Trial Outcomes & Findings for A TSEC for Symptom Management in Menopausal Women With Multiple Sclerosis (NCT NCT02710214)

N=16 with available data.

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.

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.

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.

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.

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.

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.

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.

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.

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).

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.

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.

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.

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.

The number of missed doses will be assed at the end of study visit.