Long-term Safety Study of Open-label Pramipexole ER in Patients With Advanced PD
- Registration Number
- NCT00577460
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
The general aim of this study is to obtain long-term safety and tolerability data on pramipexole extended release (ER), in daily doses from 0.375mg to 4.5mg once daily (qd), in patients who have previously completed a pramipexole double-blind study in advanced Parkinson's disease (PD) (248.525 trial).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 391
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Placebo Placebo Patients to receive placebo tablets identical to Pramipexole ER tablets only during transfer phase Pramipexole Pramipexole Patients to receive Pramipexole ER 0.375 - 4.5 mg in tablet form daily
- Primary Outcome Measures
Name Time Method Percentage of Patients With Adverse Events, Adverse Drug Reactions, Serious Adverse Events 80 weeks The aim of this study was to obtain long-term safety and tolerability data on pramipexole ER, in patients who have previously completed a pramipexole double blind study in advanced Parkinson's Disease (PD) (248.525 (NCT00466167)). Therefore these items were considered as a safety evaluation.
- Secondary Outcome Measures
Name Time Method Patients Successfully Switched From Pramipexole (PPX) IR or ER to ER Assessed on UPDRS II+III One week Unified Parkinson's Disease Rating Scale (UPDRS) Successfully switched means: UPDRS II+III baseline score \>20 without a relative worsening of UPDRS II+III score \> 15% from baseline or UPDRS II+III baseline score \<=20 without an absolute worsening of UPDRS II+III score \> 3 from baseline UPDRS II+III ranging from 0 (normal) to 160 (severe). UPDRS part II measures activities of daily living, part III measures motor symptoms
UPDRS II+III Change From Open Label (OL) Baseline OL Baseline and week 80 UPDRS II+III ranging from 0 (normal) to 160 (severe). UPDRS part II measures activities of daily living, part III measures motor symptoms
Number of Participants With UPDRS II+III Response Week 80 A response means an improvement of \>=20% in UPDRS II+III from OL baseline UPDRS II+III ranging from 0 (normal) to 160 (severe). UPDRS part II measures activities of daily living, part III measures motor symptoms
Number of Patients Successfully Switched From PPX IR or ER to ER Assessed on Off-time One week A patient was considered as successfully switched if he/she has converted to ER without a worsening of off time by more than 12.5% from baseline. Off-time is based on patient diary data and describes a period when the patient experiences increased parkinsonian symptoms (e.g. immobility or inability to move with ease).
Percentage Off Time During Waking Hours Total Score: Change From Baseline Baseline and week 80 Percentage off-time based on patient diary data, percentage ranging from 0 (best case) to 100 (worst case). Off-time describes a period when the patient experiences increased parkinsonian symptoms (e.g. immobility or inability to move with ease).
A negative change implies improvementNumber of Participants With Response in Percentage Off Time During Waking Hours 80 weeks Response means \>=20% improvement relative to OL baseline in the % off-time during waking hours
Percentage on Time Without Dyskinesia During Waking Hours: Change From Baseline After 80 Weeks Baseline and week 80 Percentage on-time based on patient diary data, percentage ranging from 0 (worst case) to 100 (best case). On-time describes a period when the patient has no symptoms of off-time and is not asleep. A positive change implies improvement.
Percentage on Time With Non Troublesome Dyskinesia During Waking Hours: Change From Baseline After 80 Weeks Baseline and week 80 Percentage on-time with non troublesome dyskinesia based on patient diary data, percentage ranging from 0 (worst case) to 100 (best case). On-time describes a period when the patient has no symptoms of off-time and is not asleep. A positive change implies improvement
Percentage on Time Without Dyskinesia or With Non Troublesome Dyskinesia During Waking Hours: Change From Baseline After 80 Weeks Baseline and week 80 Percentage on-time without dyskinesia or with non troublesome dyskinesia based on patient diary data, percentage ranging from 0 (worst case) to 100 (best case). On-time describes a period when the patient has no symptoms of off-time and is not asleep. A positive change implies improvement
Percentage on Time With Troublesome Dyskinesia During Waking Hours: Change From Baseline After 80 Weeks Baseline and week 80 Percentage on-time with troublesome dyskinesia based on patient diary data, percentage ranging from 0 (worst case) to 100 (best case). On-time describes a period when the patient has no symptoms of off-time and is not asleep. A positive change implies improvement
Number of Participants With Response in CGI-I 32 weeks Clinical Global Impression of Improvement (CGI-I), CGI-I scores ranging from '1' (very much improved) to '7' (very much worse). For patients previously treated with Placebo, all patients with at least "much improved" were considered as responders. For patients previously treated with PPX ER or IR, all patients with no change to very much improved were considered as responders
Number of Participants With Response in PGI-I 32 weeks Patient Global Impression of Improvement (PGI-I), PGI-I scores ranging from '1' (very much better) to '7' (very much worse). For patients previously treated with Placebo, all patients with at least "much better" were considered as responders. For patients previously treated with PPX ER or IR, all patients with no change to very much better were considered as responders
Number of Participants With Response in PGI-I for Early Morning Off Symptoms 32 weeks Patient Global Impression of Improvement (PGI-I) for early morning off symptoms, PGI-I scores ranging from '1' (very much better) to '7' (very much worse). For patients previously treated with Placebo, all patients with at least "much better" were considered as responders. For patients previously treated with PPX ER or IR, all patients with no change to very much better were considered as responders
UPDRS I Total Score and Change From OL Baseline at Week 80 OL baseline and week 80 UPDRS I ranging from 0 (normal) to 16 (severe). UPDRS I measures Mentation, Behavior and Mood
UPDRS II Total Score and Change From OL Baseline at Week 80 OL baseline and week 80 UPDRS II ranging from 0 (normal) to 52 (severe). UPDRS Part II is calculated as the average of UPDRS part II at on and UPDRS part II at off-period for each of the 13 activities
UPDRS III Total Score and Change From OL Baseline at Week 80 OL baseline and week 80 UPDRS III ranging from 0 (normal) to 108 (severe). UPDRS part III measures motor symptoms
UPDRS IV Total Score and Change From OL Baseline at Week 80 OL baseline and week 80 UPDRS IV ranging from 0 (normal) to 23 (severe). UPDRS IV measures complications of therapy
Parkinson Fatigue Scale (PFS-16) Score and Change From OL Baseline at Week 80 OL baseline and week 80 PFS-16 (Parkinson fatigue scale) ranging from 16 (better perceived health status) to 80 (severe symptoms of the disease) measuring aspects of fatigue that are relevant to patients with PD
Number of Participants With L-dopa Daily Dose Change: Change From OL Baseline at Week 80 OL baseline and week 80 Number of Participants With Changes in Pramipexole Doses After 80 Weeks Compared to Pramipexole Dose at OL Baseline OL baseline and week 80 Number of Participants With Serious Adverse Events 80 weeks Supine Diastolic Blood Pressure, Baseline and Week 80, Vital Signs Treated Set OL Baseline and Week 80 Standing Diastolic Blood Pressure, Baseline and Week 80, Vital Signs Treated Set OL Baseline and Week 80 Supine Systolic Blood Pressure, Baseline and Week 80, Vital Signs Treated Set OL Baseline and Week 80 Standing Systolic Blood Pressure, Baseline and Week 80, Vital Signs Treated Set OL Baseline and Week 80 Supine Pulse Rate, Baseline and Week 80, Vital Signs Treated Set OL Baseline and Week 80 Standing Pulse Rate, Baseline and Week 80, Vital Signs Treated Set OL Baseline and Week 80 Body Weight of Female Patients, Baseline and Week 80, Vital Signs Treated Set OL Baseline and Week 80 Body Weight of Male Patients, Baseline and Week 80, Vital Signs Treated Set OL Baseline and Week 80 Epworth Sleepiness Scale (ESS), Baseline and End of Open Label, Treated Set OL Baseline and Week 80 ESS Total score ranges from zero (best) to 24 (worst); scale has 8 items, each rated from zero (no chance of dozing) to 3 (high chance of dozing)
Modified Minnesota Impulsive Disorder Interview (mMIDI), Frequency of Patients With at Least One Abnormal Behavior, Treated Set Baseline, 80 weeks The mMIDI is a semi-structured interview designed to assess impulsive control disorders. The scale was modified to focus behaviors of: pathological gambling, compulsive buying and compulsive sexual behavioral.
Trial Locations
- Locations (70)
248.634.91001 Boehringer Ingelheim Investigational Site
🇮🇳Delhi, India
248.634.36005 Boehringer Ingelheim Investigational Site
🇭🇺Györ, Hungary
248.634.36003 Boehringer Ingelheim Investigational Site
🇭🇺Kecskemét, Hungary
248.634.42002 Boehringer Ingelheim Investigational Site
🇨🇿Rychnov nad Kneznou, Czech Republic
248.634.91006 Boehringer Ingelheim Investigational Site
🇮🇳Pune, India
248.634.39009 Boehringer Ingelheim Investigational Site
🇮🇹Chieti, Italy
248.634.36004 Boehringer Ingelheim Investigational Site
🇭🇺Veszprem, Hungary
248.634.82007 Boehringer Ingelheim Investigational Site
🇰🇷Pusan, Korea, Republic of
248.634.91003 Boehringer Ingelheim Investigational Site
🇮🇳Hyderabad, India
248.634.39008 Boehringer Ingelheim Investigational Site
🇮🇹Pisa, Italy
248.634.34003 Boehringer Ingelheim Investigational Site
🇪🇸Barcelona, Spain
248.634.34004 Boehringer Ingelheim Investigational Site
🇪🇸Barcelona, Spain
248.634.07003 Boehringer Ingelheim Investigational Site
🇷🇺Moscow, Russian Federation
248.634.63205 Boehringer Ingelheim Investigational Site
🇵🇭Manila, Philippines
248.634.46005 Boehringer Ingelheim Investigational Site
🇸🇪Malmö, Sweden
248.634.39001 Boehringer Ingelheim Investigational Site
🇮🇹Catania, Italy
248.634.39010 Boehringer Ingelheim Investigational Site
🇮🇹Catanzaro, Italy
248.634.07006 Boehringer Ingelheim Investigational Site
🇷🇺St. Petersburg, Russian Federation
248.634.82002 Boehringer Ingelheim Investigational Site
🇰🇷Seoul, Korea, Republic of
248.634.82003 Boehringer Ingelheim Investigational Site
🇰🇷Seoul, Korea, Republic of
248.634.38001 Boehringer Ingelheim Investigational Site
🇺🇦Zaporozhye, Ukraine
248.634.91007 Boehringer Ingelheim Investigational Site
🇮🇳Indore, India
248.634.39005 Boehringer Ingelheim Investigational Site
🇮🇹Roma, Italy
248.634.39002 Boehringer Ingelheim Investigational Site
🇮🇹Napolii, Italy
248.634.39011 Boehringer Ingelheim Investigational Site
🇮🇹Roma, Italy
248.634.36006 Boehringer Ingelheim Investigational Site
🇭🇺Szeged, Hungary
248.634.82001 Boehringer Ingelheim Investigational Site
🇰🇷Gyeonggi-do, Korea, Republic of
248.634.82004 Boehringer Ingelheim Investigational Site
🇰🇷Seoul, Korea, Republic of
248.634.63202 Boehringer Ingelheim Investigational Site
🇵🇭Cruz, Manila, Philippines
248.634.63201 Boehringer Ingelheim Investigational Site
🇵🇭Pasig City, Philippines
248.634.39007 Boehringer Ingelheim Investigational Site
🇮🇹Grosseto, Italy
248.634.82008 Boehringer Ingelheim Investigational Site
🇰🇷Kyeonggi-do, Korea, Republic of
248.634.34002 Boehringer Ingelheim Investigational Site
🇪🇸San Cugat del Valles (Barcelona), Spain
248.634.34001 Boehringer Ingelheim Investigational Site
🇪🇸Alcorcon (Madrid), Spain
248.634.34008 Boehringer Ingelheim Investigational Site
🇪🇸Tarrasa (Barcelona), Spain
