Treatment of Excessive Daytime Sleepiness in NarcolepsyPhase 3NCT01638403
Effects of BF2.649 in the Treatment of Excessive Daytime Sleepiness in Narcolepsy.
A Phase 3 study testing BF2.649, Vigil and palcebo in people with Treatment of Excessive Daytime Sleepiness in Narcolepsy, run by Bioprojet at 1 site in France.
Trial summary
3. RATIONALE FOR BF2.649 IN NARCOLEPSY Narcolepsy is a disabling syndrome affecting the generation and organizations of sleep and wakefulness, first described by Westphal and Gelineau in 19th century. Excessive Daytime Sleepiness (EDS) and cataplexy are two main symptoms of narcolepsy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Treatment of Excessive Daytime Sleepiness in Narcolepsy
- What is being tested?
- BF2.649, Vigil and palcebo
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2010to Jul 2012
- 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
- Males and females of any ethnic origin, 18 years old and over.
- Both new and previously diagnosed patients with narcolepsy with or without cataplexy could be included. All patients should meet the International Classification of Sleep Disorders (ICSD-2) criteria.
- Patients should be free of drugs or discontinue any psychostimulant medications for at least 14 days at the start of baseline period. Patients with severe cataplexy are permitted to remain on their anticataplectic medication at stable dose except tricyclic antidepressants. The authorized anticataplectic treatment should have been administrated for at least 1 month prior to the trial and these doses should not be changed throughout the trial (from V1 to V8).
- Epworth Sleepiness Scale (ESS) score should be ≥ 14 during the baseline period.
- Patients have expressed a willingness to participate in and complete the study, and signed and dated informed consent prior to beginning protocol required procedures.
- Females must be surgically sterile or 2 years postmenopausal. Females of child-bearing potential must use a medically accepted effective method of birth control (i.e. oral contraceptives of normal average dosage ≥ 0.05 mg ethinyl-oestradiol, intra-uterine device, with a barrier method such as spermicides…), agree to continue this method for the duration of the study and be negative to serum pregnancy test performed at the screening visit. Females should not be breast-feeding patient.
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- In the opinion of the investigator, the patient must have adequate support to comply with the entire study requirements as described in the protocol (e.g., transportation to and from trial site, self rating scales and diaries completion, drug compliance, scheduled visits, tests).
- If indicated by investigator, the patient must be willing to not operate a car or heavy machinery for the duration of the trial or as long as the investigator deems clinically indicated. In addition, the patient should be willing to maintain during the study their usual behaviour which could affect their diurnal sleepiness (e.g. circadian rhythm, caffeine consumption, nocturnal sleep duration).
- Patient should be assured by appropriate healthy insurance system (only applicable where mandatory e.g. in France).
Who cannot join
- The use of BF2.649 or any previous investigational drugs within 30-day period prior to initial screening visit (V1) for this trial.
- In narcoleptic patients without cataplexy, they should not have any other conditions that can be considered the primary causes of EDS: such as sleep related breathing disorders as defined by a sleep Apnea Index ≥ 10 per hour or and an Apnea/Hypopnea Index ≥ 15 per hour, periodic limbs movement (PLM) disorders as defined by a PLM arousal index (PLMAI) ≥ 10 per hour, shift work, chronic sleep deprivation, circadian sleep wake rhythm disorder or any other medical or neurological causes that could account for narcolepsy symptoms associated with EDS.
- Patients who are unable or unwilling to temporarily discontinue any no-authorized drugs or substances (see Section Non-authorized treatments).
- Current or recent (within one year) history of a substance abuse or dependence disorder including alcohol abuse as defined in Diagnostic and Statistical Manual of Mental Disorders (DSM-IV).
- Any significant serious abnormality of the cardiovascular system e.g. recent myocardial infarction, angina, hypertension or dysrhythmia (within the prior 6 months), Electrocardiogram Bazett's corrected QT interval (QT x square root[HR/60]) higher than 450 ms, history of left ventricular hypertrophy or mitral valve prolapse.
