Table 2

Visit Schedule

Pre-Randomisation

Week 3/Day 21 (+/- 3 days)

Week 12 (+/- 7 days)

Month 12 (+/- 7 days)


A detailed list of drugs and other agents that might interact with lithium will be provided to volunteers and to their general practitioners, together with a list of 24 hour emergency contact numbers.

Dose monitoring (Li levels)

ALS Interventions

ALS Interventions

Informed consent

Biochemistry

ALSFRS-R

ALSFRS-R

Registration/Demographics

Urine Pregnancy Test Adverse Events

EQ-5D

EQ-5D

SVC

Concomitant medications

HADS

HADS

ALS History

Physical Exam (inc vital signs)

Physical Exam (inc vital signs)

ALS Interventions

Dose monitoring (Li levels)

ECG

Medical HistoryNeurological Exam

Haematology

Dose monitoring (Li levels)

Inclusion/Exclusion Criteria Physical Exam (inc vital signs)

Biochemistry

Haematology

ALSFRS-R

Urine Pregnancy Test Adverse Events

Biochemistry

EQ-5D

Concomitant medications

TFTs

HADS

Trial Medication Log

Urine Pregnancy Test Adverse Events

ECG

Drug Dispensing & Returns

Concomitant medications

Dose monitoring (Li levels)

Trial Medication Log

Haematology

Drug Dispensing & Returns

Biochemistry

Thyroid Function Tests

Urine Pregnancy Test

Concomitant Medications

Adverse Events

Drug Dispensing

Trial Medication Log


Week 1/Day 7 (+/- 3 days)

Week 4/Day 28 (+/- 3 days)

Month 6 (+/- 7 days)

Month 15 (+/- 7 days)


Dose monitoring (Li levels)

Dose monitoring (Li levels)

ALS Interventions

ALS Interventions

Biochemistry

Haematology

ALSFRS-R

ALSFRS-R

Urine Pregnancy Test

Biochemistry

EQ-5D

EQ-5D

Adverse Events

Urine Pregnancy Test Adverse Events

HADS

HADS

Concomitant medications

Concomitant medications

Physical Exam (inc vital signs)

Physical Exam (inc vital signs)

Trial Medication Log

ECG

Dose monitoring (Li levels)

Drug Dispensing & Returns

Dose monitoring (Li levels)

Haematology

Haematology

Biochemistry

Biochemistry

Urine Pregnancy Test Adverse Events

TFTs

Concomitant medications

Urine Pregnancy Test Adverse Events

Trial Medication Log

Concomitant medications

Drug Dispensing & Returns

Trial Medication Log

Drug Dispensing & Returns


Week 2/Day 14 (+/- 3 days)

Week 8 (+/- 3 days)

Month 9 (+/- 7 days)

Month 18/Week 77 (+ 7 days)


Dose monitoring (Li levels)

Dose monitoring (Li levels)

ALS Interventions

ALS Interventions

Biochemistry

Haematology

ALSFRS-R

ALSFRS-R

Urine Pregnancy Test Adverse Events

Biochemistry

EQ-5D

EQ-5D

Concomitant medications

Urine Pregnancy Test Adverse Events

HADS

HADS

Concomitant medications

Physical Exam (inc vital signs)

Physical Exam (inc vital signs)

Trial Medication Log

Dose monitoring (Li levels)

ECG

Drug Dispensing & Returns

Haematology

Dose monitoring (Li levels)

Biochemistry

Haematology

Urine Pregnancy Test Adverse Events

Biochemistry

Concomitant medications

TFT's

Trial Medication Log

Urine Pregnancy Test Adverse Events

Drug Dispensing & Returns

Concomitant medications

Trial Medication Log

Drug Returns

Unscheduled Visits


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

Open Data