Pharmacological Treatment of Rett Syndrome With Statins

Completed · Phase 2

Conditions studied: Rett Syndrome

In brief

This is a phase 2 , open label, dose escalating study of Lovastatin in Rett syndrome.

Key facts

Study ID

NCT02563860

Run by

Montefiore Medical Center

People needed

20

Starts

2015-07-01

Expected to finish

2016-07-01

Last updated by the study team

2019-07-12

Who can join

Age: 3 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Females patients,
• Genetically confirmed RTT,
• Ambulatory.

You may not qualify if…

• Presence of co morbid non-Rett related disease,
• History of adverse reaction/hypersensitivity to statins,
• Levels of aspartate-amino trans-ferase (AST), alanine-amino transferase (ALT) or creatine kinase (CK) triple the normal values,
• Active liver disease,
• Concomitant use of strong CYP3A4 inhibitors,
• Condition predis-posing to renal failure secondary to rhabdomyolysis (scoliosis surgery within 6 months),
• Oral contraceptives use.

Where it is running

• Montefiore Medical center — The Bronx, New York, United States

Full record on ClinicalTrials.gov

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