- Patients with severe depression (BDI13 ≥ 16) or with a suicidal risk (item G BDI13 > 0)
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- Patients with Severe hepatic Impairment (e.g. prothrombin ratio, < 50% or factor V < 50% if the patient receiving anti-vitamin K) or with Severe Renal Impairment (e.g. serum creatine greater than 2.0 mg/dL), or with any other significant abnormality in the physical examination or clinical laboratory results.
- Psychiatric and neurological disorders, such as moderate or severe 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 and completion of this trial or comprise reliable representation of subjective symptoms.
- Prior severe adverse reactions to CNS stimulants.
- Known hypersensitivity to the tested treatment including active substance and excipients.
- The inability to continue daily activities safely, without the use of treatment against EDS.
- Other active clinically significant illness, including unstable cardiovascular, endocrine, neoplastic, gastrointestinal, hematologic, hepatic, immunologic, metabolic, neurological (other than narcolepsy/cataplexy), pulmonary, and/or renal disease which could interfere with the study conduct or counter-indicate the study treatments or place the patient at risk during the trial or compromise the study objectives.
- Any patients presenting congenital galactosemia, glucose-galactose malabsorption or lactase deficiency due to the presence of lactose in investigational treatments
- Patients participating in another study or being in a follow-up period for another study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Double-blind, Placebo and Comparator-controlled, Parallel-group, Multi-center Trial Assessing the Effects of BF2.649 in the Treatment of Excessive Daytime Sleepiness in Narcolepsy
- RATIONALE FOR BF2.649 IN NARCOLEPSY Narcolepsy is a disabling syndrome affecting the generation and organizations of sleep and wakefulness, first described by Westphal and Gelineau in 19th century. Excessive Daytime Sleepiness (EDS) and cataplexy are two main symptoms of narcolepsy. Other symptoms referred to as auxiliary symptoms are hypnagogic and hypnopompic hallucinations, sleep paralysis, dyssomnia and automatic behaviour. The prevalence of narcolepsy is estimated around 25 per 100 000 in Causasian population. It is often extremely incapacitating, interfering with every aspect of life, in work and social settings.
Several breakthroughs in the understanding of physiopathology of narcolepsy have recently shown that most narcoleptic patients display a strongly decreased CSF level of orexins, a group of hypothalamic peptides with wake-promoting activity. It was also found that sporadic narcolepsy in dogs, mice and humans may also be related to a deficiency in the production of orexin ligands. Narcolepsy may be a neurodegenerative or autoimmune disorder resulting in a loss of hypothalamic neurons containing the orexin [Baumann CR \& Bassetti CL Lancet Neurol. 2005 ; Dauvilliers Y et al, Clin Neurophysiol. 2003 ].
Read more
In accordance with guidelines published by the European task force [Billiard M et al, Eur J Neurol. 2006] , management of narcolepsy with or without cataplexy relies on several classes of drugs, namely stimulants for EDS, antidepressants for cataplexy and hypnosedative drugs for disturbed nocturnal sleep. The first line pharmacological treatment of EDS and irresistible episodes of sleep rely on Modafinil, 100-400 mg/day, given in two doses, one in the morning and one early in the afternoon, the need for amphetamines and amphetamine-like stimulants (e.g. methylphenidate) has been decreased. Sodium oxybate and antidepressants are main drug therapies of cataplexy.
BF2.649, an H3R inverse agonist promotes significantly vigilance in mice knock out for the orexin gene, a reliable model of narcolepsy, whereas the animals remain calm, a difference with treatment by amphetamine-like drugs which induce psychomotor excitation. In addition, BF2.649 shows a significant inhibitory effect on the occurrence of narcolepsy episodes during the dark period. These narcolepsy episodes are to be compared to cataplexy episodes in human [Chemelli et al., Cell 1999] 11. In agreement, Modafinil, in humans, does not show any effects on cataplexy, even if it improves wakefulness by an ill-defined mechanism. Thus anticataplectic drugs, such as antidepressants, are given in addition to Modafinil to narcoleptic patients.
Taken together, the preclinical and clinical results provide a compelling rationale for this study to verify and confirm, under randomized double-blind and placebo-controlled conditions, the safety and efficacy of escalating dose of BF2.649 in the treatment of EDS and cataplexy in narcolepsy.
It is on the basis of preclinical studies, and on the observation of the first included patients, that the doses to be administered were determined.
- Being tested
- BF2.649, Vigil, palcebo
- Keywords
- narcolepsy, excessive daytime sleepiness, cataplexy
- Medical subject headings
- Narcolepsy, Disorders of Excessive Somnolence, Cataplexy
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 is provided in capsules. One-quarter or one-half of BF2.649 tablet at 20 mg (corresponding to 5-, and 10 mg, respectively).
Patients should take 2 capsules per day with a glass of water. They will be instructed to take 1 capsule in the morning (after waking up, before breakfast around 8.00 a.m.) and 1 capsule at noon.
VigilDrug
Also called Modafinil
Modafinil is provided in capsules. The capsules are identical in appearance to ensure that neither the patient nor the investigator nor members of the clinical staff knows the identity of the study medication.
Modafinil tablet at 100 mg are enclosed in gelatine capsules. Patients should take 2 capsules per day with a glass of water. They will be instructed to take 1 capsule in the morning (after waking up, before breakfast around 8.00 a.m.) and 1 capsule at noon.
palceboDrug
Also called Placebo
placebo is provided in capsules. The capsules are identical in appearance to ensure that neither the patient nor the investigator nor members of the clinical staff knows the identity of the study medication.
placebo consist of identical capsules containing lactose only. Patients should take 2 capsules per day with a glass of water. They will be instructed to take 1 capsule in the morning (after waking up, before breakfast around 8.00 a.m.) and 1 capsule at noon.
| Study group | Role | What they receive |
|---|---|---|
| BF2.649 | Experimental | BF2.649 (pitolisant) is a novel, highly potent, selective, orally active histamine H3 receptor antagonist/inverse agonist (Ki of 0.3 nM) at the human receptor. Receives: Drug: BF2.649 |
| Vigil | Active comparator | Therapeutic indications Narcolepsy with and without cataplexy. Moderate to severe obstructive sleep apnoea syndrome with excessive daytime sleepiness despite adequate CPAP therapy.
Moderate to severe chronic shift work sleep disorder with excessive sleepiness in patients who work rotating night shifts, if other sleep hygiene measures did not lead to a satisfactory improvement. Receives: Drug: Vigil |
| Placebo | Placebo comparator | Not described Receives: Drug: palcebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Epworth Sleepiness Scale scores (ESS)
The primary efficacy endpoint is Epworth Sleepiness Scale scores (ESS) change between the BF2.649-treatment group, the placebo-group, and the Modafinil-treatment group during an 8-week treatment period.
The ESS is a self-administered questionnaire to the patients to evaluate their chances of dozing in height different situations often encountered in the daily life.
The average of ESS performed at V6 and V7 will be compared to the average of ESS performed at V2 and V3.
Measured: 10 weeks
Secondary outcomes (6)
patient sleep diary
Following secondary outcome measures will be reported in the patient sleep diary:
- Number and duration of diurnal involuntary sleep attacks and episodes of severe sleepiness
- Number of cataplexy total and partial.
- Number of hallucinations.
- Number of sleep paralysis.
- Number and duration of nocturnal awakening and total duration of nocturnal sleep time.
Measured: 10 weeks
Maintenance of Wakefulness Test (MWT)
The Maintenance of Wakefulness Test (MWT) is used in this study to assess an individual's ability to maintain awake while resisting the pressure to fall asleep. Patients will be administrated four 40-minute MWT sessions at 2 hours interval at inclusion visit (V3) and at endpoint visit (V7 or the last on-study visit), according to validated standard [Doghramji K et al, Electroencephalogr Clin Neurophysiol. 1997] . The changes in MWT will be compared between the treatment groups. The MWT will be renewed at V7 only for patients who had a MWT <11 at V3.
