Pilot Study of Varenicline (Chantix®) in the Treatment of Friedreich's Ataxia

NCT00803868

Last updated date
Study Location
University of South Florida
Tampa, Florida, 33612, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Friedreich's Ataxia
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-80 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

1. Outpatients with FA diagnosed by confirmed by genetic testing.

2. Age 18 years to 80 years.

3. Women who are not pregnant or breast feeding, and who do not intend to become pregnant. Women of child-bearing potential must use a reliable method of contraception and must provide a negative urine pregnancy test at entry into the study.

4. CBC, CMP, and diabetes lab results not indicative of clinically relevant abnormalities (results within the past 6 months prior to screening). These would include but are not limited to:

Electrolytes (Chloride, Sodium, Potassium) within laboratory defined normal limits.

Hemoglobin, white cell count, platelet count and fasting glucose within laboratory defined normal limits. Creatinine must be (≤1.5 mg/dl).

ALT (6-40 u/l) and AST (10-30 u/l) must be less than 2 times normal limit

5. Stable doses of all medications for 30 days prior to study entry and for the duration of the study.

6. Patient permission (informed consent).

7. Ambulatory status: Half of the enrolled patients must be able to ambulate with or without assistance; half of the enrolled patients must be non-ambulatory.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


1. Any unstable illness that in the investigator's opinion preclude participation in this
study.


2. Use of another investigational product within the past 28 days.


3. Patients with a history of substance abuse.


4. Presence of preexisting psychiatric illness (specifically schizophrenia, bipolar
disorder, or history of suicide attempt).


5. Presence of diabetes (as determined by fasting blood glucose labs within the past 6
months).


6. Presence of clinically significant cardiac disease (as determined by the investigator
based on EKG and echocardiogram results within the past 6 months). Specifically,
patients with an ejection fraction <40% or a prolonged QT interval (>50% of cycle
duration) will be excluded. If abnormalities are noted on the EKG or echocardiogram,
the patient will be eligible IF they provide clearance from a cardiologist.


7. Presence of current uncontrolled depression as measured by PHQ9 (criteria for
depression include all of the following to be present: At least one of the first two
questions on PHQ9 endorsed as positive (little pleasure, feeling depressed) indicating
the symptom has been present more than half the time in the past two weeks; Question
10 about difficulty at work or home or getting along with others should be answered at
least "somewhat difficult."; and the total score ≥ 10.


8. Concurrent treatment with any MAOIs, Wellbutrin, or nicotine patches.


9. Patients who currently smoke or have smoked within the past 12 months (Smoking will be
defined as having smoked any substance even on a single occasion).


10. Dementia or other psychiatric illness that prevents the patient from giving informed
consent (MMSE less than 25).


11. Legal incapacity or limited legal capacity.


12. Presence of severe renal disease (creatinine >1.6) or hepatic disease (AST or ALT>2x
times normal) (as evidenced by labs reported within the past 6 months).


13. Abnormal WBC hemoglobin or platelet count (as evidenced by labs reported within the
past 6 months).

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Friedreich's AtaxiaPilot Study of Varenicline (Chantix®) in the Treatment of Friedreich's Ataxia
NCT00803868
  1. Tampa, Florida
  2. Philadelphia, Pennsylvania
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Pilot Study of Varenicline (Chantix®) in the Treatment of Friedreich's Ataxia
Official Title  ICMJE Pilot Study of Varenicline (Chantix®) in the Treatment of Friedreich's Ataxia
Brief Summary The purpose of this study is to determine if varenicline is effective in treating symptoms of Friedreich's ataxia.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Friedreich's Ataxia
Intervention  ICMJE
  • Drug: varenicline
    up to 1mg po bid for 9 weeks
  • Drug: placebo
    placebo matching study drug up to 1mg po bid
Study Arms  ICMJE
  • Experimental: 1
    Varenicline
    Intervention: Drug: varenicline
  • Placebo Comparator: 2
    Placebo
    Intervention: Drug: placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: July 23, 2012)
28
Original Estimated Enrollment  ICMJE
 (submitted: December 5, 2008)
32
Actual Study Completion Date  ICMJE May 2010
Actual Primary Completion Date May 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Outpatients with FA diagnosed by confirmed by genetic testing.
  2. Age 18 years to 80 years.
  3. Women who are not pregnant or breast feeding, and who do not intend to become pregnant. Women of child-bearing potential must use a reliable method of contraception and must provide a negative urine pregnancy test at entry into the study.
  4. CBC, CMP, and diabetes lab results not indicative of clinically relevant abnormalities (results within the past 6 months prior to screening). These would include but are not limited to:

    Electrolytes (Chloride, Sodium, Potassium) within laboratory defined normal limits.

    Hemoglobin, white cell count, platelet count and fasting glucose within laboratory defined normal limits. Creatinine must be (?1.5 mg/dl).

    ALT (6-40 u/l) and AST (10-30 u/l) must be less than 2 times normal limit

  5. Stable doses of all medications for 30 days prior to study entry and for the duration of the study.
  6. Patient permission (informed consent).
  7. Ambulatory status: Half of the enrolled patients must be able to ambulate with or without assistance; half of the enrolled patients must be non-ambulatory.

Exclusion Criteria:

  1. Any unstable illness that in the investigator's opinion preclude participation in this study.
  2. Use of another investigational product within the past 28 days.
  3. Patients with a history of substance abuse.
  4. Presence of preexisting psychiatric illness (specifically schizophrenia, bipolar disorder, or history of suicide attempt).
  5. Presence of diabetes (as determined by fasting blood glucose labs within the past 6 months).
  6. Presence of clinically significant cardiac disease (as determined by the investigator based on EKG and echocardiogram results within the past 6 months). Specifically, patients with an ejection fraction <40% or a prolonged QT interval (>50% of cycle duration) will be excluded. If abnormalities are noted on the EKG or echocardiogram, the patient will be eligible IF they provide clearance from a cardiologist.
  7. Presence of current uncontrolled depression as measured by PHQ9 (criteria for depression include all of the following to be present: At least one of the first two questions on PHQ9 endorsed as positive (little pleasure, feeling depressed) indicating the symptom has been present more than half the time in the past two weeks; Question 10 about difficulty at work or home or getting along with others should be answered at least "somewhat difficult."; and the total score ? 10.
  8. Concurrent treatment with any MAOIs, Wellbutrin, or nicotine patches.
  9. Patients who currently smoke or have smoked within the past 12 months (Smoking will be defined as having smoked any substance even on a single occasion).
  10. Dementia or other psychiatric illness that prevents the patient from giving informed consent (MMSE less than 25).
  11. Legal incapacity or limited legal capacity.
  12. Presence of severe renal disease (creatinine >1.6) or hepatic disease (AST or ALT>2x times normal) (as evidenced by labs reported within the past 6 months).
  13. Abnormal WBC hemoglobin or platelet count (as evidenced by labs reported within the past 6 months).
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00803868
Other Study ID Numbers  ICMJE 6
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of South Florida
Study Sponsor  ICMJE University of South Florida
Collaborators  ICMJE
  • Friedreich's Ataxia Research Alliance
  • Pfizer
Investigators  ICMJE
Principal Investigator:Theresa Zesiewicz, M.D.University of South Florida
PRS Account University of South Florida
Verification Date July 2012

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