NCT01851850

Brief Summary

The purpose of the study is to extend the use of opicapone 25 or 50mg once per day by subjects who participated in the BIA 9-1067-302 clinical trial according form 4a for additional three years.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for phase_3 parkinson-disease

Timeline
Completed

Started May 2013

Typical duration for phase_3 parkinson-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 1, 2013

Completed
Same day until next milestone

Study Start

First participant enrolled

May 1, 2013

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 13, 2013

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 24, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 24, 2016

Completed
Last Updated

March 16, 2020

Status Verified

January 1, 2013

Enrollment Period

3.1 years

First QC Date

May 1, 2013

Last Update Submit

March 12, 2020

Conditions

Parkinson Disease

Keywords

PDOff periodsquality of lifedyskinesiaend-off-dose motor fluctuations

Outcome Measures

Primary Outcomes (1)

  • off periods

    number of "off" periods during the day without worsening dyskinesia.

    6 month

Study Arms (1)

Drug

EXPERIMENTAL
Drug: Opicapone

Interventions

OpicaponeDRUG

25mg or 50mg once per day

Drug

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • clinical diagnosis with PD
  • subjects who are willing to participate in the trial.
  • subjects who participated in the BIA 9-1067-302 clinical trial.

You may not qualify if:

  • subjects who didn't take part at the BIA 9-1067-302 clinical trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rabin Medical Center

Petach Tiqva, Central District, 49100, Israel

Location

MeSH Terms

Conditions

Parkinson DiseaseDyskinesias

Interventions

opicapone

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 1, 2013

First Posted

May 13, 2013

Study Start

May 1, 2013

Primary Completion

May 24, 2016

Study Completion

May 24, 2016

Last Updated

March 16, 2020

Record last verified: 2013-01

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)