Skip to main content

Advertisement

Springer Nature is making SARS-CoV-2 and COVID-19 research free. View research | View latest news | Sign up for updates

Table 3 Table of events-summary of study procedures

From: Protocol for a double-blind randomised placebo-controlled trial of lithium carbonate in patients with amyotrophic Lateral Sclerosis (LiCALS) [Eudract number: 2008-006891-31]

Phase Pre-Randomisation Double-Blind Treatment
Study Week/month Wk -4 to Day 0 Wk 0 Wk 1 Wk 2 Wk 3 Wk 4 Wk 8 Wk 12/Mth 3 Mth 6 Mth 9 Mth 12 Mth 15 Mth 18/Wk 77 Withdrawal
Informed consent X              
Registration/Demographics X              
SVC X              
ALS History X              
ALS Interventions X x       x x x x x x x
Medical History X              
Neurological Exam1 X              
Inclusion/Exclusion Criteria X x             
Physical Exam (inc vital signs) x x       x x x x x x x
ALSFRS-R   x       x x x x x x x
EQ-5D   x       x x x x x x x
HADS   x       x x x x x x x
ECG x         x   x   x  
Haematology x      x x x x x x x x  
Biochemistry x   x x x x x x x x x x x  
Dose Monitoring (Li levels) x3 x x x x x x x x x x x x x
Urine pregnancy Test2 x x     x x x x x x x x x
Thyroid Function Tests x         x   x   x  
Concomitant Medications x x x x x x x x x x x x x x
Adverse Events Form   x x x x x x x x x x x x x
Trial Medication Log   x     x x x x x x x x x
Drug Dispensing & Returns   x     x x x x x x x x4 x 4
Patient Medication Guess              x x
Physician Medication Guess              x x
Withdrawal Form               x
  1. Note: where an "x" is contained within a field this denotes that the associated data will be collected at the identified time point.
  2. 1 The neurological exam must be performed by a physician
  3. 2. Women of child-bearing potential only
  4. 3. Can be completed at anytime during the screening window but must be completed before patient is randomised
  5. 4. Returns only not dispensing