Randomized, dose-finding study of BF 2.649 5, 10, 20 and 40 mg/d in comparison to placebo in Excessive Daytime Sleepiness in Parkinson’s Disease patients (PD)

• Register: EUCTR
• Last refreshed on: 4 April 2022
• Main ID: EUCTR2007-003512-57-FR
• Date of registration: 23/07/2007
• Prospective Registration: Yes
• Primary sponsor: Bioprojet
• Public title: Randomized, dose-finding study of BF 2.649 5, 10, 20 and 40 mg/d in comparison to placebo in Excessive Daytime Sleepiness in Parkinson’s Disease patients (PD)
• Scientific title: Randomized, dose-finding study of BF 2.649 5, 10, 20 and 40 mg/d in comparison to placebo in Excessive Daytime Sleepiness in Parkinson’s Disease patients (PD)
• Date of first enrolment: 24/08/2007
• Target sample size: 130
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-003512-57
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

France

Key inclusion & exclusion criteria

Inclusion criteria:
Adult outpatients of both sex with confirmed diagnosis of idiopathic PD defined by :
- UKPD Society Brain Bank clinical diagnostic criteria
- Historical knowledge of positive response to Levodopa or dopamine agonist test
- Severity of PD
- Hoehn and Yahr < 5
- Fluctuator and non fluctuator patients
- Stable treatment of PD for at least 4 weeks
- Excessive daytime sleepiness (EDS): Epworth scale superior or equal to 13
- Patients having accepted to participate in the study and signed the informed consent form
- Patient with health insurance
- Female patients with child-bearing potential using a medically accepted methof of birth control,agreeing to continue this method for the duration of the study and to be negative to serum pregnancy test performed at the screening visit
- Patients accepting and having sufficient support (in the opinion of the investigator) to comply with the study requirements (tests, self administered diaries completion, drug compliance, scheduled visits, car driving restriction if deemed necessary by the investigator…) and to maintain during the study their usual lifestyle (i.e. circadian rhythm, caffeine consumption, nocturnal sleep duration)
- None psychostimulant treatment intake for 2 weeks (at V2)

















Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
- Other degenerative parkinsonian syndromes (supra nuclear paralysis, multisystemic atrophy, corticobasal degenerescence, diffuse Lewy’s Body dementia)
- Other condition than PD that can be considered the primary cause of excessive daytime sleepiness as:
•Previous diagnostic of severe OSAS requiring CPAP according to the investigator
•Idiopathic narcolepsy and narcolepsy secondary to structural brain lesion
•Severe chronic alcohol consumption, shift work, chronic or occasional sleep deprivation,
- Severe depression (BDI = 16 ) or with suicidal risk (item G BDI > 0) or depression treated for less than 8 weeks
- 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. recent myocardial infarction,
- Electrocardiogram Bazett’s corrected QT interval (QT x ?Racine carrée? [60/HR]) 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 = 24
- Patients taking associated treatments which are not allowed during the study course and which cannot be stopped before the inclusion visit



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Excessive daytime sleepiness associated to Parkinson disease
MedDRA version: 9.1 Level: LLT Classification code 10041014 Term: Sleepiness
MedDRA version: 9.1 Level: LLT Classification code 10061536 Term: Parkinson's disease

Intervention(s)

Product Name: BF 2.649
Product Code: BF 2.649
Pharmaceutical Form: Capsule*
Current Sponsor code: BF 2.649
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 40-
Pharmaceutical form of the placebo: Capsule*
Route of administration of the placebo: Oral use

Product Name: BF 2.649
Product Code: BF 2.649
Pharmaceutical Form: Capsule*
Current Sponsor code: BF 2.649
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-

Product Name: BF 2.649
Product Code: BF 2.649
Pharmaceutical Form: Capsule*
Current Sponsor code: BF 2.649
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-

Product Name: BF 2.649
Product Code: BF 2.649
Pharmaceutical Form: Capsule*
Current Sponsor code: BF 2.649
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-

Primary Outcome(s)

Main Objective: To determine the minimum effective dose of BF 2.649 between 5 mg, 10 mg, 20 mg and 40 mg versus placebo in reducing the effects of BF 2.649 on the excessive daytime sleepiness and unintended sleep in Parkinson disease (PD)

Primary end point(s): Epworth Sleepiness Scale scores (ESS) on the 4-week treatment period

Secondary Objective: Mean number of daytime sleep or sleepiness episodes and their duration, motor function

Secondary ID(s)

P 07-02/BF 2.649

Ethics review

Status: Approved
Approval date: 24/08/2007
Contact:

Results

• Results available: Yes
• Date Posted: 11/01/2022
• Date Completed: 09/01/2009
• URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2007-003512-57/results