Trial Outcomes & Findings for Topiramate as an Adjunct to Amantadine in the Treatment of Dyskinesia in Parkinson's Disease (NCT NCT01789047)

Last Updated: 2019-04-16

Results Overview

The Unified Dyskinesia Rating Scale (UDysRS) will be the primary outcome measure for this study. This choice is based on the outcome of the Validation of Dyskinesia Rating Scales study. In this study, the UDysRS was identified as the most sensitive scale to detect change in dyskinesia in an 8-week, double-blind, placebo-controlled trial of amatadine. The UDysRS utilizes rater information, patient self-report and objective measures of dyskinesia to provide assessments of impairment and disability due to dyskinesia. Score ranges are 0-108 with higher scores representing more severe impairment.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

42 participants

Primary outcome timeframe

Change from baseline to week 14 (end of study) on the Unified Dyskinesia Rating Scale

Results posted on

2019-04-16

Participant Flow

Participant milestones

Participant milestones
Measure	Topiramate Topiramate as adjunct to amantadine. Topiramate: Topiramate as adjunct to amantadine	Placebo (Sugar Pill) Placebo Placebo: Placebo control
Overall Study STARTED	21	21
Overall Study COMPLETED	17	17
Overall Study NOT COMPLETED	4	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Topiramate Topiramate as adjunct to amantadine. Topiramate: Topiramate as adjunct to amantadine	Placebo (Sugar Pill) Placebo Placebo: Placebo control
Overall Study Adverse Event	3	2
Overall Study Withdrawal by Subject	1	2

Baseline Characteristics

Topiramate as an Adjunct to Amantadine in the Treatment of Dyskinesia in Parkinson's Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Topiramate n=21 Participants Topiramate as adjunct to amantadine. Topiramate: Topiramate as adjunct to amantadine	Placebo (Sugar Pill) n=21 Participants Placebo Placebo: Placebo control	Total n=42 Participants Total of all reporting groups
Age, Continuous	61.5 years STANDARD_DEVIATION 6.9 • n=5 Participants	63.1 years STANDARD_DEVIATION 8.9 • n=7 Participants	62.7 years STANDARD_DEVIATION 7.4 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	9 Participants n=7 Participants	15 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants	12 Participants n=7 Participants	27 Participants n=5 Participants
Region of Enrollment United States	21 Participants n=5 Participants	21 Participants n=7 Participants	42 Participants n=5 Participants

PRIMARY outcome

Timeframe: Change from baseline to week 14 (end of study) on the Unified Dyskinesia Rating Scale

Population: Last Observation Carried Forward imputation

Outcome measures

Outcome measures
Measure	Topiramate n=21 Participants Topiramate as adjunct to amantadine. Topiramate: Topiramate as adjunct to amantadine	Placebo (Sugar Pill) n=21 Participants Placebo Placebo: Placebo control
The Unified Dyskinesia Rating Scale (UDysRS)	4.00 units on a scale Standard Deviation 11.34	1.67 units on a scale Standard Deviation 10.27

OTHER_PRE_SPECIFIED outcome

Timeframe: Assessed at Week 10 and 14 by blinded treating physician and subject

The Clinical Global Impression - Change score is an ordinal measure of change with a range of 0 (not assessed) to 7 (very much worse). A score of 4 is associated with "no change".

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Assessed at baseline, week 6, week 10 and week 14

This is a 4-part scale that rates both non-motor and motor (including dyskinesia) aspects of Parkinson's disease. Parts of the scales will be completed by the blinded treating physician while assessing the subject and other parts will be self-completed by the subject

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Assessment completed at baseline, week 6, week 10 and week 14

Hoehn \& Yahr staging of Parkinson's disease is completed by the blinded treating physician assessing the subject

Outcome measures

Outcome data not reported

Adverse Events

Topiramate

Serious events: 2 serious events

Other events: 16 other events

Deaths: 0 deaths

Placebo (Sugar Pill)

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Topiramate n=21 participants at risk Topiramate as adjunct to amantadine. Topiramate: Topiramate as adjunct to amantadine	Placebo (Sugar Pill) n=21 participants at risk Placebo Placebo: Placebo control
Nervous system disorders Transit Ischemic Attack-like symptoms	4.8% 1/21 • Number of events 1	0.00% 0/21
Injury, poisoning and procedural complications Fall leading to hospitalization	4.8% 1/21 • Number of events 1	0.00% 0/21

Other adverse events

Other adverse events
Measure	Topiramate n=21 participants at risk Topiramate as adjunct to amantadine. Topiramate: Topiramate as adjunct to amantadine	Placebo (Sugar Pill) n=21 participants at risk Placebo Placebo: Placebo control
Nervous system disorders Balance instability	4.8% 1/21 • Number of events 1	4.8% 1/21 • Number of events 1
General disorders Biting lower lip	4.8% 1/21 • Number of events 1	0.00% 0/21
Eye disorders Blurred vision	14.3% 3/21 • Number of events 3	4.8% 1/21 • Number of events 1
Nervous system disorders cognitive decline	0.00% 0/21	4.8% 1/21 • Number of events 1
Infections and infestations Common cold	4.8% 1/21 • Number of events 1	0.00% 0/21
Nervous system disorders Confusion	0.00% 0/21	4.8% 1/21 • Number of events 1
Respiratory, thoracic and mediastinal disorders Cough	9.5% 2/21 • Number of events 2	0.00% 0/21
Gastrointestinal disorders Decreased appetite	9.5% 2/21 • Number of events 2	0.00% 0/21
Nervous system disorders Dizziness	9.5% 2/21 • Number of events 2	4.8% 1/21 • Number of events 1
General disorders Dry mouth	4.8% 1/21 • Number of events 1	9.5% 2/21 • Number of events 2
General disorders Falls	9.5% 2/21 • Number of events 2	4.8% 1/21 • Number of events 1
General disorders Fatigue	4.8% 1/21 • Number of events 1	4.8% 1/21 • Number of events 1
Psychiatric disorders Hallucinations	9.5% 2/21 • Number of events 2	9.5% 2/21 • Number of events 2
General disorders Headache	4.8% 1/21 • Number of events 1	0.00% 0/21
Nervous system disorders Increased OFF time	9.5% 2/21 • Number of events 2	14.3% 3/21 • Number of events 3
Nervous system disorders Increased dreaming	0.00% 0/21	4.8% 1/21 • Number of events 1
Nervous system disorders Increased freezing of gait	0.00% 0/21	4.8% 1/21 • Number of events 1
Respiratory, thoracic and mediastinal disorders Intermittent SOB	4.8% 1/21 • Number of events 1	0.00% 0/21
Infections and infestations Ottis media	4.8% 1/21 • Number of events 1	0.00% 0/21
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pre cancerous lesion	4.8% 1/21 • Number of events 1	0.00% 0/21
Infections and infestations Sinus infection	4.8% 1/21 • Number of events 1	9.5% 2/21 • Number of events 2
Nervous system disorders Speech abnormalities	4.8% 1/21 • Number of events 1	4.8% 1/21 • Number of events 1
Metabolism and nutrition disorders Weight gain	0.00% 0/21	4.8% 1/21 • Number of events 1
Metabolism and nutrition disorders Weight loss	14.3% 3/21 • Number of events 3	0.00% 0/21
General disorders Tingling fingers and toes	4.8% 1/21 • Number of events 1	0.00% 0/21
Gastrointestinal disorders Worsening constipation	0.00% 0/21	4.8% 1/21 • Number of events 1

Additional Information

Director of Clinical Research

Rush University Medical Center

Phone: 312 942 8002

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place