Trial Outcomes & Findings for Safety and Efficacy of Long-term Daily Use of Mirapex®-LA Tablets in Patients With Parkinson's Disease (NCT NCT01525641)
NCT ID: NCT01525641
Last Updated: 2015-08-14
Results Overview
Percentage of subjects with adverse drug reactions
Recruitment status
COMPLETED
Target enrollment
615 participants
Primary outcome timeframe
From baseline up to week 52
Results posted on
2015-08-14
Participant Flow
This is an Observational study. Patients in the study have received only the standard treatment and no investigational drug was adminstered.
Participant milestones
| Measure |
Subjects With Parkinson's Disease (PD)
Subjects with Parkinson's Disease (PD) were orally administered Mirapex LA: Pramipexole Hydrochloride Hydrate tablets with starting dose of 0.375 once daily after meal and increased by 0.75 mg/day at week 2. The daily may be increased by 0.75 mg/day at weekly intervals up to maintenance dose (standard dose: 1.5 to 4.5mg/day). subjects with renal impairment were administered with the starting dose of 0.375 every other day for the first week, if necessary the dose may be increased by 0.375mg every week but not exceeding the daily dose of 2.25mg.
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|---|---|
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Overall Study
STARTED
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615
|
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Overall Study
COMPLETED
|
435
|
|
Overall Study
NOT COMPLETED
|
180
|
Reasons for withdrawal
| Measure |
Subjects With Parkinson's Disease (PD)
Subjects with Parkinson's Disease (PD) were orally administered Mirapex LA: Pramipexole Hydrochloride Hydrate tablets with starting dose of 0.375 once daily after meal and increased by 0.75 mg/day at week 2. The daily may be increased by 0.75 mg/day at weekly intervals up to maintenance dose (standard dose: 1.5 to 4.5mg/day). subjects with renal impairment were administered with the starting dose of 0.375 every other day for the first week, if necessary the dose may be increased by 0.375mg every week but not exceeding the daily dose of 2.25mg.
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|---|---|
|
Overall Study
Case report form not collected
|
25
|
|
Overall Study
No visit since the first visit
|
16
|
|
Overall Study
Adverse Event
|
73
|
|
Overall Study
Lack of Efficacy
|
24
|
|
Overall Study
Improvement
|
5
|
|
Overall Study
Lost to follow-up (relocation)
|
1
|
|
Overall Study
Lost to follow-up (Unknown reason)
|
10
|
|
Overall Study
Lost to follow-up (Changing hospital)
|
19
|
|
Overall Study
Other than stated above
|
7
|
Baseline Characteristics
Safety and Efficacy of Long-term Daily Use of Mirapex®-LA Tablets in Patients With Parkinson's Disease
Baseline characteristics by cohort
| Measure |
Subjects With Parkinson's Disease (PD)
n=569 Participants
Subjects with Parkinson's Disease (PD) were orally administered Mirapex LA: Pramipexole Hydrochloride Hydrate tablets with starting dose of 0.375 once daily after meal and increased by 0.75 mg/day at week 2. The daily may be increased by 0.75 mg/day at weekly intervals up to maintenance dose (standard dose: 1.5 to 4.5mg/day). Subjects with renal impairment were administered with the starting dose of 0.375 every other day for the first week, if necessary the dose may be increased by 0.375mg every week but not exceeding the daily dose of 2.25mg.
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|---|---|
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Age, Continuous
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68.87 years
STANDARD_DEVIATION 9.35 • n=5 Participants
|
|
Sex: Female, Male
Female
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341 Participants
n=5 Participants
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Sex: Female, Male
Male
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228 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From baseline up to week 52Population: Safety set
Percentage of subjects with adverse drug reactions
Outcome measures
| Measure |
Subjects With Parkinson's Disease (PD)
n=569 Participants
Subjects with Parkinson's Disease (PD) were orally administered Mirapex LA: Pramipexole Hydrochloride Hydrate tablets with starting dose of 0.375 once daily after meal and increased by 0.75 mg/day at week 2. The daily may be increased by 0.75 mg/day at weekly intervals up to maintenance dose (standard dose: 1.5 to 4.5mg/day). Subjects with renal impairment were administered with the starting dose of 0.375 every other day for the first week, if necessary the dose may be increased by 0.375mg every week but not exceeding the daily dose of 2.25mg.
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|---|---|
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Percentage of Adverse Drug Reactions
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24.78 percentage of participants
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SECONDARY outcome
Timeframe: Week 52Population: Efficacy set: included all patients in the "safety set" except those who had no available efficacy data and/or who did not suffer from Parkinsons Disease
Clinical global impression (CGI) of effect at the last observation, on a rating scale from very much improved to no effect.
Outcome measures
| Measure |
Subjects With Parkinson's Disease (PD)
n=509 Participants
Subjects with Parkinson's Disease (PD) were orally administered Mirapex LA: Pramipexole Hydrochloride Hydrate tablets with starting dose of 0.375 once daily after meal and increased by 0.75 mg/day at week 2. The daily may be increased by 0.75 mg/day at weekly intervals up to maintenance dose (standard dose: 1.5 to 4.5mg/day). Subjects with renal impairment were administered with the starting dose of 0.375 every other day for the first week, if necessary the dose may be increased by 0.375mg every week but not exceeding the daily dose of 2.25mg.
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|---|---|
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Clinical Global Impression of Effect
Very much improved
|
14 participants
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Clinical Global Impression of Effect
Much improved
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223 participants
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Clinical Global Impression of Effect
Minimally improved
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205 participants
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Clinical Global Impression of Effect
No effect
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67 participants
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SECONDARY outcome
Timeframe: Baseline and week 52Population: Efficacy set
Change from baseline at the last observation in the Unified Parkinson's Disease Rating Scale (UPDRS) Part III total score. UPDRS Part III (motor examination) measures the extent of physical impairment displayed by the patient. This evaluation consists of 14 separate components of patient's physical status. The UPDRS part III score is the sum of the 14 individual components. The UPDRS Part III total score ranges from 0 to 108.A reduction in UPDRS part III score over time corresponds to an improvement in motor activities. The following are the 14 separate components:1. Speech 2. Facial expression 3. Tremor at rest 4. Action or postural tremor of hands 5. Rigidity 6. Finger taps 7. Hand movements 8. Rapid alternating movements of hands 9. Leg agility 10. Arising from chair 11. Posture 12. Gait 13. Postural stability 14. Body bradykinesia and hypokinesia.
Outcome measures
| Measure |
Subjects With Parkinson's Disease (PD)
n=442 Participants
Subjects with Parkinson's Disease (PD) were orally administered Mirapex LA: Pramipexole Hydrochloride Hydrate tablets with starting dose of 0.375 once daily after meal and increased by 0.75 mg/day at week 2. The daily may be increased by 0.75 mg/day at weekly intervals up to maintenance dose (standard dose: 1.5 to 4.5mg/day). Subjects with renal impairment were administered with the starting dose of 0.375 every other day for the first week, if necessary the dose may be increased by 0.375mg every week but not exceeding the daily dose of 2.25mg.
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|---|---|
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Change From Baseline in Total Score of the UPDRS Part III to Last Observation
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-3.73 units on a scale
Standard Deviation 8.27
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SECONDARY outcome
Timeframe: Baseline and week 52Population: Efficacy set
Change from baseline at the last observation in the modified Hoehn and Yahr stage. Stages of the Parkinson's disease will be assessed on an 8-degree scale between stage 0 (no sign of the disease) and 5 (wheelchair bound or bedridden unless aided) in steps of 0, 1, 1.5, 2, 2.5, 3, 4 and 5. A reduction in the score over time represents an improvement.
Outcome measures
| Measure |
Subjects With Parkinson's Disease (PD)
n=459 Participants
Subjects with Parkinson's Disease (PD) were orally administered Mirapex LA: Pramipexole Hydrochloride Hydrate tablets with starting dose of 0.375 once daily after meal and increased by 0.75 mg/day at week 2. The daily may be increased by 0.75 mg/day at weekly intervals up to maintenance dose (standard dose: 1.5 to 4.5mg/day). Subjects with renal impairment were administered with the starting dose of 0.375 every other day for the first week, if necessary the dose may be increased by 0.375mg every week but not exceeding the daily dose of 2.25mg.
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|---|---|
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Change From Baseline in the Modified Hoehn & Yahr to Last Observation
|
-0.12 Units on a scale
Standard Deviation 0.40
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SECONDARY outcome
Timeframe: Week 52Population: Patients in safety set and with concomitant L-DOPA.
Number of patients with onset or offset of on-off phenomenon in patients with concomitant levodopa (L-DOPA). On-off phenomenon is the unpredictable shift from mobility - "on" - to a sudden inability to move - "off".
Outcome measures
| Measure |
Subjects With Parkinson's Disease (PD)
n=307 Participants
Subjects with Parkinson's Disease (PD) were orally administered Mirapex LA: Pramipexole Hydrochloride Hydrate tablets with starting dose of 0.375 once daily after meal and increased by 0.75 mg/day at week 2. The daily may be increased by 0.75 mg/day at weekly intervals up to maintenance dose (standard dose: 1.5 to 4.5mg/day). Subjects with renal impairment were administered with the starting dose of 0.375 every other day for the first week, if necessary the dose may be increased by 0.375mg every week but not exceeding the daily dose of 2.25mg.
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|---|---|
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Onset or Offset of On and Off Phenomenon in Patients With Concomitant L-DOPA
Yes
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43 participants
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Onset or Offset of On and Off Phenomenon in Patients With Concomitant L-DOPA
No
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262 participants
|
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Onset or Offset of On and Off Phenomenon in Patients With Concomitant L-DOPA
Unknown
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2 participants
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SECONDARY outcome
Timeframe: Week 52Population: Patients in safety set and with concomitant L-DOPA
Number of patients with onset or offset of wearing-off phenomena in patients with concomitant levodopa (L-DOPA). Wearing-off is when Parkinson's symptoms begin to reappear or become noticeably worse before it is time to take the next scheduled dose of medication.
Outcome measures
| Measure |
Subjects With Parkinson's Disease (PD)
n=307 Participants
Subjects with Parkinson's Disease (PD) were orally administered Mirapex LA: Pramipexole Hydrochloride Hydrate tablets with starting dose of 0.375 once daily after meal and increased by 0.75 mg/day at week 2. The daily may be increased by 0.75 mg/day at weekly intervals up to maintenance dose (standard dose: 1.5 to 4.5mg/day). Subjects with renal impairment were administered with the starting dose of 0.375 every other day for the first week, if necessary the dose may be increased by 0.375mg every week but not exceeding the daily dose of 2.25mg.
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|---|---|
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Onset or Offset of Wearing-off Phenomenon in Patients With Concomitant L-DOPA
Yes
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144 participants
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Onset or Offset of Wearing-off Phenomenon in Patients With Concomitant L-DOPA
No
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163 participants
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Adverse Events
Subjects With Parkinson's Disease (PD)
Serious events: 30 serious events
Other events: 35 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Subjects With Parkinson's Disease (PD)
n=569 participants at risk
Subjects with Parkinson's Disease (PD) were orally administered Mirapex LA: Pramipexole Hydrochloride Hydrate tablets with starting dose of 0.375 once daily after meal and increased by 0.75 mg/day at week 2. The daily may be increased by 0.75 mg/day at weekly intervals up to maintenance dose (standard dose: 1.5 to 4.5mg/day). Subjects with renal impairment were administered with the starting dose of 0.375 every other day for the first week, if necessary the dose may be increased by 0.375mg every week but not exceeding the daily dose of 2.25mg.
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|---|---|
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Blood and lymphatic system disorders
Anaemia
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0.35%
2/569 • From baseline upto Week 52.
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|
Cardiac disorders
Cardio-respiratory arrest
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0.35%
2/569 • From baseline upto Week 52.
|
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Gastrointestinal disorders
Constipation
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0.18%
1/569 • From baseline upto Week 52.
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|
Gastrointestinal disorders
Gastric ulcer haemorrhage
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0.18%
1/569 • From baseline upto Week 52.
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|
Gastrointestinal disorders
Gastritis erosive
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0.18%
1/569 • From baseline upto Week 52.
|
|
Gastrointestinal disorders
Ileus
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0.18%
1/569 • From baseline upto Week 52.
|
|
Gastrointestinal disorders
Melaena
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0.18%
1/569 • From baseline upto Week 52.
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General disorders
Death
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0.18%
1/569 • From baseline upto Week 52.
|
|
General disorders
Gait disturbance
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0.18%
1/569 • From baseline upto Week 52.
|
|
Hepatobiliary disorders
Cholecystitis
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0.18%
1/569 • From baseline upto Week 52.
|
|
Infections and infestations
Bronchopneumonia
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0.18%
1/569 • From baseline upto Week 52.
|
|
Infections and infestations
Diverticulitis
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0.18%
1/569 • From baseline upto Week 52.
|
|
Infections and infestations
Pneumonia
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0.18%
1/569 • From baseline upto Week 52.
|
|
Infections and infestations
Urinary tract infection
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0.35%
2/569 • From baseline upto Week 52.
|
|
Injury, poisoning and procedural complications
Fall
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0.70%
4/569 • From baseline upto Week 52.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
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0.35%
2/569 • From baseline upto Week 52.
|
|
Injury, poisoning and procedural complications
Femur fracture
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0.35%
2/569 • From baseline upto Week 52.
|
|
Injury, poisoning and procedural complications
Pelvic fracture
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0.18%
1/569 • From baseline upto Week 52.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
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0.18%
1/569 • From baseline upto Week 52.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.18%
1/569 • From baseline upto Week 52.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.18%
1/569 • From baseline upto Week 52.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.18%
1/569 • From baseline upto Week 52.
|
|
Musculoskeletal and connective tissue disorders
Posture abnormal
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0.18%
1/569 • From baseline upto Week 52.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.18%
1/569 • From baseline upto Week 52.
|
|
Nervous system disorders
Cerebral haemorrhage
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0.18%
1/569 • From baseline upto Week 52.
|
|
Nervous system disorders
Dementia
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0.35%
2/569 • From baseline upto Week 52.
|
|
Nervous system disorders
Dyskinesia
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0.35%
2/569 • From baseline upto Week 52.
|
|
Nervous system disorders
Parkinson's disease
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0.18%
1/569 • From baseline upto Week 52.
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Nervous system disorders
Parkinsonism
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0.18%
1/569 • From baseline upto Week 52.
|
|
Psychiatric disorders
Confusional state
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0.18%
1/569 • From baseline upto Week 52.
|
|
Psychiatric disorders
Delirium
|
0.35%
2/569 • From baseline upto Week 52.
|
|
Psychiatric disorders
Delusion
|
0.18%
1/569 • From baseline upto Week 52.
|
|
Psychiatric disorders
Hallucination
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0.18%
1/569 • From baseline upto Week 52.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.35%
2/569 • From baseline upto Week 52.
|
|
Vascular disorders
Deep vein thrombosis
|
0.18%
1/569 • From baseline upto Week 52.
|
Other adverse events
| Measure |
Subjects With Parkinson's Disease (PD)
n=569 participants at risk
Subjects with Parkinson's Disease (PD) were orally administered Mirapex LA: Pramipexole Hydrochloride Hydrate tablets with starting dose of 0.375 once daily after meal and increased by 0.75 mg/day at week 2. The daily may be increased by 0.75 mg/day at weekly intervals up to maintenance dose (standard dose: 1.5 to 4.5mg/day). Subjects with renal impairment were administered with the starting dose of 0.375 every other day for the first week, if necessary the dose may be increased by 0.375mg every week but not exceeding the daily dose of 2.25mg.
|
|---|---|
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Nervous system disorders
Somnolence
|
6.2%
35/569 • From baseline upto Week 52.
|
Additional Information
Boehringer Ingelheim Call Center
Boehringer Ingelheim
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place