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
  Purpose

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.

Condition Intervention Phase
Parkinson Disease
Drug: Pramipexole Extended Release
Drug: Pramipexole Immediate Release
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • 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


Enrollment: 156
Study Start Date: October 2007
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pramipexole Extended Release (ER)
Pramipexole Extended Release (ER) once daily
Drug: Pramipexole Extended Release
Experimental: Pramipexole Immediate Release (IR)
Pramipexole Immediate Release (IR) once daily
Drug: Pramipexole Immediate Release

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00558025

Locations
France
248.636.3303A Boehringer Ingelheim Investigational Site
Aix en Provence, France
248.636.3303B Boehringer Ingelheim Investigational Site
Aix en Provence, France
248.636.3303C Boehringer Ingelheim Investigational Site
Aix en Provence, France
248.636.3307C Boehringer Ingelheim Investigational Site
Bron cedex, France
248.636.3309B Boehringer Ingelheim Investigational Site
Clermont Ferrand, France
248.636.3305B Boehringer Ingelheim Investigational Site
Créteil, France
248.636.3305A Boehringer Ingelheim Investigational Site
Créteil, France
248.636.3313A Boehringer Ingelheim Investigational Site
Dijon cedex, France
248.636.3304A Boehringer Ingelheim Investigational Site
Evreux, France
248.636.3308E Boehringer Ingelheim Investigational Site
Lille cedex, France
248.636.3308D Boehringer Ingelheim Investigational Site
Lille cedex, France
248.636.3308B Boehringer Ingelheim Investigational Site
Lille cedex, France
248.636.3308C Boehringer Ingelheim Investigational Site
Lille cedex, France
248.636.3302B Boehringer Ingelheim Investigational Site
Marseille cedex 5, France
248.636.3302A Boehringer Ingelheim Investigational Site
Marseille cedex 5, France
248.636.3306B Boehringer Ingelheim Investigational Site
Montpellier, France
248.636.3312A Boehringer Ingelheim Investigational Site
Rouen, France
248.636.3312B Boehringer Ingelheim Investigational Site
Rouen, France
248.636.3311A Boehringer Ingelheim Investigational Site
Strasbourg, France
248.636.3301D Boehringer Ingelheim Investigational Site
Toulouse cedex, France
248.636.3301B Boehringer Ingelheim Investigational Site
Toulouse cedex, France
248.636.3301A Boehringer Ingelheim Investigational Site
Toulouse cedex, France
Germany
248.636.49006 Boehringer Ingelheim Investigational Site
Achim bei Bremen, Germany
248.636.49004 Boehringer Ingelheim Investigational Site
Berlin, Germany
248.636.49007 Boehringer Ingelheim Investigational Site
Berlin, Germany
248.636.49008 Boehringer Ingelheim Investigational Site
Berlin, Germany
248.636.49003 Boehringer Ingelheim Investigational Site
Berlin-Steglitz, Germany
248.636.49002 Boehringer Ingelheim Investigational Site
Gera, Germany
248.636.49001 Boehringer Ingelheim Investigational Site
Karlsruhe, Germany
248.636.49005 Boehringer Ingelheim Investigational Site
Unterhaching, Germany
Netherlands
248.636.31005 Boehringer Ingelheim Investigational Site
`s-hertogenbosch, Netherlands
248.636.31002 Boehringer Ingelheim Investigational Site
Geldrop, Netherlands
248.636.31003 Boehringer Ingelheim Investigational Site
Helmond, Netherlands
248.636.31006 Boehringer Ingelheim Investigational Site
Maastricht, Netherlands
248.636.31004 Boehringer Ingelheim Investigational Site
Nijmegen, Netherlands
248.636.31001 Boehringer Ingelheim Investigational Site
Sittard, Netherlands
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Additional Information:
No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00558025     History of Changes
Other Study ID Numbers: 248.636, Eudract 2007-003353-90
Study First Received: November 12, 2007
Results First Received: May 26, 2009
Last Updated: May 7, 2014
Health Authority: France: AFSSAPS 143/147, bld Anatole France 93285 Saint-Denis Cedex FRANCE
Germany: Bundesinstitut fuer Arzneimittel und Medizinprodukte (BfArM), Kurt-Georg-Kiesinger-Allee 3, D-53175
Netherlands: Central Committee on Research Involving Human Subjects (CCMO)

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Pramipexole
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents

ClinicalTrials.gov processed this record on August 28, 2014