A multicenter, randomized, double-blind, placebo-controlled, ascending dose, parallel group study exploring effects of SLV308 up to 42 mg/day administered as an adjunctive therapy to l-dopa in patients with advanced stage Parkinson’s disease

• Conditions: Parkinson Disease late stage

• Registration Number: EUCTR2005-002432-10-MT
• Lead Sponsor: Solvay Pharmaceuticals

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-10-10
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

– Patient s with idiopathic PD according to the United Kingdom Parkinson’s Disease
Society (UKPDS) Brain Bank Criteria and a disease stage corresponding to 2-4
according to classification of Modified Hoehn and Yahr.
– Stable treatment with l-dopa in terms of total daily dose and administration regimen for at least 28 days prior to randomization, requiring at least three but not more than seven dose periods of l-dopa per day.
– Presence of a recognizable on” and off” state (motor fluctuations).
– Minimum hours of off” time per day of 2.5 hours (during waking hours) as recorded per baseline diary assessment (mean of the three baseline days).
– Ability to keep an e-Diary.
– Male or female. Females must be of non-childbearing potential or having aceptable
contraceptive method (as defined in the protocol)
– Age 30 years.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

RELATED TO PARKINSON’S DISEASE

1. Presence of complex on-off” phenomena or yo-yoing” and/or an abrupt unpredictable loss of efficacy unrelated to the timing of l-dopa administration.
2. Prevalent expression of troublesome dyskinesias during on” time in waking hours based on patients’ diaries and UPDRS: dyskinesias are present at least 25% of the waking hours(UPDRS part IV, item 32 >= 2) and the degree of disability is moderate or higher (UPDRS part IV, item 33 >= 2).
3. Diagnosis is unclear or a suspicion of other parkinsonian syndromes exists, such as secondary parkinsonism (caused by drugs, toxins, infectious agents, vascular disease, trauma, brain neoplasm), Parkinson-plus syndromes (e.g. multiple system atrophy, progressive supranuclear palsy) or he redodegenerative diseases.
4. Patient s who have undergone surgery for the treatment of PD (e.g. pallidotomy, deep brain stimulation, fetal tissue transplantation) or have undergone any other brain surgery.
5. A history of non-response (according to both the clinician and the patient) to an adequate course of l-dopa.
6. Treatment within last 60 days before baseline with neuroleptics, MAO inhibitors other than selegiline or rasagiline, alpha-methyl-dopa or metoclopramide; treatment within last 30 days before baseline with any dopamine agonists, amantadine, parenteral ergots, methylphenidate, amphetamine, beta blockers for treating tremor, antiemetics, isoprenaline, adrenaline, dopamine, dobutamide, reserpine, flunarizine, cinnarizine or apomorphine.

GENERAL

1. Exposure to any investigational drug within 60 days prior to Visit 1.
2. Breast feeding or pregnant women.
3. Prior exposure to SLV308.
4. Uncooperative attitude or reasonable likelihood for non-compliance with the protocol.
5. Any other reason that, in the Investigator’s opinion, prohibits the inclusion of the patient into the study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified