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

Primary Purpose

Neuralgia, Myalgia

Status
Completed
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Cunermuspir
Placebo
Sponsored by
Mitosynergy LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neuralgia focused on measuring Copper, nicotinic acid, energy, strength, fatigue, nerve pain, muscle pain, neuralgia, myalgia

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • KGK Synergize now KGK Science

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Cunermuspir

Placebo

Arm Description

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.

Organic evaporated cane juice powder, hypromellose, titanium dioxide. Same dosing as Cunermuspir arm

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Household Chores and Neuro Muscular Sumptoms
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.
Cognition
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.
Heart Rate
heart rate is measured in beats per minute
Diastolic Blood Pressure
The diastolic blood pressure was measured in mm Hg
Systolic Blood Pressure
Systolic blood pressure was measured in mm Hg
Hemoglobin
changes measured in g/L blood
Hematocrit
changes in the fraction of whole blood occupied by red blood cells measured as L/L
WBC
changes in white blood cells (WBC) measured in units of 10^9 per liter blood
RBC
changes in red blood cells (RBC) measured in units of 10^12 per liter blood
MCV
changes in mean corpuscular volume (MCV) measured in units of fL
MCH
changes in mean corpuscular hemoglobin, measured in units of pg, the average amount of hemoglobin in a single RBC
MCHC
mean corpuscular hemoglobin concentration is the concentration of hemoglobin in a single RBC measured in units of g/L
RDW
changes in the RBC distribution width (RDW) are reported in units of percentage (%)
Platelets
changes in the platelet counts are reported in units of 10^9 per liter blood
Neutrophils
changes in neutrophils are reported in units of 10^9 per liter blood
Lymphocyte
changes in lymphocytes are reported in units of 10^9 per liter blood
Monocyte
changes in monocytes are reported in units of 10^9 per liter blood
Eosinophil
changes in eosinophils are reported in units of 10^9 cells per liter blood
Basophil
changes in basophils are reported in units of 10^9 cells per liter blood
NLR
Changes in the neutrophil to lymphocyte ratio (NLR) are reported as a dimensionless fraction of 1
Glucose
changes in blood glucose are reported in units of mmol per liter
Urea
changes in renal function as measured by blood urea are reported in units of mmol per liter
Creatinine
changes in creatinine are reported in units of micromol per liter
eGFR
changes in the estimated glomerular filtration rate (eGFR) are reported in units of mL/min/1.73m^2
Sodium
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
Potassium
changes in plasma potassium are reported in units of mmol per liter, reference value 3.5-5.4 mmol per liter, bloodbook.com
Chloride
changes in plasma chloride are reported in uits of mmol per liter The reference range is 98-106 mmol per liter, bloodbook.com
Bilirubin
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
ALT
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
AST
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
GGT
changes in the liver enzyme gamma-glutamyl transferase in the blood are reported as units per liter
Copper
changes in copper concentration in the blood are reported in units of micro moles per liter

Full Information

First Posted
January 25, 2021
Last Updated
March 24, 2021
Sponsor
Mitosynergy LLC
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1. Study Identification

Unique Protocol Identification Number
NCT04737278
Brief Title
Safety and Efficacy of Cunermuspir on Energy, Strength, and Fatigue in Patients With Nerve or Muscle Pain
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
January 28, 2014 (Actual)
Primary Completion Date
May 28, 2014 (Actual)
Study Completion Date
September 29, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mitosynergy LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuralgia, Myalgia
Keywords
Copper, nicotinic acid, energy, strength, fatigue, nerve pain, muscle pain, neuralgia, myalgia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Model Description
randomized, double--blind, placebo controlled, parallel study
Masking
ParticipantInvestigator
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.
Allocation
Randomized
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cunermuspir
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Organic evaporated cane juice powder, hypromellose, titanium dioxide. Same dosing as Cunermuspir arm
Intervention Type
Drug
Intervention Name(s)
Cunermuspir
Other Intervention Name(s)
cuprous nicotinic acid
Intervention Description
Copper Niacin Chelate, 6.06 mg per capsule Non-medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
same non-medical ingredients and encapsulation as Intervention 1
Primary Outcome Measure Information:
Title
Neuromuscular Symptoms
Description
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.
Time Frame
baseline and 28 days after enrollment
Title
Platelet ATP
Description
Platelet ATP levels were measured as previously published in the literature.
Time Frame
baseline and 28 days after enrollment
Secondary Outcome Measure Information:
Title
Household Chores and Neuro Muscular Sumptoms
Description
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.
Time Frame
baseline and 28 days after enrollment
Title
Cognition
Description
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.
Time Frame
baseline and 28 days after enrollment
Title
Heart Rate
Description
heart rate is measured in beats per minute
Time Frame
baseline and 28 days after enrollment
Title
Diastolic Blood Pressure
Description
The diastolic blood pressure was measured in mm Hg
Time Frame
baseline and 28 days after enrollment
Title
Systolic Blood Pressure
Description
Systolic blood pressure was measured in mm Hg
Time Frame
baseline and 28 days after enrollment.
Title
Hemoglobin
Description
changes measured in g/L blood
Time Frame
baseline and 28 days after enrollment.
Title
Hematocrit
Description
changes in the fraction of whole blood occupied by red blood cells measured as L/L
Time Frame
baseline and 28 days after enrollment
Title
WBC
Description
changes in white blood cells (WBC) measured in units of 10^9 per liter blood
Time Frame
baseline and 28 days after enrollment
Title
RBC
Description
changes in red blood cells (RBC) measured in units of 10^12 per liter blood
Time Frame
baseline and 28 days after enrollment
Title
MCV
Description
changes in mean corpuscular volume (MCV) measured in units of fL
Time Frame
baseline and 28 days after enrollment
Title
MCH
Description
changes in mean corpuscular hemoglobin, measured in units of pg, the average amount of hemoglobin in a single RBC
Time Frame
baseline and 28 days after enrollment
Title
MCHC
Description
mean corpuscular hemoglobin concentration is the concentration of hemoglobin in a single RBC measured in units of g/L
Time Frame
baseline and 28 days after enrollment
Title
RDW
Description
changes in the RBC distribution width (RDW) are reported in units of percentage (%)
Time Frame
baseline and 28 days after enrollment
Title
Platelets
Description
changes in the platelet counts are reported in units of 10^9 per liter blood
Time Frame
baseline and 28 days after enrollment
Title
Neutrophils
Description
changes in neutrophils are reported in units of 10^9 per liter blood
Time Frame
baseline and 28 days after enrollment
Title
Lymphocyte
Description
changes in lymphocytes are reported in units of 10^9 per liter blood
Time Frame
baseline and 28 days after enrollment
Title
Monocyte
Description
changes in monocytes are reported in units of 10^9 per liter blood
Time Frame
baseline and 28 days after enrollment
Title
Eosinophil
Description
changes in eosinophils are reported in units of 10^9 cells per liter blood
Time Frame
baseline and 28 days after enrollment
Title
Basophil
Description
changes in basophils are reported in units of 10^9 cells per liter blood
Time Frame
baseline and 28 days after enrollment
Title
NLR
Description
Changes in the neutrophil to lymphocyte ratio (NLR) are reported as a dimensionless fraction of 1
Time Frame
baseline and 28 days after enrollment
Title
Glucose
Description
changes in blood glucose are reported in units of mmol per liter
Time Frame
baseline and 28 days after enrollment
Title
Urea
Description
changes in renal function as measured by blood urea are reported in units of mmol per liter
Time Frame
baseline and 28 days after enrollment
Title
Creatinine
Description
changes in creatinine are reported in units of micromol per liter
Time Frame
baseline and 28 days after enrollment
Title
eGFR
Description
changes in the estimated glomerular filtration rate (eGFR) are reported in units of mL/min/1.73m^2
Time Frame
baseline and 28 days after enrollment
Title
Sodium
Description
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
Time Frame
baseline and 28 days after enrollment
Title
Potassium
Description
changes in plasma potassium are reported in units of mmol per liter, reference value 3.5-5.4 mmol per liter, bloodbook.com
Time Frame
baseline and 28 days after enrollment
Title
Chloride
Description
changes in plasma chloride are reported in uits of mmol per liter The reference range is 98-106 mmol per liter, bloodbook.com
Time Frame
baseline and 28 days after enrollment
Title
Bilirubin
Description
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
Time Frame
baseline and 28 days after enrollment
Title
ALT
Description
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
Time Frame
baseline and 28 days after enrollment
Title
AST
Description
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
Time Frame
baseline and 28 days after enrollment
Title
GGT
Description
changes in the liver enzyme gamma-glutamyl transferase in the blood are reported as units per liter
Time Frame
baseline and 28 days after enrollment
Title
Copper
Description
changes in copper concentration in the blood are reported in units of micro moles per liter
Time Frame
baseline and 28 days after enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
KGK Synergize now KGK Science
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5R8
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
IPD Sharing Time Frame
The data will be shared as soon as Mitosynergy meets the regulatory requirements for sharing.
IPD 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.

Learn more about this trial

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

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