NCT06170970Toboroz2. fázis
Solriamfetol for the Treatment of Multiple Sclerosis Fatigue
Solriamfetol for the Treatment of Fatigue in Patients With Multiple Sclerosis and Excessive Daytime Sleepiness
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. jún. 9.
Rövid összefoglaló (regiszter, angolul)
Fatigue is a prevalent and disabling symptom in Multiple Sclerosis (MS), affecting up to 90% of patients. Current treatments, including off-label prescriptions of wake-promoting agents, have shown limited effectiveness. Previous research indicates that these agents may be beneficial specifically for MS patients with concomitant excessive daytime sleepiness. This study uses a randomized, double-blind, placebo-controlled crossover design. Participants will undergo a 10-day lead-in with he medication/placebo, followed by two four-week treatment periods separated by a one-week washout. Outcomes will be measured primarily using the Modified Fatigue Impact Scale (MFIS), with additional exploratory measures collected via a smartphone app that assesses fatigue through keystroke dynamics. This novel approach to fatigue measurement aims to capture real-time variations and provide more granular data than traditional self-report questionnaires.
- Állapot (regiszter)
- Toboroz
- Fázis (regiszter)
- 2. fázis
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 46 (tervezett)
- Első benyújtás
- 2023. dec. 6.
- Kezdés
- 2024. jún. 1.
- Elsődleges befejezés
- 2026. dec. 1.
- Fő szponzor
- Johns Hopkins University
- Betegségek
- Sclerosis multiplex (SM)
- NCT-szám
- NCT06170970
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó · 2. fázis
- Tervezett résztvevők: 46
- 2024. jún. 1. és az elsődleges befejezés (2026. dec. 1.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
Ki nem vehet részt
Szó szerint a(z) ClinicalTrials.gov forrásból, témák szerint csoportosítva. Hogy ki vehet részt, azt csak a vizsgálat csapata dönti el.
Korábbi kezelés
- Receiving drugs/treatments that increase blood pressure or heart rate (based on the PI review of the medications/treatments)
- The use of any product with stimulating or sedating properties, unless they have been on a steady dose for at least a month prior to the screening visit and agree to stay on the same dose over the course of the study
- Use within 14 days of a monoamine oxidase (MAO) inhibitor drug
- Use of medications used for the treatment of fatigue (including amantadine, modafinil, armodafinil, and amphetamine-like stimulants) in the past two weeks of the screening visit
Más betegség
- History of coronary artery disease or congestive heart failure
- Uncontrolled hypertension at Screening (history of high blood pressure and screening systolic blood pressure >160 or diastolic blood pressure>100)
- A history of cerebrovascular disease or stroke
- A medical or neurological disorder other than MS, that was associated with excessive sleepiness.
- A history of phenylketonuria or hypersensitivity to the phenylalanine-derived product
- A history of alcohol or drug abuse within the past two years
- A history of psychosis, or bipolar disorder
- A history of cardiac arrythmias
- A known history of moderate or severe kidney dysfunction (estimated Glomerular filtration rate of less than 60 mL/min)
Laborértékek
- A known history of uncontrolled diabetes (the last known hemoglobin A1c level above 7.0%), high BMI (>35), or hyperlipidemia (last known total cholesterol >240 mg/dl, or LDL cholesterol level >160 mg/dl)
Egyéb
- Pregnant or lactating
Kiket keres a vizsgálat
- Male or female, 18 to 60 years of age, inclusive.
- Medically stable on the basis of physical examination, medical history, and vital signs
- Must meet McDonald 2024 diagnostic criteria for multiple sclerosis based on the PI review of the medical records
- Must complain from fatigue as one of their main symptoms and have a screening MFIS score of 33 or more
- A screening ESS score of 10 or more
- Must be ambulatory (able to walk at least 20 feet using bilateral assistance)
- Must have internet and email access and the ability to use a computer or tablet, or smartphone
- Own an android smartphone or an iphone
- Consent to use a medically acceptable method of contraception for the duration of the study
- Willing and able to comply with the study design schedule and other requirements
- Willing and able to provide written informed consent
Életkor a regiszterben: 18 év – 60 év · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Johns Hopkins University | Baltimore | Egyesült Államok | Toboroz |
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.