Parkinson's DiseasePhase 3HARPS2NCT01066442
Efficacy and Safety of BF2.649 in Excessive Daytime Sleepiness (EDS) in Parkinson's Disease
A Phase 3 study testing BF2.649 (Pitolisant) in people with Parkinson's Disease, run by Bioprojet at 1 site in Germany.
Trial summary
To compare the efficacy of BF2.649 over placebo (12 week Double-Blind Phase) and assess the long term safety and the efficacy maintenance(9 months Open-Label Extension Phase) of BF2.649 in the improvement of excessive daytime sleepiness in patients diagnosed with Parkinson's Disease. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- BF2.649 (Pitolisant)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 273 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2010to Aug 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 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with a documented history of Parkinson's disease according to UPDRS,fluctuator and non-fluctuator patients, Hoehn and Yahr score <5;
- stabilized on optimal antiparkinsonian treatments unmodified for 4 weeks prior to study entry;
- presenting an Excessive Daytime Sleepiness as indicated by an ESS>or=12
Who cannot join
- Patients with a known diagnosis of other degenerative parkinsonian syndromes (e.g. Progressive supra-nuclear palsy, multisystemic atrophy, corticobasal degenerescence, diffuse Lewy's Body dementia)
- Patients who have shift work, chronic or occasional sleep deprivation, circadian rhythm disorders
- Patients with a severe depression indicated by (BDI>= 16)or at suicidal risk (BDI item G>0) or depression treated for less than 8 weeks
- Patients with a cognitive impairment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised, Multicenter 12-Week Double-blind Placebo-controlled Study to Assess the Efficacy and Safety of BF2.649 in Excessive Daytime Sleepiness in Parkinson's Disease Followed by a 38 Week Open Label Extension Phase
To compare the efficacy of BF2.649 over placebo (12 week Double-Blind Phase) and assess the long term safety and the efficacy maintenance(9 months Open-Label Extension Phase) of BF2.649 in the improvement of excessive daytime sleepiness in patients diagnosed with Parkinson's Disease.
Read the detailed description
As measured by the change from baseline in the Epworth Scale Scores (ESS) at Week 12 and at Week 51, in patients diagnosed with EDS in Parkinson's Disease.
- Conditions
- Parkinson's Disease
- Being tested
- BF2.649 (Pitolisant)
- Keywords
- Excessive Daytime Sleepiness (EDS), Parkinson's Disease
- Medical subject headings
- Parkinson Disease, Disorders of Excessive Somnolence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BF2.649 (Pitolisant)Drug
Also called Pitolisant
1 capsule of BF2.649 (5mg, 10mg , 20 mg) O.D
| Study group | Role | What they receive |
|---|---|---|
| BF2.649 ( Pitolisant) | Experimental | BF2.649 (5mg, 10 mg, 20 mg) in capsules Receives: Drug: BF2.649 (Pitolisant) |
| Placebo | Placebo comparator | Placebo of BF2.649 (5mg, 10mg, 20mg) in capsules Receives: Drug: BF2.649 (Pitolisant) |
What is being measured
The primary outcome is the main question the study is designed to answer.
ESS change (Epworth Sleepiness Scale) versus baseline
Measured: at week 12 / 51 versus baseline
Secondary outcomes (1)
Safety
Any AE observed and reported during the study
Measured: 12-week and 52-week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2010 (estimated)
- Study startMar 2010
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 273 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bioprojet
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kati Gutierrez, PharmD, Study director, Bioprojet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01066442
- Sponsor's protocol ID
- P06-11 / BF2.649
- Other IDs
- 2009-013886-24, 2009
- Acronym
- HARPS2
- Status last verified
- Apr 2013
- First submitted
- 9 Feb 2010
- Last updated
- 12 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Multicenter 12-Week Double-blind Placebo-controlled Study to Assess the Efficacy and Safety of BF2.649 in Excessive Daytime Sleepiness in Parkinson's Disease Followed by a 38 Week Open Label Extension Phase
- ClinicalTrials.gov ID
- NCT01066442
- Acronym / sponsor ID
- HARPS2 / P06-11 / BF2.649
- Conditions
- Parkinson's Disease
- Keywords
- Excessive Daytime Sleepiness (EDS), Parkinson's Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 273 participants (actual)
- Lead sponsor
- BioprojetUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 10 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.
To compare the efficacy of BF2.649 over placebo (12 week Double-Blind Phase) and assess the long term safety and the efficacy maintenance(9 months Open-Label Extension Phase) of BF2.649 in the improvement of excessive daytime sleepiness in patients diagnosed with Parkinson's Disease.
Detailed description
As measured by the change from baseline in the Epworth Scale Scores (ESS) at Week 12 and at Week 51, in patients diagnosed with EDS in Parkinson's Disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BF2.649 ( Pitolisant) | Experimental | Drug: BF2.649 (Pitolisant)BF2.649 (5mg, 10 mg, 20 mg) in capsules |
| Placebo | Placebo comparator | Drug: BF2.649 (Pitolisant)Placebo of BF2.649 (5mg, 10mg, 20mg) in capsules |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with a documented history of Parkinson's disease according to UPDRS,fluctuator and non-fluctuator patients, Hoehn and Yahr score <5;
- stabilized on optimal antiparkinsonian treatments unmodified for 4 weeks prior to study entry;
- presenting an Excessive Daytime Sleepiness as indicated by an ESS>or=12
Key exclusion criteria (4 listed)
- Patients with a known diagnosis of other degenerative parkinsonian syndromes (e.g. Progressive supra-nuclear palsy, multisystemic atrophy, corticobasal degenerescence, diffuse Lewy's Body dementia)
- Patients who have shift work, chronic or occasional sleep deprivation, circadian rhythm disorders
- Patients with a severe depression indicated by (BDI>= 16)or at suicidal risk (BDI item G>0) or depression treated for less than 8 weeks
- Patients with a cognitive impairment
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 |
|---|---|---|
| BF2.649 (Pitolisant)Also: Pitolisant1 capsule of BF2.649 (5mg, 10mg , 20 mg) O.D | Drug | BF2.649 ( Pitolisant), Placebo |
Primary outcome
ESS change (Epworth Sleepiness Scale) versus baseline
Time frame: at week 12 / 51 versus baseline
1 secondary outcome
Safety
Time frame: 12-week and 52-week
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 12 Apr 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.
Kati Gutierrez, PharmD 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 3 study testing BF2.649 (Pitolisant) in people with Parkinson's Disease, run by Bioprojet at 1 site in Germany.
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 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 12 Apr 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 Germany. 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?
ESS change (Epworth Sleepiness Scale) versus baseline (time frame: at week 12 / 51 versus baseline). 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 12 Apr 2013.