Parkinson's DiseasePhase 1NCT02579473
A Study of Weekly Subcutaneous Injections of SER-214 in Subjects With Parkinson's Disease (PD), to Determine the Safety, Tolerability and Pharmacokinetic (PK) Profile of SER-214
A Phase 1 study testing SER-214 in people with Parkinson's Disease, run by Serina Therapeutics at 4 sites in United States.
Trial summary
SER-214 is a poly (2-ethyl-2oxazoline)(POZ) polymer conjugate of rotigotine, a potent dopamine agonist that has high affinity for the subclass of dopamine receptors in the brain that mediate dopamine signaling. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- SER-214
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 4 sitesUnited States
- Study dates
- Jan 2016to 31 Dec 2023
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female or male subjects 40-80 years of age inclusive
- A diagnosis of idiopathic Parkinson's disease (PD) consistent with UK brain bank criteria
- De novo PD patients and those on a stable regimen of anti-Parkinson's drugs for at least 4weeks prior to screening including anticholingerics, amantadine, MAO-B inhibitors, COMT inhibitors or levodopa, but not dopamine agonists
- Free of clinically significant motor complications as determined by the investigator
- Ability to complete up to four weeks of dosing once per week with two weeks of terminal "wash-out" PK
- Ability to return to the clinic for blood sampling, clinical and laboratory assessment on scheduled days, based upon cohort
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- Mini Mental State Exam (MMSE) > 26
- Women of child-bearing potential (WOCBP) must use a reliable method of contraception (e.g., oral contraceptive or long-term injectable or implantable hormonal contraceptive, double-barrier methods [such as condom plus diaphragm, condom plus spermicidal foam, condom plus sponge], or intra-uterine devices), and must have a negative serum pregnancy test at Screening and negative urine pregnancy test at baseline
- Willing and able to comply with the study requirements including follow-up
- Provide written informed consent
- Cognitively intact sufficient to understand and provide informed consent
- Approved by a central Eligibility Monitoring Committee (EMC) confirmed by EMC signature on the Enrollment Authorization Form (EAF)
Who cannot join
- Subject has previously participated in this study.
- Myocardial infarction within the past six months from screening
- Ischemic stroke or transient ischemic event within the past two years from screening
- Known sensitivity to dopamine agonists including nausea/vomiting, orthostatic hypotension, excessive sleep or impulse control disorder
- Any major organ disease that substantially impairs life expectancy
- History of cancer, other than basal cell carcinoma, within the past 10 years or subjects with any laboratory or physical exam or diagnostic procedure finding suggestive of current malignancy
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- Subjects who are known to be immunosuppressed or are receiving chronic treatment with immunosuppressive drugs
- Subject with an atypical or secondary Parkinsonian (e.g., due to drugs, metabolic neurogenetic disorders, encephalitis, cerebrovascular disease or degenerative disease)
- Any clinically significant medical, surgical, or psychiatric condition, laboratory value, or concomitant medication which, in the opinion of the Investigator, makes the subject unsuitable for study entry or potentially unable to complete all aspects of the study.
- Subject has moderate renal impairment (creatine > 2.5)
- Subject has moderate (Child-Pugh categorization B, score 7-9) or severe (Child-Pugh categorization C, score 10-15) hepatic impairment.
- Subject has a lifetime history of suicide attempt (including an active attempt, interrupted attempt or aborted attempt), or has suicidal ideation in the past 6 months as indicated by a positive response ('Yes') to either Question 4 or Question 5 of the Columbia-Suicide Severity Rating Scale (CSSRS) at Screening
- Subject has known hypersensitivity to rotigotine or to any components or excipients of the study drug
- Subject has a history of psychosis or hallucinations within the previous 12 months
- Subject has received an investigational drug within 30 days of screening or is currently participating in an investigational drug or investigational device trial
- Subject, who, for any reason, is judged by the Investigator to be inappropriate for this study, including a subject who is unable to communicate or cooperate with the Investigator or who has/had a clinically significant illness or abnormal physical examination that may compromise safety of the subject during the trial or affect ability of the subject to adhere to study procedures
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Georgia Regents University
Augusta, Georgia, 30912
University of Alabama Birmingham
Birmingham, Alabama, 35233
Duke University Medical Center
Durham, North Carolina, 27710
MD Clinical
Hallandale, Florida, 33009
About this study
Official title: A Multi-center, Open-label, Multiple Ascending Dosage-ranging Cohort (MAD) Study in Early, Untreated or Stably Treated Subjects With Parkinson's Disease (PD), to Determine the Safety, Tolerability and Pharmacokinetics (PK) of Injections of SER-214 Administered Subcutaneously Once a Week for Two Weeks After 0-2 Weeks of Dose Titration
SER-214 is a poly (2-ethyl-2oxazoline)(POZ) polymer conjugate of rotigotine, a potent dopamine agonist that has high affinity for the subclass of dopamine receptors in the brain that mediate dopamine signaling. SER-214 will be administered subcutaneously once a week via a standard 1 mL insulin syringe to determine the safety, tolerability and pharmacokinetic (PK) profile of released rotigotine and POZ-conjugate. Subjects in this study are eligible if they have early, stable or untreated Parkinson's disease and are still experiencing motor fluctuations.
Read the detailed description
Clinical evidence suggests that dopamine agonists should be considered as an initial or early symptomatic therapy for PD. Current information indicates that the early use of long-acting dopaminergic agonists may protect against the development of motor complications by stimulating dopamine receptors in a non-pulsatile manner and by delaying the introduction of levodopa. In pre-clinical primate studies, L-dopa (short-acting, pulsatile) and dopaminergic agonists (long-acting; non pulsatile) provide comparable clinical benefit but with agonists inducing significantly less dyskinesia.
Chronic L-dopa treated animals develop gene changes that are associated with abnormal neuronal firing patterns and dyskinesias which are not seen with long-acting dopamine agonists. Based on pre-clinical and clinical study results, treatment of Parkinson's patients with long-acting levodopa or dopamine agonists should provide symptomatic benefit, and significantly delay the onset of motor complications. This can be accomplished with duodopa or continuous sc apomorphine but these treatments are associated with significant side effects. To date, no practical method of providing continuous drug delivery using a dopaminergic agent for therapy of patients with early PD to prevent the development of motor complications has been advanced through clinical trials.
SER-214 is being developed as a weekly sc injection that provides prompt onset of dopaminergic stimulation. Continuous levels of released rotigotine within the therapeutic window for relief of motor fluctuations have been observed in MPTP-treated cynomolgus macaques. PK determinations in normal monkeys for up to 13 weeks of treatment show that weekly injections of SER-214 provide continuous drug delivery of released plasma rotigotine within a predictable therapeutic range.
- Conditions
- Parkinson's Disease
- Being tested
- SER-214
- Keywords
- Continuous dopaminergic stimulation
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SER-214Drug
Also called POZ-rotigotine
SER-214 is a poly(2-ethyl-oxazoline) (POZ) polymer conjugate of the potent dopamine agonist rotigotine that is designed to provide continuous drug delivery following a single weekly injection
| Study group | Role | What they receive |
|---|---|---|
| Cohort 0 | Experimental | Subjects in Cohort 0 will receive a single subcutaneous injection of 20 mg SER-214, followed by a two week wash-out period, to determine safety, tolerability and PK and terminal "wash-out" of rotigotine and pro-drug SER-214. Receives: Drug: SER-214 |
| Cohort 1 | Experimental | Subjects in Cohort 1 will receive a single SC injection of 50 mg SER-214 at the beginning of each week for two consecutive weeks, followed by a two week wash-out period, to determine safety, tolerability and PK and terminal "wash-out" of rotigotine and pro-drug SER-214. Receives: Drug: SER-214 |
| Cohort 2 | Experimental | Subjects in Cohort 2 will receive a single SC injection of 50 mg SER-214 at the beginning of week one, followed by a weekly SC injection of 100 mg SER-214 for two consecutive weeks, followed by a two week wash-out period, to determine safety, tolerability and PK and terminal "wash-out" of rotigotine and pro-drug SER-214. Receives: Drug: SER-214 |
| Cohort 3 | Experimental | Subjects in Cohort 3 will receive a single SC injection of 50 mg SER-214 at the beginning of week one, followed by a single SC injection of 100 mg SER-214 at the beginning of week two, followed by a single SC injection of 200 mg SER-214 for two consecutive weeks, followed by a two week wash-out period, to determine PK and terminal "wash-out" PK of rotigotine and pro-drug SER-214. Receives: Drug: SER-214 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety - Adverse Events and Serious Adverse Events
Change from Screening in frequency of adverse events (AEs) and serious adverse events (SAEs) at the Final Safety Visit
Measured: From initial sc dose of SER-214 up to six weeks of follow-up
Percentage of patients in each cohort who discontinued therapy due to any adverse events {Tolerability}
Percentage of patients in each cohort who discontinued therapy due to any adverse events will be used as an assessment of tolerability
Measured: From initial sc dose of SER-214 up to six weeks of follow-up
Safety - Vital Signs
Change from Screening in assessment of vital signs (pulse, blood pressure) at each study visit and Final Safety Visit
Measured: From initial sc dose of SER-214 up to six weeks of follow-up
Safety - Abnormal Laboratory Results
Change from Screening in number of participants with laboratory test values of potential clinical importance
Measured: From initial sc dose of SER-214 up to six weeks of follow-up
Safety - Treatment-Emergent Adverse Events
Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Relatedness to [study drug] will be assessed by the investigator (Yes/No).
Measured: From initial sc dose of SER-214 up to six weeks of follow-up
Safety - ECG Changes
Change from Screening in assessment of electrocardiogram (ECG) parameters at each injection visit
Measured: From initial sc dose of SER-214 up to six weeks of follow-up
Secondary outcomes (9)
Fluctuation index
On injection days plasma samples will be taken at time 0 (baseline), 1, 2, 4 and 8 hours post injection. PK samples will be used to determine (a) released plasma rotigotine and (b) total SER-214. PK data will be used to determine the Fluctuation Index
Measured: On injection days plasma samples will be taken at time 0, 1, 2, 4 and 8 hours
Maximum plasma concentration [C(max)]
PK samples will be used to determine (a) released plasma rotigotine and (b) total SER-214. PK data will be used to determine the C(max)
Measured: On injection days plasma samples will be taken at time 0, 1, 2, 4 and 8 hours
Time to maximum concentration [T(max)]
PK samples will be used to determine (a) released plasma rotigotine and (b) total SER-214. PK data will be used to determine the T(max)
Measured: On injection days plasma samples will be taken at time 0, 1, 2, 4 and 8 hours
Dose-adjusted area under the curve (AUC)
PK samples will be used to determine (a) released plasma rotigotine and (b) total SER-214. PK data will be used to determine the dose-adjusted AUC
Measured: On injection days plasma samples will be taken at time 0, 1, 2, 4 and 8 hours
Unified Parkinson's Disease Rating Scale
The UPDRS total (Parts I, II and III) will be determined at each study site visit and the Final Safety Visit
Measured: From Screening up to six weeks of follow-up
Unified Parkinson's Disease Rating Scale - Motor Part III Only
The Motor UPDRS (Part III) will be determined as a separate outcome measure at each injection day visit
Measured: From Screening up to six weeks of follow-up
Epworth Sleepiness Scale (ESS)
The ESS will be determined at Screening, first Follow-up visit, Final Safety Visit and any unscheduled visit to determine if escalating doses of SER-214 are associated with increase in somnolence
Measured: From Screening up to six weeks of follow-up
Columbia Suicide Severity Rating Scale (C-SSRS)
The C-SSRS will be determined at Screening and Final Safety Visit and any unscheduled visit. C-SSRS assessed whether participant experienced following: completed suicide (1), suicide attempt (2) (response of "Yes" on "actual attempt"), preparatory acts toward imminent suicidal behavior (3)("Yes" on "preparatory acts or behavior"), suicidal ideation (4) ("Yes" on "wish to be dead", "non-specific active suicidal thoughts", "active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent), any suicidal behavior or ideation, self-injurious behavior (7)("Yes" on "Has subject engaged in non-suicidal self-injurious behavior").
Measured: From Screening up to six weeks of follow-up
Questionnaire for Impulsive-Compulsive Disorders in Parkinson's disease (QUIP)
The QUIP will be assessed at Screening and on the Final Safety Visit and any unscheduled visit to determine if there is any association between Impulsive-Compulsive behavior and SER-214 dose
Measured: From screening up to six weeks of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2015 (estimated)
- Study startJan 2016
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Serina Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David G Standaert, MD, PhD, Principal investigator, Univeristy of Alabama-Birmingham School of Medicine, Division of Neurology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02579473
- Sponsor's protocol ID
- SER-214 Ia
- Status last verified
- Oct 2022
- First submitted
- 13 Oct 2015
- Last updated
- 11 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Eskow Jaunarajs KL, Standaert DG, Viegas TX, Bentley MD, Fang Z, Dizman B, Yoon K, Weimer R, Ravenscroft P, Johnston TH, Hill MP, Brotchie JM, Moreadith RW. Rotigotine polyoxazoline conjugate SER-214 provides robust and sustained antiparkinsonian benefit. Mov Disord. 2013 Oct;28(12):1675-82. doi: 10.1002/mds.25625. Epub 2013 Sep 3.
PubMed 24014074
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Open-label, Multiple Ascending Dosage-ranging Cohort (MAD) Study in Early, Untreated or Stably Treated Subjects With Parkinson's Disease (PD), to Determine the Safety, Tolerability and Pharmacokinetics (PK) of Injections of SER-214 Administered Subcutaneously Once a Week for Two Weeks After 0-2 Weeks of Dose Titration
- ClinicalTrials.gov ID
- NCT02579473
- Acronym / sponsor ID
- SER-214 Ia
- Conditions
- Parkinson's Disease
- Keywords
- Continuous dopaminergic stimulation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Serina TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Jan 2016 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 19 Oct 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.
SER-214 is a poly (2-ethyl-2oxazoline)(POZ) polymer conjugate of rotigotine, a potent dopamine agonist that has high affinity for the subclass of dopamine receptors in the brain that mediate dopamine signaling. SER-214 will be administered subcutaneously once a week via a standard 1 mL insulin syringe to determine the safety, tolerability and pharmacokinetic (PK) profile of released rotigotine and POZ-conjugate. Subjects in this study are eligible if they have early, stable or untreated Parkinson's disease and are still experiencing motor fluctuations.
Detailed description
Clinical evidence suggests that dopamine agonists should be considered as an initial or early symptomatic therapy for PD. Current information indicates that the early use of long-acting dopaminergic agonists may protect against the development of motor complications by stimulating dopamine receptors in a non-pulsatile manner and by delaying the introduction of levodopa. In pre-clinical primate studies, L-dopa (short-acting, pulsatile) and dopaminergic agonists (long-acting; non pulsatile) provide comparable clinical benefit but with agonists inducing significantly less dyskinesia.
Chronic L-dopa treated animals develop gene changes that are associated with abnormal neuronal firing patterns and dyskinesias which are not seen with long-acting dopamine agonists. Based on pre-clinical and clinical study results, treatment of Parkinson's patients with long-acting levodopa or dopamine agonists should provide symptomatic benefit, and significantly delay the onset of motor complications. This can be accomplished with duodopa or continuous sc apomorphine but these treatments are associated with significant side effects. To date, no practical method of providing continuous drug delivery using a dopaminergic agent for therapy of patients with early PD to prevent the development of motor complications has been advanced through clinical trials.
SER-214 is being developed as a weekly sc injection that provides prompt onset of dopaminergic stimulation. Continuous levels of released rotigotine within the therapeutic window for relief of motor fluctuations have been observed in MPTP-treated cynomolgus macaques. PK determinations in normal monkeys for up to 13 weeks of treatment show that weekly injections of SER-214 provide continuous drug delivery of released plasma rotigotine within a predictable therapeutic range.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 0 | Experimental | Drug: SER-214Subjects in Cohort 0 will receive a single subcutaneous injection of 20 mg SER-214, followed by a two week wash-out period, to determine safety, tolerability and PK and terminal "wash-out" of rotigotine and pro-drug SER-214. |
| Cohort 1 | Experimental | Drug: SER-214Subjects in Cohort 1 will receive a single SC injection of 50 mg SER-214 at the beginning of each week for two consecutive weeks, followed by a two week wash-out period, to determine safety, tolerability and PK and terminal "wash-out" of rotigotine and pro-drug SER-214. |
| Cohort 2 | Experimental | Drug: SER-214Subjects in Cohort 2 will receive a single SC injection of 50 mg SER-214 at the beginning of week one, followed by a weekly SC injection of 100 mg SER-214 for two consecutive weeks, followed by a two week wash-out period, to determine safety, tolerability and PK and terminal "wash-out" of rotigotine and pro-drug SER-214. |
| Cohort 3 | Experimental | Drug: SER-214Subjects in Cohort 3 will receive a single SC injection of 50 mg SER-214 at the beginning of week one, followed by a single SC injection of 100 mg SER-214 at the beginning of week two, followed by a single SC injection of 200 mg SER-214 for two consecutive weeks, followed by a two week wash-out period, to determine PK and terminal "wash-out" PK of rotigotine and pro-drug SER-214. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Female or male subjects 40-80 years of age inclusive
- A diagnosis of idiopathic Parkinson's disease (PD) consistent with UK brain bank criteria
- De novo PD patients and those on a stable regimen of anti-Parkinson's drugs for at least 4weeks prior to screening including anticholingerics, amantadine, MAO-B inhibitors, COMT inhibitors or levodopa, but not dopamine agonists
- Free of clinically significant motor complications as determined by the investigator
- Ability to complete up to four weeks of dosing once per week with two weeks of terminal "wash-out" PK
Key exclusion criteria (16 listed)
- Subject has previously participated in this study.
- Myocardial infarction within the past six months from screening
- Ischemic stroke or transient ischemic event within the past two years from screening
- Known sensitivity to dopamine agonists including nausea/vomiting, orthostatic hypotension, excessive sleep or impulse control disorder
- Any major organ disease that substantially impairs life expectancy
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 |
|---|---|---|
| SER-214Also: POZ-rotigotineSER-214 is a poly(2-ethyl-oxazoline) (POZ) polymer conjugate of the potent dopamine agonist rotigotine that is designed to provide continuous drug delivery following a single weekly injection | Drug | Cohort 0, Cohort 1, Cohort 2, Cohort 3 |
Primary outcome
Safety - Adverse Events and Serious Adverse Events
Time frame: From initial sc dose of SER-214 up to six weeks of follow-up
Change from Screening in frequency of adverse events (AEs) and serious adverse events (SAEs) at the Final Safety Visit
Percentage of patients in each cohort who discontinued therapy due to any adverse events {Tolerability}
Time frame: From initial sc dose of SER-214 up to six weeks of follow-up
Percentage of patients in each cohort who discontinued therapy due to any adverse events will be used as an assessment of tolerability
Safety - Vital Signs
Time frame: From initial sc dose of SER-214 up to six weeks of follow-up
Change from Screening in assessment of vital signs (pulse, blood pressure) at each study visit and Final Safety Visit
Safety - Abnormal Laboratory Results
Time frame: From initial sc dose of SER-214 up to six weeks of follow-up
Change from Screening in number of participants with laboratory test values of potential clinical importance
Safety - Treatment-Emergent Adverse Events
Time frame: From initial sc dose of SER-214 up to six weeks of follow-up
Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Relatedness to [study drug] will be assessed by the investigator (Yes/No).
Safety - ECG Changes
Time frame: From initial sc dose of SER-214 up to six weeks of follow-up
Change from Screening in assessment of electrocardiogram (ECG) parameters at each injection visit
9 secondary outcomes
Fluctuation index
Time frame: On injection days plasma samples will be taken at time 0, 1, 2, 4 and 8 hours
Maximum plasma concentration [C(max)]
Time frame: On injection days plasma samples will be taken at time 0, 1, 2, 4 and 8 hours
Time to maximum concentration [T(max)]
Time frame: On injection days plasma samples will be taken at time 0, 1, 2, 4 and 8 hours
Dose-adjusted area under the curve (AUC)
Time frame: On injection days plasma samples will be taken at time 0, 1, 2, 4 and 8 hours
Unified Parkinson's Disease Rating Scale
Time frame: From Screening up to six weeks of follow-up
Unified Parkinson's Disease Rating Scale - Motor Part III Only
Time frame: From Screening up to six weeks of follow-up
Epworth Sleepiness Scale (ESS)
Time frame: From Screening up to six weeks of follow-up
Columbia Suicide Severity Rating Scale (C-SSRS)
Time frame: From Screening up to six weeks of follow-up
Questionnaire for Impulsive-Compulsive Disorders in Parkinson's disease (QUIP)
Time frame: From screening up to six weeks of follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2023.
- Background: PubMed 24014074Eskow Jaunarajs KL, Standaert DG, Viegas TX, Bentley MD, Fang Z, Dizman B, Yoon K, Weimer R, Ravenscroft P, Johnston TH, Hill MP, Brotchie JM, Moreadith RW. Rotigotine polyoxazoline conjugate SER-214 provides robust and sustained antiparkinsonian benefit. Mov Disord. 2013 Oct;28(12):1675-82. doi: 10.1002/mds.25625. Epub 2013 Sep 3.
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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.
David G Standaert, MD, PhD principal investigator
Univeristy of Alabama-Birmingham School of Medicine, Division of Neurology
4 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 SER-214 in people with Parkinson's Disease, run by Serina Therapeutics at 4 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 12 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 11 Apr 2023. 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 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. 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?
Results are not available in the source record.
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?
Safety - Adverse Events and Serious Adverse Events (time frame: From initial sc dose of SER-214 up to six weeks of follow-up). The study lists 6 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 NCT02579473, which also lists 1 linked publication.
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 11 Apr 2023.