Assadi 2007.
Methods | Randomised, double‐blind, placebo‐controlled, cross‐over trial | |
Participants | 20 individuals with SCA or Friedreich ataxia were recruited and 19 completed the protocol. Of these, 14 were genetically confirmed (4 Friedreich ataxia, 1 SCA1, 4 SCA2, 2 SCA3, 1 SCA6, 1 SCA17, 1 dentatorubral‐pallidoluysian atrophy (DRPLA)) and 6 were idiopathic. Participants had clinically symptomatic ataxia and either cerebellar or brainstem atrophy on imaging studies or genetic confirmation of a hereditary SCA | |
Interventions | Participants received either buspirone hydrochloride 30 mg twice daily or placebo for 12 weeks. A titration period was implemented in the 1st 2 weeks of each arm (10 mg buspirone twice daily in week 1; 20 mg buspirone twice daily in week 2). A 4‐week washout period followed the 1st treatment phase, after which participants were crossed into the alternative treatment arm | |
Outcomes | ICARS, which includes an 8‐point speech subscale, was used to evaluate clinical features at baseline and at the end of each treatment phase (12 weeks' duration). The speech subscale was not reported separately to the total ICARS score | |
Notes | Several participants (6/20) were diagnosed with an idiopathic type of cerebellar degeneration (without a confirmed genetic diagnosis) Mr and Mrs Dennis Culnan provided the funding for the study. The provider of buspirone and placebo is not stated |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Method of randomisation is not clear |
Allocation concealment (selection bias) | Unclear risk | Method of allocation concealment is not clear |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Blinding of participants and personnel is not clear |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Blinding of investigators at assessment is not clear |
Selective reporting (reporting bias) | Low risk | All planned outcomes are reported |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 1 participant withdrew from the protocol after moving away from the treatment site |
Other bias | Low risk | None identified |