Ignite Creation Date:
2024-05-05 @ 12:07 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00240409
Status:
COMPLETED
Last Update Posted:
2013-11-03
First Post:
2005-10-14
Brief Title:
Randomized Single-blind Placebo Controlled Comparative Trial of Pramipexole and Bromocriptine in Parkinsons Disease
Sponsor:
Boehringer Ingelheim
Organization:
Boehringer Ingelheim
Study Overview
Official Title:
A Randomized Single-blind Placebo Controlled Comparative Trial of Pramipexole Tablets and Bromocriptine Tablets in Patients With Parkinsons Disease
Status:
COMPLETED
Status Verified Date:
2013-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objective of this study was to investigate the efficacy and safety of Pramipexole Tablets in patients with Parkinsons disease who can be treated with L-DOPA concomitantly in a single blind comparative method using Bromocriptine tablets as comparators phase III comparative trial
Detailed Description:
The trial was to investigate the efficacy and safety of Pramipexole in patients with Parkinsons disease who can be concomitantly treated with L-DOPA in a double-blindmethod using Bromocriptine tablets as comparators phase III comparative trial
For efficacy evaluation two primary endpoints were chosen
Totalled score according to Part III of UPDRS motor examination
Totalled score according to Part II of UPDRS activities of daily living
The safety profile of the study drug was evaluated by physical examination blood pressure Electrocardiogram Laboratory tests AEs and SAEs
Patients eligible for the trial who met all inclusion and exclusion criteria and who gave their informed consent were randomized to one of two treatment groups ie Pramipexole tablets or Bromocriptine tablets Patients were administered the study drug according to the dosing schedule
The treatment period lasted maximal 12 weeks ascending dose interval up to 8 weeks maintenance dose interval 4 weeks or longer In addition a descending dose interval was 1-4 weeks
Each patient received 7 visits except the patients drops or withdrawals
visit 1 screening visit 2 randomization and baseline visit 3-6 ascending dose interval visit 7 Maintenance dose interval
Study Hypothesis
Primary variables are both total of UPDRS Unified Parkinsons Disease Rating Scale part III items and of UPDRS part II items in change from baseline The trial hypothesis is to demonstrate non-inferiority to Bromocriptine over an equivalence margindelta the clinically largest difference judged as clinically acceptable with 90 power one sided for the above two primary variables at the error probability of 25 each The equivalency margin for the primary variables total of UPDRS Part III and of UPDRS Part II can be determined as 20 and 10 respectively referring to the results of oversea pivotal study of Pramipexole BI Trial No 248326 U96-0232 and judged by the study investigator
Comparisons
The primary endpoint of the study was the change of totalled score according to Part III of UPDRS motor examination and totalled score according to Part II of UPDRS activities of daily living after 12 weeks treatment of the study drug
For efficacy evaluation two primary endpoints were chosen
Totalled score according to Part III of UPDRS motor examination
Totalled score according to Part II of UPDRS activities of daily living
The safety profile of the study drug was evaluated by physical examination blood pressure Electrocardiogram Laboratory tests AEs and SAEs
Patients eligible for the trial who met all inclusion and exclusion criteria and who gave their informed consent were randomized to one of two treatment groups ie Pramipexole tablets or Bromocriptine tablets Patients were administered the study drug according to the dosing schedule
The treatment period lasted maximal 12 weeks ascending dose interval up to 8 weeks maintenance dose interval 4 weeks or longer In addition a descending dose interval was 1-4 weeks
Each patient received 7 visits except the patients drops or withdrawals
visit 1 screening visit 2 randomization and baseline visit 3-6 ascending dose interval visit 7 Maintenance dose interval
Study Hypothesis
Primary variables are both total of UPDRS Unified Parkinsons Disease Rating Scale part III items and of UPDRS part II items in change from baseline The trial hypothesis is to demonstrate non-inferiority to Bromocriptine over an equivalence margindelta the clinically largest difference judged as clinically acceptable with 90 power one sided for the above two primary variables at the error probability of 25 each The equivalency margin for the primary variables total of UPDRS Part III and of UPDRS Part II can be determined as 20 and 10 respectively referring to the results of oversea pivotal study of Pramipexole BI Trial No 248326 U96-0232 and judged by the study investigator
Comparisons
The primary endpoint of the study was the change of totalled score according to Part III of UPDRS motor examination and totalled score according to Part II of UPDRS activities of daily living after 12 weeks treatment of the study drug
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None