NarcolepsyPhase 3Harmony2NCT01067235
Efficacy and Safety Study of BF2.649 and BF2.649 Add on Modafinil on Cataplexy in Patients With Narcolespy
A Phase 3 study testing BF2.649 and BF2.649 add on Modafinil in people with Narcolepsy and Cataplexy, run by Bioprojet at 1 site in Switzerland.
Trial summary
The objective of this study is to evaluate and compare the efficacy and safety of escalating doses of BF2.649 and BF2.649 add on Modafinil on cataplexy in patients with narcolepsy Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Narcolepsy, Cataplexy, Excessive Daytime Sleepiness
- What is being tested?
- BF2.649 and BF2.649 add on Modafinil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteSwitzerland
- Study dates
- Oct 2009to Jul 2010
- Phase
- Phase 3
- 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
- "De novo" patients with newly diagnosed narcolespy and cataplexy , and not taking any treatment for Excessive Daytime Sleepiness(EDS) and cataplexy
- patients with previously diagnosed narcolepsy and cataplexy and not taking any treatment for EDS and cataplexy for more than 3 months
- partial or total cataplexy attacks with a frequency of at least 5 per week during a 14 day baseline period and ESS >or= 14 at the end of the baseline period
Who cannot join
- Patients who are unable or unwilling to temporarily discontinue any no-authorized drugs or substances
- Current or recent history of a substance abuse or dependence disorder including alcohol abuse
- Psychiatric and neurological disorders such as psychosis or dementia, bipolar illness, severe anxiety, clinical depression, history of seizure disorder or other problem that in the investigator's opinion would preclude the patient's participation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective, Randomized, Double-blind Study, Parallel-group, Multi-center Trial Assessing the Effects of Escalating Doses of BF2.649 and BF2.649 Add on Modafinil on Cataplexy in Patients With Narcolepsy
The objective of this study is to evaluate and compare the efficacy and safety of escalating doses of BF2.649 and BF2.649 add on Modafinil on cataplexy in patients with narcolepsy
Read the detailed description
BF 2.649, a new molecule, reduces significantly the diurnal sleepiness and demonstrated its anti-cataplexy effect in pre-clinical and clinical studies.
The objective of this POC study are firstly to evaluate and compare the efficacy and safety of escalating doses of BF2.649 and BF2.649 add on Modafinil (200 mg/day) on cataplexy attacks, and secondly to evaluate the additive/synergistic effect and safety of the combination of BF2.649 and Modafinil on EDS as assessed by both of objective and subjective measures including ESS, MWT, patients sleep diary.
- Conditions
- Narcolepsy, Cataplexy, Excessive Daytime Sleepiness
- Being tested
- BF2.649, BF2.649 add on Modafinil
- Keywords
- Narcolespy, Cataplexy, Excesssive daytime Sleepiness, Sleep Disorders, Sleep attacks, Orphan Drug, Pitolisant
- Medical subject headings
- Narcolepsy, Cataplexy, 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
BF2.649 oral capsules at 10, 20 or 40 mg/day associated with Modafinil Placebo capsules for 8 weeks
BF2.649 add on ModafinilDrug
Also called Pitolisant, Modiodal
BF2.649 oral capsules at 10, 20 or 40 mg/day associated with Modafinil capsules at 200 mg per day for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| BF2.649 + Modafinil placebo | Experimental | Not described Receives: Drug: BF2.649 |
| BF2.649 + Modafinil | Experimental | Not described Receives: Drug: BF2.649 add on Modafinil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cataplexy attacks reported on sleep diary
Measured: every days from screening visit (day-14) to final visit (day 56)
Secondary outcomes (3)
Sleep Diary: number and duration of diurnal sleep and sleepiness episodes,
Measured: every days from screening visit (day-14) to final visit (day 56)
Maintenance of Wakefulness Test (MWT), Test of Sustained Attention to Response Task (SART).
Measured: at inclusion and after 8-week treatment
Epworth Sleepiness Scale (ESS)
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 posted11 Feb 2010 (estimated)
- Study startOct 2009
- Primary completionJul 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NarcolepsyStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bioprojet
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Claudio Bassetti, Principal investigator, Neurocenter of Southern Switzerland,Lugano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01067235
- Sponsor's protocol ID
- P07-07 / BF2.649
- Other IDs
- 2008-007845-29, 2008
- Acronym
- Harmony2
- Status last verified
- Jun 2012
- First submitted
- 9 Feb 2010
- Last updated
- 11 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized, Double-blind Study, Parallel-group, Multi-center Trial Assessing the Effects of Escalating Doses of BF2.649 and BF2.649 Add on Modafinil on Cataplexy in Patients With Narcolepsy
- ClinicalTrials.gov ID
- NCT01067235
- Acronym / sponsor ID
- Harmony2 / P07-07 / BF2.649
- Conditions
- Narcolepsy, Cataplexy, Excessive Daytime Sleepiness
- Keywords
- Narcolespy, Cataplexy, Excesssive daytime Sleepiness, Sleep Disorders, Sleep attacks, Orphan Drug, Pitolisant
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- BioprojetUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 11 Feb 2010 (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 study is to evaluate and compare the efficacy and safety of escalating doses of BF2.649 and BF2.649 add on Modafinil on cataplexy in patients with narcolepsy
Detailed description
BF 2.649, a new molecule, reduces significantly the diurnal sleepiness and demonstrated its anti-cataplexy effect in pre-clinical and clinical studies.
The objective of this POC study are firstly to evaluate and compare the efficacy and safety of escalating doses of BF2.649 and BF2.649 add on Modafinil (200 mg/day) on cataplexy attacks, and secondly to evaluate the additive/synergistic effect and safety of the combination of BF2.649 and Modafinil on EDS as assessed by both of objective and subjective measures including ESS, MWT, patients sleep diary.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BF2.649 + Modafinil placebo | Experimental | Drug: BF2.649 |
| BF2.649 + Modafinil | Experimental | Drug: BF2.649 add on Modafinil |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- "De novo" patients with newly diagnosed narcolespy and cataplexy , and not taking any treatment for Excessive Daytime Sleepiness(EDS) and cataplexy
- patients with previously diagnosed narcolepsy and cataplexy and not taking any treatment for EDS and cataplexy for more than 3 months
- partial or total cataplexy attacks with a frequency of at least 5 per week during a 14 day baseline period and ESS >or= 14 at the end of the baseline period
Key exclusion criteria (3 listed)
- Patients who are unable or unwilling to temporarily discontinue any no-authorized drugs or substances
- Current or recent history of a substance abuse or dependence disorder including alcohol abuse
- Psychiatric and neurological disorders such as psychosis or dementia, bipolar illness, severe anxiety, clinical depression, history of seizure disorder or other problem that in the investigator's opinion would preclude the patient's participation
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: PitolisantBF2.649 oral capsules at 10, 20 or 40 mg/day associated with Modafinil Placebo capsules for 8 weeks | Drug | BF2.649 + Modafinil placebo |
| BF2.649 add on ModafinilAlso: Pitolisant, ModiodalBF2.649 oral capsules at 10, 20 or 40 mg/day associated with Modafinil capsules at 200 mg per day for 8 weeks | Drug | BF2.649 + Modafinil |
Primary outcome
Cataplexy attacks reported on sleep diary
Time frame: every days from screening visit (day-14) to final visit (day 56)
3 secondary outcomes
Sleep Diary: number and duration of diurnal sleep and sleepiness episodes,
Time frame: every days from screening visit (day-14) to final visit (day 56)
Maintenance of Wakefulness Test (MWT), Test of Sustained Attention to Response Task (SART).
Time frame: at inclusion and after 8-week treatment
Epworth Sleepiness Scale (ESS)
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 Feb 2013.
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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.
Claudio Bassetti principal investigator
Neurocenter of Southern Switzerland,Lugano
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing BF2.649 and BF2.649 add on Modafinil in people with Narcolepsy and Cataplexy, run by Bioprojet at 1 site in Switzerland.
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 3 inclusion and 3 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 Feb 2013. 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 Switzerland. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Cataplexy attacks reported on sleep diary (time frame: every days from screening visit (day-14) to final visit (day 56)). 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 Feb 2013.