Idiopathic Parkinson DiseasePhase 2NCT02641054
Efficacy Phase IIa Study of CVXL-0107 in Advanced Parkinson's Disease
A Phase 2 study testing CVXL-0107 and Levodopa in people with Idiopathic Parkinson Disease, run by CleveXel Pharma at 1 site in France.
Trial summary
CVXL-0107 a glutamate release inhibitor, has shown evidence of antiparkinsonian and antidyskinetic activity in a macaque model and has shown a significant effect on the UPDRS-III (Movement Disorder Society - Unified Parkinson's Disease Rating Scale) while "ON", as well as an increase of "ON-time" without dyskinesia or… Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Idiopathic Parkinson Disease
- What is being tested?
- CVXL-0107 and Levodopa
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2016to Jul 2017
- Phase
- Phase 2
- 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed written Informed Consent
- Male and female patient aged 40 -75 years
- Clinical diagnosis of idiopathic PD according to the UK Parkinson's Disease Society Brain Bank Clinical Diagnosis Criteria
- Advanced PD with clear daily motor fluctuations and dyskinesia with optimal levodopa-based therapy
- At least 2 hours in "OFF" state per day including morning OFF
- Predictable "OFF" in the morning on awakening prior to receiving morning dose of levodopa
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- During an acute levodopa challenge test : Motor improvement of at least 30% on the MDS-UPDRS part III and AIMS score ≥ 1 at least two time points
- Patient with dyskinesia: MDS-UPDRS items 4.1 ("time spent with dyskinesia") and 4.2 ("functional impact of dyskinesia") scores ≥ 1 at Screening
- Hoehn and Yahr stages of 2-4 in the "OFF" state at Screening
- Stable doses and regimens of antiparkinsonian medications for at least the last month prior to randomization (levodopa, dopamine agonists and selective monoamine oxidase type B inhibitors (selegiline, rasagiline))
- Anti-PD therapy intended to remain constant throughout the course of the study
- Normal platelets count
- Mini-mental state examination (MMSE)≥24 at Screening
- PD patient treated by DBS can be included if surgery occurred at least one year before the study
- Patient with health insurance
- Female of childbearing potential with an effective contraception
Who cannot join
- Any relevant neurologic or psychiatric disease, except idiopathic PD
- Any secondary causes for Parkinsonism or other neurodegenerative disorder with Parkinsonism symptoms
- Any neurosurgical intervention for PD planned during the study period
- Neuroleptics and any D2-receptor antagonists within the last 3 months before Screening
- Amantadine, Riluzole, dextromethorphan, apomorphine continuous infusion (pump), morphine, or memantine, during the last month before screening and during the study duration
- History of psychosis or treatment with any antipsychotic drugs within the last 2 years
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- History of seizure or epilepsy, or treatment with anticonvulsant drugs within the last year
- Any clinically significant unstable medical illness in the last month before randomization (e.g. unstable angina, unstable vascular disease etc)
- Anti-cancer treatment within the 3 months before Screening
- Treatment with anticoagulant drugs
- Any clinically significant renal (serum creatinine level ≥1.5x ULN or dialysis) or hepatic (liver enzyme values≥2x ULN) disease
- Any clinically significant condition that may compromise the safety of patient or the conduct of the study protocol according to Investigators' opinion.
- Known genetic disorder of human UDP-glucuronosyltransferase
- Participation in another trial with any investigational product within the last month before randomization or intake of any investigational product
- Pregnant, breastfeeding or lactating female
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Double-Blind Randomized Placebo-Controlled Cross-Over Phase IIa Trial to Evaluate Efficacy of CVXL-0107 on Parkinson-Related Symptoms and Levodopa-Induced Dyskinesia in Advanced Parkinson's Disease Patients Using a Levodopa Challenge Test
CVXL-0107 a glutamate release inhibitor, has shown evidence of antiparkinsonian and antidyskinetic activity in a macaque model and has shown a significant effect on the UPDRS-III (Movement Disorder Society - Unified Parkinson's Disease Rating Scale) while "ON", as well as an increase of "ON-time" without dyskinesia or without troublesome dyskinesia in a previous phase 2a proof of concept study. This study will confirm the efficacy of CVXL-0107 in combination with optimal dose of levodopa on motor symptoms of Parkinson's disease (PD) .
Read the detailed description
Phase IIa study, 1:1 randomized, double blind placebo- controlled, with cross-over. Each volunteer patient will be randomly assigned to receive CVXL-0107 or placebo as add-on PD therapy and crossed-over to the other arm in the second sequence of the study. They will be assessed during an acute levodopa challenge test with one intake of the study drug or placebo with a supra-optimal dose of levodopa after 2 weeks of daily treatment with the same study drug or placebo. Patients will be cross-overed to the other treatment and reassessed during a second acute levodopa challenge test after 2 weeks of daily treatment with the study drug or the placebo. The study will evaluate the anti-PD and the anti-dyskinesia efficacy of CVXL-0107 as measured by MDS-UPDRS part III (Movement Disorder Society - Unified Parkinson's Disease Rating Scale) and on levodopa-induced dyskinesia as measured by the AIMS (Abnormal Involuntary Movement Scale).
- Conditions
- Idiopathic Parkinson Disease
- Being tested
- CVXL-0107, Placebo, Levodopa
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CVXL-0107Drug
PlaceboDrug
LevodopaDrug
| Study group | Role | What they receive |
|---|---|---|
| CVXL-0107 then cross-over to placebo | Experimental | Study drug (CVXL-0107) 4 times per day for 2 weeks on top of usual treatment for Parkinson disease, followed by one challenge test day: one intake of study drug on top of supraoptimal dose of levodopa.
Cross-over to placebo 4 times per day for 2 weeks on top of usual treatment for Parkinson disease, followed by one challenge test day: one intake of placebo on top of supraoptimal dose of levodopa Receives: Drug: CVXL-0107; Drug: Placebo; Drug: Levodopa |
| Placebo then cross-over to CVXL-0107 | Placebo comparator | Placebo 4 times per day for 2 weeks on top of usual treatment for Parkinson disease, followed by one challenge test day: one intake of placebo on top of supraoptimal dose of levodopa.
Cross-over to study drug (CVXL-0107) 4 times per day for 2 weeks on top of usual treatment for Parkinson disease, followed by one challenge test day: one intake of study drug on top of supraoptimal dose of levodopa Receives: Drug: CVXL-0107; Drug: Placebo; Drug: Levodopa |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in MDS-UPDRS part III (Movement Disorder Society - Unified Parkinson's Disease Rating Scale Part III) score.
CVXL-0107 and placebo
Measured: at visit 3 (day 15= challenge test day) and visit 4 (day 37= challenge test day): at baseline (before L-Dopa administration), then every 20 minutes during the first hour and then every 30 minutes during 5 hours.
Change in AIMS ( Abnormal Involuntary Movement Scale) score
CVXL-0107 and placebo
Measured: at visit 3 (day 15= challenge test day) and visit 4 (day 37 = challenge test day): at baseline (before L-Dopa administration), then every 20 minutes during the first hour and then every 30 minutes during 5 hours
Secondary outcomes (7)
Incidence of Clinical Treatment-Emergent Adverse Events [Safety and Tolerability]
Physical examination, vital signs
Measured: at visit 3 (day 14) and visit 4 (day 36)
Hematology laboratory safety of CVXL-0107
complete blood count
Measured: at visit 3 (day 14) and visit 4 (day 36)
Hepatic laboratory safety of CVXL-0107
aspartate transaminase, alanine transaminase, gamma-glutamyl-transpeptidase, alkaline phosphatase
Measured: at visit 3 (day 14) and visit 4 (day 36)
Area Under the Curve [AUC] of CVXL-0107 concentrations
Blood samples at L-dopa intake and after 20', 40', 60', 90', 120', 240'.
Measured: at visit 3 (day 15= challenge test day) and visit 4 (day 37= challenge test day)
Area Under the Curve [AUC] of levodopa concentrations
Blood samples at L-dopa intake and after 20', 40', 60', 90', 120', 240'.
Measured: at visit 3 (day 15= challenge test day) and visit 4 (day 37= challenge test day)
Assessment of total daily "ON" time in Patients Diaries
Total "ON-time"
Measured: During 3 days, prior to visit 3 (days 11-13) and prior to visit 4 (days 33, 34, 35)
Assessment of daily "ON" time without dyskinesia in Patients Diaries
"ON-time" without dyskinesia
Measured: During 3 days; prior to visit 3 (days 11-13) and prior to visit 4 (days 33, 34, 35)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2015 (estimated)
- Study startFeb 2016
- Primary completionJun 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- CleveXel Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jean-Christophe Corvol, MD, PhD, Principal investigator, CIC-Neurologie, bâtiment ICM, Hôpital Pitié-Salpêtrière, 47/83 Bd de l'Hôpital, 75013 Paris, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02641054
- Sponsor's protocol ID
- CT-CVXL-0107-01
- Status last verified
- Jul 2017
- First submitted
- 7 Dec 2015
- Last updated
- 24 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-Blind Randomized Placebo-Controlled Cross-Over Phase IIa Trial to Evaluate Efficacy of CVXL-0107 on Parkinson-Related Symptoms and Levodopa-Induced Dyskinesia in Advanced Parkinson's Disease Patients Using a Levodopa Challenge Test
- ClinicalTrials.gov ID
- NCT02641054
- Acronym / sponsor ID
- CT-CVXL-0107-01
- Conditions
- Idiopathic Parkinson Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- CleveXel PharmaIndustry (pharma, biotech, devices)
- Study start
- Feb 2016 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 29 Dec 2015 (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.
CVXL-0107 a glutamate release inhibitor, has shown evidence of antiparkinsonian and antidyskinetic activity in a macaque model and has shown a significant effect on the UPDRS-III (Movement Disorder Society - Unified Parkinson's Disease Rating Scale) while "ON", as well as an increase of "ON-time" without dyskinesia or without troublesome dyskinesia in a previous phase 2a proof of concept study. This study will confirm the efficacy of CVXL-0107 in combination with optimal dose of levodopa on motor symptoms of Parkinson's disease (PD) .
Detailed description
Phase IIa study, 1:1 randomized, double blind placebo- controlled, with cross-over. Each volunteer patient will be randomly assigned to receive CVXL-0107 or placebo as add-on PD therapy and crossed-over to the other arm in the second sequence of the study. They will be assessed during an acute levodopa challenge test with one intake of the study drug or placebo with a supra-optimal dose of levodopa after 2 weeks of daily treatment with the same study drug or placebo. Patients will be cross-overed to the other treatment and reassessed during a second acute levodopa challenge test after 2 weeks of daily treatment with the study drug or the placebo. The study will evaluate the anti-PD and the anti-dyskinesia efficacy of CVXL-0107 as measured by MDS-UPDRS part III (Movement Disorder Society - Unified Parkinson's Disease Rating Scale) and on levodopa-induced dyskinesia as measured by the AIMS (Abnormal Involuntary Movement Scale).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CVXL-0107 then cross-over to placebo | Experimental | Drug: CVXL-0107, Drug: Placebo, Drug: LevodopaStudy drug (CVXL-0107) 4 times per day for 2 weeks on top of usual treatment for Parkinson disease, followed by one challenge test day: one intake of study drug on top of supraoptimal dose of levodopa. Cross-over to placebo 4 times per day for 2 weeks on top of usual treatment for Parkinson disease, followed by one challenge test day: one intake of placebo on top of supraoptimal dose of levodopa |
| Placebo then cross-over to CVXL-0107 | Placebo comparator | Drug: CVXL-0107, Drug: Placebo, Drug: LevodopaPlacebo 4 times per day for 2 weeks on top of usual treatment for Parkinson disease, followed by one challenge test day: one intake of placebo on top of supraoptimal dose of levodopa. Cross-over to study drug (CVXL-0107) 4 times per day for 2 weeks on top of usual treatment for Parkinson disease, followed by one challenge test day: one intake of study drug on top of supraoptimal dose of levodopa |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Signed written Informed Consent
- Male and female patient aged 40 -75 years
- Clinical diagnosis of idiopathic PD according to the UK Parkinson's Disease Society Brain Bank Clinical Diagnosis Criteria
- Advanced PD with clear daily motor fluctuations and dyskinesia with optimal levodopa-based therapy
- At least 2 hours in "OFF" state per day including morning OFF
Key exclusion criteria (15 listed)
- Any relevant neurologic or psychiatric disease, except idiopathic PD
- Any secondary causes for Parkinsonism or other neurodegenerative disorder with Parkinsonism symptoms
- Any neurosurgical intervention for PD planned during the study period
- Neuroleptics and any D2-receptor antagonists within the last 3 months before Screening
- Amantadine, Riluzole, dextromethorphan, apomorphine continuous infusion (pump), morphine, or memantine, during the last month before screening and during the study duration
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 |
|---|---|---|
| CVXL-0107 | Drug | CVXL-0107 then cross-over to placebo, Placebo then cross-over to CVXL-0107 |
| Placebo | Drug | CVXL-0107 then cross-over to placebo, Placebo then cross-over to CVXL-0107 |
| Levodopa | Drug | CVXL-0107 then cross-over to placebo, Placebo then cross-over to CVXL-0107 |
Primary outcome
Change in MDS-UPDRS part III (Movement Disorder Society - Unified Parkinson's Disease Rating Scale Part III) score.
Time frame: at visit 3 (day 15= challenge test day) and visit 4 (day 37= challenge test day): at baseline (before L-Dopa administration), then every 20 minutes during the first hour and then every 30 minutes during 5 hours.
CVXL-0107 and placebo
Change in AIMS ( Abnormal Involuntary Movement Scale) score
Time frame: at visit 3 (day 15= challenge test day) and visit 4 (day 37 = challenge test day): at baseline (before L-Dopa administration), then every 20 minutes during the first hour and then every 30 minutes during 5 hours
CVXL-0107 and placebo
7 secondary outcomes
Incidence of Clinical Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: at visit 3 (day 14) and visit 4 (day 36)
Hematology laboratory safety of CVXL-0107
Time frame: at visit 3 (day 14) and visit 4 (day 36)
Hepatic laboratory safety of CVXL-0107
Time frame: at visit 3 (day 14) and visit 4 (day 36)
Area Under the Curve [AUC] of CVXL-0107 concentrations
Time frame: at visit 3 (day 15= challenge test day) and visit 4 (day 37= challenge test day)
Area Under the Curve [AUC] of levodopa concentrations
Time frame: at visit 3 (day 15= challenge test day) and visit 4 (day 37= challenge test day)
Assessment of total daily "ON" time in Patients Diaries
Time frame: During 3 days, prior to visit 3 (days 11-13) and prior to visit 4 (days 33, 34, 35)
Assessment of daily "ON" time without dyskinesia in Patients Diaries
Time frame: During 3 days; prior to visit 3 (days 11-13) and prior to visit 4 (days 33, 34, 35)
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 24 Jul 2017.
- 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.
Jean-Christophe Corvol, MD, PhD principal investigator
CIC-Neurologie, bâtiment ICM, Hôpital Pitié-Salpêtrière, 47/83 Bd de l'Hôpital, 75013 Paris, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CVXL-0107 and Levodopa in people with Idiopathic Parkinson Disease, run by CleveXel Pharma 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 16 inclusion and 15 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 24 Jul 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Change in MDS-UPDRS part III (Movement Disorder Society - Unified Parkinson's Disease Rating Scale Part III) score. (time frame: at visit 3 (day 15= challenge test day) and visit 4 (day 37= challenge test day): at baseline (before L-Dopa administration), then every 20 minutes during the first hour and then every 30 minutes during 5 hours.). The study lists 2 primary outcomes in all. 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 24 Jul 2017.