Kremer B.

Methods	120‐week double‐blind, parallel study. Method of randomisation: stratification by age and gender. Results presented for each arm of the trial. Intention‐to‐treat data analysis. Location: 7 centres (Canada).
Participants	64 patients, 9 drop‐outs. 23 male and 32 female patients completed the trial. Mean age of participants: 44,7± 3,8 years. Mean duration of disease: 2,9 ±0.7 years. Inclusion criteria: HD diagnosis defined by the appearance of motor abnormalities, disease duration<5 years, presence of neurological abnormalities (e.g., chorea, gait abnormalities, dysarthria) and expanded CAG repeat. Exclusion criteria: heart, kidney or liver disease, Diabetes Mellitus, unable to cope cognitively with trial requirements, <18 years, use of antidepressants or neuroleptics, ongoing depression or psychosis on recruitment.
Interventions	Oral Lamotrigine 400 mg/day (maximum), increase every 2 weeks for 12 weeks (no dosage described) (33 patients) and placebo (31 patients).
Outcomes	Primary: Change in TFC‐UHDRS. Secondary: Change in QNE. Change in Cognitive function (MMSE, WAIS‐R, WMS, Paired associates, paragraph recall, word fluency tests). Change in motor function (Klove Grooved Pegboard, Finger Tapping test). PET scanning (PET‐ deoxyglucose).
Notes	Negative for efficacy measures.
Risk of bias
Bias	Authors' judgement	Support for judgement
Allocation concealment?	Low risk	A ‐ Adequate