Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Validation of Dyskinesia Rating Scales

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01071395
Recruitment Status : Completed
First Posted : February 19, 2010
Results First Posted : May 28, 2015
Last Update Posted : May 28, 2015
Sponsor:
Collaborator:
Michael J. Fox Foundation for Parkinson's Research
Information provided by (Responsible Party):
Christopher G. Goetz, MD, Rush University Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Condition Parkinson's Disease
Interventions Drug: Amantadine
Drug: Placebo
Enrollment 68
Recruitment Details Location: Medical clinics
Pre-assignment Details  
Arm/Group Title Amantadine Placebo
Hide Arm/Group Description Amantadine: Amantadine hydrochloride 300mg daily in three divided doses Placebo: Sugar pill given 3 times daily
Period Title: Overall Study
Started 36 32
Completed 31 30
Not Completed 5 2
Reason Not Completed
Withdrawal by Subject             2             1
Adverse Event             3             1
Arm/Group Title Amantadine Placebo Total
Hide Arm/Group Description Amantadine: Amantadine hydrochloride 300mg daily in three divided doses Placebo: Sugar pill given 3 times daily Total of all reporting groups
Overall Number of Baseline Participants 36 32 68
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 36 participants 32 participants 68 participants
65.4  (8.2) 68.5  (6.9) 66.8  (7.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants 32 participants 68 participants
Female
10
  27.8%
11
  34.4%
21
  30.9%
Male
26
  72.2%
21
  65.6%
47
  69.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 36 participants 32 participants 68 participants
France 2 4 6
United States 25 23 48
Canada 4 1 5
Austria 5 4 9
Movement Disorder Society revision of the Unified Parkinson's Disease Rating Scale MDS-UPDRS Part I   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 36 participants 32 participants 68 participants
9.8  (5.2) 10.2  (5.2) 10.0  (5.2)
[1]
Measure Description: The Movement Disorder Society sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part I provides a measure of Non-Motor Experiences of Daily Living for the patient. These non-motor experiences include such items as cognitive function, psychosis and mood disturbances. Each item is rated on a 0 to 4 Likert type scale with 0 representing no impairment and 4 representing severe impairment. Part I score can range from 0 to 52.
MDS-UPDRS Part II   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 36 participants 32 participants 68 participants
13.8  (5.8) 14.3  (6.5) 14.0  (6.1)
[1]
Measure Description: The Movement Disorder Society sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II provides a measure of Motor Experiences of Daily Living for the patient using a Patient Reported Outcome approach. These motor experiences include such items as walking, fine motor or tremor disturbances. Each item is rated on a 0 to 4 Likert type scale with 0 representing no impairment and 4 representing severe impairment. Total Part II score can range from 0 to 52.
MDS-UPDRS Part III   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 36 participants 32 participants 68 participants
24.3  (10.7) 20.3  (13.6) 22.5  (12.2)
[1]
Measure Description: The Movement Disorder Society sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III provides an objective (rater administered) measure of Parkinsonian motor impairment for the patient. These ratings are based on physical examination of the patient for signs such as tremor, rigidity, bradykinesia and postural instability. Each item is rated on a 0 to 4 Likert type scale with 0 representing no impairment and 4 representing severe impairment. Total Part III score can range from 0 to 132.
MDS-UPDRS Part IV   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 36 participants 32 participants 68 participants
8.5  (3.1) 9.9  (3.6) 9.2  (3.4)
[1]
Measure Description: The Movement Disorder Society sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part IV provides a measure of complications of anti-parkinsonian treatment for the patient. These complications include such items as dyskinesia and dystonia. Each item is rated on a 0 to 4 Likert type scale with 0 representing no impairment and 4 representing severe impairment. Total Part IV score can range from 0 to 24.
Hoehn & Yahr Stage   [1] 
Median (Full Range)
Unit of measure:  Units on a scale
Number Analyzed 36 participants 32 participants 68 participants
2
(1 to 4)
2
(1 to 4)
2
(1 to 4)
[1]
Measure Description: The Hoehn and Yahr stage is a 0 to 5 Likert-type rating of global parkinsonian impairment with 0 representing no impairment and 5 representing inability to get out of bed or a wheelchair.
1.Primary Outcome
Title The Investigators Will Assess Effect Size With Each Scale for Detecting Change From Baseline and Change Between Amantadine and Placebo; Allowing Assessment of Sensitivity and Specificity for Each Scale Based on Receiver Operator Characteristics (ROC).
Hide Description Analyses of primary outcome measures tested sensitivity to change in dyskinesia (time effect) as well as sensitivity to differences in treatment effect (time-by-treatment interaction). These analyses were conducted using repeated-measures ANOVA (RM-ANOVA) or nonparametric analyses (Friedman’s ANOVA with follow-up Wilcoxon tests). The RM-ANOVAs tested for changes in scale scores over baseline, week 4, and week 8 visits across the entire sample (time effect), as well as differences in these changes over time between treatment groups (time-by-treatment interaction). Effect size of time to change was compared using a partial eta-square estimate of effect size. An eta-squared less than or equal to 0.01 is considered small; 0.06 is considered medium; and, 0.14 is considered large.
Time Frame 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Amantadine Placebo
Hide Arm/Group Description:
Amantadine: Amantadine hydrochloride 300mg daily in three divided doses
Placebo: Sugar pill given daily in three divided doses
Overall Number of Participants Analyzed 31 30
Measure Type: Number
Unit of Measure: unitless
0.061 0.061
2.Secondary Outcome
Title Differences in Slope From Baseline (BL) to End of Study (Data Will Include the 4 Week Scores) Between Placebo and Amantadine to Determine Which Scales Demonstrate Sensitivity Across Time.
Hide Description [Not Specified]
Time Frame 18 months
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Change Score Differences Between Week 4 and 8 to Measure Stability of Scales Over Two Visits on Stable Doses of Amantadine or Placebo
Hide Description [Not Specified]
Time Frame 18 months
Outcome Measure Data Not Reported
4.Secondary Outcome
Title If Sufficient Number Are Maintained on 200 mg/Day, Differences in Change Scores Between 200 mg/Day and 300 mg/Day Amantadine. (This Analysis Will be BL vs End of Study)
Hide Description [Not Specified]
Time Frame 18 months
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Correlations Among the Scales
Hide Description [Not Specified]
Time Frame 18 months
Outcome Measure Data Not Reported
6.Secondary Outcome
Title Correlations Between Scale Values and Clinical Global Impressions-Severity (CGI-s) and Correlations Between Scale Changes and Clinical Global Impression of Change (CGI-c)
Hide Description [Not Specified]
Time Frame 18 months
Outcome Measure Data Not Reported
7.Secondary Outcome
Title Safety Monitoring Will be Operative Throughout the Study
Hide Description [Not Specified]
Time Frame 18 months
Outcome Measure Data Not Reported
Time Frame Adverse event recording occurred throughout the study duration.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Amantadine Placebo
Hide Arm/Group Description Amantadine: Amantadine hydrochloride 300mg daily in three divided doses Placebo: Sugar pill given 3 times daily
All-Cause Mortality
Amantadine Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Amantadine Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/36 (0.00%)      0/32 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Amantadine Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/36 (11.11%)      3/32 (9.38%)    
Gastrointestinal disorders     
Dry mouth   4/36 (11.11%)  4 3/32 (9.38%)  3
Indicates events were collected by systematic assessment
Study limitations include the patient population universally derived from university centers and the short duration of the program.
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: Dr. Christopher G. Goetz
Organization: Rush University of Medical Center
Phone: 312-942-8016
Responsible Party: Christopher G. Goetz, MD, Rush University Medical Center
ClinicalTrials.gov Identifier: NCT01071395     History of Changes
Other Study ID Numbers: Valid Dyskin Rating Scales
First Submitted: February 17, 2010
First Posted: February 19, 2010
Results First Submitted: November 17, 2014
Results First Posted: May 28, 2015
Last Update Posted: May 28, 2015