A Pilot Study to Assess Efficacy and Safety of Pardoprunox as Adjunct Therapy to L-dopa in the Treatment of Patients With Parkinson's Disease Experiencing Motor Fluctuations and Dyskinesia.

NCT00903838 | Terminated Phase 2

• 2 other identifiers: S308.2.0082008-000400-81
• Study Type: interventional
• Target: 37
• Locations: 3 countries
• Sites: 9

Brief Summary

This is a multicenter, randomized, double blind, pramipexole-controlled parallel group study of pardoprunox as adjunctive treatment to levodopa.

Conditions

Advanced Stage Parkinson's Disease

Keywords

Parkinson's disease

Outcome Measures

Primary Outcomes (1)

• Change from baseline to endpoint in ON-time without dyskinesia

  16 weeks

Secondary Outcomes (1)

• Change from baseline in ON-time with (troublesome) dyskinesia; OFF-time; UDysRS, UPDRS (part II + III during ON and OFF state) and Part 4

  16 weeks

Study Arms (2)

1

EXPERIMENTAL

Drug: pardoprunox

2

ACTIVE COMPARATOR

Drug: pramipexole

Interventions

pardoprunox DRUG

1.5 to 12 mg/day

1

pramipexole DRUG

0.75-4.5 mg/day

2

Eligibility Criteria

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

You may qualify if:

• Patients who have signed informed consent
• Diagnosis of idiopathic Parkinson's Disease
• Stable treatment with L-dopa and dopamine agonist for at least 28 days prior to randomization
• Presence of a recognizable ON and OFF state (motor fluctuations)
• Minimum hours of OFF-time per day of 1.5 hours (during waking hours including early morning akinesia) as recorded per baseline diaries
• Minimum hours of ON time with troublesome dyskinesia of 2 hours (during waking hours) as recorded per baseline diaries
• Prevalent expression of severely disabling dyskinesias during the waking day, i.e. dyskinesias are present at least 25% of the waking hours (UPDRS Part 4 item 32 \>= 2) in combination with a degree of disability which is moderate or higher (UPDRS Part 4 item 33 \>=2)

You may not qualify if:

• Diagnosis is unclear or a suspicion of other parkinsonian syndromes
• Patients who have undergone surgery for the treatment of PD

Sponsors & Collaborators

• Abbott Products: lead

Study Sites (9)

Site Reference ID/Investigator# 45433

Göttingen, 37075, Germany

Location

Site Reference ID/Investigator# 45428

Kassel, 34128, Germany

Location

Site Reference ID/Investigator# 45422

Tübingen, BW 72076, Germany

Location

Site Reference ID/Investigator# 45427

Ulm, 89081, Germany

Location

Site Reference ID/Investigator# 45435

Cassino, 03043, Italy

Location

Site Reference ID/Investigator# 45436

Chieti Scalo, 66013, Italy

Location

Site Reference ID/Investigator# 45437

Rome, 00163, Italy

Location

Site Reference ID/Investigator# 45438

Coimbra, 3000-075, Portugal

Location

Site Reference ID/Investigator# 45439

Lisbon, 1649-035, Portugal

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

pardoprunox; 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

Study Officials

• Juliana Bronzova, MD

  Abbott Healthcare Products B.V.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• 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: May 14, 2009
• First Posted: May 18, 2009
• Study Start: September 1, 2009
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: August 26, 2011

Record last verified: 2011-08

Locations

DE (4); IT (3); PT (2)