Your session is about to expire
← Back to Search
SER-214 Injections for Parkinson's Disease
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.
Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2018 Phase 4 trial • 40 Patients • NCT03103919Trial Design
Find a Location
Who is running the clinical trial?
Media Library
- 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.
- Group 1: Cohort 0
- Group 2: Cohort 2
- Group 3: Cohort 3
- Group 4: Cohort 1
- 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.
- 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.
Frequently Asked Questions
Have any other experiments been conducted using SER-214?
"SER-214 was first tested in 2016 at MD Clinical, and since then 66 trials have concluded. Currently, there are four ongoing studies occurring primarily from Birmingham, Alabama."
Are there still opportunities for patients to join this research endeavor?
"This research initiative is no longer recruiting individuals. Initially posted on the 1st of January 2016, and last updated 24th October 2022, this medical trial has been concluded. However, there are still 484 studies looking for people with Parkinson's disease and 4 trials targeting SER-214 that require participants."
What are the primary objectives of this clinical experiment?
"According to the sponsor of this trial, Serina Therapeutics, safety (vital signs) will be monitored as the primary outcome over a period extending up to 6 weeks after initial administration of SER-214. This study will also measure secondary outcomes such as fluctuation index derived from PK samples taken at multiple times post injection and questionnaires for impulsive-compulsive disorders in [Parkinson's disease](https://www.withpower.com/clinical-trials/parkinson's-disease) (QUIP). Lastly, Unified Parkinson's Disease Rating Scale (UPDRS) scores will be determined across each visit and Final Safety Visit."
Is this exploration of a new treatment novel in its approach?
"Since its initial testing in 2016, SER-214 has seen a steady progression of clinical trials. Initially the drug was approved for Phase 1 after being tested on 20 participants; furthermore, there are presently 4 active studies happening across five cities and two countries."
Is this clinical trial inclusive of individuals aged 70 and above?
"The study is seeking participants between the ages of 40 and 80, but there are alternative trials available for minors or seniors. Specifically, 29 studies exist to cater towards patients aged 18 and below while 483 medical experiments focus on individuals above 65 years old."
Is it possible for me to enroll in this clinical research?
"Candidates eligible for inclusion in this trial must have Parkinson's disease and aged between 40 to 80. The study is currently looking to recruit 20 participants."
Has SER-214 been given a stamp of approval by the FDA?
"Our experts rate SER-214's safety as a 1 due to its Phase 1 status, indicating that this drug is still in the process of being tested for both efficacy and safety."
What is the maximum capacity of participants for this clinical trial?
"This investigation is no longer accepting applicants. Initially posted on 1/1/2016 and most recently modified 10/24/2022, this trial has now closed. If you are searching for other studies related to Parkinson's disease, there are presently 484 options open while 4 research projects require participants for SER-214 testing."
Are any Canadian healthcare facilities investigating this research project?
"The 4 sites running this research are located in Birmingham, Augusta, Durham and other cities. It is beneficial to opt for the closest site to reduce movability demands when participating in the study."
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger