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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
Study 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.Check my eligibility
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.See study design
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ from screening up to six weeks of follow-up
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from screening up to six weeks of follow-up
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 moreSecondary outcome measures
Columbia Suicide Severity Rating Scale (C-SSRS)
Dose-adjusted area under the curve (AUC)
Epworth Sleepiness Scale (ESS)
+6 moreSide effects data
From 2018 Phase 4 trial • 40 Patients • NCT0310391915%
Somnolence
15%
Nausea
5%
Abdominal distension
5%
Abdominal discomfort
5%
Vomiting
5%
Feeling abnormal
5%
Muscular weakness
5%
Headache
5%
Dizziness
5%
Binge eating
5%
Fatigue
5%
Dehydration
5%
Renal impairment
5%
Hallucination, visual
5%
Sleep disorder
5%
Dyspnoea
5%
Constipation
5%
Hallucination, auditory
100%
80%
60%
40%
20%
0%
Study treatment Arm
Rotigotine + Standard Care
Rotigotine + Standard Care + Kinesia-360™ Wearable Device
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.
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Who is running the clinical trial?
Serina TherapeuticsLead Sponsor
David G Standaert, MD, PhDPrincipal InvestigatorUniveristy of Alabama-Birmingham School of Medicine, Division of Neurology
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You had a heart attack in the last six months.You have had a stroke or mini-stroke in the past two years.You have a serious disease in an important organ that could significantly shorten your life.Your kidneys are not working well, as shown by a high level of creatinine in your blood.You have moderate or severe liver problems.You have experienced severe mental health issues like seeing or hearing things that aren't there in the past year.People between 40 and 80 years old, regardless of gender.You have been diagnosed with Parkinson's disease according to specific criteria.You are allergic to rotigotine or any ingredients in the study drug.You are taking medication that weakens your immune system or have a weakened immune system.You have Parkinson's disease caused by something other than the usual reasons, like certain medications or other medical conditions.You are currently taking specific medications for Parkinson's disease, but not dopamine agonists.You don't have any major movement problems, as decided by the researcher.You have tried to harm yourself in the past, or have thought about hurting yourself in the last 6 months.Your Mini Mental State Exam score is higher than 26.You have experienced strong reactions to dopamine agonist medications, such as feeling sick, fainting, sleeping too much, or struggling to control urges.You have had cancer, except for a certain type of skin cancer, in the last 10 years, or you have any signs of current cancer.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 3
- Group 2: Cohort 2
- Group 3: Cohort 0
- Group 4: Cohort 1
Awards:
This trial has 3 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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