NCT04737278

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

Completed Phase 1, PHASE2 Results posted Last updated 20 April 2021

What this trial tests

Phase 1, PHASE2 trial testing Cunermuspir in Neuralgia in 56 participants. Completed in 29 September 2014.

Timeline

28 January 2014

Primary endpoint
28 May 2014

29 September 2014

Quick facts

Lead sponsor	Mitosynergy LLC
Phase	Phase 1, PHASE2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	56
Start date	28 January 2014
Primary completion	28 May 2014
Estimated completion	29 September 2014
Sites	1 location across Canada

Drugs / interventions tested

• Cunermuspir — full drug profile →
• Placebo

Conditions studied

• Neuralgia — all drugs for Neuralgia →
• Myalgia — all drugs for Myalgia →

Sponsor

Mitosynergy LLC

Who can join

Adults 18 to 75, any sex, with Neuralgia or Myalgia. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Neuromuscular Symptoms Primary · 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.

baseline

Group	Value	95% CI
Cunermuspir	36.5	± 16.4
Placebo	43.5	± 21.1

Day 28

Group	Value	95% CI
Cunermuspir	28.5	± 18.6
Placebo	32.7	± 23.0

Platelet ATP Primary · baseline and 28 days after enrollment

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

baseline

Group	Value	95% CI
Cunermuspir	43.6	± 16.4
Placebo	42	± 13.1

day 28

Group	Value	95% CI
Cunermuspir	59.2	± 20.1
Placebo	51.2	± 15.0

Household Chores and Neuro Muscular Sumptoms Secondary · 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 emotion

baseline

Group	Value	95% CI
Cunermuspir	27.6	± 16.8
Placebo	34.9	± 16.9

day 28

Group	Value	95% CI
Cunermuspir	16.7	± 10.9
Placebo	29.3	± 28.7

Cognition Secondary · 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. Si

baseline

Group	Value	95% CI
Cunermuspir	18
Placebo	16

day 28

Group	Value	95% CI
Cunermuspir	22
Placebo	18

Heart Rate Secondary · baseline and 28 days after enrollment

heart rate is measured in beats per minute

baseline

Group	Value	95% CI
Cunermuspir	70.3	± 10.8
Placebo	68.2	± 8.1

day 28

Group	Value	95% CI
Cunermuspir	68.3	± 9.7
Placebo	69.7	± 9.4

Diastolic Blood Pressure Secondary · baseline and 28 days after enrollment

The diastolic blood pressure was measured in mm Hg

baseline

Group	Value	95% CI
Cunermuspir	70.5	± 6.4
Placebo	75.0	± 9.4

day 28

Group	Value	95% CI
Cunermuspir	69.3	± 7.3
Placebo	74.6	± 7.3

Systolic Blood Pressure Secondary · baseline and 28 days after enrollment.

Systolic blood pressure was measured in mm Hg

baseline

Group	Value	95% CI
Cunermuspir	111.7	± 10.6
Placebo	114.6	± 13.1

day 28

Group	Value	95% CI
Cunermuspir	109.5	± 15.8
Placebo	112.3	± 11.2

Hemoglobin Secondary · baseline and 28 days after enrollment.

changes measured in g/L blood

baseline

Group	Value	95% CI
Cunermuspir	140.3	± 12.9
Placebo	141.3	± 12.4

day 28

Group	Value	95% CI
Cunermuspir	142.2	± 14.3
Placebo	141.0	± 12.0

Hematocrit Secondary · baseline and 28 days after enrollment

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

baseline

Group	Value	95% CI
Cunermuspir	0.411	± 0.034
Placebo	0.416	± 0.032

day 28

Group	Value	95% CI
Cunermuspir	0.416	± 0.038
Placebo	0.415	± 0.031

WBC Secondary · baseline and 28 days after enrollment

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

baseline

Group	Value	95% CI
Cunermuspir	5.93	± 1.57
Placebo	5.82	± 1.50

day 28

Group	Value	95% CI
Cunermuspir	5.88	± 1.81
Placebo	6.00	± 1.34

RBC Secondary · baseline and 28 days after enrollment

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

baseline

Group	Value	95% CI
Cunermuspir	4.76	± 0.38
Placebo	4.74	± 0.38

day 28

Group	Value	95% CI
Cunermuspir	4.82	± 0.41
Placebo	4.73	± 0.38

MCV Secondary · baseline and 28 days after enrollment

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

baseline

Group	Value	95% CI
Cunermuspir	86.2	± 3.9
Placebo	87.7	± 3.1

day 28

Group	Value	95% CI
Cunermuspir	86.4	± 4.3
Placebo	87.7	± 3.1

Adverse events — posted to ClinicalTrials.gov

Time frame: 28 days. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Cunermuspir

Serious: 0/28 (0%)

Deaths: 0/28

Placebo

Serious: 0/28 (0%)

Deaths: 0/28

Other adverse events (4 terms — click to expand)

Reaction	System	Cunermuspir	Placebo
nasea	Gastrointestinal disorders	—	—
seasonal respiratory infections	Infections and infestations	—	—
head ache	Nervous system disorders	—	—
moderate dermatitis	Skin and subcutaneous tissue disorders	—	—

Data from ClinicalTrials.gov NCT04737278 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. The Role of Copper Homeostasis in Brain Disease.
   An Y, Li S, Huang X, Chen X, et al · · 2022 · cited 108× · PMID 36430330 · DOI 10.3390/ijms232213850