Clinical Trial

For everything and anything else not covered in the other RLS sections.
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ViewsAskew
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Joined: Thu Oct 28, 2004 6:37 am
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Clinical Trial

Post by ViewsAskew »

I saw this on Johns Hopkins' website, then realized that it's a study at multiple facilities! https://clinicaltrials.gov/ct2/show/NCT02397057

The biggest hurdle for many of us would be that they require monotherapy (only currently using one drug, not a combination). They also require regular sleep hours - somewhere between 9 PM and 9 AM. I also can't see the Appendices, so am not sure what they approved treatment regimens are - could be that some of the drugs we take are excluded.


Detailed 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.

Eligibility

Ages Eligible for Study: 18 Years and older (Adult, Senior)
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Criteria

Inclusion Criteria:
  1. Male or female subject's ≥18 years of age, willing and able to give informed consent to the study.
  2. RLS symptoms affirming diagnosis. The IRLS Diagnostic Criteria must be met:
    • An urge (distressing need) to move the legs usually associated with painful or uncomfortable sensations in the legs.
    • The urge to move may be present without the uncomfortable sensations. The arms or other body parts may be involved in addition to the legs.
    • The urge to move or unpleasant sensations are worse or exclusively present at rest or inactivity, such as lying down or sitting.
    • The urge to move or unpleasant sensations are partially/temporarily relieved with walking or moving the legs.
    • The urge to move or unpleasant sensations are worse in the evening or night than during the day or only occur in the evening or night. When symptoms are severe, the worsening at night may not be noticeable but must have been previously present.
  3. 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).
  4. A score ≥15 on the IRLS Rating Scale at screening and on Day 0 prior to dosing.
  5. Subjects on anti-depressants and sleep medications must be on a stable dose for at least 6 months.
  6. Subject has regular sleep hours between 9 pm and 9 am.
  7. 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:
  1. RLS 2° to other disease or injury.
  2. Disorders that require treatment with the same medications used for RLS include: peripheral neuropathy and neurodegenerative disorders (i.e. Parkinson's Disease or Dementia).
  3. Stage 4 - 5 CKD, subjects on dialysis or anticipated to start dialysis while participating in this study.
  4. Any pain related (e.g., frequent muscle cramps, myalgia, fibromyalgia) or sleep related disorders (e.g. sleep apnea, unless on stable Continuous Positive Airway Pressure [CPAP]) which may confound the outcome measures.
  5. Subjects with multiple sclerosis.
  6. History of neuroleptic akathisia.
  7. Parenteral iron use within 6 weeks prior to screening.
  8. History of >10 blood transfusions in the past 2 years.
  9. Anticipated need for blood transfusion during the study.
  10. Known hypersensitivity reaction to any component of Injectafer® (Ferric Carboxymaltose).
  11. Previously randomized to Injectafer® (FCM or VIT-45) in a clinical trial.
  12. Current, active or acute or chronic infection other than viral upper respiratory tract infection
  13. Malignancy (other than basal or squamous cell skin cancer or the subject has been cancer free for ≥ 5 years).
  14. Pregnant or lactating women.
  15. Seizure disorder currently being treated with medication.
  16. Baseline ferritin ≥300 ng/mL.
  17. Baseline TSAT ≥45%.
  18. History of hemochromatosis, hemosiderosis, or other iron storage disorders.
  19. AST or ALT greater than 2 times the upper limit of normal (ULN).
  20. Hemoglobin greater than the ULN.
  21. Known positive hepatitis B antigen (HBsAg), unless positive test can be attributed to receipt of hepatitis B vaccination in childhood or hepatitis C viral antibody (HCV) with evidence of active hepatitis (i.e., AST/ALT greater than the upper limit of normal).
  22. Known positive HIV-1/HIV-2 antibodies (anti-HIV).
  23. Received an investigational drug within 30 days before randomization.
  24. Chronic alcohol or drug abuse within the past 6 months.
  25. Any other pre-existing laboratory abnormality, medical condition or disease, which per the investigator may put the subject at risk if they participate in the study.
  26. Subject unable or unwilling to comply with the study requirements.
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02397057

Contacts
Contact: Angelia Butcher 610-650-4200 ext 811 abutcher@lpicrd.com
Contact: Marc Tokars 610-650-4200 ext 805 mtokars@lpicrd.com

Locations
United States, Alabama,
Coastal Clinical Research, Inc. Recruiting
Mobile, Alabama, United States, 36608
Contact: Michael Ledet, M.D. 251-414-1984
Contact: Trisha Starling, BS, CCRC t.riffle@ccr-research.com

United States, California
Synergy San Diego Recruiting
National City, California, United States, 91950
Contact: Mohammed A Bari, MD 619-327-0155
Contact: Gayathri Natarajan, CRC natarajang@synergysandiego.com

Desert Valley Research Recruiting
Rancho Mirage, California, United States, 92270
Contact: Dennis K. Anderson, M.D. 760-464-0470
Contact: Ashley Auer, CRC ala@desertvalleyresearch.com

Anderson Clinical Research Recruiting
Redlands, California, United States, 92374
Contact: Donald L. Anderson, M.D. 909-792-9007
Contact: Tanya Powell, CRC tsp@andersonstudies.com

United States, Florida
Neurology Offices of South FL Recruiting
Boca Raton, Florida, United States, 33428
Contact: Michelle Ferreira, D.O. 561-482-1027
Contact: Cody Paauwe cody@nsofl.net

Elite Research Institute Recruiting
Miami, Florida, United States, 33169
Contact: Diego Rielo, M.D. 305-620-7002
Contact: Kirenia Correa kcorrea@eliteresearchinst.com

United States, Kansas
MidAmmerica Neuroscience Institute Recruiting
Lenexa, Kansas, United States, 66214-1505
Contact: Vernon Rowe, M.D. 913-894-1500
Contact: LeAnn Cannon lcannon@neurokc.com

United States, Kentucky

Central Kentucky Research Assoc., Inc. Recruiting
Lexington, Kentucky, United States, 40509
Contact: Mark S Adams, M.D. 859-264-8999
Contact: Crystal Reed, CMA creed@ckrainc.com

United States, Louisiana
Neuromedical Clinical of Central Louisiana Recruiting
Alexandria, Louisiana, United States, 71301
Contact: Gonzalo I Hidalgo, MD 318-443-0490
Contact: Mary Eves, RN Meves@intrafusion.com

United States, Maryland

Ctr for Brain & Neuro Care, LLC Recruiting
Fulton, Maryland, United States, 20759
Contact: Ruwani Gunawardane, M.D. 301-490-3700
Contact: Alicia Nye anye@intrafusion.com

United States, Massachusetts
Massachusetts General Hospital, Sleep Disorders Clinical Research Program Recruiting
Boston, Massachusetts, United States, 02114
Contact: John W. Winkelman, M.D. Ph.D. 617-643-9101
Contact: Leslie Mei lamei@partners.org

United States, Nevada
Desert Neurology Recruiting
Las Vegas, Nevada, United States, 89119
Contact: Nicole F. Theuvenet, M.D. 702-933-0971
Contact: Bonnie Doane, CRC bdoane@intrafusion.com

Neurology Center of Las Vegas Recruiting
Las Vegas, Nevada, United States, 89128
Contact: Shanker N. Dixit, M.D. 702-405-7100
Contact: Natalie Bergevin nbergevin@intrafusion.com

United States, North Carolina

Guilford Neurologic Associates Recruiting
Greensboro, North Carolina, United States, 27405
Contact: Carmen Dohmeier, M.D. 336-273-2511
Contact: Teodora Barbu tbarbu@intrafusion.org

United States, South Carolina
Metrolina Neurological Associates Recruiting
Indian Land, South Carolina, United States, 29707
Contact: Howard Mandell, M.D. 808-818-2166
Contact: Melanie Boyd mboyd@intrafusion.com

Saad Upstate Neurology Recruiting
Spartanburg, South Carolina, United States, 29307
Contact: Juliette S. Saad, MD 864-316-2587
Contact: Kim Williams 864-345-8497 kimw2685@gmail.com

United States, Tennessee
Tri-State Mountain Neurology Associates Recruiting
Johnson City, Tennessee, United States, 37604
Contact: John M. Dengler, M.D. 423-928-6174
Contact: Melissa Saylor, RN msaylor@intrafusion.com

United States, Texas
Egret Bay Neurology Recruiting
Houston, Texas, United States, 77058
Contact: Mavis Fujii, MD 281-333-9933
Contact: Dianne Stryk dstryl@intrafusion.com

United States, Washington
The Polyclinic, Madison Center Recruiting
Seattle, Washington, United States, 98104
Contact: Meghana Doreswamy, M.D. 206-860-5433
Contact: Victoria Saetern victoria.saetern@polyclinic.com

Sponsors and Collaborators
Luitpold Pharmaceuticals
Ann - Take what you need, leave the rest

Managing Your RLS

Opinions presented by Discussion Board Moderators are personal in nature and do not, in any way, represent the opinion of the RLS Foundation, and are not medical advice.

67java89
Posts: 38
Joined: Tue Jul 26, 2016 3:35 pm

Re: Clinical Trial

Post by 67java89 »

I am constantly searching the clinical research trial databases in hopes that a study will come to my area. I would participate in a heartbeat. I'm also registered with Researchmatch.org but no luck so far. I keep hoping.
Sleep is a basic need.

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