Phase 4
Completed N=328
Rasagiline as Add on to Dopamine Agonists in the Treatment of Parkinson's Disease
Source: ClinicalTrials.gov NCT01049984 ↗Enrolled (actual)
328
Serious AEs
4.0%
Results posted
Oct 2014
Primary outcomePrimary: Change From Baseline to Week 18 in the Unified Parkinson's Disease Rating Scale (UPDRS) Total Score for Parts I, II and III — -3.6; -1.2 units on a scale — p=0.012
Summary
To assess the efficacy of rasagiline 1 mg as a first add-on treatment to dopamine agonist therapy in early Parkinson Disease (PD) patients, , not optimally controlled on dopamine agonists as compared to placebo.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to Week 18 in the Unified Parkinson's Disease Rating Scale (UPDRS) Total Score for Parts I, II and III |
-3.6; -1.2 | 0.012 sig |
| SECONDARY Change From Baseline to Week 18 in the Unified Parkinson's Disease Rating Scale (UPDRS) Total Score for Part II - Activities of Daily Living |
-0.1; 0.3 | 0.301 |
| SECONDARY Change From Baseline to Week 18 in the Unified Parkinson's Disease Rating Scale (UPDRS) Total Score for Part III - Motor Function |
-3.4; -1.6 | 0.007 sig |
| SECONDARY Clinical Global Improvement (CGI) Score at Week 18 As Assessed by the Site Rater |
0; 1; 5; 5; 21; 20 | 0.255 |
| SECONDARY Clinical Global Improvement (CGI) Score at Week 18 As Assessed by the Participant |
0; 1; 7; 7; 18; 18 | 0.996 |
| SECONDARY Illness Severity Score at Day 0 and Week 18 As Assessed by the Site Rater |
0; 0; 4; 5; 18; 26 | 0.967 |
Eligibility Criteria
Inclusion Criteria
- receiving stable dose of oral ropinirole or pramipexole whose symptoms are not optimally controlled or whose oral dopamine agonist titration regimen was truncated due to intolerability:
- 1) Minimum dose of agonist will be 6 mg/day for ropinirole and 1.0 mg/day for pramipexole
- 2) Stable dopamine agonist treatment must have been ongoing for ≥ 30 days, no longer than 5 years preceding baseline
- Males and females. Women of childbearing potential must agree to practice an acceptable method of birth control.
- Idiopathic Parkinson Disease confirmed at baseline by presence of at least 2 cardinal signs (resting tremor, bradykinesia, rigidity), w/o other known or suspected cause of Parkinsonism
- Hoehn & Yahr > 1 (symptoms on only one side of the body) with treatment and 21 consecutive days within 90 days prior baseline
- moderate to severe motor fluctuations
- hepatic impairment
- investigational medications 30 days preceding baseline
- dopamine agonist use > 5 years prior to baseline
- major depression as defined by Beck Depression Inventory (BDI) short form score greater than 14
- significant cognitive impairment as defined by Mini-Mental State Exam (MMSE) score less than 26.
- impulse control disorder (ICD) based on the Questionnaire for Impulsive-compulsive Disorders in Parkinson's Disease form (QUIP).
- pregnant or lactating or planning on becoming pregnant in the next 18 weeks
- uncontrolled hypertension. Patients whose hypertension is controlled with medications are eligible.
- Concomitant monoamine oxidase (MAO) inhibitors or medicines contraindicated w/ MAO inhibitors not allowed
Data sourced from ClinicalTrials.gov (NCT01049984). 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.