Therapeutic Confirmatory Clinical Trial to Evaluate the Safety & Efficacy

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

See also
Status	Clinical Trial	Phase
Completed	`NCT03216473` - Clinical Study to Evaluate the Efficacy and Safety of Neuronox and Botox With Essential Blepharospasm	Phase 3
Completed	`NCT01259557` - Efficacy and Safety Study of Meditoxin® to Treat Essential Blepharospasm	Phase 4
Completed	`NCT03641950` - The Objective of This Study is to Evaluate the Efficacy and Safety of Botulax® in Patients With Essential Blepharospasm.	Phase 4

See also

Status

Clinical Trial

Phase

Completed

NCT03216473 - Clinical Study to Evaluate the Efficacy and Safety of Neuronox and Botox With Essential Blepharospasm

Phase 3

Completed

NCT01259557 - Efficacy and Safety Study of Meditoxin® to Treat Essential Blepharospasm

Phase 4

Completed

NCT03641950 - The Objective of This Study is to Evaluate the Efficacy and Safety of Botulax® in Patients With Essential Blepharospasm.

Phase 4

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	NCT01791881
Study type	Interventional
Source	Hugel
Contact
Status	Completed
Phase	Phase 3
Start date	April 2008
Completion date	July 2009

Therapeutic Confirmatory Clinical Trial to Evaluate the Safety and Efficacy of "Hugeltox Inj." in Essential Blepharospasm

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms