Long-term Safety Study of Open-label Pramipexole Extended Release (ER) in Patients With Early Parkinson´s Disease (PD).

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00601523
First received: January 15, 2008
Last updated: June 3, 2014
Last verified: March 2014
  Purpose

The general aim of this study is to obtain long-term safety and tolerability data on pramipexole ER, in daily doses from 0.375mg to 4.5mg once daily (q.d), in patients who have previously completed a pramipexole double-blind study in early PD (248.524(NCT00479401) or 248.636(NCT00558025) trial).


Condition Intervention Phase
Parkinson Disease
Drug: Placebo
Drug: Pramipexole
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Long-term Safety Study of Open-label Pramipexole Extended Release (ER) in Patients With Early Parkinson´s Disease (PD).

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Percentage of Patients With Adverse Events, Adverse Drug Reactions, Serious Adverse Events [ Time Frame: 80 weeks (patients from 248.524) or 72 weeks (patients from 248.636) ] [ Designated as safety issue: No ]
    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 early PD (248.524 (NCT00479401) or 248.636 (NCT00558025)). Therefore these items were considered as a safety evaluation


Secondary Outcome Measures:
  • Unified Parkinson's Disease Rating Scale (UPDRS) II+III Total Score: Change From Baseline [ Time Frame: Open Label (OL) baseline and week 80 (patients from 248.524) or week 72 (patients from 248.636) ] [ Designated as safety issue: No ]
    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 With UPDRS II+III Response From OL Baseline at Week 80 (Patients From 248.524) or Week 72 (Patients From 248.636) [ Time Frame: OL Baseline and week 80 (patients from 248.524) or week 72 (patients from 248.636) ] [ Designated as safety issue: No ]
    A response means an improvement of >=20% 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

  • UPDRS I Total Score: Change From OL Baseline [ Time Frame: OL baseline and week 80 (patients from 248.524) or week 72 (patients from 248.636) ] [ Designated as safety issue: No ]
    UPDRS I ranging from 0 (normal) to 16 (severe), measures Mentation, Behavior and Mood

  • UPDRS II Total Score: Change From OL Baseline [ Time Frame: OL baseline and week 80 (patients from 248.524) or week 72 (patients from 248.636) ] [ Designated as safety issue: No ]
    UPDRS II ranging from 0 (normal) to 52 (severe), measures activity of daily living.

  • UPDRS III Total Score: Change From OL Baseline [ Time Frame: OL baseline and week 80 (patients from 248.524) or week 72 (patients from 248.636) ] [ Designated as safety issue: No ]
    UPDRS III ranging from 0 (normal) to 108 (severe) measures motor symptoms

  • Response in Clinical Global Impression of Improvement (CGI-I) [ Time Frame: OL Baseline and week 32 (patients from 248.524) or week 24 (patients from 248.636) ] [ Designated as safety issue: No ]
    Clinicians evaluation in a rating scale of 7 steps, 1 meaning very much improved to 7 meaning 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 Pramipexole ER or Immediate Release (IR), all patients with no change to very much improved were considered as responders

  • Response in Patient Global Impression of Improvement (PGI-I) [ Time Frame: OL Baseline and week 32 (patients from 248.524) or week 24 (patients from 248.636) ] [ Designated as safety issue: No ]
    Patient rated evaluation of the PD symptoms on a rating scale of 7 steps, 1 meaning very much better to 7 meaning 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 pramipexole (PPX) ER or IR, all patients with no change to very much better were considered as responders

  • Parkinson Fatigue Scale (PFS-16) : Change From OL Baseline [ Time Frame: OL baseline and week 80 (patients from 248.524) or week 72 (patients from 248.636) ] [ Designated as safety issue: No ]
    PFS-16 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 Patients Introducing L-Dopa Medication in OL Trial [ Time Frame: 80 weeks (patients from 248.524) or 72 weeks (patients from 248.636) ] [ Designated as safety issue: No ]
    Number of patients requiring Levodopa supplementation during the study

  • L-Dopa Dose: Change From OL Baseline [ Time Frame: OL baseline and week 80 (patients from 248.524) or week 72 (patients from 248.636) ] [ Designated as safety issue: No ]
    Change from open-label baseline in Levodopa dose

  • Pramipexole Doses Respectively After 80 Weeks Compared to Pramipexole Doses at Week 8 for Previously 248.524 Patients and After 72 Weeks Compared to Pramipexole Doses at Week 0 for Previously 248.636 Patients [ Time Frame: Week 8 and week 80 (patients from 248.524) or week 0 and week 72 (patients from 248.636) ] [ Designated as safety issue: No ]
    Change from open-label baseline in Levodopa dose over the final 72 weeks of open-label assessment

