Other Clinical Trial - An Open Label SLV308 Safety Extension to Study

Clinical Trial Description

n/a

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Advanced Stage Parkinson's Disease
Parkinson Disease

See also
Status	Clinical Trial	Phase
Terminated	`NCT00903838` - 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.	Phase 2
Completed	`NCT00406588` - SLV308 for Treatment of Patients With Parkinson's Disease Experiencing Motor Fluctuations	Phase 3
Completed	`NCT00501969` - An Open-Label Extension Trial to Assess the Safety of Long-Term Treatment of Rotigotine in Advanced-Stage Parkinson's Disease	Phase 3

See also

Status

Clinical Trial

Phase

Terminated

NCT00903838 - 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.

Phase 2

Completed

NCT00406588 - SLV308 for Treatment of Patients With Parkinson's Disease Experiencing Motor Fluctuations

Phase 3

Completed

NCT00501969 - An Open-Label Extension Trial to Assess the Safety of Long-Term Treatment of Rotigotine in Advanced-Stage Parkinson's Disease

Phase 3

Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.

Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.

Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

NCT number	NCT00407095
Study type	Interventional
Source	Solvay Pharmaceuticals
Contact
Status	Completed
Phase	Phase 3
Start date	August 2007
Completion date	May 2009

An Open Label SLV308 Safety Extension to Study S308.3.002 in Patients With Parkinson's Disease Experiencing Motor Fluctuations.

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms