Tolerability and Efficacy of CBD Extract for RLS Treatment
A legfontosabb adatok
- Hol
- Aurora (Egyesült Államok)A helyszín megnézése
- Fázis
- 2. fázis
Neked szólhat?
Magadról válaszolj. Ez nem döntés: hogy részt vehetsz-e, azt csak a vizsgálat csapata mondhatja meg.
- 18 és 79 év között vagy?
Forrás: NCT07224932: ki vehet részt
Helyszínek itt: Egyesült Államok
- Colorado Clinical and Translational Sciences Institute (CCTSI) - Anschutz Medical CampusAurora, Egyesült ÁllamokContact: Jacquelyn Bainbridge, PharmDNo longer taking part
Kérdések a vizsgálat csapatának
- Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
- Megtérítik az utazási költséget?
- Megtarthatom a saját orvosomat?
- Mi történik, ha ki akarok lépni?
Contact the study team: see the registry record → Contacts and Locations
Oldal nyomtatása az orvosomnakA vizsgálat adatai
- Ki végzi
- University of Colorado, Denver
- Azonosító
- NCT07224932
- A regiszteradat frissítve
- 2026. október 8.
- Eredeti leírás
This study plans to learn more about the safety and tolerability of high Cannabidiol (CBD) cannabis extract (BRC-002) for use in Idiopathic Restless Legs Syndrome. Symptoms and side effects experienced while taking the study drug will be tracked to determine if this medication is safe to use.A teljes eredeti leírásKevesebb
A Randomized, Double-blind, Placebo-controlled Parallel Study of the Tolerability and Efficacy of High Cannabidiol (CBD) Cannabis Extract for the Treatment of Patients With Idiopathic Restless Legs Syndrome (RLS)
This study plans to learn more about the safety and tolerability of high Cannabidiol (CBD) cannabis extract (BRC-002) for use in Idiopathic Restless Legs Syndrome. Symptoms and side effects experienced while taking the study drug will be tracked to determine if this medication is safe to use.
Bevonási feltételek: Male or female subjects between 18 and 79 years of age, inclusive; Willing and able to give informed consent; Idiopathic RLS, meeting all 4 International RLS Study Group diagnostic criteria; Moderate or severe symptoms, defined as an IRLS score ≥ 15 at screening visit; RLS medications unchanged for 4 weeks prior to baseline; Must have a driver or available transportation (including provided Uber vouchers) to drive them to and from study visits and for other transportation needs during the treatment period; Has a significant other, caregiver, or close acquaintance who knows the subject well and agrees to participate in the subject's neuropsychiatric assessment; Agrees to not take more than 1 gram per day of acetaminophen; Whereas applicable, agrees to utilize an effective method of contraception from screening through at least 4 weeks after the completion of study treatment.
Kizáró feltételek: Currently on night shift work schedule; Use of dopamine blockers, cocaine, or MAO-A inhibitors within 90 days of baseline; Use of any drugs with known interactions with cannabinoids (e.g., tolcapone, clopidogrel, felbamate, warfarin, barbiturates, benzodiazepines, niacin, nicotinamide, isoniazid, ketoconazole, clobazam, valproate, mTOR inhibitors) within 90 days of baseline; Planned elective surgery during study participation; Secondary RLS, such as Parkinson's disease or end-stage renal disease; Present or past history of another severe sleep disorder; History or diagnosis of schizophrenia, bipolar or a psychotic disorder, severe depression, or any mental health illness that would compromise the safety of the participant; Severe cognitive impairment (e.g., Alzheimer's Disease, traumatic brain injury); Uncontrolled hypertension; Known or suspected allergy or hypersensitivity to cannabinoids or excipients used in the study drug formulation; History of drug or alcohol dependence; Unstable medical condition; Moderate or severe hepatic impairment; Clinically significant laboratory abnormalities; Current suicidal ideation; Pending legal action or workers compensation; Cannabis use (THC) detectable at the screening/baseline visits; Is pregnant, lactating, or has a positive pregnancy test result pre-dose.