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 | Â | Physical Exam (inc vital signs) | Physical Exam (inc vital signs) |
ALS Interventions | Â | Dose monitoring (Li levels) | ECG |
Medical HistoryNeurological Exam | Â | Haematology | Dose monitoring (Li levels) |
Inclusion/Exclusion Criteria Physical Exam (inc vital signs) | Â | Biochemistry | Haematology |
ALSFRS-R | Â | Urine Pregnancy Test Adverse Events | Biochemistry |
EQ-5D | Â | Concomitant medications | TFTs |
HADS | Â | Trial Medication Log | Urine Pregnancy Test Adverse Events |
ECG | Â | Drug Dispensing & Returns | Concomitant medications |
Dose monitoring (Li levels) | Â | Â | Trial Medication Log |
Haematology | Â | Â | Drug Dispensing & Returns |
Biochemistry | Â | Â | Â |
Thyroid Function Tests | Â | Â | Â |
Urine Pregnancy Test | Â | Â | Â |
Concomitant Medications | Â | Â | Â |
Adverse Events | Â | Â | Â |
Drug Dispensing | Â | Â | Â |
Trial Medication Log | Â | Â | Â |
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) |
| Â | Trial Medication Log | ECG | Dose monitoring (Li levels) |
| Â | Drug Dispensing & Returns | Dose monitoring (Li levels) | Haematology |
| Â | Â | Haematology | Biochemistry |
| Â | Â | Biochemistry | Urine Pregnancy Test Adverse Events |
| Â | Â | TFTs | Concomitant medications |
| Â | Â | Urine Pregnancy Test Adverse Events | Trial Medication Log |
| Â | Â | Concomitant medications | Drug Dispensing & Returns |
| Â | Â | Trial Medication Log | Â |
| Â | Â | Drug Dispensing & Returns | Â |
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 |
| Â | Concomitant medications | Physical Exam (inc vital signs) | Physical Exam (inc vital signs) |
| Â | Trial Medication Log | Dose monitoring (Li levels) | ECG |
| Â | Drug Dispensing & Returns | Haematology | Dose monitoring (Li levels) |
| Â | Â | Biochemistry | Haematology |
| Â | Â | Urine Pregnancy Test Adverse Events | Biochemistry |
| Â | Â | Concomitant medications | TFT's |
| Â | Â | Trial Medication Log | Urine Pregnancy Test Adverse Events |
| Â | Â | Drug Dispensing & Returns | Concomitant medications |
| Â | Â | Â | Trial Medication Log |
| Â | Â | Â | Drug Returns |
| Â | Â | Â | Unscheduled Visits |