Overnight Switch Trial From Pramipexole IR to Pramipexole ER in Patients With Early Parkinson Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00558025
First received: November 12, 2007
Last updated: May 7, 2014
Last verified: May 2012

November 12, 2007
May 7, 2014
October 2007
May 2008   (final data collection date for primary outcome measure)
Percentage of Patients Who Successfully Switched From Pramipexole Immediate Release (IR) to Pramipexole ER After a Possible Dose Adaptation, Full Analysis Set (FAS), Last Observation Carried Forward (LOCF) [ Time Frame: from baseline to week 9 ] [ Designated as safety issue: No ]
A successful switch was defined by no change of the Unified Parkinson's Disease Rating Scale (UPDRS) II+III by more than 15% from baseline to week 9, UPDRS II+III score ranging from 0 (no impairment) to 160 (worst impairment)
The primary efficacy endpoint is the proportion of patients successfully switched from pramipexole IR to pramipexole ER or IR at the end of the maintenance phase N? 2 (visit 5).
Complete list of historical versions of study NCT00558025 on ClinicalTrials.gov Archive Site
  • Percentage of Patients Who Successfully Switched From Pramipexole IR to Pramipexole ER With no Dose Adaptation, FAS (LOCF) [ Time Frame: from baseline to week 4 ] [ Designated as safety issue: No ]
    A successful switch was defined by no change of the UPDRS II+III by more than 15% from baseline to week 4, UPDRS II+III score ranging from 0 (no impairment) to 160 (worst impairment).
  • Change From Baseline in UPDRS Part II+III Total Score at Week 9, FAS (LOCF) [ Time Frame: Baseline and week 9 ] [ Designated as safety issue: No ]
    Unified Parkinson's Disease Rating Scale part II+III total score on FAS, Week 9 - baseline, UPDRS II+III score ranging from 0 (no impairment) to 160 (worst impairment)
  • Change From Baseline in UPDRS Part II Total Score at Week 9, FAS (LOCF) [ Time Frame: Baseline and week 9 ] [ Designated as safety issue: No ]
    Unified Parkinson's Disease Rating Scale part II total score on FAS, Week 9 - baseline, UPDRS II score ranging from 0 (no impairment) to 52 (worst impairment)
  • Change From Baseline in UPDRS Part III Total Score at Week 9, FAS (LOCF) [ Time Frame: Baseline and week 9 ] [ Designated as safety issue: No ]
    Unified Parkinson's Disease Rating Scale part III total score on FAS, week 9 - baseline, UPDRS II+III score ranging from 0 (no impairment) to 108 (worst impairment)
  • Clinical Global Impression - Improvement (CGI-I), FAS (LOCF) [ Time Frame: Week 9 ] [ Designated as safety issue: No ]
    Clinical Global Impression - Improvement on FAS, CGI-I was rated from 1: very much improved, to 7: very much worse, CGI-I responder are defined as being rated as 'unchanged', 'minimally improved', 'much improved', or 'very much improved', CGI-I non-responder are defined as being rated 'minimally worse', 'much worse' or 'very much worse'
  • Patient Global Impression - Improvement (PGI-I), FAS (LOCF) [ Time Frame: Week 9 ] [ Designated as safety issue: No ]
    Patient Global Impression - Improvement on FAS, PGI-I was rated from 1: very much better, to 7: very much worse, PGI-I responder are defined as being rated as 'unchanged', 'minimally better', 'much better', or 'very much better', PGI-I non-responder are defined as being rated as 'minimally worse', 'much worse', or 'very much worse'
  • Pramipexole Dose Adaptation, FAS (LOCF) [ Time Frame: Week 9 ] [ Designated as safety issue: No ]
    Patients with increase in daily Pramipexole dose on FAS
  • Final Pramipexole Dose (mg) After 9 Weeks, Treated Set [ Time Frame: Week 9 ] [ Designated as safety issue: No ]
    The mean final daily Pramipexole dose is displayed
Key secondary:Proportion of patients successfully switched from PPX IR to PPX ER or IR without a dose adaptation UPDRS II+III score and separately CGI I PGI I % of pts requiring dose adaptation, % of pts successfully at V4 PPX daily dose
Not Provided
Not Provided
 
Overnight Switch Trial From Pramipexole IR to Pramipexole ER in Patients With Early Parkinson Disease
A Double-blind, Double-dummy, Randomized, Parallel Groups Study to Assess the Efficacy, Safety and Tolerability of Switching Patients With Early Parkinson's Disease (PD) From Pramipexole IR to Pramipexole ER or Pramipexole IR

