A Registry-Based Clinical Trial of Pimozide in Patients With Neuromuscular Junction Transmission Dysfunction Due to ALS

Exclusion Criteria

• •1. Diagnosis of clinically possible or clinically suspected ALS as defined by the El-Escorial diagnostic criteria for ALS
• •2. If the subject is taking riluzole the dose must be stable for 30 days prior to randomization visit. Riluzole cannot be initiated during the study.
• •3. History of Parkinson's disease
• •4. History of traumatic brain injury
• •5. History of neuroleptic malignant syndrome
• •6. History of hypersensitivity or serious adverse reaction(s) to a neuroleptic medication
• •7. History of prolonged QTc interval \> 500 ms
• •8. History of hyponatremia \< 130 mmol/L
• •9. History of current heparin or warfarin use
• •10. History of hepatic and/or renal impairment that may affect pimozide metabolism
• •11. History of current pregnancy or breastfeeding
• •12. Current antipsychotic use
• •13. Presence of central nervous system depression, comatose states, liver disorders, renal insufficiency, and blood dyscrasias
• •14. Presence of depressive disorders or Parkinson's syndrome
• •15. History of congenital long QT syndrome or with a family history of this syndrome and in patients with a history of cardiac arrhythmias or Torsade de Pointes
• •16. Presence of acquired long QT interval, such as associated with concomitant use of drugs known to prolong the QT interval
• •17. Presence of hypokalemia or hypomagnesemia
• •18. Presence of clinically significant bradycardia (heart rate \< 50 beats per minute)
• •19. The concomitant use of CYP 3A4-inhibiting drugs such as azole antimycotics, antiviral protease inhibitors, macrolide antibiotics and nefazodone
• •20. The concomitant use of CYP 2D6-inhibiting drugs such as quinidine is also contraindicated
• •21. Concomitant use of serotonin reuptake inhibitors, such as, sertraline, paroxetine, citalopram and escitalopram
• •22. Severe dysphagia with risk of aspiration
• •23. Has taken any compound under current or known future study as a potential therapy for ALS less than 30 days prior to dosing OR history of exposure to stem cell therapy for treatment of ALS at any time