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Completed

NCT Number: NCT04737278

Safety and Efficacy of Cunermuspir on Energy, Strength, and Fatigue in Patients With Nerve or Muscle Pain

Male and female participants were selected based on chronic neuromuscular pain. Patients were instructed to take two doses of the placebo or cuprous nicotinic acid chelate Cunermusmir twice a day for 28 days. Hypothesis: Cunermuspir would improve quality of life as determined by several questionnaires.

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Key information

Conditions

Neuralgia Fatigue Muscular Diseases Musculoskeletal Diseases Musculoskeletal Pain Myalgia Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

KGK Synergize now KGK Science

London, Ontario, N6A 5R8, Canada

About this study

A total of 72 subjects were consented and screened, with 56 subjects (28 males and 28 female) being eligible to participate in the study. Fifty-six subjects with muscle/nerve pain were randomized at a ratio of 1:1 to one of two treatment groups. To evaluate primary and secondary objectives, study assessments were conducted at Baseline, and Day 28 ± 2. The Individualized Neuromuscular Quality of Life Questionnaire (INQoL), Symptom Impact Questionnaire (SQIR), Mini-Mental State Examination (MMSE) were completed by participants to assess physical function, pain, fatigue/energy and cognitive function.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female age 18-75
  • If female, subject is not of child bearing potential. Defined as females who have
  • had a hysterectomy or oophorectomy.
  • bilateral tubal ligation or are post-menopausal (natural or surgically with > 1 year since last menstruation).
  • Female subject of childbearing potential must agree to use a medically approved method of birth control and have a negative urine pregnancy test result. Acceptable methods of birth control include: Hormonal contraceptives including oral contraceptives, hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (Depo--Provera, Lunelle), or hormone implant (Norplant System), Intrauterine devices, Vasectomy of partner, Total Abstinence
  • Subject has unresolved persistent muscle or nerve pain (muscle or nerve pain population)
  • Subjects using other therapies for nerve/muscle pain (e.g., exercise, TENS, acupuncture, exercise, psychotherapy, massage, physiotherapy, etc), must be used at a stable schedule for 1 month prior to the trial and subject agrees to continue these therapies at the same schedule during the trial avoiding changes in frequency or intensity and to record therapies in the study diary
  • Agrees to comply with study procedures
  • Has given voluntary, written, informed consent to participate in
  • the study

Exclusion criteria

  • Women who are pregnant, breastfeeding, or planning to become pregnant during the course of the trial
  • Planned surgery during the course of the trial
  • Use of prescription drugs for fibromyalgia or nerve pain (e.g.Lyrica, Cymbalta and Savella and others).
  • Use of prescription medications for depression, anxiety or other mental disorders
  • Requires the use of prescription drugs to control pain (other than provided rescue medication)
  • Use of oral or topical prescription or over the counter medications or natural health products for pain relief 3 days prior to randomization and during the trial (other than provided rescue medication)
  • Use of natural health products including vitamins and minerals within 3 days prior to randomization and during the trial
  • Use of blood thinning medications (e.g. warfarin)
  • Chronic lyme disease or chronic parasitic infections
  • Uncontrolled hypertension defined as untreated systolic blood pressure > 160 mmHg and/or diastolic blood pressure > 100 mmHg
  • Subjects with diabetes
  • History of bleeding disorders, or significant blood loss in the past 3 months
  • Alcohol use >2 standard alcoholic drinks per day and/or alcohol or drug abuse within the past year
  • Allergy or sensitivity to study supplement ingredients or acetaminophen
  • Participation in a clinical research trial within 30 days prior to randomization
  • Individuals who are cognitively impaired and/or who are unable to give informed consent
  • Any other condition which in the Investigator's opinion may adversely affect the subject's ability to complete the study or its measures or which may pose significant risk to the subject

Treatment and study plan

Cunermuspir

Drug

Copper Niacin Chelate, 6.06 mg per capsule Non-medicinal ingredients:

Organic evaporated cane juice powder, hypromellose, titanium dioxide

Other names: cuprous nicotinic acid

Placebo

Other

same non-medical ingredients and encapsulation as Intervention 1

Primary outcomes

  1. Neuromuscular Symptoms

    Time frame: baseline and 28 days after enrollment

    Quality of life was assessed by using the Individualized Neuromuscular Quality of Life Questionnaire (INQoL) Answers to symptom questions are scored from 0 to 6 or 7 with 0 being "none at all" and and 6 to 7 being "an extreme amount" There are three questions regarding pain. The pain score is (a+b+c)/19 x100. The higher the score, the greater the symptom impact.

  2. Platelet ATP

    Time frame: baseline and 28 days after enrollment

    Platelet ATP levels were measured as previously published in the literature.

Secondary outcomes

  1. Household Chores and Neuro Muscular Sumptoms

    Time frame: baseline and 28 days after enrollment

    Physical function in performing household chores was assessed using the Revised Symptom Impact Questionnaire (SQIR) For each household chore participants are asked to check 1 of 11 boxes between "no difficulty" and "extremely difficult" No difficulty is scored as 0 and extreme difficulty with the task is scored as 10. The higher the score, the more difficulty experienced performing the chore. Friend & Bennett Arthritis Res & Therapy 2011. Household chores are just one module with 9 questions for a maximum of 90 points. These scores are summed and divided by 3. Module 2 relates to the emotional impact with only two questions for a total of 20 points. Module 3 relates to physical symptoms with a total of ten questions worth a maximum of 100 points. This score is divided by 2. The three modules are summed for a total impact score of 100 points. A score of 0 indicates absolutely no impact and a score of 100 the greatest possible impact.

  2. Cognition

    Time frame: baseline and 28 days after enrollment

    Cognition is the mental process of knowing, including aspects such as awareness, perception, reasoning, and judgment. The mini-mental state exam (MMSE) puts a number to "cognition." Any score of 24 or more out of a total 30 points is considered normal cognition. A test taker may be asked to orientate in space and time by recalling aspects of the physical location as well as month, day, year, and perhaps season. Simple mathematical calculations like counting backwards from 100 by seven may also be included. A complex command such as redrawing geometric figures scores six points in this exam. Since none of the participates were cognitively impaired, the investigators decided to make obtaining a perfect score on this exam an outcome measure.

  3. Heart Rate

    Time frame: baseline and 28 days after enrollment

    heart rate is measured in beats per minute

  4. Diastolic Blood Pressure

    Time frame: baseline and 28 days after enrollment

    The diastolic blood pressure was measured in mm Hg

  5. Systolic Blood Pressure

    Time frame: baseline and 28 days after enrollment.

    Systolic blood pressure was measured in mm Hg

  6. Hemoglobin

    Time frame: baseline and 28 days after enrollment.

    changes measured in g/L blood

  7. Hematocrit

    Time frame: baseline and 28 days after enrollment

    changes in the fraction of whole blood occupied by red blood cells measured as L/L

  8. WBC

    Time frame: baseline and 28 days after enrollment

    changes in white blood cells (WBC) measured in units of 10^9 per liter blood

  9. RBC

    Time frame: baseline and 28 days after enrollment

    changes in red blood cells (RBC) measured in units of 10^12 per liter blood

  10. MCV

    Time frame: baseline and 28 days after enrollment

    changes in mean corpuscular volume (MCV) measured in units of fL

  11. MCH

    Time frame: baseline and 28 days after enrollment

    changes in mean corpuscular hemoglobin, measured in units of pg, the average amount of hemoglobin in a single RBC

  12. MCHC

    Time frame: baseline and 28 days after enrollment

    mean corpuscular hemoglobin concentration is the concentration of hemoglobin in a single RBC measured in units of g/L

  13. RDW

    Time frame: baseline and 28 days after enrollment

    changes in the RBC distribution width (RDW) are reported in units of percentage (%)

  14. Platelets

    Time frame: baseline and 28 days after enrollment

    changes in the platelet counts are reported in units of 10^9 per liter blood

  15. Neutrophils

    Time frame: baseline and 28 days after enrollment

    changes in neutrophils are reported in units of 10^9 per liter blood

  16. Lymphocyte

    Time frame: baseline and 28 days after enrollment

    changes in lymphocytes are reported in units of 10^9 per liter blood

  17. Monocyte

    Time frame: baseline and 28 days after enrollment

    changes in monocytes are reported in units of 10^9 per liter blood

  18. Eosinophil

    Time frame: baseline and 28 days after enrollment

    changes in eosinophils are reported in units of 10^9 cells per liter blood

  19. Basophil

    Time frame: baseline and 28 days after enrollment

    changes in basophils are reported in units of 10^9 cells per liter blood

  20. NLR

    Time frame: baseline and 28 days after enrollment

    Changes in the neutrophil to lymphocyte ratio (NLR) are reported as a dimensionless fraction of 1

  21. Glucose

    Time frame: baseline and 28 days after enrollment

    changes in blood glucose are reported in units of mmol per liter

  22. Urea

    Time frame: baseline and 28 days after enrollment

    changes in renal function as measured by blood urea are reported in units of mmol per liter

  23. Creatinine

    Time frame: baseline and 28 days after enrollment

    changes in creatinine are reported in units of micromol per liter

  24. eGFR

    Time frame: baseline and 28 days after enrollment

    changes in the estimated glomerular filtration rate (eGFR) are reported in units of mL/min/1.73m^2

  25. Sodium

    Time frame: baseline and 28 days after enrollment

    changes in plasma sodium are reported in units of mmol per liter, reference range is 133-146 mEq/L, same as mM/L bloodbook.com

  26. Potassium

    Time frame: baseline and 28 days after enrollment

    changes in plasma potassium are reported in units of mmol per liter, reference value 3.5-5.4 mmol per liter, bloodbook.com

  27. Chloride

    Time frame: baseline and 28 days after enrollment

    changes in plasma chloride are reported in uits of mmol per liter The reference range is 98-106 mmol per liter, bloodbook.com

  28. Bilirubin

    Time frame: baseline and 28 days after enrollment

    changes in total bilirubin are reported in units of micro moles per liter. Direct: up to 0.4 mg/dL, Total: up to 1.0 mg/dL bloodbook.com, Converts to 6.84-17.1 micro moles per liter. https://unitslab.com/node/37

  29. ALT

    Time frame: baseline and 28 days after enrollment

    changes in the liver enzyme alanine aminotransferase (ALT) in the blood are reported as units per liter Reference range 1 - 21 units/L bloodbook.com

  30. AST

    Time frame: baseline and 28 days after enrollment

    changes in the liver enzyme aspartate aminotransferase (AST) in the blood are reported as units per liter Reference range 7 - 27 units/L bloodbook.com

  31. GGT

    Time frame: baseline and 28 days after enrollment

    changes in the liver enzyme gamma-glutamyl transferase in the blood are reported as units per liter

  32. Copper

    Time frame: baseline and 28 days after enrollment

    changes in copper concentration in the blood are reported in units of micro moles per liter

Sponsors and collaborators

Lead sponsor

Mitosynergy LLC

Industry

Registry information

Official study title

A Randomized, Double Blind, Placebo Controlled, Parallel Study Evaluating the Safety and Efficacy of Cunermuspir on Energy, Strength, Fatigue and Discomfort in Subjects With Nerve or Muscle Pain

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Feb 3, 2021
Registry last updated
Apr 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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