Age
Item
men and women ≥ 18 years of age
boolean
C0001779 (UMLS CUI [1])
Childbearing Potential Sexually active Contraceptive methods | Female Condoms | Vaginal Foam Contraception | Vaginal Gel Contraception | Vaginal contraceptive diaphragm | Intrauterine Devices | Contraceptives, Oral | Injectable contraception | Bilateral tubal ligation | Bilateral oophorectomy | Hysterectomy | Partner had vasectomy
Item
sexually active women who are of child bearing potential will practice an acceptable method of birth control for the duration of the trial as judged by the investigator. examples of acceptable contraception are: condoms, foams, jellies, diaphragm, intrauterine device, oral or long-acting injected contraceptives, bilateral tubal ligation, bilateral oophorectomy, hysterectomy, or having a partner who is incapable of initiating conception. the practice of contraception must have started at least 3 months prior to trial entry.
boolean
C3831118 (UMLS CUI [1,1])
C0241028 (UMLS CUI [1,2])
C0700589 (UMLS CUI [1,3])
C0221829 (UMLS CUI [2])
C0042254 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0042257 (UMLS CUI [4,1])
C0700589 (UMLS CUI [4,2])
C0042241 (UMLS CUI [5])
C0021900 (UMLS CUI [6])
C0009905 (UMLS CUI [7])
C1262153 (UMLS CUI [8])
C0589114 (UMLS CUI [9])
C0278321 (UMLS CUI [10])
C0020699 (UMLS CUI [11])
C0420842 (UMLS CUI [12])
Gender Pregnancy test negative
Item
if female, negative pregnancy test result at screening
boolean
C0079399 (UMLS CUI [1,1])
C0427780 (UMLS CUI [1,2])
Multiple Sclerosis | Spasticity
Item
diagnosed with ms and a known history of spasticity
boolean
C0026769 (UMLS CUI [1])
C0026838 (UMLS CUI [2])
Criteria Fulfill Quantity
Item
meet one of the following criteria
boolean
C0243161 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
Completion of clinical trial Phase Specified
Item
subjects who completed the double-blind randomized withdrawal phase (part 3) of trial clr_09_21 with no major protocol violation
boolean
C2732579 (UMLS CUI [1,1])
C1710475 (UMLS CUI [1,2])
C0205369 (UMLS CUI [1,3])
Spasticity Due to Multiple Sclerosis | Antispasticity Agents Absent | Baclofen Absent
Item
subjects who are newly diagnosed with spasticity due to ms with no history of treatment using any anti-spasticity medications, or, with a history of spasticity due to ms but with no previous exposure to baclofen treatment
boolean
C0026838 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C0026769 (UMLS CUI [1,3])
C4020576 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0004609 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Baclofen Dose Stable U/day
Item
subjects who are receiving a stable baclofen ir dose (ie, a dose of 10 mg to 80 mg daily, having started at least 30 days prior to enrollment)
boolean
C0004609 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0456683 (UMLS CUI [1,4])