Parkinson DiseasePhase 1NCT04295642
A 2-Part Trial of CVL-751 in Subjects With Parkinson's Disease
A Phase 1 study testing CVL-751 in people with Parkinson Disease, run by Cerevel Therapeutics, LLC at 2 sites in United States.
Trial summary
This trial will be a 2-part, adaptive, open label, single and/or multiple oral dose, safety, tolerability, food effect trial of CVL-751 in subjects with Parkinson's disease. Part 1 is a placebo-controlled, single dose cohort intended for assessment of safety and tolerability. Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- CVL-751
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 2 sitesUnited States
- Study dates
- 8 Jan 2020to 23 Jul 2021
- Phase
- Phase 1
- 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 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female subjects, ages 45 to 75 years, inclusive, at the time of signing the informed consent form (ICF).
- Body mass index (BMI) of 17.5 to 38.0 kg/m2 and a total body weight >50 kg (110 lbs).
- Subjects with a diagnosis of that is consistent with the UK Parkinson's Disease Society Brain Bank diagnostic criteria, with bradykinesia and motor asymmetry.
- Must be modified Hoehn \& Yahr (HY) Stage I - III inclusive.
- Must be on a stable dose of L-Dopa of at least 300 mg daily in conjunction with a dopa-decarboxylase inhibitor (eg, L-Dopa/carbidopa or L-Dopa/benserazide) administered at least 3 times per day but no more than 6 times per day for at least 2 weeks prior to the Day 1 Visit. Must be willing and able to refrain from L-Dopa treatment (in Part 1 and Part 2B) as outlined in the schedule of assessments.
- A female subject of childbearing potential (see Section 10.4, Appendix 4) who is sexually active with a nonsterilized male partner or male subject with a pregnant or a nonpregnant partner of childbearing potential must agree to use an acceptable or a highly effective method of contraception (see Section 10.4, Appendix 4) from signing of informed consent throughout the duration of the trial and for 7 days post last dose.
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- Capable of giving signed informed consent as described in Section 10.1.3 (Appendix 1), which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
- Ability, in the opinion of the investigator, to understand the nature of the trial and comply with protocol requirements, including the prescribed dosage regimens, scheduled visits, laboratory tests, and other trial procedures.
- Capable of consuming the standard high-fat meal.
Who cannot join
- Any significant Axis I psychiatric disease as defined by the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (American Psychiatric Association).
- In the opinion of the investigator (or caregiver, as applicable), has signs/symptoms suggestive of clinically significant cognitive impairment that would interfere with the ability to comply with trial procedures.
- Subjects with a Montreal Cognitive Assessment score <26.
- History or clinical features consistent with an atypical parkinsonian syndrome (eg, ataxia, dystonia, clinically significant orthostatic hypotension).
- Has a history of psychotic symptoms requiring treatment with an antipsychotic medication within the 12 months prior to signing ICF.
- Subjects with epilepsy, or history of epilepsy, or conditions that lower seizure threshold, seizures of any etiology (including substance or drug withdrawal), or who have increased risk of seizures as evidenced by history of electroencephalogram with epileptiform activity.
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- Subjects with a history of febrile seizures only are allowed. Subjects with a history of head trauma with loss of consciousness requiring overnight hospitalization will be excluded as well.
- Subjects with a current history of significant cardiovascular, pulmonary, gastrointestinal, renal, hepatic, metabolic, hematological, immunological, or neurological disease that, in the opinion of the investigator or medical monitor, could compromise either subject safety or the results of the trial.
- Medical conditions that are minor or well-controlled may be considered acceptable if the condition does not expose the subject to an undue risk of a significant AE or interfere with the assessments of safety or efficacy during the course of the trial. The medical monitor should be contacted in any instance where the investigator is uncertain regarding the stability of a subject's medical conditions(s) and the potential impact of the condition(s) on trial participation.
- History of substance or alcohol-use disorder (excluding nicotine; Diagnostic and Statistical Manual of Mental Disorders, 5th edition criteria) within 2 years prior to signing the ICF.
- History of regular alcohol consumption exceeding 7 drinks/week for females or 14 drinks/week for males [1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor] within 6 months prior to signing ICF.
- If a current smoker, is unable to comply with the following guidelines: agrees not to smoke on the mornings of trial dosing days and for the entire trial dosing day until completion of all trial assessments for that day.
- Subjects who answer "Yes" on the Columbia-Suicide Severity Rating Scale (C-SSRS) Suicidal Ideation Item 4 (Active Suicidal Ideation with Some Intent to Act, Without Specific Plan) and whose most recent episode meeting criteria for this C-SSRS Item 4 occurred within the last 6 months, OR Subjects who answer "Yes" on the C-SSRS Suicidal Ideation Item 5 (Active Suicidal Ideation with Specific Plan and Intent) and whose most recent episode meeting criteria for this C-SSRS Item 5 occurred within the last 6 months OR Subjects who answer "Yes" on any of the 5 C-SSRS Suicidal Behavior Items (actual attempt, interrupted attempt, aborted attempt, preparatory acts, or behavior) and whose most recent episode meeting criteria for any of these 5 C-SSRS Suicidal Behavior Items occurred within the last 2 years, OR Subjects who, in the opinion of the investigator, present a serious risk of suicide.
- Subjects who have attempted suicide in the past.
- Human immunodeficiency virus seropositive status or acquired immunodeficiency syndrome, acute or chronic hepatitis B or C, with HbsAg, or hepatitis C virus antibodies at screening.
- Subjects with a positive drug screen for illicit drugs are excluded and may not be retested or rescreened. Subjects with a positive urine drug screen resulting from use of marijuana (any cannabinoids), prescription medications, over-the-counter medications, or products that, in the investigator's documented opinion, do not signal a clinical condition that would impact the safety of the subject or interpretation of the trial results may continue evaluation for the trial following consultation and approval by the medical monitor.
- Subjects with a 12-lead electrocardiogram (ECG) demonstrating the following:
- QT interval corrected for heart rate using Fridericia's formula (QTcF) >450 msec.
- Subjects with any of the following abnormalities in clinical laboratory tests at the Screening Visit, as assessed by the central laboratory and confirmed by a single repeat measurement, if deemed necessary:
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥2 × upper limit of normal (ULN)
- Total bilirubin ≥1.5 × ULN. Subjects with a history of Gilbert's syndrome may be eligible provided the direct bilirubin is <ULN.
- Subjects with other abnormal laboratory test results, vital sign results, or ECG findings unless, based on the investigator's judgment, the findings are not medically significant and would not impact the safety of the subjects or the interpretation of the trial results. The medical monitor should be contacted to discuss individual cases, as needed.
- Tests with exclusionary results should be repeated to ensure reproducibility of the abnormality before excluding a subject based on criteria provided in the protocol. For ECGs, three consecutive recordings are required and if two of the three remain exclusionary, then the subject is not eligible for the trial.
- Subjects taking other prohibited medication or who would be likely to require prohibited concomitant therapy during the trial (see Section 6.5).
- Female subjects who are breastfeeding and/or who have a positive serum pregnancy test result prior to receiving IMP.
- Any condition possibly affecting drug absorption (eg, gastrectomy).
- Subjects with difficulty swallowing.
- Subjects who are known to be allergic or hypersensitive to the IMP or any of its components.
- Subjects who are known to be allergic or hypersensitive to contents of high-fat diet.
- Subjects who have participated in any clinical trial within 60 days prior to signing the ICF or who participated in more than two clinical trials within the year prior to signing the ICF.
- Any subject who, in the opinion of the sponsor, investigator, or medical monitor, should not participate in the trial.
- Subjects who are investigational site staff members directly involved in the conduct of the trial and their family members, site staff members otherwise supervised by the investigator.
- Unwilling or unable to comply with the lifestyle modifications described in this protocol.
- Subjects who participated in Part 1 of the trial are ineligible to participate in Part 2.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Atlanta Center for Medical Research
Atlanta, Georgia, 30331
CNS Network
Long Beach, California, 90806
About this study
Official title: A 2-Part, Open Label, Adaptive, Single and/or Multiple Oral Dose, Safety, Tolerability, and Food Effect Trial of CVL-751 in Subjects With Parkinson's Disease
This trial will be a 2-part, adaptive, open label, single and/or multiple oral dose, safety, tolerability, food effect trial of CVL-751 in subjects with Parkinson's disease. Part 1 is a placebo-controlled, single dose cohort intended for assessment of safety and tolerability. In case of intolerable AEs, Part 2 would proceed as a multiple dose titration trial to achieve a 15 mg once daily dose while maintaining L-Dopa treatment (Part 2A). In case of a favorable tolerability profile in Part 1, Part 2B would proceed as a single dose trial (similar to Part 1), with discontinuation of L-Dopa for 24 hours (12 hours pre-Day 1 dose and 12 hours post-Day 1 dose).
- Conditions
- Parkinson Disease
- Being tested
- CVL-751
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CVL-751Drug
Oral tablet
| Study group | Role | What they receive |
|---|---|---|
| Part 1 | Placebo comparator | Will include 4 subjects (3 active + 1 placebo) that will receive a single 15mg dose with approximately 48 hours of confinement and a follow-up after 7 days. Receives: Drug: CVL-751 |
| Part 2 | Experimental | 2A: will include 14 subjects to complete 12 with 28 days of dosing with 7 days (+/-2) of follow-up, with at least 14 days of confinement.
-or- 2B: will include 20 subjects to complete 12 with 2 dosing days and 5 days of washout with 7 days (+/-2) of follow-up, with 4 days of confinement (may be increased up to 12 days at the investigators discretion). Receives: Drug: CVL-751 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Single Dose: Peak Plasma Concentration
Peak Plasma Concentration (Cmax) for CVL-751 and its metabolite (PF-06752844) under fasted and fed conditions
Measured: Day 1 to 12
Single Dose:Area under the plasma concentration-time curve
Area under the plasma concentration-time curve (AUC) for CVL-751 and its metabolite (PF-06752844) under fasted and fed conditions
Measured: Day 1 to 12
Single Dose: Area under the plasma concentration-time curve from time zero to infinity
Area under the plasma concentration-time curve from time zero to infinity (AUCinf) for CVL-751 and its metabolite (PF-06752844) under fasted and fed conditions
Measured: Day 1 to 12
Single Dose: Time to Maximum Concentration
Time to Maximum Concentration (Tmax) for CVL-751 and its metabolite (PF-06752844) under fasted and fed conditions
Measured: Day 1 to 12
Multiple Dose: Peak Plasma Concentration
Peak Plasma Concentration (Cmax) for CVL-751 and its metabolite (PF-06752844) under fasted and fed conditions
Measured: Day 16 to 29
Multiple Dose: Area under the plasma concentration-time curve
Area under the plasma concentration-time curve (AUCτ) for CVL-751 and its metabolite (PF-06752844) under fasted and fed conditions
Measured: Day 16 to 29
Multiple Dose: Time to Maximum Concentration
Time to Maximum Concentration (Tmax) for CVL-751 and its metabolite (PF-06752844) under fasted and fed conditions
Measured: Day 16 to 29
Secondary outcomes (5)
Secondary Outcome (AE) Number of subjects with reported Treatment Emergent Adverse Events (TEAEs)
Number of subjects with reported Treatment Emergent Adverse Events (TEAEs)
Measured: up to Day 35
Secondary Outcome (Labs) Number of subjects with clinically significant changes in laboratory measures
Number of subjects with clinically significant changes in laboratory measures
Measured: up to Day 35
Secondary Outcome (ECGs)Number of subjects with Clinically significant changes in Electrocardiogram
Number of subjects with Clinically significant changes in Electrocardiogram measures (PR,RR,QT and QTcF)
Measured: up to Day 35
Secondary Outcome (Vital Signs) Number of subjects with Clinically meaningful changes in Vital signs
Number of subjects with Clinically meaningful changes in Vital signs
Measured: up to Day 35
Secondary Outcome (C-SSRS) - Change from baseline of the Columbia-Suicide Severity Rating Scale(C-SSRS)
Change from baseline of the Columbia-Suicide Severity Rating Scale(C-SSRS) The C-SSRS rates an individual's degree of suicidal ideation (SI) on a scale, ranging from "wish to be dead" to "active suicidal ideation with specific plan and intent." The scale identifies SI severity and intensity, which may be indicative of an individual's intent to commit suicide. C-SSRS SI severity subscale ranges from 0 (no SI) to 5 (active SI with plan and intent).
Measured: up to Day 35
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2020
- Study start8 Jan 2020
- Primary completion23 Jul 2021
- Study completion23 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cerevel Therapeutics, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Matthew Leoni, MD, Study director, Cerevel Therapeutics, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04295642
- Sponsor's protocol ID
- CVL-751-PD-005
- Status last verified
- Aug 2021
- First submitted
- 24 Jan 2020
- Last updated
- 31 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hoehn MM, Yahr MD. Parkinsonism: onset, progression, and mortality. 1967. Neurology. 2001 Nov;57(10 Suppl 3):S11-26. No abstract available.
PubMed 11775596Nasreddine ZS, Phillips NA, Bedirian V, Charbonneau S, Whitehead V, Collin I, Cummings JL, Chertkow H. The Montreal Cognitive Assessment, MoCA: a brief screening tool for mild cognitive impairment. J Am Geriatr Soc. 2005 Apr;53(4):695-9. doi: 10.1111/j.1532-5415.2005.53221.x.
PubMed 15817019Posner K, Brown GK, Stanley B, Brent DA, Yershova KV, Oquendo MA, Currier GW, Melvin GA, Greenhill L, Shen S, Mann JJ. The Columbia-Suicide Severity Rating Scale: initial validity and internal consistency findings from three multisite studies with adolescents and adults. Am J Psychiatry. 2011 Dec;168(12):1266-77. doi: 10.1176/appi.ajp.2011.10111704.
PubMed 22193671Nussbaum RL, Ellis CE. Alzheimer's disease and Parkinson's disease. N Engl J Med. 2003 Apr 3;348(14):1356-64. doi: 10.1056/NEJM2003ra020003. No abstract available.
PubMed 12672864Rascol O, Brooks DJ, Korczyn AD, De Deyn PP, Clarke CE, Lang AE. A five-year study of the incidence of dyskinesia in patients with early Parkinson's disease who were treated with ropinirole or levodopa. N Engl J Med. 2000 May 18;342(20):1484-91. doi: 10.1056/NEJM200005183422004.
PubMed 10816186Schrag A, Banks P. Time of loss of employment in Parkinson's disease. Mov Disord. 2006 Nov;21(11):1839-43. doi: 10.1002/mds.21030.
PubMed 16941456Yamamoto M, Schapira AH. Dopamine agonists in Parkinson's disease. Expert Rev Neurother. 2008 Apr;8(4):671-7. doi: 10.1586/14737175.8.4.671.
PubMed 18416667
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 2-Part, Open Label, Adaptive, Single and/or Multiple Oral Dose, Safety, Tolerability, and Food Effect Trial of CVL-751 in Subjects With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT04295642
- Acronym / sponsor ID
- CVL-751-PD-005
- Conditions
- Parkinson Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Cerevel Therapeutics, LLCIndustry (pharma, biotech, devices)
- Study start
- 8 Jan 2020 (actual)
- Primary completion
- 23 Jul 2021 (actual)
- Study completion
- 23 Jul 2021 (actual)
- First posted
- 4 Mar 2020 (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 trial will be a 2-part, adaptive, open label, single and/or multiple oral dose, safety, tolerability, food effect trial of CVL-751 in subjects with Parkinson's disease. Part 1 is a placebo-controlled, single dose cohort intended for assessment of safety and tolerability. In case of intolerable AEs, Part 2 would proceed as a multiple dose titration trial to achieve a 15 mg once daily dose while maintaining L-Dopa treatment (Part 2A). In case of a favorable tolerability profile in Part 1, Part 2B would proceed as a single dose trial (similar to Part 1), with discontinuation of L-Dopa for 24 hours (12 hours pre-Day 1 dose and 12 hours post-Day 1 dose).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part 1 | Placebo comparator | Drug: CVL-751Will include 4 subjects (3 active + 1 placebo) that will receive a single 15mg dose with approximately 48 hours of confinement and a follow-up after 7 days. |
| Part 2 | Experimental | Drug: CVL-7512A: will include 14 subjects to complete 12 with 28 days of dosing with 7 days (+/-2) of follow-up, with at least 14 days of confinement. -or- 2B: will include 20 subjects to complete 12 with 2 dosing days and 5 days of washout with 7 days (+/-2) of follow-up, with 4 days of confinement (may be increased up to 12 days at the investigators discretion). |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male and female subjects, ages 45 to 75 years, inclusive, at the time of signing the informed consent form (ICF).
- Body mass index (BMI) of 17.5 to 38.0 kg/m2 and a total body weight >50 kg (110 lbs).
- Subjects with a diagnosis of that is consistent with the UK Parkinson's Disease Society Brain Bank diagnostic criteria, with bradykinesia and motor asymmetry.
- Must be modified Hoehn \& Yahr (HY) Stage I - III inclusive.
- Must be on a stable dose of L-Dopa of at least 300 mg daily in conjunction with a dopa-decarboxylase inhibitor (eg, L-Dopa/carbidopa or L-Dopa/benserazide) administered at least 3 times per day but no more than 6 times per day for at least 2 weeks prior to the Day 1 Visit. Must be willing and able to refrain from L-Dopa treatment (in Part 1 and Part 2B) as outlined in the schedule of assessments.
Key exclusion criteria (34 listed)
- Any significant Axis I psychiatric disease as defined by the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (American Psychiatric Association).
- In the opinion of the investigator (or caregiver, as applicable), has signs/symptoms suggestive of clinically significant cognitive impairment that would interfere with the ability to comply with trial procedures.
- Subjects with a Montreal Cognitive Assessment score <26.
- History or clinical features consistent with an atypical parkinsonian syndrome (eg, ataxia, dystonia, clinically significant orthostatic hypotension).
- Has a history of psychotic symptoms requiring treatment with an antipsychotic medication within the 12 months prior to signing ICF.
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 |
|---|---|---|
| CVL-751Oral tablet | Drug | Part 1, Part 2 |
Primary outcome
Single Dose: Peak Plasma Concentration
Time frame: Day 1 to 12
Peak Plasma Concentration (Cmax) for CVL-751 and its metabolite (PF-06752844) under fasted and fed conditions
Single Dose:Area under the plasma concentration-time curve
Time frame: Day 1 to 12
Area under the plasma concentration-time curve (AUC) for CVL-751 and its metabolite (PF-06752844) under fasted and fed conditions
Single Dose: Area under the plasma concentration-time curve from time zero to infinity
Time frame: Day 1 to 12
Area under the plasma concentration-time curve from time zero to infinity (AUCinf) for CVL-751 and its metabolite (PF-06752844) under fasted and fed conditions
Single Dose: Time to Maximum Concentration
Time frame: Day 1 to 12
Time to Maximum Concentration (Tmax) for CVL-751 and its metabolite (PF-06752844) under fasted and fed conditions
Multiple Dose: Peak Plasma Concentration
Time frame: Day 16 to 29
Peak Plasma Concentration (Cmax) for CVL-751 and its metabolite (PF-06752844) under fasted and fed conditions
Multiple Dose: Area under the plasma concentration-time curve
Time frame: Day 16 to 29
Area under the plasma concentration-time curve (AUCτ) for CVL-751 and its metabolite (PF-06752844) under fasted and fed conditions
Multiple Dose: Time to Maximum Concentration
Time frame: Day 16 to 29
Time to Maximum Concentration (Tmax) for CVL-751 and its metabolite (PF-06752844) under fasted and fed conditions
5 secondary outcomes
Secondary Outcome (AE) Number of subjects with reported Treatment Emergent Adverse Events (TEAEs)
Time frame: up to Day 35
Secondary Outcome (Labs) Number of subjects with clinically significant changes in laboratory measures
Time frame: up to Day 35
Secondary Outcome (ECGs)Number of subjects with Clinically significant changes in Electrocardiogram
Time frame: up to Day 35
Secondary Outcome (Vital Signs) Number of subjects with Clinically meaningful changes in Vital signs
Time frame: up to Day 35
Secondary Outcome (C-SSRS) - Change from baseline of the Columbia-Suicide Severity Rating Scale(C-SSRS)
Time frame: up to Day 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 31 Aug 2021.
- Background: PubMed 11775596Hoehn MM, Yahr MD. Parkinsonism: onset, progression, and mortality. 1967. Neurology. 2001 Nov;57(10 Suppl 3):S11-26. No abstract available.
- Background: PubMed 15817019Nasreddine ZS, Phillips NA, Bedirian V, Charbonneau S, Whitehead V, Collin I, Cummings JL, Chertkow H. The Montreal Cognitive Assessment, MoCA: a brief screening tool for mild cognitive impairment. J Am Geriatr Soc. 2005 Apr;53(4):695-9. doi: 10.1111/j.1532-5415.2005.53221.x.
- Background: PubMed 22193671Posner K, Brown GK, Stanley B, Brent DA, Yershova KV, Oquendo MA, Currier GW, Melvin GA, Greenhill L, Shen S, Mann JJ. The Columbia-Suicide Severity Rating Scale: initial validity and internal consistency findings from three multisite studies with adolescents and adults. Am J Psychiatry. 2011 Dec;168(12):1266-77. doi: 10.1176/appi.ajp.2011.10111704.
- Results publication: PubMed 12672864Nussbaum RL, Ellis CE. Alzheimer's disease and Parkinson's disease. N Engl J Med. 2003 Apr 3;348(14):1356-64. doi: 10.1056/NEJM2003ra020003. No abstract available.
- Results publication: PubMed 10816186Rascol O, Brooks DJ, Korczyn AD, De Deyn PP, Clarke CE, Lang AE. A five-year study of the incidence of dyskinesia in patients with early Parkinson's disease who were treated with ropinirole or levodopa. N Engl J Med. 2000 May 18;342(20):1484-91. doi: 10.1056/NEJM200005183422004.
- Results publication: PubMed 16941456Schrag A, Banks P. Time of loss of employment in Parkinson's disease. Mov Disord. 2006 Nov;21(11):1839-43. doi: 10.1002/mds.21030.
- Results publication: PubMed 18416667Yamamoto M, Schapira AH. Dopamine agonists in Parkinson's disease. Expert Rev Neurother. 2008 Apr;8(4):671-7. doi: 10.1586/14737175.8.4.671.
- 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.
Matthew Leoni, MD study director
Cerevel Therapeutics, LLC
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CVL-751 in people with Parkinson Disease, run by Cerevel Therapeutics, LLC at 2 sites in United States.
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 34 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 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Single Dose: Peak Plasma Concentration (time frame: Day 1 to 12). The study lists 7 primary outcomes in all. 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 NCT04295642, which also lists 7 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 31 Aug 2021.