Phase 2
N=20
Atomoxetine and Huntington's Disease
Huntington Disease · Chorea
Bottom Line
View on ClinicalTrials.gov: NCT00368849 ↗Enrolled (actual)
20
Serious AEs
7.5%
Results posted
Nov 2012
Primary outcome: Primary: Conners' Adult Attention Rating Scale (CAARS) — -2.88; -2.24 units on a scale — p=0.63
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- atomoxetine (Drug); Matching Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Iowa
- Primary completion
- Feb 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Conners' Adult Attention Rating Scale (CAARS) |
-2.88; -2.24 | 0.63 |
| PRIMARY Attention Composite Score |
-0.13; 0.02 | 0.09 |
| PRIMARY Executive Composite Score |
-1.68; -2.94 | 0.46 |
| SECONDARY Symptom Checklist-90-Revised (SCL-90-R) |
-4.20; -4.64 | 0.84 |
| SECONDARY Unified Huntington Disease Rating Scale (UHDRS) Total Motor Score |
0.42; -0.35 | 0.76 |
Summary
The purpose of this research study is to evaluate the effect of atomoxetine (also known as Strattera) compared to placebo (inactive substance) on daily activities such as attention and focus, thinking ability and muscle movements in subjects with early Huntington Disease (HD) and attention deficit disorder (ADD).
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00368849). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.