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

• ClinicalTrials.gov Identifier: NCT04737278
• Recruitment Status: Completed
• First Posted: February 3, 2021
• Results First Posted: April 20, 2021
• Last Update Posted: April 20, 2021
• Sponsor: Mitosynergy LLC
• Information provided by (Responsible Party): Mitosynergy LLC

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Neuralgia; Myalgia	Drug: Cunermuspir; Other: Placebo	Phase 1; Phase 2

Detailed Description:

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 56 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: randomized, double--blind, placebo controlled, parallel study
• Masking: Double (Participant, Investigator)
• Masking Description: The investigational product bottles were labeled according to the requirements of ICH--GCP guidelines and applicable local regulatory guidelines. Investigational products were coded by the unblinded personnel at KGK Synergize who were not involved in the collecting or analyzing of study data. Each package contained a similar label differing only in randomization number.
• Primary Purpose: Treatment
• Official 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
• Actual Study Start Date: January 28, 2014
• Actual Primary Completion Date: May 28, 2014
• Actual Study Completion Date: September 29, 2014

Arms and Interventions

Arm	Intervention/treatment
Experimental: Cunermuspir; Cunermuspir (Copper Niacin Chelate) 6.06mg per capsule. Non--medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide Two doses per day: one with the morning meal and the other with a mid afternoon snack. The study duration was 28 days.	Drug: Cunermuspir; Copper Niacin Chelate, 6.06 mg per capsule Non-medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide; Other Name: cuprous nicotinic acid
Placebo Comparator: Placebo; Organic evaporated cane juice powder, hypromellose, titanium dioxide. Same dosing as Cunermuspir arm	Other: Placebo; same non-medical ingredients and encapsulation as Intervention 1

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

Canada, Ontario

KGK Synergize now KGK Science

London, Ontario, Canada, N6A 5R8

Sponsors and Collaborators

Mitosynergy LLC

More Information

• Responsible Party: Mitosynergy LLC
• ClinicalTrials.gov Identifier: NCT04737278
• Other Study ID Numbers: 13MFHM
• First Posted: February 3, 2021
• Results First Posted: April 20, 2021
• Last Update Posted: April 20, 2021
• Last Verified: March 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: Close collaboration with KGK Synergize/Science will be needed to determine which data can be legally shared. In retrospective analysis of data six years later, raw data in the form of a spreadsheet proved to be extremely valuable.
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR)
• Time Frame: The data will be shared as soon as Mitosynergy meets the regulatory requirements for sharing.
• Access Criteria: Access will be determined by regulatory requirements. Mitosynergy favors as broad access as the law allows. If the law permits access on company websites, Mitosynergy will favor this.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Mitosynergy LLC:

Copper; nicotinic acid; energy; strength; fatigue; nerve pain; muscle pain; neuralgia; myalgia

Additional relevant MeSH terms:

Myalgia; Neuralgia; Fatigue; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Muscular Diseases; Musculoskeletal Diseases; Musculoskeletal Pain; Nicotinic Acids; Niacin; Vitamin B Complex; Vitamins; Micronutrients; Physiological Effects of Drugs; Hypolipidemic Agents; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Lipid Regulating Agents; Vasodilator Agents