Lange 1998.
Methods | Randomized, placebo controlled, double‐blind study Duration: 6 months | |
Participants | Country: USA Multicentre: 2 sites Diagnosis: criteria for classical ALS Number of participants: 133 (67 treated, 66 placebo, 62% male) Age: mean 57 years Inclusion criteria: 25 to 65 years, symptom duration less than 3 years, mild to moderate disease with Appel ALS total score 30 to 80, no drug therapy for at least 3 months before enrolment Exclusion criteria: multifocal motor neuropathy with conduction block, paraproteinemia, elevated GM1 antibodies, sensorimotor peripheral neuropathy, previous infection with poliovirus, lower motor neuron disease only, primary lateral sclerosis, previous allergy to selegiline, abnormal endocrinology, serious medical problems, poor family support | |
Interventions | 1. selegiline 5 mg twice daily 2. placebo | |
Outcomes | Primary: rate of change of Appel ALS (AALS) total score Secondary: AALS component scores, survival analysis | |
Notes | Subjects with AALS score below 115 or forced vital capacity below 39% predicted were considered treatment failures and entered an open‐label phase | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Comment: not addressed |
Allocation concealment (selection bias) | Unclear risk | Comment: not addressed |
Blinding (performance bias and detection bias) All outcomes | Low risk | "The research team at each site consisted of 2 investigators and a study coordinator unaware of randomization status and another investigator who reviewed laboratory data." Comment: appears adequate |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Comment: not addressed |
Selective reporting (reporting bias) | Low risk | Comment: appears adequate |
Other bias | Low risk | Comment: appears adequate |