Phase 3
Completed N=90
A Phase 3b, Open-Label, Safety and Efficacy Study of Rotigotine as Add-On Therapy With Low Doses of Pramipexole or Ropinirole in Patients With Advanced Parkinson's Disease
Advanced Parkinson's Disease
Source: ClinicalTrials.gov NCT01723904 ↗
Enrolled (actual)
90
Serious AEs
5.6%
Results posted
Jun 2014
Primary outcomePrimary: Clinical Global Impression (CGI) Item 4 (Side Effects) at the End of the Treatment Period — 61; 22; 3; 3 participants
Summary
This study is to investigate the safety and efficacy of Rotigotine add-on therapy with low doses of Pramipexole or Ropinirole in patients with advanced-stage Parkinson's Disease (PD) who have insufficient response to L-dopa and low doses dopamine receptor agonists.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinical Global Impression (CGI) Item 4 (Side Effects) at the End of the Treatment Period |
61; 22; 3; 3; 6 | — |
| PRIMARY Change From Baseline to the End of the Treatment Period in the Unified Parkinson's Disease Rating Scale (UPDRS) Part III ("on" State) Total Score |
-5.3 | — |
| PRIMARY Change From Baseline to the End of the Treatment Period in the Unified Parkinson's Disease Rating Scale (UPDRS) Part II (Average of "on" and "Off" State) Total Score |
-1.5 | — |
| PRIMARY Change From Baseline to the End of the Treatment Period in Absolute Time Spent "Off" |
-2.1 | — |
| SECONDARY Change From Baseline to the End of the Treatment Period in Time Spent "on" Without Troublesome Dyskinesia |
1.9 | — |
| SECONDARY Change From Baseline to the End of Treatment Period in Parkinson's Disease Sleep Scale 2 (PDSS-2) Total Score |
-3.2 | — |
| SECONDARY Change From Baseline to the End of Treatment Period in the Pittsburgh Sleep Quality Index (PSQI) Global Score |
-0.7 | — |
Eligibility Criteria
Inclusion Criteria
- Subject is male or female, aged ≥ 30 and < 80 years at informed consent
- Subject has idiopathic Parkinson's Disease, of more than 3 years duration, as defined by the cardinal sign, bradykinesia, and the presence of at least 1 of the following: resting tremor, rigidity, impairment of postural reflexes, and without any known or suspected cause of Parkinsonism
- Subject has motor fluctuations such as wearing, dyskinesia
- Subject has experienced nocturias for at least 3 nights within 7 days prior to Baseline
- Subject is taking levodopa (L-DOPA, immediate and/or controlled release) in combination with benserazide or carbidopa and has been on a stable dose of L-DOPA for at least 28 days prior to Baseline (Visit 2)
- Subject is taking a non-ergot dopamine agonist (pramipexole ≤ 1.5 mg/day or ropinirole ≤ 6.0 mg/day) and has been on a stable dose of non-ergot dopamine agonist for at least 28 days prior to Baseline (Visit 2)
Exclusion Criteria
- Subject is receiving therapy with tolcapone or budipine
- Subject is receiving therapy with one of the following drugs either concurrently or within 28 days prior to Baseline (Visit 2): alpha-methyl dopa, metoclopramide, reserpine, neuroleptics (except specific atypical neuroleptics: olanzapine, ziprasidone, aripiprazole, clozapine, quetiapine), monoamine oxidase A (MAO-A) inhibitors, methylphenidate, or amphetamine
- Subject has a history of symptomatic (not asymptomatic) orthostatic hypotension within the 6 months prior to Baseline (Visit 2)
- Subject has a known hypersensitivity to any components of the study medication, such as a history of significant skin hypersensitivity to adhesives, known hypersensitivity to other transdermal medications, or has unresolved contact dermatitis
- Subject is pregnant or nursing, or is of child-bearing potential (ie, is (i) not surgically sterile, or, (ii) not using adequate birth control methods [including at least one barrier method] or, (iii) not sexually abstinent, or (iv) not at least 2 years post menopausal)
- Subject had a previous diagnosis of narcolepsy, sleep apnea syndrome, restless legs syndrome, or periodic limb movement disorder
Data sourced from ClinicalTrials.gov (NCT01723904). 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.