NCT00642928

Brief Summary

The objective of this trial is to define the minimum effective dose of BF 2.649 between 5 mg, 10 mg, 20 mg or 40 mg versus placebo in reducing the Excessive Daytime Sleepiness of Parkinson's disease patients

Trial Health

87
On Track

Trial Health Score

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

Enrollment
108

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Oct 2007

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

Study Start

First participant enrolled

October 1, 2007

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 21, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 25, 2008

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

June 11, 2012

Status Verified

June 1, 2012

Enrollment Period

1.4 years

First QC Date

March 21, 2008

Last Update Submit

June 8, 2012

Conditions

Excessive Daytime SleepinessParkinson's Disease

Keywords

Excessive Daytime SleepinessParkinson's disease

Outcome Measures

Primary Outcomes (1)

  • Epworth Sleepiness Scale scores (ESS)

    At selection visit (Day-14 to Day-7)/Inclusion visit (Day0)/ Interim visit (Day14)/Final visit (Day28)

Secondary Outcomes (4)

  • Mean number of daytime sleep or sleepiness episodes and their duration

    During 5 days before each visit

  • frequency of sleep attacks

    recorded at each visit

  • UPDRS III for motor function

    at each visit

  • Clinical global impression scale

    at each visit

Study Arms (5)

Placebo

PLACEBO COMPARATOR
Drug: Placebo

BF 2.649-5 mg

EXPERIMENTAL
Drug: BF 2.649 5 mg

BF 2.649 10 mg

EXPERIMENTAL
Drug: BF 2.649 10 mg

BF 2.649 20 mg

EXPERIMENTAL
Drug: BF 2.649 20 mg

BF 2.649 40 mg

EXPERIMENTAL
Drug: BF 2.649 40 mg

Interventions

PlaceboDRUG

1 capsule per day during 4 weeks

Placebo
BF 2.649 5 mgDRUG

one BF 2.649 capsule of 5 mg per day during 4 weeks

Also known as: pitolisant
BF 2.649-5 mg
BF 2.649 10 mgDRUG

One BF 2.649 capsule of 10 mg per day during 4 weeks

Also known as: pitolisant
BF 2.649 10 mg
BF 2.649 20 mgDRUG

One BF 2.649 capsule of 20 mg per day during 4 weeks

Also known as: pitolisant
BF 2.649 20 mg
BF 2.649 40 mgDRUG

One BF 2.649 capsule of 40 mg per day during 4 weeks

Also known as: pitolisant
BF 2.649 40 mg

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Idiopathic Parkinson disease
  • Hoehn and Yahr \< 5
  • Stable treatment of Parkinson disease for at least 4 weeks
  • Excessive Daytime Sleepiness : Epworth scale superior or equal to 13
  • None psychostimulant treatment intake for 2 weeks

You may not qualify if:

  • Other degenerative parkinsonian syndrome
  • other condition than PD that is the primary cause of excessive daytime sleepiness
  • Severe depression or suicidal risk
  • Pregnant or breast-feeding women
  • Patients having an occupation that requires night shift
  • History of drugs, alcohol, narcotic or other substance abuse or dependence
  • Refusal from the patient to stop any current therapy for excessive daytime sleepiness or predictable risks for the patient to stop the therapy
  • Any significant abnormality in the physical examination or clinical laboratory results e.g. liver or kidney function deficiency
  • Any significant serious abnormality of the ECG e.g. myocardial infarction,
  • Electrocardiogram corrected QT interval higher than 450 ms
  • Other active clinically significant illness which could interfere with the study conduct or contra-indicate the study treatments or put patients at risk
  • Dementia with MMS inferior or equal to 24

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pitié-Salpêtrière Hospital

Paris, 75013, France

Location

MeSH Terms

Conditions

Disorders of Excessive SomnolenceParkinson Disease

Interventions

pitolisant

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental DisordersParkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • ARNULF Isabelle

    Pitié-Salpêtrière Hospital, Paris, France

    PRINCIPAL INVESTIGATOR

  • Carsten Moeller

    Universitätsklinikum Giessen und Marburg, Marburg, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 21, 2008

First Posted

March 25, 2008

Study Start

October 1, 2007

Primary Completion

March 1, 2009

Study Completion

June 1, 2009

Last Updated

June 11, 2012

Record last verified: 2012-06

Locations

FR(1)