ClinicalTrials.gg
Sign In
CompletedNCT02641054Updated Jul 24, 2017

Efficacy Phase IIa Study of CVXL-0107 in Advanced Parkinson's Disease

A Phase 2 interventional study of CVXL-0107 and Placebo in Idiopathic Parkinson Disease, sponsored by CleveXel Pharma. Completed at 1 site in France. Open to participants aged 40 Years to 75 Years. Per ClinicalTrials.gov, last updated 2017-07-24.

Sponsored by CleveXel Pharma · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
21
Allocation
Randomized
Ages
40 Years to 75 Years
Sex
All
01

Study 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 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).

02

Conditions studied

  • Idiopathic Parkinson Disease

Browse trials for

03

In context

Parkinson Disease

4,583 studies on the registry are indexed under Parkinson Disease; 1,097 are open to participants now.

This study's enrollment of 21 is below the median of 40 across 3,365 interventional studies indexed under Parkinson Disease.

Browse Parkinson Disease studies →

Lead sponsor

This is the only study on the registry with CleveXel Pharma as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Signed written Informed Consent
  2. Male and female patient aged 40 -75 years
  3. Clinical diagnosis of idiopathic PD according to the UK Parkinson's Disease Society Brain Bank Clinical Diagnosis Criteria
  4. Advanced PD with clear daily motor fluctuations and dyskinesia with optimal levodopa-based therapy
  5. At least 2 hours in "OFF" state per day including morning OFF
  6. Predictable "OFF" in the morning on awakening prior to receiving morning dose of levodopa
  7. 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
  8. Patient with dyskinesia: MDS-UPDRS items 4.1 ("time spent with dyskinesia") and 4.2 ("functional impact of dyskinesia") scores ≥ 1 at Screening
  9. Hoehn and Yahr stages of 2-4 in the "OFF" state at Screening
  10. 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))
  11. Anti-PD therapy intended to remain constant throughout the course of the study
  12. Normal platelets count
  13. Mini-mental state examination (MMSE)≥24 at Screening
  14. PD patient treated by DBS can be included if surgery occurred at least one year before the study
  15. Patient with health insurance
  16. Female of childbearing potential with an effective contraception

Exclusion criteria

Exclusion Criteria:

  1. Any relevant neurologic or psychiatric disease, except idiopathic PD
  2. Any secondary causes for Parkinsonism or other neurodegenerative disorder with Parkinsonism symptoms
  3. Any neurosurgical intervention for PD planned during the study period
  4. Neuroleptics and any D2-receptor antagonists within the last 3 months before Screening
  5. Amantadine, Riluzole, dextromethorphan, apomorphine continuous infusion (pump), morphine, or memantine, during the last month before screening and during the study duration
  6. History of psychosis or treatment with any antipsychotic drugs within the last 2 years
  7. History of seizure or epilepsy, or treatment with anticonvulsant drugs within the last year
  8. Any clinically significant unstable medical illness in the last month before randomization (e.g. unstable angina, unstable vascular disease etc)
  9. Anti-cancer treatment within the 3 months before Screening
  10. Treatment with anticoagulant drugs
  11. Any clinically significant renal (serum creatinine level ≥1.5x ULN or dialysis) or hepatic (liver enzyme values≥2x ULN) disease
  12. Any clinically significant condition that may compromise the safety of patient or the conduct of the study protocol according to Investigators' opinion.
  13. Known genetic disorder of human UDP-glucuronosyltransferase
  14. Participation in another trial with any investigational product within the last month before randomization or intake of any investigational product
  15. Pregnant, breastfeeding or lactating female
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
21 participants (actual)

Study arms

  • Experimental
    CVXL-0107 then cross-over to placebo

    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

    Drug: CVXL-0107 · Drug: Placebo · Drug: Levodopa

  • Placebo comparator
    Placebo then cross-over to CVXL-0107

    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

    Drug: CVXL-0107 · Drug: Placebo · Drug: Levodopa

Interventions

06

What researchers measure

Primary outcomes

  1. Change in MDS-UPDRS part III (Movement Disorder Society - Unified Parkinson's Disease Rating Scale Part III) score.

    CVXL-0107 and placebo

    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.

  2. Change in AIMS ( Abnormal Involuntary Movement Scale) score

    CVXL-0107 and placebo

    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

Secondary outcomes

  1. Incidence of Clinical Treatment-Emergent Adverse Events [Safety and Tolerability]

    Physical examination, vital signs

    Time frame: at visit 3 (day 14) and visit 4 (day 36)

  2. Hematology laboratory safety of CVXL-0107

    complete blood count

    Time frame: at visit 3 (day 14) and visit 4 (day 36)

  3. Hepatic laboratory safety of CVXL-0107

    aspartate transaminase, alanine transaminase, gamma-glutamyl-transpeptidase, alkaline phosphatase

    Time frame: at visit 3 (day 14) and visit 4 (day 36)

  4. Area Under the Curve [AUC] of CVXL-0107 concentrations

    Blood samples at L-dopa intake and after 20', 40', 60', 90', 120', 240'.

    Time frame: at visit 3 (day 15= challenge test day) and visit 4 (day 37= challenge test day)

  5. Area Under the Curve [AUC] of levodopa concentrations

    Blood samples at L-dopa intake and after 20', 40', 60', 90', 120', 240'.

    Time frame: at visit 3 (day 15= challenge test day) and visit 4 (day 37= challenge test day)

  6. Assessment of total daily "ON" time in Patients Diaries

    Total "ON-time"

    Time frame: During 3 days, prior to visit 3 (days 11-13) and prior to visit 4 (days 33, 34, 35)

  7. Assessment of daily "ON" time without dyskinesia in Patients Diaries

    "ON-time" without dyskinesia

    Time frame: During 3 days; prior to visit 3 (days 11-13) and prior to visit 4 (days 33, 34, 35)

07

Study locations

1 site
  • Clevexel Pharma
    Maisons-Alfort, 94700, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Feb 2016 to primary completion in Jun 2017, 16 months.

Of 97 industry-sponsored phase 2 interventional studies under Parkinson Disease, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 33. This study's 16 months is below that.

Counting every sponsor, half of 200 studies reached it within 28 months; a quarter within 16 and three quarters within 44.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 7, 2015
First posted
Dec 29, 2015
StartActual
Feb 2016
Primary completionActual
Jun 2017
CompletionActual
Jul 2017
Last update
Jul 24, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 24, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02641054
Lead sponsor
CleveXel Pharma
Responsible party
Sponsor
First posted
Dec 29, 2015
Start date
Feb 2016
Primary completion
Jun 2017
Completion
Jul 2017
Last update
Jul 24, 2017

Study contacts

Jean-Christophe Corvol, MD, PhD
principal investigator · CIC-Neurologie, bâtiment ICM, Hôpital Pitié-Salpêtrière, 47/83 Bd de l'Hôpital, 75013 Paris, France

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2017. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: Levodopa

Other studies in this condition

Parkinson Disease →

Start the discussion