Excessive Daytime SleepinessPhase 2NCT00642928
Dose Range Finding Study of BF2.649 Versus Placebo to Treat Excessive Daytime Sleepiness in Parkinson's Disease Patients
A Phase 2 study testing BF 2.649 5 mg, BF 2.649 10 mg and BF 2.649 20 mg in people with Excessive Daytime Sleepiness and Parkinson's Disease, run by Bioprojet at 1 site in France.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Excessive Daytime Sleepiness, Parkinson's Disease
- What is being tested?
- BF 2.649 5 mg, BF 2.649 10 mg and BF 2.649 20 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 108 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2007to Jun 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
- Patients taking associated treatments which are not allowed during the study course and which cannot be stopped before the inclusion visit
Trial locations and contacts
1 site in 1 country.
About this study
Official 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)
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
Read the detailed description
Parkinson's disease (PD) is a progressive neurodegenerative disorder characterized by resting tremor, rigidity, bradykinesia and loss of postural reflexes that affects 1% of the North American population. Besides these motor problems there are also so called non-motor problems.
Excessive daytime sleepiness (EDS) is a bothersome non-motor problem, which affects 20% to 50% of all PD patients and currently, there isn't any registered treatment for that trouble.
The study medication BF2.649 tested here is a novel, highly potent, selective, orally active inverse agonist at the histamine H3 receptor, therefore strengthens histaminergic transmission in the brain and increases wakefulness EDS is characterized by daytime somnolence and sudden sleep episodes. This problem has several consequences, e.g., an impairment of quality of life, an interference with activities of daily living and other handicaps in the management of social and family affairs.
The primary endpoint of this study will be measured by the change in the well-validated Epworth sleepiness scale (ESS). The ESS is a simple self-administered 8-item questionnaire. The outcome is to get an impression about the level of the daytime sleepiness in several real-life situations.
On the basis of this pharmacological and clinical rationale it is considered relevant to carry out a dose-finding study for this original, non-amphetamine molecule in PD patients affected by excessive daytime sleepiness. PD severity will be assessed by the routinely used UPDRS.
- Conditions
- Excessive Daytime Sleepiness, Parkinson's Disease
- Being tested
- Placebo, BF 2.649 5 mg, BF 2.649 10 mg, BF 2.649 20 mg, BF 2.649 40 mg
- Keywords
- Excessive Daytime Sleepiness, Parkinson's disease
- Medical subject headings
- Disorders of Excessive Somnolence, Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
1 capsule per day during 4 weeks
BF 2.649 5 mgDrug
Also called pitolisant
one BF 2.649 capsule of 5 mg per day during 4 weeks
BF 2.649 10 mgDrug
Also called pitolisant
One BF 2.649 capsule of 10 mg per day during 4 weeks
BF 2.649 20 mgDrug
Also called pitolisant
One BF 2.649 capsule of 20 mg per day during 4 weeks
BF 2.649 40 mgDrug
Also called pitolisant
One BF 2.649 capsule of 40 mg per day during 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| BF 2.649-5 mg | Experimental | Not described Receives: Drug: BF 2.649 5 mg |
| BF 2.649 10 mg | Experimental | Not described Receives: Drug: BF 2.649 10 mg |
| BF 2.649 20 mg | Experimental | Not described Receives: Drug: BF 2.649 20 mg |
| BF 2.649 40 mg | Experimental | Not described Receives: Drug: BF 2.649 40 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Epworth Sleepiness Scale scores (ESS)
Measured: 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
Measured: During 5 days before each visit
frequency of sleep attacks
Measured: recorded at each visit
UPDRS III for motor function
Measured: at each visit
Clinical global impression scale
Measured: at each visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2008 (estimated)
- Study startOct 2007
- Primary completionMar 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Excessive Daytime SleepinessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bioprojet
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- ARNULF Isabelle, Principal investigator, Pitié-Salpêtrière Hospital, Paris, FranceCarsten Moeller, Principal investigator, Universitätsklinikum Giessen und Marburg, Marburg, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00642928
- Sponsor's protocol ID
- P07-02 / BF 2.649
- Other IDs
- 2007-003512-57
- Status last verified
- Jun 2012
- First submitted
- 21 Mar 2008
- Last updated
- 11 Jun 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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)
- ClinicalTrials.gov ID
- NCT00642928
- Acronym / sponsor ID
- P07-02 / BF 2.649
- Conditions
- Excessive Daytime Sleepiness, Parkinson's Disease
- Keywords
- Excessive Daytime Sleepiness, Parkinson's disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- BioprojetUniversity, hospital or other
- Study start
- Oct 2007
- Primary completion
- Mar 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 25 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Parkinson's disease (PD) is a progressive neurodegenerative disorder characterized by resting tremor, rigidity, bradykinesia and loss of postural reflexes that affects 1% of the North American population. Besides these motor problems there are also so called non-motor problems.
Excessive daytime sleepiness (EDS) is a bothersome non-motor problem, which affects 20% to 50% of all PD patients and currently, there isn't any registered treatment for that trouble.
The study medication BF2.649 tested here is a novel, highly potent, selective, orally active inverse agonist at the histamine H3 receptor, therefore strengthens histaminergic transmission in the brain and increases wakefulness EDS is characterized by daytime somnolence and sudden sleep episodes. This problem has several consequences, e.g., an impairment of quality of life, an interference with activities of daily living and other handicaps in the management of social and family affairs.
The primary endpoint of this study will be measured by the change in the well-validated Epworth sleepiness scale (ESS). The ESS is a simple self-administered 8-item questionnaire. The outcome is to get an impression about the level of the daytime sleepiness in several real-life situations.
On the basis of this pharmacological and clinical rationale it is considered relevant to carry out a dose-finding study for this original, non-amphetamine molecule in PD patients affected by excessive daytime sleepiness. PD severity will be assessed by the routinely used UPDRS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebo1 capsule per day during 4 weeks | Drug | Placebo |
| BF 2.649 5 mgAlso: pitolisantone BF 2.649 capsule of 5 mg per day during 4 weeks | Drug | BF 2.649-5 mg |
| BF 2.649 10 mgAlso: pitolisantOne BF 2.649 capsule of 10 mg per day during 4 weeks | Drug | BF 2.649 10 mg |
| BF 2.649 20 mgAlso: pitolisantOne BF 2.649 capsule of 20 mg per day during 4 weeks | Drug | BF 2.649 20 mg |
| BF 2.649 40 mgAlso: pitolisantOne BF 2.649 capsule of 40 mg per day during 4 weeks | Drug | BF 2.649 40 mg |
Primary outcome
Epworth Sleepiness Scale scores (ESS)
Time frame: At selection visit (Day-14 to Day-7)/Inclusion visit (Day0)/ Interim visit (Day14)/Final visit (Day28)
4 secondary outcomes
Mean number of daytime sleep or sleepiness episodes and their duration
Time frame: During 5 days before each visit
frequency of sleep attacks
Time frame: recorded at each visit
UPDRS III for motor function
Time frame: at each visit
Clinical global impression scale
Time frame: at each visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ARNULF Isabelle principal investigator
Pitié-Salpêtrière Hospital, Paris, France
Carsten Moeller principal investigator
Universitätsklinikum Giessen und Marburg, Marburg, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BF 2.649 5 mg, BF 2.649 10 mg and BF 2.649 20 mg in people with Excessive Daytime Sleepiness and Parkinson's Disease, run by Bioprojet at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Epworth Sleepiness Scale scores (ESS) (time frame: At selection visit (Day-14 to Day-7)/Inclusion visit (Day0)/ Interim visit (Day14)/Final visit (Day28)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2012; AzTrials last refreshed its copy on 2 Nov 2026.