Parkinson DiseasePhase 4NCT04870372
Selegiline for the Treatment of Excessive Daytime Sleepiness in Parkinson's Disease
A Phase 4 study testing Selegiline in people with Parkinson Disease, run by Second Affiliated Hospital of Soochow University at 4 sites in China.
Trial summary
This is a multi-center, open-label, single-arm 8-week investigation of Selegiline for treatment of EDS in PD patients. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Selegiline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 141 participants
- Where
- 4 sitesChina
- Study dates
- 1 Mar 2020to 30 Apr 2021
- Phase
- Phase 4
- 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
- Male or female and greater from 30 to 80.
- Diagnosis of idiopathic PD according to the UK Brain Bank criteria.
- Epworth Sleepiness Scale (ESS) >7.
- Stable dose of anti-Parkinson drugs for at least 30 days.
- No use of MAO-B inhibitors within the preceding 4 weeks.
- No cognitive impairment, defined by Mini-Mental State Exam score ≤ 26.
Who cannot join
- Diagnosis of atypical Parkinsonian syndrome, vascular Parkinsonism or drug-induced Parkinsonism.
- Shift-work, which cannot ensure a stable sleep-wake cycle habits.
- History of contraindications.
Trial locations and contacts
4 sites in 1 country.
China4 sites
Changshu Hospital Affiliated to Nanjing University of Chinese Medicine
Changshu, Jiangsu
Second Affiliated Hospital of Nantong University
Nantong, Jiangsu
Department of Neurology, Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215004
Jiang Yuan Hospital Affiliated to Jiangsu Institute of Nuclear Medicine
Wuxi, Jiangsu
About this study
Official title: A Multi-center, Open-Label Study to Evaluate the Efficacy and Safety of Selegiline for the Treatment of Excessive Daytime Sleepiness in Parkinson's Disease
This is a multi-center, open-label, single-arm 8-week investigation of Selegiline for treatment of EDS in PD patients.
Read the detailed description
This is a multi-center, open-label, single-arm 8-week investigation of Selegiline. Subjects who have a diagnosis of PD based on UK brain bank criteria with ESS> 7 will be received Selegiline as an adjunctive therapy or monotherapy. This study will assess the impact of Selegiline treatment on the severity of sleep disturbances among PD patients.
- Conditions
- Parkinson Disease
- Being tested
- Selegiline
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SelegilineDrug
Also called ELDEPRYL
Subjects will receive one Selegiline tablet (5 mg) per day administered at breakfast. The initial dose of Selegiline is 5 mg/day and be up-titrated in 2-week intervals in increments of 5 mg up to 10 mg (which can be taken at breakfast or divided doses of 5 mg each taken at breakfast and lunch) according to the investigator's judgment, based on individual clinical response and tolerability.
| Study group | Role | What they receive |
|---|---|---|
| Selegiline | Experimental | Subjects who meet all of the inclusion and none of the exclusion criteria will be received Selegiline.The study medication dosage will be escalated from 5mg/daily to the target dose(5~10mg/daily) in 2 weeks and then maintained for the remaining 6 weeks. Receives: Drug: Selegiline |
What is being measured
The primary outcome is the main question the study is designed to answer.
The mean change of ESS score will be assessed from baseline to 8 weeks when given Selegiline as an adjunctive therapy or monotherapy in PD patients with daytime sleepiness.
This outcome was used to assess relationships among changes in ESS from baseline to the endpoint.
Measured: 8 weeks
Secondary outcomes (3)
The proportion of patients with daytime sleepiness (ESS> 7) will be evaluated at the baseline and after 8 weeks treatment.
This outcome corresponds to the number of patients with daytime sleepiness.
Measured: 8 weeks
The mean change of PDQ-8 scores will be assessed from baseline to 8 weeks of treatment.
This outcome reflects change of patients'daily quality.
Measured: 8 weeks
The mean change of UPDRS IV items 32 and 39 scores will be assessed from baseline to 8 weeks of treatment.
This outcome corresponds to motor complications.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2021
- Study start1 Mar 2020
- Primary completion31 Dec 2020
- Study completion30 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Parkinson 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 141 participants (actual)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital of Soochow University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chun-feng Liu, MD,PhD, Study chair, Second Affiliated Hospital of Soochow University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04870372
- Sponsor's protocol ID
- JD-LK-2019-103-02
- Status last verified
- May 2021
- First submitted
- 15 Jan 2020
- Last updated
- 7 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tholfsen LK, Larsen JP, Schulz J, Tysnes OB, Gjerstad MD. Development of excessive daytime sleepiness in early Parkinson disease. Neurology. 2015 Jul 14;85(2):162-8. doi: 10.1212/WNL.0000000000001737. Epub 2015 Jun 17.
PubMed 26085603Panisset M, Stril JL, Belanger M, Lehoux G, Coffin D, Chouinard S. Open-Label Study of Sleep Disturbances in Patients with Parkinson's Disease Treated with Rasagiline. Can J Neurol Sci. 2016 Nov;43(6):809-814. doi: 10.1017/cjn.2016.289.
PubMed 27827298
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Open-Label Study to Evaluate the Efficacy and Safety of Selegiline for the Treatment of Excessive Daytime Sleepiness in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT04870372
- Acronym / sponsor ID
- JD-LK-2019-103-02
- Conditions
- Parkinson Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 141 participants (actual)
- Lead sponsor
- Second Affiliated Hospital of Soochow UniversityUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 3 May 2021 (actual)
- 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.
This is a multi-center, open-label, single-arm 8-week investigation of Selegiline for treatment of EDS in PD patients.
Detailed description
This is a multi-center, open-label, single-arm 8-week investigation of Selegiline. Subjects who have a diagnosis of PD based on UK brain bank criteria with ESS> 7 will be received Selegiline as an adjunctive therapy or monotherapy. This study will assess the impact of Selegiline treatment on the severity of sleep disturbances among PD patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Selegiline | Experimental | Drug: SelegilineSubjects who meet all of the inclusion and none of the exclusion criteria will be received Selegiline.The study medication dosage will be escalated from 5mg/daily to the target dose(5~10mg/daily) in 2 weeks and then maintained for the remaining 6 weeks. |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female and greater from 30 to 80.
- Diagnosis of idiopathic PD according to the UK Brain Bank criteria.
- Epworth Sleepiness Scale (ESS) >7.
- Stable dose of anti-Parkinson drugs for at least 30 days.
- No use of MAO-B inhibitors within the preceding 4 weeks.
Key exclusion criteria (3 listed)
- Diagnosis of atypical Parkinsonian syndrome, vascular Parkinsonism or drug-induced Parkinsonism.
- Shift-work, which cannot ensure a stable sleep-wake cycle habits.
- History of contraindications.
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 |
|---|---|---|
| SelegilineAlso: ELDEPRYLSubjects will receive one Selegiline tablet (5 mg) per day administered at breakfast. The initial dose of Selegiline is 5 mg/day and be up-titrated in 2-week intervals in increments of 5 mg up to 10 mg (which can be taken at breakfast or divided doses of 5 mg each taken at breakfast and lunch) according to the investigator's judgment, based on individual clinical response and tolerability. | Drug | Selegiline |
Primary outcome
The mean change of ESS score will be assessed from baseline to 8 weeks when given Selegiline as an adjunctive therapy or monotherapy in PD patients with daytime sleepiness.
Time frame: 8 weeks
This outcome was used to assess relationships among changes in ESS from baseline to the endpoint.
3 secondary outcomes
The proportion of patients with daytime sleepiness (ESS> 7) will be evaluated at the baseline and after 8 weeks treatment.
Time frame: 8 weeks
The mean change of PDQ-8 scores will be assessed from baseline to 8 weeks of treatment.
Time frame: 8 weeks
The mean change of UPDRS IV items 32 and 39 scores will be assessed from baseline to 8 weeks of treatment.
Time frame: 8 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 7 May 2021.
- Background: PubMed 26085603Tholfsen LK, Larsen JP, Schulz J, Tysnes OB, Gjerstad MD. Development of excessive daytime sleepiness in early Parkinson disease. Neurology. 2015 Jul 14;85(2):162-8. doi: 10.1212/WNL.0000000000001737. Epub 2015 Jun 17.
- Background: PubMed 27827298Panisset M, Stril JL, Belanger M, Lehoux G, Coffin D, Chouinard S. Open-Label Study of Sleep Disturbances in Patients with Parkinson's Disease Treated with Rasagiline. Can J Neurol Sci. 2016 Nov;43(6):809-814. doi: 10.1017/cjn.2016.289.
- Individual participant dataSharing planned: No
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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.
Chun-feng Liu, MD,PhD study chair
Second Affiliated Hospital of Soochow University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Selegiline in people with Parkinson Disease, run by Second Affiliated Hospital of Soochow University at 4 sites in China.
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 6 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 7 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
The mean change of ESS score will be assessed from baseline to 8 weeks when given Selegiline as an adjunctive therapy or monotherapy in PD patients with daytime sleepiness. (time frame: 8 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 NCT04870372, which also lists 2 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 7 May 2021.