NCT02786667

Brief Summary

Clinical description and pathophysiological study of recently diagnosed untreated patients with Parkinson's Disease. Effect of a dopamine agonist (rotigotine) on apathy in de novo patients with Parkinson disease: A controlled, randomized, double blind study.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
199

participants targeted

Target at P25-P50 for phase_3 parkinson-disease

Timeline
Completed

Started Jun 2012

Longer than P75 for phase_3 parkinson-disease

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

June 1, 2012

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

May 18, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 1, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

October 26, 2017

Status Verified

October 1, 2017

Enrollment Period

5.4 years

First QC Date

May 18, 2016

Last Update Submit

October 25, 2017

Conditions

Parkinson DiseaseApathy

Outcome Measures

Primary Outcomes (1)

  • Change of LARS (Lille Apathy Rating Scale) score in the rotigotine versus placebo group

    6 months

Study Arms (2)

Rotigotine

EXPERIMENTAL

6 months treatment with Rotigotine up to 8 mg per day with a titration period for one month

Drug: Rotigotine

Placebo

PLACEBO COMPARATOR

6 months treatment with Placebo up to 8 mg per day with a titration period for one month

Drug: Placebo

Interventions

RotigotineDRUG

6 months treatment with Rotigotine up to 8 mg per day with a titration period for one month

Also known as: Neupro
Rotigotine
PlaceboDRUG

6 months treatment with Placebo up to 8 mg per day with a titration period for one month

Placebo

Eligibility Criteria

Age30 Years - 72 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with Parkinson disease without treatment for Parkinson disease
  • Recent diagnosis (\< 2 years)
  • Without cognitive troubles

You may not qualify if:

  • Patients with cognitive troubles
  • Treated patients with L-Dopa or Dopamine agonists
  • Other severe illness
  • Pregnant or parturient woman

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Grenoble

Grenoble, 38043, France

Location

MeSH Terms

Conditions

Parkinson DiseaseLethargy

Interventions

rotigotine

Condition Hierarchy (Ancestors)

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

Study Officials

  • Anna Castrioto, MD

    University Hospital, Grenoble

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 18, 2016

First Posted

June 1, 2016

Study Start

June 1, 2012

Primary Completion

October 15, 2017

Study Completion

December 1, 2017

Last Updated

October 26, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)