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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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19 October 2017 |
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Main ID: |
NCT01120626 |
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Date of registration:
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07/05/2010 |
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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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Randomized Controlled Study of Donepezil in Fragile X Syndrome
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Scientific title:
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Augmentation of the Cholinergic System in Fragile X Syndrome: A Double-Blind Placebo-Controlled Randomized Study of Donepezil |
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Date of first enrolment:
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September 2009 |
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Target sample size:
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45 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01120626 |
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Study type:
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Interventional |
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Study design:
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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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Allan L Reiss |
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Address:
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Telephone:
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Email:
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Affiliation:
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Stanford University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. confirmed genetic diagnosis of fragile X syndrome
2. age >=12, <=29
3. Verbal IQ >= 50, <=75
4. Tanner pubertal stage >= 3
Exclusion Criteria:
1. Current or lifetime DSM-IV diagnosis of bipolar disorder, schizophrenia,
schizoaffective disorder, or psychotic disorder, NOS based upon reported history
2. Poorly controlled seizure disorder or taking more than one anticonvulsant (subjects
cannot be prescribed carbamazepine, phenytoin, or phenobarbital due to potential
interaction effects with donepezil). The investigators will permit one anticonvulsant
as monotherapy for seizures if the seizure disorder is well controlled with no
evidence of break through seizures within the past year
3. Concomitant or anticipated use of other medications having prominent effects on the
cholinergic system (e.g., bethanechol, benztropine, atropine, succinylcholine)
4. Medications or nutritional supplements that have the potential to significantly alter
donepezil levels, clinical effects or adverse reactions (antifungal agents,
corticosteroids, erythromycin, beta-blockers, calcium channel blockers, NSAIDs, gingko
biloba, St. John's wort)
5. Medical illnesses where donepezil could worsen the condition such as asthma, cardiac
conduction abnormalities, urinary obstruction or gastrointestinal disease with gastric
bleeding
6. Pregnancy or sexually active females not using a reliable method of contraception
7. If considering participation in brain MRI part of the study, then any
contraindications for MRI (e.g., orthodontia, metal in or on the body, etc.)
Age minimum:
12 Years
Age maximum:
29 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Fragile X Syndrome
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Intervention(s)
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Drug: donepezil
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Drug: sugar pill
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Primary Outcome(s)
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Contingency Naming Test (CNT) Performance Score
[Time Frame: Week 12]
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Secondary Outcome(s)
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Aberrant Behavior Checklist (ABC)
[Time Frame: Week 12]
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Secondary ID(s)
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SU-02042010-4923
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Autism Speaks 5907
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R34MH085899-01A1
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SPO#42922
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SPO#45612
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eProtocol 13773 (SQL 96239)
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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