Skip to main content

Table 1 Participant timeline

From: Lithium carbonate in amyotrophic lateral sclerosis patients homozygous for the C-allele at SNP rs12608932 in UNC13A: protocol for a confirmatory, randomized, group-sequential, event-driven, double-blind, placebo-controlled trial

 

Screening (−45 days)

Baseline

Days 7, 14, 21, 28, and 56

Month 3 (±7 days)

Month 6 (±7 days)

Month 9 (±7 days)

Month 12 (±7 days)

Month 15 (±7 days)

Month 18 (±7 days)

Month 21 (±7 days)

Month 24 (±7 days)

Informed consent

X

          

Eligibility criteria review

X

X

         

DNA sample (10 mL)a

X

          

Randomization

 

X

         

Demographic data and medical history

X

X

         

Neurological examination

 

X

    

X

   

X

12-lead ECG

 

X

 

X

  

X

   

X

Dispense study medication

 

X

 

X

X

X

X

X

X

X

 

Drug accountability and compliance

   

X

X

X

X

X

X

X

X

Vital signs and body weight

 

X

 

X

X

X

X

X

X

X

X

Blood sample (30 ml)

 

X

 

X

X

X

X

X

X

X

X

Blood sample (lithium level)

  

X

X

X

X

X

X

X

X

X

Urine sample (20 ml)

 

X

 

X

X

X

X

X

X

X

X

Pregnancy testb

For WOCBP patients: at a monthly interval

Spirometry (SVC)

X

X

 

X

X

X

X

X

X

X

X

ALSFRS-R

X

X

 

X

X

X

X

X

X

X

X

Quality of life (VAS and EQ-5D)

 

X

 

X

X

X

X

X

X

X

X

LiSERS questionnaire

  

X

X

       

King’s staging system

 

X

 

X

X

X

X

X

X

X

X

ECAS

 

X

    

X

   

X

ALS-FTD-Q

 

X

    

X

   

X

Optional: liquor biomarker sample

 

X

  

X

 

X

    

Optional: CMAP scanc

 

X

 

X

X

X

X

    

Survival data and ALS interventionsd

X

X

 

X

X

X

X

X

X

X

X

  1. aEnd-of-Study or early-termination visit
  2. bPregnancy tests can be performed by the patient themselves at home
  3. cCMAP scan is only performed in the UMC Utrecht
  4. dALS interventions are gastrostomy, non-invasive ventilation, wheelchair use and tracheostomy
Back to article page

Trials

ISSN: 1745-6215