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Table 1 Inclusion and exclusion criteria for patient selection

From: Effects of acetyl-DL-leucine on cerebellar ataxia (ALCAT trial): study protocol for a multicenter, multinational, randomized, double-blind, placebo-controlled, crossover phase III trial

Inclusion criteria Exclusion criteria
• Clinically confirmed CA with a SARA total score ≥ 3 (range 0-40) (CA (hereditary or non-hereditary, non-acquired)
• Patient did not receive any of the following prohibited medication within 4 weeks prior to randomization:
o Aminopyridines
o Acetyl-DL-leucine
o Riluzole
o Gabapentin
o Varenicline
o Chlorzoxazone
• The ability to follow study instructions and likely to attend and complete all required visits
• Written informed consent of the subject prior to any study-specific intervention
• Age ≥ 18 years
• Subject is not able to give consent
• Onset of ataxia in association with stroke, encephalitis, sepsis, hyperthermia or heat stroke
• Toxic causes for ataxia of cerebellar type
• Rapid progression of ataxia (development of severe ataxia in less than 12 weeks)
• Subject suffers from any of the following:
o chronic diarrhea
o unexplained visual loss
o malignancies
o insulin-dependent diabetes mellitus
• Ataxia due to multiple sclerosis, ischemia, hemorrhage or tumor of the posterior fossa as confirmed by imaging
• Ataxia due to clinically likely multisystem atrophy type C (MSA-C)
• Diagnosis of clinically likely Friedreich’s ataxia
• Known history of hypersensitivity to the investigational drug or derivatives
• Liver failure defined as AST/ALT > 300 U/l
• Simultaneous participation in another clinical trial or participation in any clinical trial involving administration of an investigational medical product within 30 days prior to the beginning of the clinical trial
• Subjects with a physical or psychiatric condition which, in the opinion of the investigator, may put the subject at risk, may confound the trial results, or may interfere with the subject’s participation in this clinical trial
• Known or persistent abuse of medication, drugs or alcohol
• Females of childbearing potential, who are not using and not willing to use medically reliable methods of contraception for the entire study duration as listed in the patient informed consent form
• Current or planned pregnancy or nursing women
• Patient has received any of the following prohibited medication within 4 weeks prior to randomization
o Aminopyridines (including sustained-release form)
o Acetyl-DL-leucine
o Riluzole
o Gabapentin
o Varenicline
o Chlorzoxazone