Trial record 1 of 1 for:    NCT01280123
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Pioglitazone in Early Parkinson's Disease

This study has been completed.
Sponsor:
Collaborators:
National Institute of Neurological Disorders and Stroke (NINDS)
Michael J. Fox Foundation for Parkinson's Research
Information provided by (Responsible Party):
University of Rochester
ClinicalTrials.gov Identifier:
NCT01280123
First received: December 3, 2010
Last updated: September 15, 2015
Last verified: September 2013
Results First Received: August 13, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Parkinson's Disease
Interventions: Drug: Pioglitazone
Drug: placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
15 mg Pioglitazone

15 mg pioglitazone

Pioglitazone: Oral capsules of Pioglitazone (15 mg capsules) either 15 mg/qd or 45 mg/qd or matching placebo

44 weeks: Subjects who are on stable dose of rasagiline 1 mg/day or selegiline 10 mg/day, for at least 8 weeks but no more than 8 months, will begin randomized dose of study drug. Subjects will titrate in a blinded fashion to 30 mg/day after 2 weeks and to 45 mg per day) 2 weeks later as tolerated. Subjects will be followed on study drug for 44 weeks.

45 mg Pioglitazone

45 mg pioglitazone

Pioglitazone: Oral capsules of Pioglitazone (15 mg capsules) either 15 mg/qd or 45 mg/qd or matching placebo

44 weeks: Subjects who are on stable dose of rasagiline 1 mg/day or selegiline 10 mg/day, for at least 8 weeks but no more than 8 months, will begin randomized dose of study drug. Subjects will titrate in a blinded fashion to 30 mg/day after 2 weeks and to 45 mg per day) 2 weeks later as tolerated. Subjects will be followed on study drug for 44 weeks.

Matching Placebo

Placebo

placebo: Placebo will contain microcrystalline cellulose. An over-encapsulation process will be conducted in accordance with Clinical Good Manufacturing Procedures (cGMP) regulations to create a dosage form for the active study drug that will be indistinguishable from the comparator (Placebo) capsule.


Participant Flow:   Overall Study
    15 mg Pioglitazone     45 mg Pioglitazone     Matching Placebo  
STARTED     72     67     71  
COMPLETED     71     63     70  
NOT COMPLETED     1     4     1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
15 mg Pioglitazone

15 mg pioglitazone

Pioglitazone: Oral capsules of Pioglitazone (15 mg capsules) either 15 mg/qd or 45 mg/qd or matching placebo

44 weeks: Subjects who are on stable dose of rasagiline 1 mg/day or selegiline 10 mg/day, for at least 8 weeks but no more than 8 months, will begin randomized dose of study drug. Subjects will titrate in a blinded fashion to 30 mg/day after 2 weeks and to 45 mg per day) 2 weeks later as tolerated. Subjects will be followed on study drug for 44 weeks.

45 mg Pioglitazone

45 mg pioglitazone

Pioglitazone: Oral capsules of Pioglitazone (15 mg capsules) either 15 mg/qd or 45 mg/qd or matching placebo

44 weeks: Subjects who are on stable dose of rasagiline 1 mg/day or selegiline 10 mg/day, for at least 8 weeks but no more than 8 months, will begin randomized dose of study drug. Subjects will titrate in a blinded fashion to 30 mg/day after 2 weeks and to 45 mg per day) 2 weeks later as tolerated. Subjects will be followed on study drug for 44 weeks.

Matching Placebo

Placebo

placebo: Placebo will contain microcrystalline cellulose. An over-encapsulation process will be conducted in accordance with Clinical Good Manufacturing Procedures (cGMP) regulations to create a dosage form for the active study drug that will be indistinguishable from the comparator (Placebo) capsule.

Total Total of all reporting groups

Baseline Measures
    15 mg Pioglitazone     45 mg Pioglitazone     Matching Placebo     Total  
Number of Participants  
[units: participants]
  72     67     71     210  
Age  
[units: years]
Mean (Standard Deviation)
  61.3  (10.6)     58.8  (9.2)     59.0  (9.9)     59.7  (9.9)  
Gender, Customized  
[units: participants]
       
Males     53     47     48     148  
Females     19     20     23     62  
Race/Ethnicity, Customized  
[units: participants]
       
Non-Latino whites     58     63     63     184  
Racial/Ethnic Minority     14     4     8     26  
Years of education  
[units: years]
Mean (Standard Deviation)
  17.1  (3.1)     16.2  (3.3)     16.8  (3.0)     16.7  (3.1)  
Right-handed  
[units: participants]
       
