CYTE-I-HD: phase I dose finding and tolerability study of cysteamine (Cystagon) in Huntington's disease

Mov Disord. 2006 Apr;21(4):530-3. doi: 10.1002/mds.20756.

Abstract

Cystamine, an inhibitor of transglutaminases, slows progression of Huntington's disease in the murine model by approximately 20%. Cysteamine, the dimer of cystamine, is an orphan drug approved for the treatment of nephropathic cystinosis and has a similar benefit in the murine model but with a narrower therapeutic window. In a single-center open-label study, we determined the maximum tolerable dose (MTD) and side effects of cysteamine in people with Huntington's disease. Cysteamine was started at a dose of 10 mg/kg per day, divided into four doses, and increased by 10 mg/kg per day weekly until the development of intolerable side effects or a maximum dose of 70 mg/kg per day. Of the 9 subjects, 1 had an MTD of 10 mg/kg per day, 1 had an MTD of 20 mg/kg per day, the maximum dose was 30 mg/kg per day for 2, 40 mg/kg per day for 2, and 50 mg/kg per day for 3. Dose-limiting side effects were motoric impairment in 5 and nausea in 4. The dose found tolerable by 8 of the subjects was 20 mg/kg per day. All had a noticeable hydrogen sulfide odor at doses of 40 mg/kg per day or higher. We conclude that, at a dose of 20 mg/kg per day, cysteamine was tolerable in people with Huntington's disease. Nausea and motoric impairment were the dose-limiting side effects.

Publication types

  • Clinical Trial, Phase I
  • Comparative Study
  • Evaluation Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Cysteamine / therapeutic use*
  • Drug Administration Schedule
  • Drug Tolerance
  • Female
  • Humans
  • Huntington Disease / drug therapy*
  • Male
  • Middle Aged
  • Radiation-Protective Agents / therapeutic use*
  • Severity of Illness Index

Substances

  • Radiation-Protective Agents
  • Cysteamine