Trial Outcomes & Findings for Validation of Dyskinesia Rating Scales (NCT NCT01071395)

Last Updated: 2022-12-29

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

68 participants

Primary outcome timeframe

18 months

Results posted on

2022-12-29

Participant Flow

Location: Medical clinics

Participant milestones

Participant milestones
Measure	Amantadine Amantadine: Amantadine hydrochloride 300mg daily in three divided doses	Placebo Placebo: Sugar pill given 3 times daily
Overall Study STARTED	36	32
Overall Study COMPLETED	31	30
Overall Study NOT COMPLETED	5	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Amantadine Amantadine: Amantadine hydrochloride 300mg daily in three divided doses	Placebo Placebo: Sugar pill given 3 times daily
Overall Study Withdrawal by Subject	2	1
Overall Study Adverse Event	3	1

Baseline Characteristics

Validation of Dyskinesia Rating Scales

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Amantadine n=36 Participants Amantadine: Amantadine hydrochloride 300mg daily in three divided doses	Placebo n=32 Participants Placebo: Sugar pill given 3 times daily	Total n=68 Participants Total of all reporting groups
Age, Continuous	65.4 years STANDARD_DEVIATION 8.2 • n=5 Participants	68.5 years STANDARD_DEVIATION 6.9 • n=7 Participants	66.8 years STANDARD_DEVIATION 7.7 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	11 Participants n=7 Participants	21 Participants n=5 Participants
Sex: Female, Male Male	26 Participants n=5 Participants	21 Participants n=7 Participants	47 Participants n=5 Participants
Region of Enrollment France	2 participants n=5 Participants	4 participants n=7 Participants	6 participants n=5 Participants
Region of Enrollment United States	25 participants n=5 Participants	23 participants n=7 Participants	48 participants n=5 Participants
Region of Enrollment Canada	4 participants n=5 Participants	1 participants n=7 Participants	5 participants n=5 Participants
Region of Enrollment Austria	5 participants n=5 Participants	4 participants n=7 Participants	9 participants n=5 Participants
Movement Disorder Society revision of the Unified Parkinson's Disease Rating Scale MDS-UPDRS Part I	9.8 units on a scale STANDARD_DEVIATION 5.2 • n=5 Participants	10.2 units on a scale STANDARD_DEVIATION 5.2 • n=7 Participants	10.0 units on a scale STANDARD_DEVIATION 5.2 • n=5 Participants
MDS-UPDRS Part II	13.8 units on a scale STANDARD_DEVIATION 5.8 • n=5 Participants	14.3 units on a scale STANDARD_DEVIATION 6.5 • n=7 Participants	14.0 units on a scale STANDARD_DEVIATION 6.1 • n=5 Participants
MDS-UPDRS Part III	24.3 units on a scale STANDARD_DEVIATION 10.7 • n=5 Participants	20.3 units on a scale STANDARD_DEVIATION 13.6 • n=7 Participants	22.5 units on a scale STANDARD_DEVIATION 12.2 • n=5 Participants
MDS-UPDRS Part IV	8.5 units on a scale STANDARD_DEVIATION 3.1 • n=5 Participants	9.9 units on a scale STANDARD_DEVIATION 3.6 • n=7 Participants	9.2 units on a scale STANDARD_DEVIATION 3.4 • n=5 Participants
Hoehn & Yahr Stage	2 units on a scale n=5 Participants	2 units on a scale n=7 Participants	2 units on a scale n=5 Participants

PRIMARY outcome

Timeframe: 18 months

Outcome measures

Outcome measures
Measure	Amantadine n=31 Participants Amantadine: Amantadine hydrochloride 300mg daily in three divided doses	Placebo n=30 Participants Placebo: Sugar pill given daily in three divided doses
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).	0.061 unitless	0.061 unitless

Adverse Events

Amantadine

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Amantadine n=36 participants at risk Amantadine: Amantadine hydrochloride 300mg daily in three divided doses	Placebo n=32 participants at risk Placebo: Sugar pill given 3 times daily
Gastrointestinal disorders Dry mouth	11.1% 4/36 • Number of events 4 • Adverse event recording occurred throughout the study duration.	9.4% 3/32 • Number of events 3 • Adverse event recording occurred throughout the study duration.

Additional Information

Dr. Christopher G. Goetz

Rush University of Medical Center

Phone: 312-942-8016

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place