Parkinson's trials measure motor function in the clinic, fluctuations at home and non-motor symptoms that matter as much to patients. Capture puts MDS-UPDRS sections, medication timing and home diaries in one study.
Free sandbox · No credit card · 21 CFR Part 11 aligned
OFF time (h/day)
4.5
Good ON time (h/day)
10.0
Diary days valid
3/3
What matters in Parkinson's trials
Study design
A motor examination captures one moment in the clinic. People with fluctuating Parkinson's may be well controlled at 10 a.m. and barely able to move at 2 p.m. That is why fluctuation trials rely on home diaries, in which participants record their state across the day, typically for three consecutive days before each visit. Diary endpoints such as change in daily OFF time are primary in many trials of adjunct therapies.
The classic paper diary asks participants to record their state for every half-hour period while awake. Electronic diaries improve timing and legibility, but the design needs care: participants must be trained, entries should be made close to real time, and valid diary days should be defined in the protocol. Plan how the diary will be structured and validated before building it.
Advanced Parkinson's often involves a care partner who helps with questionnaires and diaries. Record who completed each entry, and decide in advance whether caregiver-assisted entries are acceptable for each measure.
Medication state
MEDSTATETime of last levodopa dose
LDTIMTime of examination
EXTIMHoehn and Yahr stage
HYSTAGETiming
Calculated fields show the minutes or hours between two date-times read-only during entry, so the time since the last dose is computed from what the site records rather than typed by hand. Participant sections of the MDS-UPDRS can be completed on a clinic device at the start of the visit, and rater sections are site forms completed by the certified rater.
BMI (Body Mass Index)
Auto-derivedHeight (cm)
172
Weight (kg)
68.5
Result
23.2 kg/m²
Reference: WHO · shown read-only during data entry
Set it up in the free sandbox and test the calculated fields.
Endpoints
| Trial type | Typical endpoints |
|---|---|
| Symptomatic, early PD | MDS-UPDRS Parts II and III, CGI or PGI |
| Adjunct therapy for fluctuations | Daily OFF time and good ON time from home diaries, MDS-UPDRS Part IV |
| Dyskinesia treatment | Dyskinesia rating scales, diary ON time with troublesome dyskinesia |
| Disease modification | MDS-UPDRS Parts I to III sum, time to symptomatic treatment, digital measures |
| Non-motor symptoms | Cognition, sleep, mood, orthostatic hypotension measures |
New measures
Disease-modification trials in early Parkinson's face a problem: change is slow and rating scales are noisy. Wearable sensors that measure gait, tremor and activity at home, and biomarkers such as dopamine transporter imaging or alpha-synuclein assays, are increasingly used to enrich populations and as exploratory outcomes. These need the same data discipline as any endpoint: defined collection windows, time alignment with clinical assessments, and clear links between device data and study records.
See digital biomarker validation study software for how reference measures and device metrics fit in one study, and EDC for wearable device studies.
Study build
OFF-state withholding period and timing fields.
MDS-UPDRS parts and state defined for the primary analysis.
Structure, training, days before visits and valid-day rules.
Before rating participants.
Who may assist and how assistance is recorded.
Cognition, sleep and mood scheduled if relevant.
The MDS-UPDRS, with participant-completed sections on daily living and a rater-led motor examination.
Motor scores change greatly with medication. The state and time since the last dose are needed to interpret each examination.
A home diary in which participants record their motor state across the day, used to measure OFF time and good ON time.
Yes. Calculated fields can show the minutes or hours between two date-times during entry.
Yes, if the protocol allows it. Record who completed each entry.
Yes, in the free sandbox with every feature.
Ratings, timing and diaries in one study. Free sandbox.