248.634.82005 Boehringer Ingelheim Investigational Site
🇰🇷Seoul, Korea, Republic of
248.634.46001 Boehringer Ingelheim Investigational Site
🇸🇪Stockholm, Sweden
248.634.42104 Boehringer Ingelheim Investigational Site
🇸🇰Bratislava, Slovakia
248.634.42105 Boehringer Ingelheim Investigational Site
🇸🇰Bratislava, Slovakia
248.634.42101 Boehringer Ingelheim Investigational Site
🇸🇰Trnava, Slovakia
248.634.38003 Boehringer Ingelheim Investigational Site
🇺🇦Dnipropetrovsk, Ukraine
248.634.38002 Boehringer Ingelheim Investigational Site
🇺🇦Kiev, Ukraine
248.634.07002 Boehringer Ingelheim Investigational Site
🇷🇺Moscow, Russian Federation
248.634.38006 Boehringer Ingelheim Investigational Site
🇺🇦Kharkiv, Ukraine
248.634.46002 Boehringer Ingelheim Investigational Site
🇸🇪Nyköping, Sweden
248.634.44007 Boehringer Ingelheim Investigational Site
🇬🇧Blackburn, United Kingdom
248.634.63204 Boehringer Ingelheim Investigational Site
🇵🇭Quezon City, Philippines
248.634.63207 Boehringer Ingelheim Investigational Site
🇵🇭Ermita, Manila, Philippines
248.634.48002 Boehringer Ingelheim Investigational Site
🇵🇱Warsaw, Poland
248.634.38004 Boehringer Ingelheim Investigational Site
🇺🇦Kiev, Ukraine
248.634.38005 Boehringer Ingelheim Investigational Site
🇺🇦Zaporizhzhya, Ukraine
248.634.82006 Boehringer Ingelheim Investigational Site
🇰🇷Seoul, Korea, Republic of
248.634.43005 Boehringer Ingelheim Investigational Site
🇦🇹Linz, Austria
248.634.42003 Boehringer Ingelheim Investigational Site
🇨🇿Pardubice, Czech Republic
248.634.42001 Boehringer Ingelheim Investigational Site
🇨🇿Praha, Czech Republic
248.634.42005 Boehringer Ingelheim Investigational Site
🇨🇿Rakovnik, Czech Republic
248.634.91002 Boehringer Ingelheim Investigational Site
🇮🇳Chennai, India
248.634.63206 Boehringer Ingelheim Investigational Site
🇵🇭Manila, Philippines
248.634.07004 Boehringer Ingelheim Investigational Site
🇷🇺Moscow, Russian Federation
248.634.07007 Boehringer Ingelheim Investigational Site
🇷🇺Moscow, Russian Federation
248.634.44003 Boehringer Ingelheim Investigational Site
🇬🇧Salford, United Kingdom
248.634.34005 Boehringer Ingelheim Investigational Site
🇪🇸Madrid, Spain
248.634.63210 Boehringer Ingelheim Investigational Site
🇵🇭Makati City, Philippines
248.634.42004 Boehringer Ingelheim Investigational Site
🇨🇿Valasske Mezirici, Czech Republic
248.634.91005 Boehringer Ingelheim Investigational Site
🇮🇳Karnataka, India
248.634.48001 Boehringer Ingelheim Investigational Site
🇵🇱Gdansk, Poland
248.634.42103 Boehringer Ingelheim Investigational Site
🇸🇰Dubnica nad Vahom, Slovakia
248.634.63208 Boehringer Ingelheim Investigational Site
🇵🇭Quezon, Philippines
248.634.48003 Boehringer Ingelheim Investigational Site
🇵🇱Krakow, Poland
248.634.07001 Boehringer Ingelheim Investigational Site
🇷🇺Moscow, Russian Federation