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Ascending Dose Tolerability/Safety of SLV308 for the Treatment of Parkinson's Disease

NCT ID: NCT00134251

Last Updated: 2009-01-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2005-10-31

Brief Summary

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This study is a multicenter, randomized, double-blind, placebo controlled, parallel group study of a seven-week ascending dose period of SLV308 adjunctive to L-dopa treatment in patients with advanced stage Parkinson's disease (PD) and dose-dependent motor fluctuations. Patients (outpatients) will be randomized to one of three different treatment arms.

Detailed Description

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Conditions

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Parkinson's Disease

Keywords

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Parkinson's disease adjunctive to L-dopa therapy Advanced stage Parkinson's disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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SLV308

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients who have signed an informed consent; diagnosis of idiopathic PD.
* Presence of recognizable "on" and "off" stages
* Minimum hours of "off" time per day of 2.5 hours
* Able to keep diaries.

Exclusion Criteria

* Unclear diagnosis or a suspicion of other parkinsonian syndromes
* Have undergone surgical treatment for PD
* History of non-response to L-dopa.
Minimum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Solvay Pharmaceuticals

INDUSTRY

Sponsor Role lead

Principal Investigators

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Global Clinical Director Solvay

Role: STUDY_DIRECTOR

Solvay Pharmaceuticals

Locations

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Site 16

Plovdiv, , Bulgaria

Site Status

Site 11

Sofia, , Bulgaria

Site Status

Site 12

Sofia, , Bulgaria

Site Status

Site 13

Sofia, , Bulgaria

Site Status

Site 14

Sofia, , Bulgaria

Site Status

Site 15

Sofia, , Bulgaria

Site Status

Site 21

Guardamangia, , Malta

Site Status

Site 31

Belgrade, , Serbia

Site Status

Site 34

Belgrade, , Serbia

Site Status

Site 33

Niš, , Serbia

Site Status

Countries

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Serbia and Montenegro Bulgaria Malta Serbia

Other Identifiers

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EuDract no 2005-002432-10

Identifier Type: -

Identifier Source: secondary_id

S308.3.005

Identifier Type: -

Identifier Source: org_study_id