An Open Label SLV308 Safety Extension to Study S308.3.003 in Early PD

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

See also
Status	Clinical Trial	Phase
Completed	`NCT00269516` - SLV308 for Treatment of Patients With Early Parkinson's Disease	Phase 3
Completed	`NCT00623324` - The Effects of Aplindore on the Treatment of Signs and Symptoms of Parkinson's Disease	Phase 2
Completed	`NCT00332917` - An Open Label SLV308 Safety Extension to Study S308.3.001 in Early PD Patients	Phase 3
Completed	`NCT00599196` - An Open-Label Extension Trial to Assess the Safety of Long-Term Treatment of Rotigotine in Early-Stage Parkinson's Disease	Phase 3

See also

Status

Clinical Trial

Phase

Completed

NCT00269516 - SLV308 for Treatment of Patients With Early Parkinson's Disease

Phase 3

Completed

NCT00623324 - The Effects of Aplindore on the Treatment of Signs and Symptoms of Parkinson's Disease

Phase 2

Completed

NCT00332917 - An Open Label SLV308 Safety Extension to Study S308.3.001 in Early PD Patients

Phase 3

Completed

NCT00599196 - An Open-Label Extension Trial to Assess the Safety of Long-Term Treatment of Rotigotine in Early-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	NCT00335374
Study type	Interventional
Source	Solvay Pharmaceuticals
Contact
Status	Completed
Phase	Phase 3
Start date	August 2007
Completion date	November 2008

An Open Label SLV308 Safety Extension to Study S308.3.003 in Early PD Patients

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms