Phase 3 Completed N=514 Randomized Triple-blind Treatment

Trial to Assess Parkinson's Disease (PD) Symptom Control to Four Doses of Rotigotine in a Transdermal Patch

Parkinson's Disease

Source: ClinicalTrials.gov NCT00522379 ↗

Enrolled (actual)

514

Serious AEs

2.7%

Results posted

Dec 2012

Primary outcomePrimary: The Change in the Absolute Time Spent "Off" From Baseline to the End of the Maintenance Period as Recorded by the Subject in a Daily Diary — -1.948; -2.052; -2.138; -2.360 Hours

Summary

The purpose of this study is to show Rotigotine dose response at four doses of Rotigotine used with L-dopa in treating advanced stage Parkinson's disease.

Outcome Measures

Outcome	Result	p-value
PRIMARY The Change in the Absolute Time Spent "Off" From Baseline to the End of the Maintenance Period as Recorded by the Subject in a Daily Diary	-1.948; -2.052; -2.138; -2.360; -1.499	—
SECONDARY The Change in Relative Time Spent "Off" From Baseline to the End of the Maintenance Period as Recorded by the Subject in a Daily Diary	-12.058; -13.463; -13.410; -14.529; -9.250	—
SECONDARY The Change in the Absolute Time Spent "on" From Baseline to the End of the Maintenance Period as Recorded by the Subject in a Daily Diary	1.821; 2.095; 2.118; 2.364; 1.335	—
SECONDARY The Change in the Relative Time Spent "on" From Baseline to the End of the Maintenance Period as Recorded by the Subject in a Daily Diary	12.058; 13.463; 13.410; 14.529; 9.250	—
SECONDARY The Change in the Status of the Subject After Wake-Up From Baseline to the End of the Maintenance Period as Recorded by the Subject in a Daily Diary	23.688; 24.593; 20.935; 21.083; 19.712; -0.667	—
SECONDARY The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part II From Baseline to the End of the Maintenance Period	-2.1; -2.2; -1.5; -2.1; -0.9	—
SECONDARY The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part III From Baseline to the End of the Maintenance Period	-3.4; -4.5; -3.5; -5.9; -2.5	—
SECONDARY The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - What Proportion of the Waking Day Are Dyskinesias Present?	15; 14; 13; 15; 12; 74	—
SECONDARY The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Disability: How Disabling Are the Dyskinesias?	7; 6; 2; 6; 9; 80	—
SECONDARY The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Painful Dyskinesias: How Painful Are the Dyskinesias?	2; 3; 4; 2; 8; 90	—
SECONDARY The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Presence of Early Morning Dystonia	5; 9; 7; 6; 14; 81	—
SECONDARY The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Are "Off" Periods Predictable?	6; 4; 12; 3; 11; 80	—
SECONDARY The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Are "Off" Periods Unpredictable?	15; 12; 8; 8; 12; 71	—
SECONDARY The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Do "Off" Periods Come on Suddenly?	6; 7; 11; 9; 15; 80	—
SECONDARY The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - What Proportion of the Waking Day is the Subject "Off", on Average?	8; 4; 8; 7; 11; 52	—
SECONDARY The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Does the Patient Have Anorexia, Nausea, or Vomiting?	4; 2; 3; 5; 3; 88	—
SECONDARY The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Does the Patient Have Any Sleep Disturbances Such as Insomnia or Hypersomnolence?	13; 14; 7; 4; 12; 70	—
SECONDARY The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Does the Patient Have Symptomatic Orthostasis?	0; 6; 2; 4; 8; 91	—
SECONDARY The Change in Number of "Off" Periods From Baseline to the End of the Maintenance Period as Recorded by the Subject in a Daily Diary	-1.144; -1.294; -1.323; -1.304; -1.006	—

Eligibility Criteria

Inclusion Criteria

PD greater than 3 years
Stable dose L-dopa but symptoms not adequately controlled and have "off" time
Able and willing to complete diary on specific days

Exclusion Criteria

Previous use of rotigotine or Neupro
Atypical Parkinson's syndrome
Pallidotomy
Thalamotomy
Deep brain stimulation
Fetal tissue transplant
Dementia
Psychosis
Hallucinations
Epilepsy
Renal or hepatic dysfunction
Clinically relevant cardiac dysfunction
Symptomatic orthostatic hypotension
Skin sensitivity to adhesives or unresolved contact dermatitis
History of chronic alcohol or drug abuse
Pregnant or of child-bearing potential
Impulse control disorder

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00522379). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.