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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02563860 |
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Date of registration:
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20/07/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Pharmacological Treatment of Rett Syndrome With Statins
Statins |
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Scientific title:
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Pharmacological Treatment of Rett Syndrome With 3-Hydroxy-3 Methylglutaryl-coenzyme A Reductase Inhibitor-Lovastatin (Mevacor) |
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Date of first enrolment:
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July 2015 |
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Target sample size:
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20 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02563860 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 2
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Countries of recruitment
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United States
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Contacts
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Name:
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Aleksandra Djukic, MD PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Montefiore Medical Center |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Females patients,
- Genetically confirmed RTT,
- Ambulatory.
Exclusion Criteria:
- 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.
Age minimum:
3 Years
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Rett Syndrome
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Intervention(s)
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Drug: Lovastatin
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Primary Outcome(s)
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Gait Velocity as Measured by GAITRite System
[Time Frame: During final week of treatment, week 32]
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Secondary Outcome(s)
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Visual Memory Novelty Score as Assessed by TobiiTX 300 Eyetracking System
[Time Frame: final week of treatment, Week 32]
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Secondary ID(s)
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2014-4253
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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