NeuralgiaPhase 1/2NCT04737278
Safety and Efficacy of Cunermuspir on Energy, Strength, and Fatigue in Patients With Nerve or Muscle Pain
A Phase 1/2 study testing Cunermuspir in people with Neuralgia and Myalgia, run by Mitosynergy LLC at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- What is being tested?
- Cunermuspir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteCanada
- Study dates
- 28 Jan 2014to 29 Sep 2014
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Show all 10Show fewer
- 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
Who cannot join
- 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)
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Being tested
- Cunermuspir, Placebo
- Keywords
- Copper, nicotinic acid, energy, strength, fatigue, nerve pain, muscle pain, neuralgia, myalgia
- Medical subject headings
- Neuralgia, Myalgia, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CunermuspirDrug
Also called cuprous nicotinic acid
Copper Niacin Chelate, 6.06 mg per capsule Non-medicinal ingredients:
Organic evaporated cane juice powder, hypromellose, titanium dioxide
PlaceboOther
same non-medical ingredients and encapsulation as Intervention 1
| Study group | Role | What they receive |
|---|---|---|
| Cunermuspir | Experimental | 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. Receives: Drug: Cunermuspir |
| Placebo | Placebo comparator | Organic evaporated cane juice powder, hypromellose, titanium dioxide. Same dosing as Cunermuspir arm Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline and 28 days after enrollment
Platelet ATP
Platelet ATP levels were measured as previously published in the literature.
Measured: baseline and 28 days after enrollment
Secondary outcomes (32)
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.
Measured: baseline and 28 days after enrollment
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.
Measured: baseline and 28 days after enrollment
Heart Rate
heart rate is measured in beats per minute
Measured: baseline and 28 days after enrollment
Diastolic Blood Pressure
The diastolic blood pressure was measured in mm Hg
Measured: baseline and 28 days after enrollment
Systolic Blood Pressure
Systolic blood pressure was measured in mm Hg
Measured: baseline and 28 days after enrollment.
Hemoglobin
changes measured in g/L blood
Measured: baseline and 28 days after enrollment.
Hematocrit
changes in the fraction of whole blood occupied by red blood cells measured as L/L
Measured: baseline and 28 days after enrollment
WBC
changes in white blood cells (WBC) measured in units of 10^9 per liter blood
Measured: baseline and 28 days after enrollment
RBC
changes in red blood cells (RBC) measured in units of 10^12 per liter blood
Measured: baseline and 28 days after enrollment
MCV
changes in mean corpuscular volume (MCV) measured in units of fL
Measured: baseline and 28 days after enrollment
MCH
changes in mean corpuscular hemoglobin, measured in units of pg, the average amount of hemoglobin in a single RBC
Measured: baseline and 28 days after enrollment
MCHC
mean corpuscular hemoglobin concentration is the concentration of hemoglobin in a single RBC measured in units of g/L
Measured: baseline and 28 days after enrollment
RDW
changes in the RBC distribution width (RDW) are reported in units of percentage (%)
Measured: baseline and 28 days after enrollment
Platelets
changes in the platelet counts are reported in units of 10^9 per liter blood
Measured: baseline and 28 days after enrollment
Neutrophils
changes in neutrophils are reported in units of 10^9 per liter blood
Measured: baseline and 28 days after enrollment
Lymphocyte
changes in lymphocytes are reported in units of 10^9 per liter blood
Measured: baseline and 28 days after enrollment
Monocyte
changes in monocytes are reported in units of 10^9 per liter blood
Measured: baseline and 28 days after enrollment
Eosinophil
changes in eosinophils are reported in units of 10^9 cells per liter blood
Measured: baseline and 28 days after enrollment
Basophil
changes in basophils are reported in units of 10^9 cells per liter blood
Measured: baseline and 28 days after enrollment
NLR
Changes in the neutrophil to lymphocyte ratio (NLR) are reported as a dimensionless fraction of 1
Measured: baseline and 28 days after enrollment
Glucose
changes in blood glucose are reported in units of mmol per liter
Measured: baseline and 28 days after enrollment
Urea
changes in renal function as measured by blood urea are reported in units of mmol per liter
Measured: baseline and 28 days after enrollment
Creatinine
changes in creatinine are reported in units of micromol per liter
Measured: baseline and 28 days after enrollment
eGFR
changes in the estimated glomerular filtration rate (eGFR) are reported in units of mL/min/1.73m^2
Measured: baseline and 28 days after enrollment
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
Measured: baseline and 28 days after enrollment
Potassium
changes in plasma potassium are reported in units of mmol per liter, reference value 3.5-5.4 mmol per liter, bloodbook.com
