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

NCT00558025 | Completed Phase 3 Results

• 2 other identifiers: 248.636Eudract 2007-003353-90
• Study Type: interventional
• Target: 156
• Locations: 3 countries
• Sites: 36

Brief Summary

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.

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (1)

• 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)

  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)

  from baseline to week 9

Secondary Outcomes (8)

• Percentage of Patients Who Successfully Switched From Pramipexole IR to Pramipexole ER With no Dose Adaptation, FAS (LOCF)

  from baseline to week 4

• Change From Baseline in UPDRS Part II+III Total Score at Week 9, FAS (LOCF)

  Baseline and week 9

• Change From Baseline in UPDRS Part II Total Score at Week 9, FAS (LOCF)

  Baseline and week 9

• Change From Baseline in UPDRS Part III Total Score at Week 9, FAS (LOCF)

  Baseline and week 9

• Clinical Global Impression - Improvement (CGI-I), FAS (LOCF)

  Week 9

Study Arms (2)

Pramipexole Extended Release (ER)

EXPERIMENTAL

Pramipexole Extended Release (ER) once daily

Drug: Pramipexole Extended Release

Pramipexole Immediate Release (IR)

EXPERIMENTAL

Pramipexole Immediate Release (IR) once daily

Drug: Pramipexole Immediate Release

Interventions

Pramipexole Extended Release DRUG

Pramipexole Extended Release (ER)

Pramipexole Immediate Release DRUG

Pramipexole Immediate Release (IR)

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patient with idiopathic Parkinson's disease (PD) confirmed by at least two of the following signs: resting tremor, bradykinesia, rigidity.
• Parkinson's disease diagnosed within 5 years.
• Patients 30 years of age or older at the time of diagnosis.
• Modified Hoehn and Yahr stage of 1 to 3.
• Patients receiving pramipexole IR for at least three months prior to baseline visit (randomization visit, V2).
• 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).
• Patients willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.
• 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).

You may not qualify if:

• Motor complications under levodopa therapy at V1.
• Atypical parkinsonian syndromes due to drugs, metabolic disorders, encephalitis or degenerative diseases.
• Dementia, as defined by a Mini-Mental State Exam score \< 24 at V1
• Any psychiatric disorder according to Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) criteria
• History of psychosis, except history of drug induced hallucinations
• Clinically significant electrocardiogram (ECG) abnormalities at V1.
• Clinically significant hypotension either at screening visit or at baseline visit.
• Malignant melanoma or history of previously treated malignant melanoma.
• Any other clinically significant disease
• Pregnancy or breast-feeding.
• Sexually active female of childbearing potential
• 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).
• Patients with a creatinine clearance \< 50 mL/min
• Any dopamine agonist (except pramipexole IR) within three months prior to baseline visit.
• History of discontinuation of treatment with pramipexole IR

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (36)

248.636.3303A Boehringer Ingelheim Investigational Site

Aix-en-Provence, France

Location

248.636.3303B Boehringer Ingelheim Investigational Site

Aix-en-Provence, France

Location

248.636.3303C Boehringer Ingelheim Investigational Site

Aix-en-Provence, France

Location

248.636.3307C Boehringer Ingelheim Investigational Site

Bron, France

Location

248.636.3309B Boehringer Ingelheim Investigational Site

Clermont-Ferrand, France

Location

248.636.3305A Boehringer Ingelheim Investigational Site

Créteil, France

Location

248.636.3305B Boehringer Ingelheim Investigational Site

Créteil, France

Location

248.636.3313A Boehringer Ingelheim Investigational Site

Dijon, France

Location

248.636.3304A Boehringer Ingelheim Investigational Site

Évreux, France

Location

248.636.3308B Boehringer Ingelheim Investigational Site

Lille, France

Location

248.636.3308C Boehringer Ingelheim Investigational Site

Lille, France

Location

248.636.3308D Boehringer Ingelheim Investigational Site

Lille, France

Location

248.636.3308E Boehringer Ingelheim Investigational Site

Lille, France

Location

248.636.3302A Boehringer Ingelheim Investigational Site

Marseille, France

Location

248.636.3302B Boehringer Ingelheim Investigational Site

Marseille, France

Location

248.636.3306B Boehringer Ingelheim Investigational Site

Montpellier, France

Location

248.636.3312A Boehringer Ingelheim Investigational Site

Rouen, France

Location

248.636.3312B Boehringer Ingelheim Investigational Site

Rouen, France

Location

248.636.3311A Boehringer Ingelheim Investigational Site

Strasbourg, France

Location

248.636.3301A Boehringer Ingelheim Investigational Site

Toulouse, France

Location

248.636.3301B Boehringer Ingelheim Investigational Site

Toulouse, France

Location

248.636.3301D Boehringer Ingelheim Investigational Site

Toulouse, France

Location

248.636.49006 Boehringer Ingelheim Investigational Site

Achim Bei Bremen, Germany

Location

248.636.49004 Boehringer Ingelheim Investigational Site

Berlin, Germany

Location

248.636.49007 Boehringer Ingelheim Investigational Site

Berlin, Germany

Location

248.636.49008 Boehringer Ingelheim Investigational Site

Berlin, Germany

Location

248.636.49002 Boehringer Ingelheim Investigational Site

Gera, Germany

Location

248.636.49001 Boehringer Ingelheim Investigational Site

Karlsruhe, Germany

Location

248.636.49003 Boehringer Ingelheim Investigational Site

Steglitz, Germany

Location

248.636.49005 Boehringer Ingelheim Investigational Site

Unterhaching, Germany

Location

248.636.31005 Boehringer Ingelheim Investigational Site

's-Hertogenbosch, Netherlands

Location

248.636.31002 Boehringer Ingelheim Investigational Site

Geldrop, Netherlands

Location

248.636.31003 Boehringer Ingelheim Investigational Site

Helmond, Netherlands

Location

248.636.31006 Boehringer Ingelheim Investigational Site

Maastricht, Netherlands

Location

248.636.31004 Boehringer Ingelheim Investigational Site

Nijmegen, Netherlands

Location

248.636.31001 Boehringer Ingelheim Investigational Site

Sittard, Netherlands

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

Pramipexole

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Benzothiazoles; Thiazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Limitations and Caveats

There were no serious adverse events in the trial and no non-serious adverse events with an incidence \>5%.

Results Point of Contact

• Title: Boehringer Ingelheim Pharmaceuticals
• Organization: Boehringer Ingelheim Pharmaceuticals

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2007
• First Posted: November 14, 2007
• Study Start: October 1, 2007
• Primary Completion: May 1, 2008
• Last Updated: May 16, 2014
• Results First Posted: November 20, 2009

Record last verified: 2012-05

Locations

NL (6); DE (8); FR (22)