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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: |
NCT00368849 |
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Date of registration:
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24/08/2006 |
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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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Atomoxetine and Huntington's Disease
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Scientific title:
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Atomoxetine for Attention Deficits in Adults With Mild HD: A Randomized, Placebo-Controlled Crossover Study |
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Date of first enrolment:
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November 2005 |
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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/NCT00368849 |
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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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Leigh J Beglinger, Ph.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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The University of Iowa |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Confirmed Huntington's disease (HD) diagnosis
- Age 18 to 65
- Must have mild HD
- Must have complaints of poor attention
Exclusion Criteria:
- Childhood history of attention deficit hyperactivity disorder (ADHD) symptoms
- Diagnosis of schizophrenia, bipolar affective disorder, dementia, delirium or severe
anxiety
- Current use of a monoamine oxidase inhibitor (MAOI) medication
- Pregnancy
- Uncontrolled hypertension
- Tachycardia
- Cardiovascular or cerebrovascular disease
- History of a loss of consciousness for greater than (or equal to) 5 minutes
- Having any neurological disorder or insult other than Huntington disease
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Huntington Disease
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Chorea
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Intervention(s)
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Drug: atomoxetine
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Drug: Matching Placebo
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Primary Outcome(s)
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Attention Composite Score
[Time Frame: There are two time points for this measure: baseline and after 4 weeks of treatment]
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Conners' Adult Attention Rating Scale (CAARS)
[Time Frame: There are two time points for this measure: baseline and after 4 weeks of treatment]
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Executive Composite Score
[Time Frame: There are two time points for this measure: baseline and after 4 weeks of treatment]
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Secondary Outcome(s)
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Symptom Checklist-90-Revised (SCL-90-R)
[Time Frame: There are two time points for this measure: baseline and after 4 weeks of treatment]
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Unified Huntington Disease Rating Scale (UHDRS) Total Motor Score
[Time Frame: There are two time points for this measure: baseline and after 4 weeks of treatment]
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Secondary ID(s)
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200508775
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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