Modafinil + Solriamfetol for Excessive Daytime Sleepiness from Long COVID
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Duke University
Must not be taking: Stimulants, Hypnotics, MAOIs, Dopaminergics
Disqualifiers: Hypertension, Hepatic impairment, Heart problems, others
Prior Safety Data
Trial Summary
What is the purpose of this trial?The platform protocol is designed to be flexible so that it is suitable for a range of study settings and intervention types. Therefore, the platform protocol provides a general protocol structure that can be shared by multiple interventions and allows comparative analysis across the interventions. For example, objectives, measures, and endpoints are generalized in the platform protocol, but intervention-specific features are detailed in separate appendices.
This platform protocol is a prospective, multi-center, multi-arm, randomized controlled platform trial evaluating potential interventions for PASC-mediated sleep disturbances. The hypothesis is that symptoms of sleep and circadian disorders that emerge in patients with PASC can be improved by phenotype-targeted interventions. Specific sleep and circadian disorders addressed in this protocol include sleep-related daytime impairment (referred to as hypersomnia) and complex PASC-related sleep disturbance (reflecting symptoms of insomnia and sleep-wake rhythm disturbance).
Will I have to stop taking my current medications?
The trial may require you to stop taking certain medications. If you are currently using stimulant or wake-promoting medications, or prescribed hypnotics for sleep, a washout period (time without taking these medications) is permitted. Additionally, if you are taking medications that interact with Modafinil or Solriamfetol, you may need to modify or stop those medications.
Is the combination of Modafinil and Solriamfetol safe for treating excessive daytime sleepiness?
Modafinil and Solriamfetol have been studied for safety in treating excessive daytime sleepiness in conditions like narcolepsy and obstructive sleep apnea. Modafinil has been used since 1998, but its use is now limited to narcolepsy due to safety reviews. Solriamfetol is generally well tolerated, with common side effects including headache, nausea, decreased appetite, insomnia, and anxiety.
12345How is the drug combination of Modafinil and Solriamfetol unique for treating excessive daytime sleepiness from Long COVID?
This drug combination is unique because it combines Modafinil, a central nervous system stimulant, with Solriamfetol, a dopamine-norepinephrine reuptake inhibitor, both of which are used to improve wakefulness in conditions like narcolepsy and obstructive sleep apnea. This combination may offer a novel approach to managing excessive daytime sleepiness in Long COVID, a condition with no standard treatment.
14678Eligibility Criteria
This trial is for individuals experiencing excessive daytime sleepiness associated with COVID-19, known as Long COVID Syndrome or Post-COVID Syndrome. Participants should meet the general criteria outlined in the RECOVER-SLEEP platform protocol.Inclusion Criteria
I meet the general requirements listed in the RECOVER-SLEEP study.
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Baseline Assessment
Participants complete baseline assessments before randomization
1 week
Treatment
Participants receive either modafinil, solriamfetol, or placebo for 10 weeks
10 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Participant Groups
The trial is testing Modafinil and Solriamfetol against their respective placebos to see if they can improve sleep-related issues caused by PASC. It's a multi-center study where participants are randomly assigned to different treatment arms.
2Treatment groups
Active Control
Placebo Group
Group I: Wake-promoting drug: Modafinil or solriamfetolActive Control2 Interventions
Participants in Appendix A will be randomized to study drug or control. Participants who meet the eligibility criteria for modafinil will receive either active modafinil or the modafinil-matched control. If modafinil is contraindicated for any reason, participants will be assessed for their ability to take solriamfetol. If participants are eligible for solriamfetol, they will receive either active solriamfetol or the solriamfetol-matched control. If solriamfetol is contraindicated, participants will be excluded from Appendix A. Modafinil and solriamfetol will be analyzed as a single wake-promoting drug condition versus control. The intervention duration will be 10 weeks.
Group II: Modafinil-matched placebo or solriamfetol-matched placeboPlacebo Group2 Interventions
Participants in Appendix A will be randomized to study drug or control. Participants who meet the eligibility criteria for modafinil will receive either active modafinil or the modafinil-matched control. If modafinil is contraindicated for any reason, participants will be assessed for their ability to take solriamfetol. If participants are eligible for solriamfetol, they will receive either active solriamfetol or the solriamfetol-matched control. If solriamfetol is contraindicated, participants will be excluded from Appendix A. Modafinil and solriamfetol will be analyzed as a single wake-promoting drug condition versus control. The intervention duration will be 10 weeks.
Modafinil is already approved in United States, European Union, Canada, Australia for the following indications:
🇺🇸 Approved in United States as Provigil for:
- Narcolepsy
- Shift Work Sleep Disorder
- Obstructive Sleep Apnea
🇪🇺 Approved in European Union as Modafinil for:
- Excessive daytime sleepiness associated with narcolepsy
- Shift work sleep disorder
- Obstructive sleep apnea
🇨🇦 Approved in Canada as Alertec for:
- Narcolepsy
- Shift Work Sleep Disorder
- Obstructive Sleep Apnea
🇦🇺 Approved in Australia as Modvigil for:
- Narcolepsy
- Shift Work Sleep Disorder
- Obstructive Sleep Apnea
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
All sites listed under NCT06404086Durham, NC
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Who Is Running the Clinical Trial?
