Table 3

Table of events-summary of study procedures

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


Note: where an "x" is contained within a field this denotes that the associated data will be collected at the identified time point.

1 The neurological exam must be performed by a physician

2. Women of child-bearing potential only

3. Can be completed at anytime during the screening window but must be completed before patient is randomised

4. Returns only not dispensing

Al-Chalabi et al. BMC Neurology 2011 11:111   doi:10.1186/1471-2377-11-111

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