RLS Rating Scale
Vital signs
after 5min sitting
integer
after 5 minutes sitting
integer
Sitting diastolic blood pressure
integer
Medical Procedures
Concomitant Medication
Adverse reaction
Instructions for the investigator
Guided by the CGI Efficacy Index (below) determine dose level to be dispensed and dispense appropriate study medication (depending on whether patient is omitting Week 7). Complete the Study Medication and Compliance Section at the back of this module. If the patient’s dose has been increased at this clinic visit: a) Instruct the patient to return to the clinic this evening or remain to perform orthostatic vital signs*: - 2 sets of pre-dose orthostatic blood pressure and pulse - Patient takes evening dose in the clinic - One set of 2 hour post-dose orthostatic blood pressure and pulse Instruct the patient to take the appropriate number of tablet(s), at the same time, no earlier than 3 hours prior to and no later than one hour prior to bedtime (except on the first night of each new dose increase). Patient must return the bottle(s) with any unused medication at the next visit. Arrange for the patient to return in 7 days (plus or minus 3 days) for the Week 7 clinic visit, if the Week 7 visit is required. If Week 7 is not required, please arrange for the patient to return for the Week 8 Visit in 14 days. * Where possible this visit should be performed in the evening with dosing approximately 8:00 P.M. However, for scheduling convenience, this visit (including dosing) may occur during the afternoon hours (as late in the day as possible) to accomodate the collection of orthostatic blood pressure/pulse assessments during the normal clinic hours.
text
Clinical Global impression
Dose reduction
If the patient requires a dose reduction between this and the next visit please complete Dose Reductions Due To Adverse Experiences pages at the back of this module. Dosage reduction may occur between scheduled clinic visits, if necessary. The subject will be instructed to contact the site to arrange a visit should a dose decrease become necessary outside of the regularly specified protocol visit.
text