Duke UniversityLead Sponsor
References
Randomized Controlled Trial of Solriamfetol for Excessive Daytime Sleepiness in OSA: An Analysis of Subgroups Adherent or Nonadherent to OSA Treatment. [2021]Solriamfetol, a dopamine-norepinephrine reuptake inhibitor, is approved in the United States to improve wakefulness in adults with excessive daytime sleepiness (EDS) associated with OSA (37.5-150 mg/d).
Safety profile of modafinil across a range of prescribing indications, including off-label use, in a primary care setting in England: results of a modified prescription-event monitoring study. [2021]Modafinil (Provigil) was marketed in the UK in 1998 to promote wakefulness in the treatment of narcolepsy. In April 2004, the licence was extended to include chronic pathological conditions; 2 years later, the prescription of modafinil was restricted to patients with shift work sleep disorder, narcolepsy and obstructive sleep apnoea/hypopnoea syndrome. Following a recent review of the safety data, the licence has been further restricted to only treat patients with narcolepsy. The review highlighted the degree of off-label usage of modafinil, including patients with multiple sclerosis.
Solriamfetol for the treatment of excessive daytime sleepiness associated with narcolepsy. [2020]Introduction: Narcolepsy is a chronic disabling condition, excessive daytime somnolence is the main symptoms of it. There is currently no cure for narcolepsy, and hence there is a great need for new treatment options. Solriamfetol is a new selective dopamine and norepinephrine reuptake inhibitor with robust wake-promoting effects. The purpose of this paper is to review solriamfetol. Areas covered: The chemical property, mechanism of action, pharmacokinetics, clinical efficacy, and safety of solriamfetol are introduced in this paper. Expert opinion: Solriamfetol can bind to dopamine and norepinephrine transporters and inhibit reuptake of dopamine and norepinephrine. Clinical trials showed that solriamfetol could significantly improve the ability to stay awake and subjective symptoms of excessive sleepiness in adults with narcolepsy. Solriamfetol was well tolerated. Very common adverse reactions were headache, nausea, decreased appetite, insomnia, and anxiety.
Efficacy and safety of solriamfetol for excessive daytime sleepiness in narcolepsy and obstructive sleep apnea: a systematic review and meta-analysis of clinical trials. [2021]Excessive daytime sleepiness (EDS) is the inability to maintain wakefulness and alertness during the major waking episodes of the day, with sleep occurring unintentionally or at inappropriate times. Solriamfetol is a selective norepinephrine-dopamine reuptake inhibitor approved for EDS. This review was done to assess the efficacy and safety of solriamfetol in patients with EDS in narcolepsy or OSA.
Solriamfetol for the Management of Excessive Daytime Sleepiness. [2022]To review efficacy, safety, and place in therapy of solriamfetol for management of excessive daytime sleepiness (EDS) in patients with narcolepsy and obstructive sleep apnea (OSA).
Efficacy and safety of solriamfetol for excessive sleepiness in narcolepsy and obstructive sleep apnea: findings from randomized controlled trials. [2021]Solriamfetol is developed for the treatment of excessive sleepiness in adult patients with narcolepsy and obstructive sleep apnea (OSA). No systematic review of existing literature has been investigated before. Therefore, the meta-analysis is conducted to assess the efficacy and safety of solriamfetol for excessive sleepiness in narcolepsy and OSA.
Modafinil for the Improvement of Patient Outcomes Following Traumatic Brain Injury. [2020]Objective: The authors sought to assess the literature evidence on the efficacy of modafinil use in patients with fatigue or excessive daytime sleepiness (EDS) secondary to traumatic brain injury (TBI). Method of Research: A literature search of Medline and PubMed was performed using the EBSCOhost database. Primary literature, observational studies, meta-analyses, case reports, and systematic reviews were assessed for content regarding modafinil and psychostimulant use in patients with TBI. Of the 23 articles collected, three randomized, controlled studies, three observational studies, one case report, and two systematic reviews gave a description of modafinil use in TBI patients. Results and Conclusion: Modafinil is a central nervous system stimulant with well-established effectiveness in the treatment of narcolepsy and shift-work sleep disorder. There is conflicting evidence about the benefits of modafinil in the treatment of fatigue and EDS secondary to TBI. One randomized, controlled study states that modafinil does not significantly improve patient wakefulness, while another concludes that modafinil corrects EDS but not fatigue. An observational study provides evidence that modafinil increases alertness in fatigued patients with past medical history of brainstem diencephalic stroke or multiple sclerosis. Modafinil appears to have the potential to improve wakefulness in patients with TBI. A prospective, double-blinded, randomized, crossover trial of modafinil for the management of fatigue in ischemic stroke patients is currently being conducted, and further studies demonstrating consistent results are needed before making a conclusive decision.
Solriamfetol real world experience study (SURWEY): Initiation, titration, safety, effectiveness, and experience during follow-up for patients with narcolepsy from Germany. [2023]Excessive daytime sleepiness (EDS) is a core narcolepsy symptom, for which solriamfetol (Sunosi®) was recently approved in the European Union. SURWEY characterises real-world strategies used by physicians when initiating solriamfetol, and patient outcomes after follow-up.