Measured: 10 weeks
Test of Sustained Attention to Response Task (SART)
The Test of Sustained Attention to Response Task (SART) has been used for the quantification of vigilance and attention in narcolepsy patients [Fronczek R et al, Sleep 2006] . The SART will be performed at inclusion visit (V3) and at endpoint (V7 or the last on-study visit for prematurely withdrawn patients). The changes in SART will be compared between the treatment groups.
Measured: 10 weeks
Clinical Global Impressions of Change
The severities of EDS and of cataplexy will be measured at baseline by the investigator using the Clinical Global Impression of Severity (CGI-S) in order to describe the population. At each follow-up visit, the patients' change in EDS and in cataplexy compared to baseline will be rated by the same investigator using Clinical Global Impression of Change (CGI-C) to document the perceived change in patients' illness.
Measured: 10 weeks
European Quality of life questionnaire (EQ-5D)
EQ-5D is a reliable and validated measure of quality of life. Narcolepsy has a clear negative effect on this outcome measure [Dodel R. et al, Sleep Med. 2007] . EQ-5D will be completed at baseline visit (V2), inclusion visit (V3), stable-dose visit (V5), endpoint visit (V7) and withdrawal visit (V8). The changes between treatment groups will be analysed as an evaluation of the illness evolution.
Measured: 10 weeks
Patient's Global Opinion on the effect of treatment
At each visit under treatment (V4, V5, V6, V7 and V8 or last on-study visit), patients evaluate the Global effect of their treatment by comparing the period prior to that visit with the patient's prestudy condition.
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2012 (estimated)
- Study startNov 2010
- Primary completionApr 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Treatment of Excessive Daytime Sleepiness in 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
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bioprojet
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- DAUVILLIERS Yves, Study chair, Hôpital Gui de Chauliac - 80, avenue A. Fliche , 34295 Montpellier cedex 5 - FRANCE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01638403
- Sponsor's protocol ID
- P09-15/ BF2.649 Harmony 1bis
- Status last verified
- Jan 2017
- First submitted
- 9 Jul 2012
- Last updated
- 31 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Fronczek R, Middelkoop HA, van Dijk JG, Lammers GJ. Focusing on vigilance instead of sleepiness in the assessment of narcolepsy: high sensitivity of the Sustained Attention to Response Task (SART). Sleep. 2006 Feb;29(2):187-91.
PubMed 16494086
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind, Placebo and Comparator-controlled, Parallel-group, Multi-center Trial Assessing the Effects of BF2.649 in the Treatment of Excessive Daytime Sleepiness in Narcolepsy
- ClinicalTrials.gov ID
- NCT01638403
- Acronym / sponsor ID
- P09-15/ BF2.649 Harmony 1bis
- Keywords
- narcolepsy, excessive daytime sleepiness, cataplexy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- BioprojetUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Apr 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 11 Jul 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.
- RATIONALE FOR BF2.649 IN NARCOLEPSY Narcolepsy is a disabling syndrome affecting the generation and organizations of sleep and wakefulness, first described by Westphal and Gelineau in 19th century. Excessive Daytime Sleepiness (EDS) and cataplexy are two main symptoms of narcolepsy. Other symptoms referred to as auxiliary symptoms are hypnagogic and hypnopompic hallucinations, sleep paralysis, dyssomnia and automatic behaviour. The prevalence of narcolepsy is estimated around 25 per 100 000 in Causasian population. It is often extremely incapacitating, interfering with every aspect of life, in work and social settings.
Several breakthroughs in the understanding of physiopathology of narcolepsy have recently shown that most narcoleptic patients display a strongly decreased CSF level of orexins, a group of hypothalamic peptides with wake-promoting activity. It was also found that sporadic narcolepsy in dogs, mice and humans may also be related to a deficiency in the production of orexin ligands. Narcolepsy may be a neurodegenerative or autoimmune disorder resulting in a loss of hypothalamic neurons containing the orexin [Baumann CR \& Bassetti CL Lancet Neurol. 2005 ; Dauvilliers Y et al, Clin Neurophysiol. 2003 ].
In accordance with guidelines published by the European task force [Billiard M et al, Eur J Neurol. 2006] , management of narcolepsy with or without cataplexy relies on several classes of drugs, namely stimulants for EDS, antidepressants for cataplexy and hypnosedative drugs for disturbed nocturnal sleep. The first line pharmacological treatment of EDS and irresistible episodes of sleep rely on Modafinil, 100-400 mg/day, given in two doses, one in the morning and one early in the afternoon, the need for amphetamines and amphetamine-like stimulants (e.g. methylphenidate) has been decreased. Sodium oxybate and antidepressants are main drug therapies of cataplexy.
BF2.649, an H3R inverse agonist promotes significantly vigilance in mice knock out for the orexin gene, a reliable model of narcolepsy, whereas the animals remain calm, a difference with treatment by amphetamine-like drugs which induce psychomotor excitation. In addition, BF2.649 shows a significant inhibitory effect on the occurrence of narcolepsy episodes during the dark period. These narcolepsy episodes are to be compared to cataplexy episodes in human [Chemelli et al., Cell 1999] 11. In agreement, Modafinil, in humans, does not show any effects on cataplexy, even if it improves wakefulness by an ill-defined mechanism. Thus anticataplectic drugs, such as antidepressants, are given in addition to Modafinil to narcoleptic patients.
Taken together, the preclinical and clinical results provide a compelling rationale for this study to verify and confirm, under randomized double-blind and placebo-controlled conditions, the safety and efficacy of escalating dose of BF2.649 in the treatment of EDS and cataplexy in narcolepsy.
It is on the basis of preclinical studies, and on the observation of the first included patients, that the doses to be administered were determined.
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: BF2.649BF2.649 (pitolisant) is a novel, highly potent, selective, orally active histamine H3 receptor antagonist/inverse agonist (Ki of 0.3 nM) at the human receptor. |
| Vigil | Active comparator | Drug: VigilTherapeutic indications Narcolepsy with and without cataplexy. Moderate to severe obstructive sleep apnoea syndrome with excessive daytime sleepiness despite adequate CPAP therapy. Moderate to severe chronic shift work sleep disorder with excessive sleepiness in patients who work rotating night shifts, if other sleep hygiene measures did not lead to a satisfactory improvement. |
| Placebo | Placebo comparator | Drug: palcebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Males and females of any ethnic origin, 18 years old and over.
- Both new and previously diagnosed patients with narcolepsy with or without cataplexy could be included. All patients should meet the International Classification of Sleep Disorders (ICSD-2) criteria.
- Patients should be free of drugs or discontinue any psychostimulant medications for at least 14 days at the start of baseline period. Patients with severe cataplexy are permitted to remain on their anticataplectic medication at stable dose except tricyclic antidepressants. The authorized anticataplectic treatment should have been administrated for at least 1 month prior to the trial and these doses should not be changed throughout the trial (from V1 to V8).
- Epworth Sleepiness Scale (ESS) score should be ≥ 14 during the baseline period.
- Patients have expressed a willingness to participate in and complete the study, and signed and dated informed consent prior to beginning protocol required procedures.
Key exclusion criteria (14 listed)
- The use of BF2.649 or any previous investigational drugs within 30-day period prior to initial screening visit (V1) for this trial.
- In narcoleptic patients without cataplexy, they should not have any other conditions that can be considered the primary causes of EDS: such as sleep related breathing disorders as defined by a sleep Apnea Index ≥ 10 per hour or and an Apnea/Hypopnea Index ≥ 15 per hour, periodic limbs movement (PLM) disorders as defined by a PLM arousal index (PLMAI) ≥ 10 per hour, shift work, chronic sleep deprivation, circadian sleep wake rhythm disorder or any other medical or neurological causes that could account for narcolepsy symptoms associated with EDS.
