SUVN-G3031 for Narcolepsy

Research Centers of America, Miami, FL
SUVN-G3031 +1 morePhase 2Waitlist AvailableResearch Sponsored by Suven Life Sciences Limited

Study Summary

This trial is testing a new drug for narcolepsy with or without cataplexy. They want to see if it's effective and safe compared to placebo.

Eligible Conditions
  • Narcolepsy

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below
You must be between 18 and 65 years old to participate.
Your body weight is within the range of 18 to 45 kg/m2 based on your height.


Screening ~ 1 months
Treatment ~ Varies
Follow Up ~7 days
This trial's timeline: 1 months for screening, Varies for treatment, and 7 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Maintenance of Wakefulness Test (MWT)
Secondary outcome measures
Clinical Global Impression of Severity (CGI-S)
Epworth Sleepiness Scale (ESS)

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: SUVN-G3031 4mgExperimental Treatment1 Intervention
Orally taken once daily for 14 days
Group II: SUVN-G3031 2mgExperimental Treatment1 Intervention
Orally taken once daily for 14 days
Group III: PlaceboPlacebo Group1 Intervention
Orally taken once daily for 14 days
First Studied
Drug Approval Stage
How many patients have taken this drug
Not yet FDA approved

Find a site


Other reimbursement is provided

Other forms of reimbursement are provided for this trial.

Who is running the clinical trial?

Suven Life Sciences LimitedLead Sponsor
10 Previous Clinical Trials
1,211 Total Patients Enrolled
1 Trials studying Narcolepsy

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any remaining opportunities for individuals to join this research endeavor?

"The records on clinicaltrials.gov attest to the fact that this experimental trial is recruiting participants, with initial postings dating back to September 21st 2019 and recent edits made on September 9th 2022."

Answered by AI

Is this a pioneering attempt at research?

"Research on SUVN-G3031 dates back to 2019, when Suven Life Sciences Limited sponsored a trial with 171 participants. After successfully completing its Phase 2 evaluation stage, the drug is now being studied in further detail by the same sponsor via an active clinical study."

Answered by AI

Has the experimental drug SUVN-G3031 been previously subject to clinical testing?

"SUVN-G3031 was first trialled at Research Centers of America in 2019, and has since seen 18,322 concluded clinical trials. Currently there is one active trial being conducted, primarily located near Gainesville, Georgia."

Answered by AI

To what extent are people participating in this research?

"Suven Life Sciences Limited, the trial's sponsor, requires 171 eligible patients to commence. These participants will be recruited from two sites: The Neuro Center in Gainesville and IACT Health in Lawrenceville."

Answered by AI

Are adolescents and young adults being included among the participants of this research?

"The requirements for entry into this medical experiment stipulate that participants must be at least 18 years of age and younger than 65."

Answered by AI

Is it possible for me to register as a participant in this research trial?

"This clinical trial is recruiting 171 participants aged between 18 and 65 that suffer from narcolepsy. Other eligibility requirements include: height, weight, female birth control measures (if applicable), Epworth Sleepiness Scale score of 12 or above, Multiple Wakefulness Test time below 12 minutes, BMI ranging from 18 to 45 kg/m2, negative urine drug screen results and willingness to comply with the study protocol while signing an ICF form."

Answered by AI

In what capacity are the multiple sites administering this clinical trial?

"Patients can enroll in this trial at The Neuro Center located in Gainesville, Georgia as well as IACT Health situated in Lawrenceville, Ohio and the Ohio Sleep Medicine Institute found in Dublin, Minnesota. In total there are 57 other sites available for enrollment."

Answered by AI

Has the drug SUVN-G3031 been sanctioned by the Food and Drug Administration?

"Despite being in Phase 2 of the trial, our team has surmised a safety rating of 2 for SUVN-G3031 due to existing evidence that attests its security yet lacks any efficacy data."

Answered by AI

Who else is applying?

What state do they live in?
New York
How old are they?
18 - 65
What site did they apply to?
Stanford Sleep Medicine Center
Santa Monica Clinical Trials
Helene A. Emsellem, MD PC
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?

Why did patients apply to this trial?

I'm having trouble finding a medication that works for me. I'm in a seemingly endless downward spiral with less and less hope for my existence.

How responsive is this trial?

Typically responds via
Most responsive sites:
  1. Montefiore Medical Center: < 24 hours
  2. Intrepid Research, LLC: < 48 hours
Average response time
  • < 1 Day
~38 spots leftby Sep 2024