Skip to main content

Table 1 Observation schedule

From: Evaluating the impact of adjunctive istradefylline on the cumulative dose of levodopa-containing medications in Parkinson’s disease: study protocol for the ISTRA ADJUST PD randomized, controlled study

 

Date of consent or enrollment

Observation period (week)

0

1a

4

8

12

16

20

24

28

32

36b

37c

Informed consent

            

Eligibility confirmation

           

MMSE

           

Patient background

            

Medical history/complications

 

           

Decision on dose increase of levodopa-containing medications

   

 

CGI-S

 

 

 

CGI-I

   

 

PGI-S

 

 

 

PGI-I

   

 

mH&Y (ON/OFF)

 

   

  

  

 

MDS-UPDRS

(part I, II, III, IV)

 

   

  

  

 

PDQ-39

 

   

  

  

 

Wearable device data

    

  

  

e

 

Symptom diaryd

    

  

  

e

 

Hospitalizations

Concomitant medication check

Adverse events

Information on discontinuation

 

At any time

Data entry into the case report form

 

Within 2 weeks after each visit

  1.  CGI-I clinical global impressions of improvement, CGI-S clinical global impressions of severity, MDS-UPDRS Movement Disorder Society Unified Parkinson’s Disease Rating Scale, mH&Y modified Hoehn & Yahr scale, MMSE Mini-Mental State Examination, PDQ Parkinson’s disease questionnaire, PGI-I patient global impressions of improvement, PGI-S patient global impressions of severity
  2. aIstradefylline group only
  3. bOr the day immediately after discontinuation
  4. cNot a mandated visit if judged to be unnecessary
  5. dSymptoms will be recorded in symptom diaries by study participants or their family members/caregivers. The investigator, subinvestigator, or study cooperator are also allowed to record symptoms in the diary during the visit, or in the case that the patients are hospitalized. Visits will be conducted in an outpatient setting; however, inpatient visits will also be allowed if needed
  6. eWearable devices will be worn for one additional week after the end of the observation period (from Week 36), and symptoms are also recorded in the diary during this period; if the patient has discontinued, these recordings are terminated on the day of discontinuation