Modafinil Versus Amphetamines for the Treatment of Narcolepsy Type 2 and Idiopathic Hypersomnia

NCT03772314 | Completed Phase 2 Results FDA Drug

• 1 other identifier: IRB00108167
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

For diseases that cause excessive daytime sleepiness (such as narcolepsy and idiopathic hypersomnia), there are several medications that can be used to treat sleepiness. However, it can be difficult to decide which medication to use for a particular individual for several reasons: 1) there are very few studies that directly compare two medications to see which works best; 2) there are very few studies that include people with a disorder of sleepiness called idiopathic hypersomnia. To address this gap in knowledge, the researchers propose a randomized clinical trial comparing modafinil and amphetamine salts in patients with narcolepsy type 2 or idiopathic hypersomnia. All participants will either receive modafinil or amphetamine salts - no participant will receive placebo. This study will evaluate which medication works better to improve sleepiness. The researchers will also see which medication is better for other symptoms including difficulty waking up and difficulty thinking, as well as seeing which medication causes fewer side effects. Finally, this study will see if any information about patients (such as age or sleep study features) predicts responding better to one medication or the other.

Conditions

Idiopathic Hypersomnia; Narcolepsy Without Cataplexy

Outcome Measures

Primary Outcomes (1)

• Change in Epworth Sleepiness Scale (ESS) Score

  The Epworth Sleepiness Scale (ESS) asks respondents to indicate how likely they are to doze off or fall asleep during daytime situations such as reading or talking to someone. There are 8 items which are answered on a scale of 0 to 4 where 0 = would never doze and 4 = high chance of dozing. Total score can range from 0 to 24, with higher scores indicating more sleepiness. A score of 0 to 5 can be interpreted as "lower normal daytime sleepiness", a score of 6 to 10 is "higher normal daytime sleepiness", score between 11 to 12 are "mild excessive daytime sleepiness, scores of 13 to 15 are "moderate excessive daytime sleepiness" and scores of 16 to 24 indicate "severe excessive daytime sleepiness". The change in ESS score is obtained by subtracting the total score at week 12 from the baseline score. Scores above 0 mean that the mean score at Week 12 was lower than the mean score at Baseline, indicating less sleepiness.

  Baseline, Week 12

Secondary Outcomes (10)

• Number of Participants Reporting Any Improvement by Patient Global Impression of Change (PGIC) for Overall Disease Severity Score

  Week 12

• Number of Participants Reporting Much or Very Much Improvement by Patient Global Impression of Change (PGIC) for Overall Disease Severity Score

  Week 12

• Number of Participants Reporting Any Improvement From Baseline on Patient Global Impression of Change (PGIC) for Sleepiness Score

  Week 12

• Number of Participants Reporting Much or Very Much Improvement From Baseline on Patient Global Impression of Change (PGIC) for Sleepiness Score

  Week 12

• Number of Participants Reporting Any Improvement With Patient Global Impression of Change (PGIC) for Cognitive Dysfunction Score

  Week 12

Study Arms (2)

Modafinil

ACTIVE COMPARATOR

Participants in this study arm will take modafinil.

Drug: Modafinil

Amphetamine-dextroamphetamine

EXPERIMENTAL

Participants in this study arm will take amphetamine-dextroamphetamine (amphetamine salts).

Drug: Amphetamine-Dextroamphetamine

Interventions

Modafinil DRUG

Participants will received 100-400 milligrams (mg) per day of modafinil for 12 weeks.

Also known as: Provigil

Modafinil

Amphetamine-Dextroamphetamine DRUG

Participants will receive 10-40 mg/day of oral amphetamine salts for 12 weeks.

Also known as: Adderall

Amphetamine-dextroamphetamine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• narcolepsy type 2 or idiopathic hypersomnia
• ability to give informed consent

You may not qualify if:

• contraindication to modafinil or amphetamine salts (history of left ventricular hypertrophy, mitral valve prolapse, other cardiac structural abnormalities, severe cardiovascular disease, unstable angina, myocardial infarction, cardiomyopathy, severe arrhythmias, uncontrolled hypertension, severe hepatic impairment, substance abuse history, psychosis, glaucoma, Tourette's syndrome, and epilepsy)
• obstructive sleep apnea (Apnea-Hypopnea Index (AHI) \> 15)
• severe periodic limb movements of sleep with arousals (periodic limb movements (PLM) arousal index \> 30)
• allergy to either of the study drugs
• pregnancy or breastfeeding

Sponsors & Collaborators

• Emory University: lead
• American Academy of Sleep Medicine: collaborator

Study Sites (1)

Emory Sleep Center

Atlanta, Georgia, 30329, United States

Location

Related Publications (1)

• Trotti LM, Blake T, Hoque R, Rye DB, Sharma S, Bliwise DL. Modafinil Versus Amphetamine-Dextroamphetamine For Idiopathic Hypersomnia and Narcolepsy Type 2: A Randomized, Blinded, Non-inferiority Trial. CNS Drugs. 2024 Nov;38(11):909-920. doi: 10.1007/s40263-024-01122-y. Epub 2024 Sep 21.

  PMID: 39306601 DERIVED

MeSH Terms

Conditions

Idiopathic Hypersomnia

Interventions

Modafinil; SLI381; Adderall

Condition Hierarchy (Ancestors)

Disorders of Excessive Somnolence; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: Dr. Lynn Marie Trotti
• Organization: Emory University

lbecke2@emory.edu

404-712-7240

Study Officials

• Lynn Marie Trotti, MD, MSc

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 10, 2018
• First Posted: December 11, 2018
• Study Start: April 15, 2019
• Primary Completion: May 4, 2023
• Study Completion: May 4, 2023
• Last Updated: May 23, 2024
• Results First Posted: May 23, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)