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GABA Receptor Modulator
SAGE-324 for Essential Tremor
Phase 2 & 3
Recruiting
Research Sponsored by Sage 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 up to approximately 5 years
Awards & highlights
Study Summary
This trial will assess the safety of a new drug for essential tremor, a nervous system disorder that causes involuntary shaking.
Who is the study for?
This trial is for individuals with a confirmed diagnosis of Essential Tremor (ET) who have completed a previous SAGE-324 study without early termination. Participants must limit alcohol and maintain nicotine product consumption levels, be in good health excluding ET, and not use alcohol within 24 hours before clinic visits.Check my eligibility
What is being tested?
The study tests the long-term safety and tolerability of a drug called SAGE-324 in people with Essential Tremor. It aims to understand how well participants can handle the drug over an extended period.See study design
What are the potential side effects?
While specific side effects are not listed here, the trial focuses on identifying any adverse reactions or discomforts that may arise from taking SAGE-324 over time.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Participants With at least One Treatment-Emergent Adverse Events (TEAEs)
Secondary outcome measures
Percentage of Participants With Change from Baseline in Clinical Laboratory Parameters
Percentage of Participants With Change from Baseline in Columbia-Suicide Severity Rating Scale (C-SSRS) Responses
Percentage of Participants With Change from Baseline in Electrocardiogram (ECG) Parameters
+3 moreSide effects data
From 2021 Phase 2 trial • 69 Patients • NCT0430527568%
Somnolence
38%
Dizziness
15%
Fatigue
15%
Balance disorder
12%
Diplopia
12%
Dysarthria
12%
Gait disturbance
9%
Disturbance in attention
9%
Myoclonus
6%
Lethargy
6%
Speech disorder
6%
Mental status changes
6%
Diarrhoea
6%
Paraesthesia
3%
Asthenia
3%
Dehydration
3%
Headache
3%
Transient ischaemic attack
3%
Coordination abnormal
3%
Insomnia
3%
Urinary tract infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
SAGE-324 60 mg
SAGE-324 Matched Placebo
Trial Design
1Treatment groups
Experimental Treatment
Group I: SAGE-324 60 mgExperimental Treatment1 Intervention
Participants will receive SAGE-324 oral tablets from Day 1 to the End of Treatment (EOT) Period at a starting dose of 15 milligrams (mg). The dose will be up titrated in 15 mg increments to 60 mg. In case of intolerable adverse events, the dose will be down titrated in 15 mg decrements.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
SAGE-324
2020
Completed Phase 2
~70
Find a Location
Who is running the clinical trial?
Sage TherapeuticsLead Sponsor
49 Previous Clinical Trials
11,011 Total Patients Enrolled
4 Trials studying Essential Tremor
288 Patients Enrolled for Essential Tremor
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I will not drink alcohol 24 hours before my clinic visits.My doctor confirmed I have essential thrombocythemia.I haven't taken strong medications or certain foods that affect my liver enzymes recently.I cannot stop taking primidone before starting SAGE-324.I have a history of substance abuse or tested positive for drugs, alcohol, or nicotine.I have had cancer (other than minor skin cancer) in the last 3 years or have it now.I have been diagnosed with Essential Tremor by a doctor, without signs of other neurological issues or psychological causes.You are experiencing symptoms of alcohol withdrawal.I am not pregnant, confirmed by a test, and I am not breastfeeding.I experienced a nerve injury or trauma before my tremor started.I am willing to follow guidelines on limiting my alcohol intake.I am allergic to SAGE-324 or its ingredients.
Research Study Groups:
This trial has the following groups:- Group 1: SAGE-324 60 mg
Awards:
This trial has 1 awards, including:- 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.
Essential Tremor Patient Testimony for trial: Trial Name: NCT05366751 — Phase 2 & 3
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any specific qualifications that participants must meet to join this clinical trial?
"This study is seeking 750 patients with familial tremor who are between the ages of 18 and 80. In addition to this, participants must also meet the following criteria: be in good physical health with no clinically significant findings that could impact their ability to participate in the study (as determined by the investigator), have a duration of at least 3 years, absence of other neurological signs such as dystonia, ataxia, parkinsonism, task- and position-specific tremors, sudden tremor onset, or evidence of stepwise deterioration of tremor , Absence of historical or clinical evidence of tremor with psychogenic origin"
Answered by AI
Are there any documented dangers of SAGE-324 for patients?
"SAGE-324 falls into the Phase 2 category, meaning that while there is safety data available, there are no studies yet demonstrating its efficacy. Therefore, it was given a score of 2."
Answered by AI
For this particular research project, are they working with any volunteers who are younger than 65 years old?
"The age limit for this clinical trial is 80 years old, and participants must be of legal age in their jurisdiction."
Answered by AI
Are there any vacant spots in this trial that patients could fill?
"Yes, the information available on clinicaltrials.gov suggests that this research is still recruiting individuals. This specific trial was originally posted on June 13th, 2022 and updated as recently as July 13th, 2022. The study needs to recruit 750 people total from 1 location."
Answered by AI
Who else is applying?
What state do they live in?
Texas
California
Florida
What site did they apply to?
Sage Investigational Site
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
2
3+
0
Why did patients apply to this trial?
Tried other drugs with little success. I need to get my essential tremor fixed.
PatientReceived 2+ prior treatments
Essential tremor is interfering with music and art activities. I have recently been diagnosed with essential tremors and want to investigate.
PatientReceived 1 prior treatment
I've begun a weight loss/active exercise program and the tremor has gotten worse.
PatientReceived 1 prior treatment
What questions have other patients asked about this trial?
How long is the study? How long is the study, how often will I need to go/stay in Spokane?
PatientReceived 1 prior treatment
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