The objectives of this trial conducted in early Parkinson's disease (PD) patients are:

  • To assess if patients with early Parkinson's disease (PD) can be successfully switched (overnight switching) from Pramipexole (PPX) Immediate Release (IR) to Pramipexole Extended Release (ER). A successful switch at a specific visit is defined as no worsening of the Unified Parkinsons Disease Rating Scale (UPDRS) parts II+III score by more than 15% from baseline and no drug-related adverse events leading to withdrawal;
  • To establish if this successful switch can be obtained with or without dose-adaptation;
  • To provide information about the conversion ratio (mg:mg) from Pramipexole IR to Pramipexole ER.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Parkinson Disease
  • Drug: Pramipexole Extended Release
  • Drug: Pramipexole Immediate Release
  • Experimental: Pramipexole Extended Release (ER)
    Pramipexole Extended Release (ER) once daily
    Intervention: Drug: Pramipexole Extended Release
  • Experimental: Pramipexole Immediate Release (IR)
    Pramipexole Immediate Release (IR) once daily
    Intervention: Drug: Pramipexole Immediate Release
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
156
Not Provided
May 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Male or female patient with idiopathic Parkinson's disease (PD) confirmed by at least two of the following signs: resting tremor, bradykinesia, rigidity.
  2. Parkinson's disease diagnosed within 5 years.
  3. Patients 30 years of age or older at the time of diagnosis.
  4. Modified Hoehn and Yahr stage of 1 to 3.
  5. Patients receiving pramipexole IR for at least three months prior to baseline visit (randomization visit, V2).
  6. Pramipexole dose should be optimized (according investigator¿s judgement), greater or equal to 1.5 mg/day, stable and equally divided 3 times per day, for a least 4 weeks prior to baseline visit (V2).
  7. Patients willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.
  8. Signed informed consent obtained before any study procedures are carried out in accordance with International Conference on Harmonization - Good Clinical Practice (ICH-GCP) guidelines and local legislation).

Exclusion Criteria:

  1. Motor complications under levodopa therapy at V1.
  2. Atypical parkinsonian syndromes due to drugs, metabolic disorders, encephalitis or degenerative diseases.
  3. Dementia, as defined by a Mini-Mental State Exam score < 24 at V1
  4. Any psychiatric disorder according to Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) criteria
  5. History of psychosis, except history of drug induced hallucinations
  6. Clinically significant electrocardiogram (ECG) abnormalities at V1.
  7. Clinically significant hypotension either at screening visit or at baseline visit.
  8. Malignant melanoma or history of previously treated malignant melanoma.
  9. Any other clinically significant disease
  10. Pregnancy or breast-feeding.
  11. Sexually active female of childbearing potential
  12. Serum levels of Aspartate Aminotransferase (Serum Glutamic Oxaloacetic Transaminase) (AST (SGOT)), Alanine Aminotransferase (Serum Glutamate Pyruvate Transaminase) (ALT (SGPT)), alkaline phosphatases or bilirubin > 2 Upper Limit of Normal (ULN) (on screening lab test).
  13. Patients with a creatinine clearance < 50 mL/min
  14. Any dopamine agonist (except pramipexole IR) within three months prior to baseline visit.
  15. History of discontinuation of treatment with pramipexole IR
  16. Previous treatment with pramipexole ER.
  17. Any medication (including intra-muscular formulations) with central dopaminergic antagonist activity within 4 weeks prior to the baseline visit (i.e. typical neuroleptics, atypical antipsychotics, reserpine, methyldopa, centrally-active antiemetics, etc).
  18. Any of the following drugs within 4 weeks prior to the baseline visit: methylphenidate, cinnarizine, amphetamines.
  19. Flunarizine within 3 months prior to baseline visit.
  20. Known hypersensitivity to Pramipexole or its excipients.
  21. Drug abuse (including alcohol), according to Investigator¿s judgement, within 2 years prior to screening.
  22. Participation in other investigational drug studies or use of other investigational drugs within 4 weeks or five times the half-life of the investigational drug (whichever is longer) prior to baseline visit.
Both
30 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Netherlands,   France,   Germany
 
NCT00558025
248.636, Eudract 2007-003353-90
Not Provided
Boehringer Ingelheim
Boehringer Ingelheim
Not Provided
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP