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Dopamine Agonist

SER-214 Injections for Parkinson's Disease

Phase 1
Waitlist Available
Led By David G Standaert, MD, PhD
Research Sponsored by Serina Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up on injection days plasma samples will be taken at time 0, 1, 2, 4 and 8 hours
Awards & highlights
All Individual Drugs Already Approved
Approved for 5 Other Conditions
No Placebo-Only Group

Summary

This trial will test a drug (SER-214) that may help treat Parkinson's, administered via syringe to assess safety & effect in people with early, stable or untreated PD.

Who is the study for?
This trial is for adults aged 40-80 with early, stable or untreated Parkinson's disease who can handle weekly injections and follow-up visits. They must not have used dopamine agonists recently but may be on other Parkinson's medications. Women of childbearing age need to use contraception and test negative for pregnancy.
What is being tested?
SER-214, a new form of rotigotine (a drug that acts like dopamine in the brain), given as a weekly subcutaneous injection, is being tested for safety and how it's processed by the body in people with Parkinson’s Disease.
What are the potential side effects?
Potential side effects include reactions at the injection site, nausea/vomiting, low blood pressure when standing up, excessive sleepiness or impulse control disorders due to sensitivity to dopamine agonists.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from screening up to six weeks of follow-up
This trial's timeline: 3 weeks for screening, Varies for treatment, and from screening up to six weeks of follow-up for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percentage of patients in each cohort who discontinued therapy due to any adverse events {Tolerability}
Safety - Abnormal Laboratory Results
Safety - Adverse Events and Serious Adverse Events
+3 more
Secondary study objectives
Columbia Suicide Severity Rating Scale (C-SSRS)
Dose-adjusted area under the curve (AUC)
Epworth Sleepiness Scale (ESS)
+6 more

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups
Experimental Treatment
Group I: Cohort 3Experimental Treatment1 Intervention
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.
Group II: Cohort 2Experimental Treatment1 Intervention
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.
Group III: Cohort 1Experimental Treatment1 Intervention
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.
Group IV: Cohort 0Experimental Treatment1 Intervention
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.

Find a Location

Who is running the clinical trial?

Serina TherapeuticsLead Sponsor
David G Standaert, MD, PhDPrincipal InvestigatorUniveristy of Alabama-Birmingham School of Medicine, Division of Neurology

Media Library

SER-214 (Dopamine Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT02579473 — Phase 1
Parkinson's Disease Research Study Groups: Cohort 2, Cohort 3, Cohort 0, Cohort 1
Parkinson's Disease Clinical Trial 2023: SER-214 Highlights & Side Effects. Trial Name: NCT02579473 — Phase 1
SER-214 (Dopamine Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02579473 — Phase 1
~2 spots leftby Nov 2025