Yes     62     62     62     186  
No     10     5     9     24  
Duration of PD symptoms (years)  
[units: years]
Mean (Standard Deviation)
  2.3  (1.9)     2.0  (1.2)     2.3  (2.3)     2.2  (1.9)  
Time since PD diagnosis (years)  
[units: years]
Mean (Standard Deviation)
  0.8  (0.7)     0.7  (0.7)     0.8  (0.7)     0.7  (0.7)  
Total Unified Parkinson's Disease Rating Scale (UPDRS) [1]
[units: units on a scale]
Mean (Standard Deviation)
  23.8  (9.9)     21.2  (8.8)     21.7  (8.7)     22.2  (9.2)  
UPDRS mental [2]
[units: units on a scale]
Mean (Standard Deviation)
  0.8  (0.9)     0.8  (0.9)     0.9  (1.1)     0.8  (1.0)  
UPDRS motor [3]
[units: units on a scale]
Mean (Standard Deviation)
  17.7  (7.7)     15.0  (7.1)     15.3  (6.5)     15.8  (7.1)  
UPDRS ADL [4]
[units: units on a scale]
Mean (Standard Deviation)
  5.9  (3.2)     5.5  (2.9)     5.5  (3.0)     5.6  (3.0)  
Ambulatory capacity [5]
[units: units on a scale]
Mean (Standard Deviation)
  1.1  (0.9)     0.8  (0.8)     1.1  (0.9)     1.0  (0.9)  
Schwab and England Activities of Daily Living scale (SEADL) [6]
[units: units on a scale]
Mean (Standard Deviation)
  93.8  (4.9)     94.1  (5.0)     93.9  (5.0)     93.9  (4.9)  
Parkinson's Disease Questionnaire 39 (PDQ-39) Summary Index [7]
[units: units on a scale]
Mean (Standard Deviation)
  8.5  (8.1)     8.1  (5.9)     10.6  (7.9)     9.1  (7.4)  
Geriatric Depression Scale (GDS) [8]
[units: units on a scale]
Mean (Standard Deviation)
  1.4  (1.4)     1.1  (1.3)     1.8  (1.9)     1.4  (1.6)  
Mattis-Dementia Rating scale [9]
[units: units on a scale]
Mean (Standard Deviation)
  138.6  (8.2)     138.8  (10.2)     138  (11.4)     138.4  (9.9)  
rasagiline/selegiline use [10]
[units: participants]
       
rasagiline use     60     57     60     177  
selegiline use     12     10     11     33  
[1] The Total UPDRS is the sum of parts I, II, and III. The possible range of the total UPDRS is from 0-176. Higher values indicate worse outcomes.
[2] The UPDRS mental score is the sum of the questions in part I. The possible range of the UPDRS mental is from 0-16. Higher values indicate worse outcomes.
[3] The UPDRS motor score is the sum of the questions in part III. The possible range of the UPDRS motor is from 0-108. Higher values indicate worse outcomes.
[4] The UPDRS ADL score is the sum of the questions in part II (activities of daily living). The possible range of the UPDRS ADL is from 0-52. Higher values indicate worse outcomes.
[5] Ambulatory Capacity is calculated as the sum of items 13-15, 29, 30 of the Unified Parkinson's Disease Rating Scale (UPDRS). It ranges from 0-20. Higher scores are worse.
[6] The modified Schwab and England Activities of Daily Living is a single question ranging from 0-100% with anchors for each 10% interval. Higher scores are better (100% completely independent- 0% vegetative).
[7] The PDQ-39 is a 39-item self-report questionnaire, which assesses Parkinson’s disease-specific health related quality. The total score ranges from 0 (never have difficulty) to 100 (always have difficulty). Lower scores reflect better quality of life.
[8] Short version. 15 questions. A score of 0 to 5 is normal. A score greater than 5 suggests depression.
[9] Mattis Dementia Rating scale (DRS-2) raw score is the sum of 5 raw sub-scores (attention has possible 37 points, initiation/perseveration has possible 37 points, construction has possible 6 points, conceptualization has possible 39 points, memory has possible 25 points). Total range is 0-144. Higher scores are better.
[10] Proportion of patients on stable regimen of either 1 mg/day rasagiline or 10 mg/day selegiline at baseline.



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change in Total Unified Parkinson's Disease Rating Scale (UPDRS) Score From Baseline to 44 Weeks   [ Time Frame: 44 weeks ]

2.  Secondary:   Change in Ambulatory Capacity From Baseline to 44 Weeks   [ Time Frame: 44 weeks ]

3.  Secondary:   Change in Schwab and England Scale From Baseline to 44 Weeks   [ Time Frame: 44 weeks ]

4.  Secondary:   Change in Parkinson's Disease Questionnaire (PDQ-39) From Baseline to 44 Weeks   [ Time Frame: 44 weeks ]

5.  Secondary:   Change in the Mattis Dementia Rating Scale (DRS-2)From Baseline to 44 Weeks   [ Time Frame: 44 weeks ]

6.  Secondary:   Change in the 15-item Geriatric Depression Scale (GDS-15)From Baseline to 44 Weeks   [ Time Frame: 44 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Tanya Simuni, MD
Organization: Northwestern University
e-mail: TSimuni@nm.org


Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: University of Rochester
ClinicalTrials.gov Identifier: NCT01280123     History of Changes
Other Study ID Numbers: FS-ZONE
5U01NS043128-12 ( US NIH Grant/Contract Award Number )
Study First Received: December 3, 2010
Results First Received: August 13, 2015
Last Updated: September 15, 2015
Health Authority: United States: Food and Drug Administration