Obstructive Sleep ApnoeaPhase 2NCT01620554
Dose-range Finding Study of BF2.649 Effect on Patients With Obstructive Sleep Apnea (OSA)
A Phase 2 study testing BF2.649 in people with Obstructive Sleep Apnoea and Excessive Daytime Sleepiness, run by Bioprojet at 1 site in France.
Trial summary
Prospective, multicenter, double-blind, phase II, randomized, dose-response study in 5 parallel groups (dose-range). Read more about this study
- Who is it for?
- Ages 21 to 90 years
- Conditions the study is for
- Obstructive Sleep Apnoea, Excessive Daytime Sleepiness
- What is being tested?
- BF2.649
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2010to Dec 2011
- 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 21 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Main inclusion Criteria:
- Patient with OSA (treated or not with nCPAP) and still complaining of EDS
- Epworth Sleepiness Scale score > or = to 11
Main exclusion Criteria:
- Patient suffering from chronic severe insomnia in accordance with the International Classification of Sleep Disorders, but without OSA
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Minimum Effective Dose-Finding Study of BF2.649, in Patients With Moderate to Severe OSA, Experiencing EDS Despite Regular Use of nCPAP, and Patients Having Refused This Therapy - Randomized, Double Blind Study With BF2.649 or Placebo
Prospective, multicenter, double-blind, phase II, randomized, dose-response study in 5 parallel groups (dose-range).
Read the detailed description
Obstructive sleep apnea (OSA) is a relatively common condition and is estimated to affect 2 to 4% of middle-aged adults
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.
In this study, each patient will be treated during 2 weeks, and randomly assigned to one the 5 arms (BF2.649 at one of the 4 possible dosages or placebo).
The patient will then attend a end-of-treatment visit, in order to assess the particularly the ESS score.
- Being tested
- BF2.649, Placebo
- Keywords
- Sleep disorder, Obstructive Sleep Apnoea, Excessive Daytime Sleepiness
- Medical subject headings
- Sleep Apnea, Obstructive, Disorders of Excessive Somnolence, Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BF2.649Drug
Also called Pitolisant
1 capsule per week during 2 weeks
BF2.649Drug
Also called Pitolisant
1 capsule per week during 2 weeks
BF2.649Drug
Also called Pitolisant
1 capsule per week during 2 weeks
BF2.649Drug
Also called Pitolisant
1 capsule per week during 2 weeks
PlaceboDrug
1 capsule per week during 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| BF2.649 5mg | Experimental | Not described Receives: Drug: BF2.649 |
| BF2.649 10mg | Experimental | Not described Receives: Drug: BF2.649 |
| BF2.649 20mg | Experimental | Not described Receives: Drug: BF2.649 |
| BF2.649 40mg | Experimental | Not described Receives: Drug: BF2.649 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Epworth Sleepiness Scale scores (ESS)
ESS value compared from baseline (Day 0) and End of treatment period (Day 14)
Measured: change of ESS at 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2012 (estimated)
- Study startOct 2010
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApnoeaStudies 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
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bioprojet
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Evelyne De Paillette, MD, Study director, Bioprojet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01620554
- Sponsor's protocol ID
- P09-16 / BF2.649
- Other IDs
- 2010-019413-25
- Status last verified
- Jun 2012
- First submitted
- 8 Jun 2012
- Last updated
- 15 Jun 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minimum Effective Dose-Finding Study of BF2.649, in Patients With Moderate to Severe OSA, Experiencing EDS Despite Regular Use of nCPAP, and Patients Having Refused This Therapy - Randomized, Double Blind Study With BF2.649 or Placebo
- ClinicalTrials.gov ID
- NCT01620554
- Acronym / sponsor ID
- P09-16 / BF2.649
- Keywords
- Sleep disorder, Obstructive Sleep Apnoea, Excessive Daytime Sleepiness
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- BioprojetUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 15 Jun 2012 (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.
Prospective, multicenter, double-blind, phase II, randomized, dose-response study in 5 parallel groups (dose-range).
Detailed description
Obstructive sleep apnea (OSA) is a relatively common condition and is estimated to affect 2 to 4% of middle-aged adults
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.
In this study, each patient will be treated during 2 weeks, and randomly assigned to one the 5 arms (BF2.649 at one of the 4 possible dosages or placebo).
The patient will then attend a end-of-treatment visit, in order to assess the particularly the ESS score.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| BF2.649 5mg | Experimental | Drug: BF2.649 |
| BF2.649 10mg | Experimental | Drug: BF2.649 |
| BF2.649 20mg | Experimental | Drug: BF2.649 |
| BF2.649 40mg | Experimental | Drug: BF2.649 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 21 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| BF2.649Also: Pitolisant1 capsule per week during 2 weeks | Drug | BF2.649 5mg |
| BF2.649Also: Pitolisant1 capsule per week during 2 weeks | Drug | BF2.649 10mg |
| BF2.649Also: Pitolisant1 capsule per week during 2 weeks | Drug | BF2.649 20mg |
| BF2.649Also: Pitolisant1 capsule per week during 2 weeks | Drug | BF2.649 40mg |
| Placebo1 capsule per week during 2 weeks | Drug | Placebo |
Primary outcome
Change in Epworth Sleepiness Scale scores (ESS)
Time frame: change of ESS at 2 weeks
ESS value compared from baseline (Day 0) and End of treatment period (Day 14)
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 15 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.
Evelyne De Paillette, MD study director
Bioprojet
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 BF2.649 in people with Obstructive Sleep Apnoea and Excessive Daytime Sleepiness, 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?
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 15 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?
Change in Epworth Sleepiness Scale scores (ESS) (time frame: change of ESS at 2 weeks). 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 15 Jun 2012.