Safety, Tolerability, and Effectiveness of Rasagiline Mesylate in Patients With Parkinson's Disease

A Multicenter, Open-Label, Phase III Study for the Safety, Tolerability and Clinical Effect of Rasagiline Mesylate in Patients With Parkinson's Disease

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00203138

Enrollment

306

Registered

2005-09-20

Start date

2004-06-30

Completion date

2006-12-31

Last updated

2011-04-12

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

Conditions

Parkinson's Disease

Brief summary

Patients who completed the study TVP-1012/232 are eligible to enter the extension study to continue their rasagiline therapy for their Parkinson's disease (PD). During this study the patient's safety, tolerability of rasagiline, and effectiveness of this therapy will be monitored.

Interventions

DRUGrasagiline mesylate

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

35 Years to No maximum

Healthy volunteers

Inclusion criteria

• Patients who completed evaluations of week 52 of the TVP 1012/232 protocol, where continued rasagiline therapy is warranted, in the opinion of the principal investigator

Exclusion criteria

• Patients having suffered adverse effects that were probably drug-related in the TVP-1012/232 study

Design outcomes

Primary

Measure	Time frame
Tolerability - Number of patients completing study on their original treatment assignment (dose reduction and dropout)	2.5 years

Outcome results

None listed

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