  • Patient Preference Regarding Treatment Dosing [ Time Frame: 80 weeks (patients from 248.524) or 72 weeks (patients from 248.636) ] [ Designated as safety issue: No ]
    Patients were surveyed on their preference for Once Daily dosing versus Three Times Daily dosing

  • Patient Rating of Convenience of Treatment Dosing [ Time Frame: 80 weeks (patients from 248.524) or 72 weeks (patients from 248.636) ] [ Designated as safety issue: No ]
    Patients were surveyed on the convenience of Once Daily dosing versus Three Times Daily dosing


Enrollment: 511
Study Start Date: January 2008
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Pramipexole
Patient to receive Pramipexole ER 0.375-4.5 mg tabl form daily
Drug: Pramipexole
ER 0.375-4,5 mg
Placebo Comparator: Placebo
Patient to receive placebo tablets identical to Pramipexole ER tablets. Only during transfer phase.
Drug: Placebo
Patient to receive placebo tablets identical to Pramipexole ER tablets. Only during transfer phase.

  Eligibility

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

Inclusion criteria:

  1. Completion of the double-blind trial 248.524 or 248.636
  2. Male or female patient with early idiopathic Parkinson´s disease (PD), and with a Modified Hoehn and Yahr stage of I to III.
  3. Patient willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.
  4. Signed informed consent obtained before any study procedures are carried out (in accordance with International Conference on Harmonisation (ICH) - Good Clinical Practice (GCP) guidelines and local legislation).

Exclusion criteria:

  1. Patients prematurely withdrawn from the double-blind trials 248.524 or 248.636.
  2. Atypical parkinsonian syndromes due to drugs,metabolic disorders, encephalitis or degenerative diseases.
  3. Any psychiatric disorder according to Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV) criteria that could prevent compliance or completion of the study and/or put the patient at risk if he/she takes part in the study.4.History of psychosis, except history of drug induced hallucinations.

5. Clinically significant electrocardiogram (ECG) abnormalities at baseline. 6.Clinically significant hypotension 7.Malignant melanoma or history of previously treated malignant melanoma. 8.Any other clinically significant disease, that could put the patient at risk or could prevent compliance or completion of the study. 9. Pregnancy or breast-feeding.

10. Sexually active female of childbearing potential not using a medically approved method of birth control for at least one month prior to the baseline and throughout the study.11 Serum levels of aspartate aminotransferase (AST) (SGOT), alanine aminotransferase (ALT) (SGPT), alkaline phosphatase or bilirubin > 2 upper limit of normal (ULN) at baseline 12. Patients with a creatinine clearance < 50 mL/min (estimated by the Cockcroft and Gault formula). 13. Motor complications under levodopa therapy (e.g. on-off phenomena, dyskinesia) at baseline.

14. Any medication (including intra-muscular formulations) with central dopaminergic antagonist activity within 4 weeks prior to the baseline visit. 15.Any of the following drugs within 4 weeks prior to baseline: methylphenidate, cinnarizine, amphetamines. 16. Flunarizine within 3 months prior to baseline.

17. Known hypersensitivity to pramipexole or its excipients. 18. Drug abuse (including alcohol), according to investigator´s judgement, within 2 years prior to baseline.

19. Participation in investigational drug studies other than trials 248.524 and 248.636 or use of other investigational drug within one month or five times the half-life of the investigational drug prior to baseline.

  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: NCT00601523

  Show 119 Study Locations
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: NCT00601523     History of Changes
Other Study ID Numbers: 248.633, 2007-004234-16
Study First Received: January 15, 2008
Results First Received: June 6, 2011
Last Updated: June 3, 2014
Health Authority: Austria: Federal Office for Safety in Health Care
Czech Republic: State Institute for Drug Control (SUKL), CZ-100 41 Prague 10
Finland: Finnish Medicines Agency
France: Agence Française de Securite Sanitaire des Produits de Sante
Germany: Federal Institute for Drugs and Medical Devices
Hungary: National Institute of Pharmacy, H-1051 Budapest
India: Drug Control General of India
Japan: Ministry of Health, Labor and Welfare
Malaysia: Ministryof Health, Malaysia
Netherlands: Central Committee on Research Involving Human Subjects (CCMO)
Russia: Ministry of Healthcare and Social Development of Russian Federation, Moscow
Slovakia: SUKL (state institute for drug control), SK-825 08 Bratislava 26
Taiwan: Department of Health, Executive Yuan, Taiwan
Ukraine: Ministry of Health Care of Ukraine (MoH of Ukraine)
United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on October 20, 2014