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About
This will be a Phase III, double blinded, multi-center, randomized, placebo-controlled study. Eligible subjects will be randomized in a 1:1 ratio to receive Injectafer or Placebo on days 0 and 5. All treated subjects will be followed for efficacy and safety for 12 months. The subject's participation in the study will be for approximately 1 year from Day 0.
Full description
This will be a Phase III, double blinded, multi-center, randomized, placebo-controlled study. Eligible subjects will be randomized in a 1:1 ratio to receive Injectafer or Placebo on days 0 and 5. All treated subjects will be followed for efficacy and safety for 12 months. Subjects will visit the clinic on Days 0 and 5 for treatment, and then on Days 14, 42, 168, and 365. In between the clinic visits subjects will be contacted remotely on Days 84, 126, 210, 252, 294, and 336. The subject's participation in the study will be for approximately 1 year from Day 0.
Enrollment
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Inclusion criteria
Male or female subject's ≥18 years of age, willing and able to give informed consent to the study.
RLS symptoms affirming diagnosis. The IRLS Diagnostic Criteria must be met:
Subjects should be on monotherapy for RLS. Treatment should be stable for at least 8 weeks prior to screening (See approved RLS Therapies/Regimen in Appendix III).
A score ≥15 on the IRLS Rating Scale at screening and on Day 0 prior to dosing.
Subjects on anti-depressants and sleep medications must be on a stable dose for at least 6 months.
Subject has regular sleep hours between 9 pm and 9 am.
Subjects at risk for pregnancy must have a negative pregnancy test at baseline and be practicing an acceptable form of birth control: have had a hysterectomy or tubal ligation, or otherwise be incapable of pregnancy, or have practiced any of the following methods of contraception for at least one month prior to study entry: hormonal contraceptives, spermicide with barrier, intrauterine device, or partner sterility.
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
209 participants in 2 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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