Measured: baseline and 28 days after enrollment
Chloride
changes in plasma chloride are reported in uits of mmol per liter The reference range is 98-106 mmol per liter, bloodbook.com
Measured: baseline and 28 days after enrollment
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
Measured: baseline and 28 days after enrollment
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
Measured: baseline and 28 days after enrollment
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
Measured: baseline and 28 days after enrollment
GGT
changes in the liver enzyme gamma-glutamyl transferase in the blood are reported as units per liter
Measured: baseline and 28 days after enrollment
Copper
changes in copper concentration in the blood are reported in units of micro moles per liter
Measured: baseline and 28 days after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2021
- Study start28 Jan 2014
- Primary completion28 May 2014
- Study completion29 Sep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for NeuralgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized, double--blind, placebo controlled, parallel study
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mitosynergy LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04737278
- Sponsor's protocol ID
- 13MFHM
- Status last verified
- Mar 2021
- First submitted
- 25 Jan 2021
- Last updated
- 20 Apr 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04737278
- Acronym / sponsor ID
- 13MFHM
- Keywords
- Copper, nicotinic acid, energy, strength, fatigue, nerve pain, muscle pain, neuralgia
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Mitosynergy LLCIndustry (pharma, biotech, devices)
- Study start
- 28 Jan 2014 (actual)
- Primary completion
- 28 May 2014 (actual)
- Study completion
- 29 Sep 2014 (actual)
- First posted
- 3 Feb 2021 (actual)
- Results
- Posted 20 Apr 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- randomized, double--blind, placebo controlled, parallel study
| Arm | Type | Receives |
|---|---|---|
| Cunermuspir | Experimental | Drug: CunermuspirCunermuspir (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. |
| Placebo | Placebo comparator | Other: PlaceboOrganic evaporated cane juice powder, hypromellose, titanium dioxide. Same dosing as Cunermuspir arm |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (17 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CunermuspirAlso: cuprous nicotinic acidCopper Niacin Chelate, 6.06 mg per capsule Non-medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide | Drug | Cunermuspir |
| Placebosame non-medical ingredients and encapsulation as Intervention 1 | Other | Placebo |
Primary outcome
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.
Platelet ATP
Time frame: baseline and 28 days after enrollment
Platelet ATP levels were measured as previously published in the literature.
32 secondary outcomes
Household Chores and Neuro Muscular Sumptoms
Time frame: baseline and 28 days after enrollment
Cognition
Time frame: baseline and 28 days after enrollment
Heart Rate
Time frame: baseline and 28 days after enrollment
Diastolic Blood Pressure
Time frame: baseline and 28 days after enrollment
Systolic Blood Pressure
Time frame: baseline and 28 days after enrollment.
Hemoglobin
Time frame: baseline and 28 days after enrollment.
Hematocrit
Time frame: baseline and 28 days after enrollment
WBC
Time frame: baseline and 28 days after enrollment
RBC
Time frame: baseline and 28 days after enrollment
MCV
Time frame: baseline and 28 days after enrollment
MCH
Time frame: baseline and 28 days after enrollment
MCHC
Time frame: baseline and 28 days after enrollment
RDW
Time frame: baseline and 28 days after enrollment
Platelets
Time frame: baseline and 28 days after enrollment
Neutrophils
Time frame: baseline and 28 days after enrollment
Lymphocyte
Time frame: baseline and 28 days after enrollment
Monocyte
Time frame: baseline and 28 days after enrollment
Eosinophil
Time frame: baseline and 28 days after enrollment
Basophil
Time frame: baseline and 28 days after enrollment
NLR
Time frame: baseline and 28 days after enrollment
Glucose
Time frame: baseline and 28 days after enrollment
Urea
Time frame: baseline and 28 days after enrollment
Creatinine
Time frame: baseline and 28 days after enrollment
eGFR
Time frame: baseline and 28 days after enrollment
Sodium
Time frame: baseline and 28 days after enrollment
Potassium
Time frame: baseline and 28 days after enrollment
Chloride
Time frame: baseline and 28 days after enrollment
Bilirubin
Time frame: baseline and 28 days after enrollment
ALT
Time frame: baseline and 28 days after enrollment
AST
Time frame: baseline and 28 days after enrollment
GGT
Time frame: baseline and 28 days after enrollment
Copper
Time frame: baseline and 28 days after enrollment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Cunermuspir in people with Neuralgia and Myalgia, run by Mitosynergy LLC at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neuromuscular Symptoms (time frame: baseline and 28 days after enrollment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2021.