Higher scores indicate worse bladder function. | Data for this measure available only for 16 participants, due to missing data. | Posted | Median | Inter-Quartile Range | units on a scale | Baseline and 8 weeks |
|
|
|
| Secondary | Change in the Multiple Sclerosis Rating Scale (MSRS) | Patient reported disability will be measured by the MSRS at baseline and end of study (8 weeks). Scores range of 0 to 32; higher scores indicate worse patient reported disability. | Data for this measure available only for 16 participants, due to missing data. | Posted | Median | Inter-Quartile Range | units on a scale | Baseline and 8 weeks |
|
|
|
| Secondary | Change in the Multiple Sclerosis Neuropsychological Questionnaire (MSNQ) | Cognitive function will be assessed by the MSNQ at baseline and end of study (8 weeks). Scores range 0 to 60 (scores >27 indicate cognitive impairment). | Data for this measure available only for 16 participants, due to missing data. | Posted | Median | Inter-Quartile Range | units on a scale | Baseline and 8 weeks |
|
|
|
| Secondary | Change in the Symbol Digit Modalities Test (SDMT) Raw Score | SDMT is a screening instrument commonly used in clinical and research settings to assess cognitive dysfunction in MS. The SDMT will be administered at baseline and end of study (8 weeks). The final raw score is the correct number responses completed in 90 seconds and scores range between 0 and 110; higher scores indicate better performance. | Data for this measure available only for 21 participants, due to missing data. | Posted | Median | Inter-Quartile Range | units on a scale | Baseline and 8 weeks |
|
|
|
| Secondary | Change in SDMT Z-score | Regression-based norms for the SDMT were used to convert participants' raw scores at baseline and end of study (8 weeks) to demographically adjusted Z-scores, correcting for the effects of age, gender, and education. Scores are normalized so that 0 represents the mean, scores above 0 fall above the mean and are associated with greater performance on the SDMT. Scores below 0 fall below the mean and are associated with poorer performance on the SDMT. | N=21 with available data. | Posted | Median | Inter-Quartile Range | z-score | Baseline and 8 weeks |
|
|
|
| Secondary | Change in Letter Number Sequencing (LNS) Performance | The LNS is administered to asses working memory and processing speed at baseline and end of study (8 weeks). The score range is 0 to 21; higher scores indicate better performance on this test. | Data for this measure available only for 21 participants, due to missing data. | Posted | Median | Inter-Quartile Range | units on a scale | Baseline and 8 weeks |
|
|
|
| Secondary | Number of Participants With New or Enhancing Lesions on MRI | To verify that CE+BZA does not yield any marked changes in inflammatory activity, a randomized subset of 12 participants will undergo MRI at baseline and end of study (8 weeks) to evaluate for new T2 lesions and new gadolinium enhancing lesions. | N=12 with MRI; participants were randomized to the MRI or no MRI group in this double blinded study; thus, by chance a higher number of women allocated to the Duavee arm received MRI's. | Posted | Count of Participants | Participants | 8 weeks |
|
|
|
| Secondary | Number of Missed Doses | The number of missed doses will be assed at the end of study visit. | Posted | Median | Inter-Quartile Range | missed doses | 8 weeks |
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 0 |
| 12 |
| EG001 | Placebo | Placebo pill daily for 8 weeks. Placebo: Once-daily dosing of placebo for 8 weeks | 1 | 12 | 0 | 12 | 0 | 12 |
Not provided
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| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| MSQOL-54: Energy |
|