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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00134251

Enrollment

Unknown

Registered

2005-08-24

Start date

2005-10-31

Completion date

Unknown

Last updated

2009-01-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson's Disease

Keywords

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

Brief summary

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.

Interventions

DRUGSLV308

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

30 Years to No maximum

Healthy volunteers

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.

Countries

Bulgaria, Malta, Serbia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026