Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Treatment of Executive Dysfunction in Parkinson's Disease

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2005 by Johns Hopkins University.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00286949
First received: February 3, 2006
Last updated: July 25, 2006
Last verified: November 2005

February 3, 2006
July 25, 2006
September 2004
Not Provided
General clinical improvement in executive dysfunction.
Same as current
Complete list of historical versions of study NCT00286949 on ClinicalTrials.gov Archive Site
Safety and tolerability .
Same as current
Not Provided
Not Provided
 
Treatment of Executive Dysfunction in Parkinson's Disease
Atomoxetine for the Treatment of Executive Dysfunction in Patients With Parkinson's Disease: A Pilot Open-Label Study

Atomoxetine (Strattera) is a drug that is currently approved for treatment of attention deficit hyperactivity disorder (ADHD) in children and adults. Atomoxetine works to enhance levels of brain chemicals that may be affected in people with executive dysfunction, (difficulties with organization, task completion, and priority setting). Thus, atomoxetine has the potential to improve executive dysfunction in people with Parkinson's disease (PD).

The goal of this study is to provide preliminary data on the effectiveness and tolerability of atomoxetine for the treatment of executive dysfunction in patients with PD.

Parkinson’s disease (PD), while defined by its motor abnormalities and associated dopaminergic loss, is invariably accompanied by cognitive impairment. Early in the disease course, the deficits are characterized by executive dysfunction with difficulties on tasks that involve information processing, attention, sorting, planning, set-shifting, and working memory and are subserved by neural connections with prefrontal brain regions. There has been little effort to identify treatments for these PD-related cognitive impairments, despite their disabling and distressing effects. Accordingly, the goal of this proposal is to conduct a small pilot study to determine the effectiveness and tolerability of atomoxetine, a selective norepinephrine reuptake inhibitor, for the treatment of executive dysfunction in patients with PD.

Atomoxetine (Strattera) is currently approved by the FDA for treatment of attention deficit hyperactivity disorder (ADHD) in children and adults. Atomoxetine enhances dopaminergic and noradrenergic transmission in frontal regions that are also implicated in executive dysfunction and thus has the potential to improve executive dysfunction in PD as well as other neurological conditions. Results of the study will be used to develop a larger placebo-controlled trial of atomoxetine, if appropriate, as well as inform the design of other clinical trials on potential treatments for cognitive dysfunction in PD.

The overall hypothesis is that atomoxetine will be an effective and safe treatment for executive dysfunction in PD.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Parkinson's Disease
Drug: Atomoxetine (Strattera)
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
12
September 2006
Not Provided

Inclusion Criteria:

  1. Men and women with idiopathic Parkinson’s Disease, as defined by UK Brain Bank Criteria.
  2. Adults, ages 21 to 65 years old.
  3. Clinically significant executive dysfunction, as defined by the reported presence of problems with disorganization, distractibility, task completion, planning or problem solving that represents a decline from premorbid (pre-PD) status and is confirmed by the patient’s informant.
  4. Mini-Mental State Exam (MMSE) score > 26.
  5. Absence of Dementia due to Parkinson’s Disease, as defined by DSM-IV-TR.
  6. Clinical Dementia Rating (CDR) Scale score < 1.
  7. Functional Assessment Staging (FAST) score < 4.
  8. Hamilton Depression Rating Scale (HDRS) Score < 11.
  9. Able to provide informed consent and participate in follow-up visits during the 8-week study duration.
  10. Availability of informant who knows the patient well and is willing to provide collateral information on the patient’s clinical status and response to treatment.
  11. On stable antiparkinsonian therapy for 3 months.
  12. Any stage of PD severity, e.g., Hoehn and Yahr stage I-V, but must be able to participate in testing battery and be capable of independent function so as to manifest executive dysfunction.
  13. Stable medical health with stable medication regimen for 3 months.
  14. If history of major depression or anxiety disorder, must have stable symptoms and be on stable therapy for 3 months.
  15. For women of childbearing potential, negative pregnancy test and reliable use of contraception.

Exclusion Criteria:

  1. Prior exposure to atomoxetine within the last 6 months.
  2. Current problems with urinary hesitancy or urinary retention.
  3. Uncontrolled hypertension or tachycardia.
  4. Narrow angle glaucoma.
  5. Current presence of hallucinations without insight or uncontrolled delusions (patients with benign visual hallucinations of any sensory modality with insight, e.g., passage or presence hallucinations, or controlled stable delusions will be enrolled).
  6. Illicit substance use or alcohol abuse or dependence within the last 6 months.
  7. Current symptomatic Major Depressive Disorder or Anxiety Disorder that warrants additional treatment, as assessed on clinical interview, or 21-item Hamilton Depression Scale > 10.
  8. For women, current pregnancy or nursing.
  9. Current use of potent CYP2D6 inhibitors, e.g., paroxetine, fluoxetine, quinidine.
  10. Current use of stimulant or wakefulness therapy, e.g., methylphenidate or modafinil.
  11. Current hepatic dysfunction, defined as values of two times or greater than the upper limit of normal on the AST or ALT hepatic enzymes or any disorder affecting the liver that in the opinion of the enrolling investigator would interfere with hepatic metabolism of the medication or interfere with the participant’s ability to complete the study.
  12. Current use of monoamine oxidase inhibitors that are typically used for treatment of depression (isocarboxazid, phenelzine, and tranylcypromine).
Both
21 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00286949
WIRB#20040223, B4Z-US-X029
Not Provided
Not Provided
Johns Hopkins University
Eli Lilly and Company
Principal Investigator: Laura Marsh, MD Johns Hopkins University
Johns Hopkins University
November 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP