NarcolepsyPhase 3Harmony1NCT01067222
Efficacy and Safety Study of BF2.649 in the Treatment of Excessive Daytime Sleepiness in Narcolepsy
A Phase 3 study testing BF2.649 and Modafinil in people with Narcolepsy and Excessive Daytime Sleepiness, run by Bioprojet at 1 site in Switzerland.
Trial summary
The objective of this study is to evaluate the efficacy and safety of BF2.649 administered by individual titration in narcoleptic patients with excessive daytime sleepiness (EDS) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Narcolepsy, Excessive Daytime Sleepiness, Cataplexy
- What is being tested?
- BF2.649 and Modafinil
- 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 siteSwitzerland
- Study dates
- May 2009to Dec 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
- diagnosis of narcolepsy with or without cataplexy
- patients need to free of or discontinue psychostimulant medications for at least 14 days,
- patients with severe cataplexy are permitted to remain on their anticataplectic medications at stable doses
- patients must have adequate support to comply with the entire study requirements
Who cannot join
- Other conditions than Narcolepsy that can be considered as the primary causes of excessive daytime sleepiness
- Patients who are unable or unwilling to temporarily discontinue any no-authorized drugs or substances
- 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
- Current or recent history of a substance abuse or dependence disorder including alcohol abuse
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective, Randomized, Double-blind Study, Placebo-controlled, Parallel-group, Multi-center Trial Assessing the Effects of BF2.649 in Treatment of Excessive Daytime Sleepiness in Narcolepsy
The objective of this study is to evaluate the efficacy and safety of BF2.649 administered by individual titration in narcoleptic patients with excessive daytime sleepiness (EDS)
Read the detailed description
BF 2.649, a new experimental drug, significantly decreases, in patient with narcolepsy, the excessive daytime sleepiness (EDS) evaluated by Epworth Sleepiness Scale (ESS), according the results of two previous clinical studies.
The objective of this study is to determine the efficacy and safety of BF2.649 administered by escalating dose (10, 20 or 40 mg/d) in narcoleptic patients with excessive daytime sleepiness versus placebo and Modafinil as assessed by both of objective and subjective measures including ESS, MWT, patients sleep diary.
60 patients with narcolepsy with or without cataplexy will be included.
- Conditions
- Narcolepsy, Excessive Daytime Sleepiness, Cataplexy, Sleep Disorders
- Being tested
- BF2.649, Modafinil, Placebo
- Keywords
- Narcolepsy, Excessive daytime Sleepiness, Cataplexy, Sleep Disorders, Sleep attacks, Orphan Drug, Pitolisant
- Medical subject headings
- Narcolepsy, Disorders of Excessive Somnolence, Cataplexy, 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 or 20 or 40 mg per day
ModafinilDrug
Also called Modiodal
Modafinil oral capsules at 100 or 200 or 400 mg per day
PlaceboDrug
Placebo oral capsules, 4 capsules per day
| Study group | Role | What they receive |
|---|---|---|
| BF2.649 | Experimental | Not described Receives: Drug: BF2.649 |
| Modafinil | Active comparator | Not described Receives: Drug: Modafinil |
| 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.
Epworth Sleepiness Scale (ESS)
Measured: between baseline and at the end of 8 week DB phase
Secondary outcomes (2)
Sleep Diary: Number and duration of diurnal sleep and sleepiness episodes, number of cataplexy attacks
Measured: 14 days before randomization and 7 days before each visit
Maintenance of Wakefulness Test (MWT), Test of Sustained Attention to Response Task (SART).
Measured: at inclusion and after 8-week treatment
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 startMay 2009
- Primary completionJul 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bioprojet
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Claudio Bassetti, Principal investigator, Neurocenter (EOC) of Southern Switzerland, Lugano, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01067222
- Sponsor's protocol ID
- P07-03 / BF2.649
- Other IDs
- 2008-007866-46, 2008
- Acronym
- Harmony1
- Status last verified
- Jun 2012
- First submitted
- 9 Feb 2010
- Last updated
- 11 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Meskill GJ, Davis CW, Zarycranski D, Doliba M, Schwartz JC, Dayno JM. Clinical Impact of Pitolisant on Excessive Daytime Sleepiness and Cataplexy in Adults With Narcolepsy: An Analysis of Randomized Placebo-Controlled Trials. CNS Drugs. 2022 Jan;36(1):61-69. doi: 10.1007/s40263-021-00886-x. Epub 2021 Dec 21.
PubMed 34935103Watson NF, Davis CW, Zarycranski D, Vaughn B, Dayno JM, Dauvilliers Y, Schwartz JC. Time to Onset of Response to Pitolisant for the Treatment of Excessive Daytime Sleepiness and Cataplexy in Patients With Narcolepsy: An Analysis of Randomized, Placebo-Controlled Trials. CNS Drugs. 2021 Dec;35(12):1303-1315. doi: 10.1007/s40263-021-00866-1. Epub 2021 Nov 25.
PubMed 34822113Dauvilliers Y, Bassetti C, Lammers GJ, Arnulf I, Mayer G, Rodenbeck A, Lehert P, Ding CL, Lecomte JM, Schwartz JC; HARMONY I study group. Pitolisant versus placebo or modafinil in patients with narcolepsy: a double-blind, randomised trial. Lancet Neurol. 2013 Nov;12(11):1068-75. doi: 10.1016/S1474-4422(13)70225-4. Epub 2013 Oct 7.
PubMed 24107292
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
- Prospective, Randomized, Double-blind Study, Placebo-controlled, Parallel-group, Multi-center Trial Assessing the Effects of BF2.649 in Treatment of Excessive Daytime Sleepiness in Narcolepsy
- ClinicalTrials.gov ID
- NCT01067222
- Acronym / sponsor ID
- Harmony1 / P07-03 / BF2.649
- Conditions
- Narcolepsy, Excessive Daytime Sleepiness, Cataplexy, Sleep Disorders
- Keywords
- Narcolepsy, Excessive daytime Sleepiness, Cataplexy, Sleep Disorders, Sleep attacks, Orphan Drug, Pitolisant
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- BioprojetUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- Jul 2010 (actual)
- Study completion
- Dec 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 the efficacy and safety of BF2.649 administered by individual titration in narcoleptic patients with excessive daytime sleepiness (EDS)
Detailed description
BF 2.649, a new experimental drug, significantly decreases, in patient with narcolepsy, the excessive daytime sleepiness (EDS) evaluated by Epworth Sleepiness Scale (ESS), according the results of two previous clinical studies.
The objective of this study is to determine the efficacy and safety of BF2.649 administered by escalating dose (10, 20 or 40 mg/d) in narcoleptic patients with excessive daytime sleepiness versus placebo and Modafinil as assessed by both of objective and subjective measures including ESS, MWT, patients sleep diary.
60 patients with narcolepsy with or without cataplexy will be included.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| BF2.649 | Experimental | Drug: BF2.649 |
| Modafinil | Active comparator | Drug: Modafinil |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- diagnosis of narcolepsy with or without cataplexy
- patients need to free of or discontinue psychostimulant medications for at least 14 days,
- patients with severe cataplexy are permitted to remain on their anticataplectic medications at stable doses
- patients must have adequate support to comply with the entire study requirements
Key exclusion criteria (4 listed)
- Other conditions than Narcolepsy that can be considered as the primary causes of excessive daytime sleepiness
- Patients who are unable or unwilling to temporarily discontinue any no-authorized drugs or substances
- 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
- Current or recent history of a substance abuse or dependence disorder including alcohol abuse
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 or 20 or 40 mg per day | Drug | BF2.649 |
| ModafinilAlso: ModiodalModafinil oral capsules at 100 or 200 or 400 mg per day | Drug | Modafinil |
| PlaceboPlacebo oral capsules, 4 capsules per day | Drug | Placebo |
Primary outcome
Epworth Sleepiness Scale (ESS)
Time frame: between baseline and at the end of 8 week DB phase
2 secondary outcomes
Sleep Diary: Number and duration of diurnal sleep and sleepiness episodes, number of cataplexy attacks
Time frame: 14 days before randomization and 7 days before each visit
Maintenance of Wakefulness Test (MWT), Test of Sustained Attention to Response Task (SART).
Time frame: at inclusion and after 8-week treatment
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.
- Derived from this study: PubMed 34935103Meskill GJ, Davis CW, Zarycranski D, Doliba M, Schwartz JC, Dayno JM. Clinical Impact of Pitolisant on Excessive Daytime Sleepiness and Cataplexy in Adults With Narcolepsy: An Analysis of Randomized Placebo-Controlled Trials. CNS Drugs. 2022 Jan;36(1):61-69. doi: 10.1007/s40263-021-00886-x. Epub 2021 Dec 21.
- Derived from this study: PubMed 34822113Watson NF, Davis CW, Zarycranski D, Vaughn B, Dayno JM, Dauvilliers Y, Schwartz JC. Time to Onset of Response to Pitolisant for the Treatment of Excessive Daytime Sleepiness and Cataplexy in Patients With Narcolepsy: An Analysis of Randomized, Placebo-Controlled Trials. CNS Drugs. 2021 Dec;35(12):1303-1315. doi: 10.1007/s40263-021-00866-1. Epub 2021 Nov 25.
- Derived from this study: PubMed 24107292Dauvilliers Y, Bassetti C, Lammers GJ, Arnulf I, Mayer G, Rodenbeck A, Lehert P, Ding CL, Lecomte JM, Schwartz JC; HARMONY I study group. Pitolisant versus placebo or modafinil in patients with narcolepsy: a double-blind, randomised trial. Lancet Neurol. 2013 Nov;12(11):1068-75. doi: 10.1016/S1474-4422(13)70225-4. Epub 2013 Oct 7.
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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 (EOC) of Southern Switzerland, Lugano, Switzerland
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 Modafinil in people with Narcolepsy and Excessive Daytime Sleepiness, 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 4 inclusion and 4 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 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. 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 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?
Epworth Sleepiness Scale (ESS) (time frame: between baseline and at the end of 8 week DB phase). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01067222, which also lists 3 linked publications.
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.