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Central Nervous System Stimulant

Amphetamine-Dextroamphetamine for Idiopathic Hypersomnia

Phase 2
Waitlist Available
Led By Lynn Marie Trotti, MD, MSc
Research Sponsored by Emory University
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 weeks 4, 8, 12
Awards & highlights

Study Summary

This trial will compare modafinil and amphetamine salts to see which is better for treating excessive daytime sleepiness.

Eligible Conditions
  • Idiopathic Hypersomnia
  • Narcolepsy

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weeks 4, 8, 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and weeks 4, 8, 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Epworth Sleepiness Scale (ESS) Score
Secondary outcome measures
Change in Hypersomnia Severity Index (HSI) from Baseline
Impaired cognition
Change in Patient Global Impression of Change (PGIc) for Overall Disease Severity Score
+3 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Amphetamine-dextroamphetamineExperimental Treatment1 Intervention
Participants in this study arm will take amphetamine-dextroamphetamine (amphetamine salts).
Group II: ModafinilActive Control1 Intervention
Participants in this study arm will take modafinil.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Amphetamine-Dextroamphetamine
2019
Completed Phase 2
~50

Find a Location

Who is running the clinical trial?

Emory UniversityLead Sponsor
1,639 Previous Clinical Trials
2,560,602 Total Patients Enrolled
1 Trials studying Idiopathic Hypersomnia
92 Patients Enrolled for Idiopathic Hypersomnia
American Academy of Sleep MedicineOTHER
22 Previous Clinical Trials
2,594 Total Patients Enrolled
1 Trials studying Idiopathic Hypersomnia
45 Patients Enrolled for Idiopathic Hypersomnia
Lynn Marie Trotti, MD, MSc4.29 ReviewsPrincipal Investigator - Emory University
Emory University
1 Previous Clinical Trials
92 Total Patients Enrolled
1 Trials studying Idiopathic Hypersomnia
92 Patients Enrolled for Idiopathic Hypersomnia
5Patient Review
This doctor is extremely knowledgeable about sleep disorders, easy to communicate with, and she really allows the patient to be an active participant in their care.

Frequently Asked Questions

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

Have researchers conducted prior investigations with Amphetamine-Dextroamphetamine?

"Currently, 11 clinical trials on Amphetamine-Dextroamphetamine are in progress with two of them reaching Phase 3. Seattle, Washington is one of the 51 locations conducting this research and development."

Answered by AI

Is it possible for me to join this experiment?

"This medical trial is enrolling 44 individuals between 18 and 65 years old who have been diagnosed with idiopathic hypersomnia. In addition to this, they must be medically approved for the study after a consent process has taken place."

Answered by AI

Does this medical study include individuals older than twenty-five?

"Applicable patients need to be within the ages of 18 and 65 in order to qualify for this trial. Additionally, there are other 11 trials open to those younger and 21 studies opened up to seniors."

Answered by AI

Is recruitment ongoing for this clinical trial?

"Affirmative. Data accessible on clinicaltrials.gov validates that this research trial, posted originally on April 15th 2019, is currently recruiting participants. The study requires 44 patients to be recruited from a single site."

Answered by AI

What are the traditional applications of Amphetamine-Dextroamphetamine?

"Amphetamine-Dextroamphetamine is mainly prescribed to combat fatigue, but also benefits those with multiple sclerosis and chronic pain symptoms, as well as obstructive sleep apnea (OSA) sufferers."

Answered by AI

Is Amphetamine-Dextroamphetamine an innocuous treatment for individuals?

"Amphetamine-Dextroamphetamine was given a score of 2 on the safety scale, since this is currently in Phase 2 trials and there are existing data points supporting its relative safety but no evidence yet for efficacy."

Answered by AI

What is the total number of participants in this clinical research endeavor?

"Affirmative. According to information found on clinicaltrials.gov, this trial is still open and recruiting individuals. The study was initially posted in mid-April of 2019 but has since been updated as recently as July 13th 2022. Altogether, 44 patients are needed for the single site enrolling participants in this experiment."

Answered by AI

Who else is applying?

What state do they live in?
Nevada
New York
Pennsylvania
How old are they?
18 - 65
What site did they apply to?
Emory Sleep Center
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Modafinil Versus Amphetamines for the Treatment of Narcolepsy Type 2 and Idiopathic Hypersomnia
Lynn Marie Trotti 2019. "Modafinil Versus Amphetamines for the Treatment of Narcolepsy Type 2 and Idiopathic Hypersomnia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03772314.
~7 spots leftby Apr 2025
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