MND-SMART visit and assessment schedule
| Appointment | Time | Informed consent | Inclusion/exclusion review | Eligibility confirmation | Demography | Disease history | Medical history | Current medications | Safety bloods | ECG | Suicide ideation (CSSRS) | Pregnancy test | Randomisation | FVC | ALSFRS-R and King’s staging* | EQ-5D-5L | HADS | ECAS† | Substudies | Research bloods | Drug supply | Titration up | Compliance check | Adverse events |
| 1 Screening | x | x | x | x | x | x | x | x | x | x | x‡ | x | x | |||||||||||
| 2 Baseline | Time 0 | x | x | x | x§ | x | x | x | x | x | x | x | x | x | ¶ | x | ||||||||
| 3, 4, 5** | Weeks 1, 2 and 3 | x | x | x | x | |||||||||||||||||||
| 6, 7, 9, 10, 12, 13** | Months 2, 4, 8, 10, 14, 16 | x | x | x | x | x | x | |||||||||||||||||
| 8†† | Month 6 | x | x | x | x | x | x | x | x | x | x | |||||||||||||
| 11†† | Month 12 | x | x | x | x | x | x | x | x | x | x | x | ||||||||||||
| 14†† | Month 18 | x | x | x | x | x | x | x | x | x | x | x | ||||||||||||
| 15, 16, 17 …** | Months 20, 22, 24 … | x | x | x | x | x |
*Modified King’s staging will take place at remote appointments.
†This assessment includes an interview with a partner/relative/friend/carer if the participant has consented. If an arm is dropped the investigational medicinal product (IMP) dose should be halved at the next scheduled appointment and participants then complete the two treatment cessation appointments. Appointments from 15 onwards are the same to be repeated every 2 months.
‡For women of childbearing potential.
§If more than 7 days from previous test.
¶Start IMP.
**These appointments can be completed using video conferencing or telephone call.
††These appointments should be completed face to face wherever possible.
ALSFRS-R, Amyotrophic Lateral Sclerosis Functional Rating Scale Revised; CSSRS, Columbia-Suicide Severity Rating Scale; ECAS, Edinburgh Cognitive and Behavioural ALS Screen; FVC, forced vital capacity; HADS, Hospital Anxiety and Depression Scale; MND-SMART, Motor Neuron Disease-Systematic Multi-Arm Adaptive Randomised Trial.