- Patients who are unable or unwilling to temporarily discontinue any no-authorized drugs or substances (see Section Non-authorized treatments).
- Current or recent (within one year) history of a substance abuse or dependence disorder including alcohol abuse as defined in Diagnostic and Statistical Manual of Mental Disorders (DSM-IV).
- Any significant serious abnormality of the cardiovascular system e.g. recent myocardial infarction, angina, hypertension or dysrhythmia (within the prior 6 months), Electrocardiogram Bazett's corrected QT interval (QT x square root[HR/60]) higher than 450 ms, history of left ventricular hypertrophy or mitral valve prolapse.
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 is provided in capsules. One-quarter or one-half of BF2.649 tablet at 20 mg (corresponding to 5-, and 10 mg, respectively). Patients should take 2 capsules per day with a glass of water. They will be instructed to take 1 capsule in the morning (after waking up, before breakfast around 8.00 a.m.) and 1 capsule at noon. | Drug | BF2.649 |
| VigilAlso: ModafinilModafinil is provided in capsules. The capsules are identical in appearance to ensure that neither the patient nor the investigator nor members of the clinical staff knows the identity of the study medication. Modafinil tablet at 100 mg are enclosed in gelatine capsules. Patients should take 2 capsules per day with a glass of water. They will be instructed to take 1 capsule in the morning (after waking up, before breakfast around 8.00 a.m.) and 1 capsule at noon. | Drug | Vigil |
| palceboAlso: Placeboplacebo is provided in capsules. The capsules are identical in appearance to ensure that neither the patient nor the investigator nor members of the clinical staff knows the identity of the study medication. placebo consist of identical capsules containing lactose only. Patients should take 2 capsules per day with a glass of water. They will be instructed to take 1 capsule in the morning (after waking up, before breakfast around 8.00 a.m.) and 1 capsule at noon. | Drug | Placebo |
Primary outcome
Epworth Sleepiness Scale scores (ESS)
Time frame: 10 weeks
The primary efficacy endpoint is Epworth Sleepiness Scale scores (ESS) change between the BF2.649-treatment group, the placebo-group, and the Modafinil-treatment group during an 8-week treatment period. The ESS is a self-administered questionnaire to the patients to evaluate their chances of dozing in height different situations often encountered in the daily life. The average of ESS performed at V6 and V7 will be compared to the average of ESS performed at V2 and V3.
6 secondary outcomes
patient sleep diary
Time frame: 10 weeks
Maintenance of Wakefulness Test (MWT)
Time frame: 10 weeks
Test of Sustained Attention to Response Task (SART)
Time frame: 10 weeks
Clinical Global Impressions of Change
Time frame: 10 weeks
European Quality of life questionnaire (EQ-5D)
Time frame: 10 weeks
Patient's Global Opinion on the effect of treatment
Time frame: 10 weeks
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 31 Jan 2017.
- Background: PubMed 16494086Fronczek R, Middelkoop HA, van Dijk JG, Lammers GJ. Focusing on vigilance instead of sleepiness in the assessment of narcolepsy: high sensitivity of the Sustained Attention to Response Task (SART). Sleep. 2006 Feb;29(2):187-91.
- Related InfoLink provided by the sponsor.
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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.
DAUVILLIERS Yves study chair
Hôpital Gui de Chauliac - 80, avenue A. Fliche , 34295 Montpellier cedex 5 - FRANCE
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, Vigil and palcebo in people with Treatment of Excessive Daytime Sleepiness in Narcolepsy, 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 9 inclusion and 14 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 31 Jan 2017. 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 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 scores (ESS) (time frame: 10 weeks). 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 NCT01638403, which also lists 1 linked publication.
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 31 Jan 2017.