Influence of Piribedil (Clarium®) on Vigilance and Cognitive Function in Patients With Parkinson's Disease Compared to Other Non-Ergot Dopamine Agonists

NCT01007864 | Completed Phase 3

• 1 other identifier: PIR-007/K
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 12

Brief Summary

The purpose of this clinical trial is to investigate the effects of the non-ergot dopamine agonist piribedil on vigilance and cognitive performances in patients with Parkinson's disease in comparison with other oral non-ergot dopamine agonists. It should be tested whether piribedil is superior to continued pramipexole or ropinirole treatment regarding improvement of reduced vigilance and cognitive performance in patients with Parkinson's disease.

Conditions

Idiopathic Parkinson's Disease

Keywords

Parkinson; piribedil; vigilance; dopamine agonist; cognition

Outcome Measures

Primary Outcomes (1)

• The primary efficacy variable will be the 'median reaction time during the second 15 minutes (minutes 16-30)' of the subtest 'vigilance', visual test condition 'moving bar', of the Test battery for Attention Performances (TAP) at end of treatment.

  Baseline and End of Treatment

Secondary Outcomes (8)

• Other vigilance parameters of the TAP test

  Baseline and End of Treatment

• Other neuropsychological tests: Test of verbal fluency (RWT), Verbal learning memory test (VLMT), Stroop test (FWIT)

  Baseline and End of Treatment

• Epworth Sleepiness Scale (ESS)

  Baseline and End of Treatment

• Parkinson's Disease Sleeping Scale (PDSS)

  Baseline and End of Treatment

• Unified Parkinson's Disease Rating Scale (UPDRS) subscores I to IV and total score

  Baseline and End of Treatment

Study Arms (2)

piribedil

EXPERIMENTAL

Drug: piribedil

pramipexole or ropinirole

ACTIVE COMPARATOR

Drug: pramipexole or ropinirole

Interventions

piribedil DRUG

Oral application of piribedil at an equivalent dose of pramipexole or ropinirole according to a defined equivalence scheme (dose range 100 - 300 mg per day) for 11 weeks.

Also known as: Clarium®

piribedil

pramipexole or ropinirole DRUG

continuation of pre-study treatment regimen

pramipexole or ropinirole

Eligibility Criteria

• Age: 35 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female Caucasian patients aged 35 to 80 years;
• Patients with idiopathic Parkinson's disease;
• Hoehn \& Yahr stages 1 to 4;
• Stable medication with anti-parkinsonian medication, including stable treatment with pramipexole or ropinirole, for at least 4 weeks prior to Screening;
• Significant daytime sleepiness: Epworth Sleepiness Scale score equals or is higher than 11 under previous therapy with pramipexole or ropinirole;
• Patients who have read and understood the patient information sheet and have provided a signed written informed consent form;
• Patients are considered to be compliant to the study regimen.

You may not qualify if:

• Treatment of Parkinson's disease with any dopamine agonist other than pramipexole or ropinirole within 4 weeks prior to Screening;
• Known hypersensitivity to Clarium® or its excipients;
• Patients with daytime sleepiness caused by other factor's than Parkinson's disease, i.e., idiopathic narcolepsy, shift work, severe alcohol abuse, obstructive diseases, sleep apnea syndrome, or Periodic limb movement disorder;
• Secondary and atypical Parkinson syndrome;
• Depression (Beck Depression Inventory score higher than 16);
• Dementia (Mini-Mental State Examination score equals or is lower than 24);
• Severe disability in extremities which could influence clinical assessments;
• Clinically significant disease concerning the lung, liver or kidney;
• Any acute or chronic infection that may influence the outcome of the study;
• Cardiovascular shock;
• Acute myocardial infarction;
• Congestive heart failure NYHA class III or IV;
• Uncontrolled arterial hypertension (diastolic blood pressure equals or is higher than 105 mmHg) or clinically relevant hypotension;
• Evidence of clinically active cancer;
• Color vision defect that may have impact on assessment of FWIT;

Sponsors & Collaborators

• Desitin Arzneimittel GmbH: lead
• FGK Clinical Research GmbH: collaborator

Study Sites (12)

Unknown Facility

Ulm, Baden-Wurttemberg, 89081, Germany

Location

Unknown Facility

Wolfach, Baden-Wurttemberg, 77709, Germany

Location

Unknown Facility

München, Bavaria, 80804, Germany

Location

Unknown Facility

Marburg, Hesse, 35043, Germany

Location

Unknown Facility

Göttingen, Lower Saxony, 37075, Germany

Location

Unknown Facility

Dresden, Saxony, 01307, Germany

Location

Unknown Facility

Leipzig, Saxony, 04107, Germany

Location

Unknown Facility

Berlin, State of Berlin, 12200, Germany

Location

Unknown Facility

Berlin, State of Berlin, 13353, Germany

Location

Unknown Facility

Steglitz, State of Berlin, 12163, Germany

Location

Unknown Facility

Gera, Thuringia, 07551, Germany

Location

Unknown Facility

Stadtroda, Thuringia, 07646, Germany

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

Piribedil; Loratadine; Pramipexole; ropinirole

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)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Cyproheptadine; Dibenzocycloheptenes; Benzocycloheptenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperidines; Polycyclic Compounds; Benzothiazoles; Thiazoles; Azoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Martina Wangemann, Dr.

  Desitin Arzneimittel GmbH

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2009
• First Posted: November 4, 2009
• Study Start: January 1, 2010
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: May 24, 2012

Record last verified: 2012-04

Locations

DE (12)