Phase 2 N=56 Randomized Double-blind Treatment

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

Neuralgia · Myalgia

Bottom Line

View on ClinicalTrials.gov: NCT04737278 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2021

Primary outcome: Primary: Neuromuscular Symptoms — 36.5; 43.5; 28.5; 32.7 score on a scale — p=<0.01

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Cunermuspir (Drug); Placebo (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Mitosynergy LLC
Primary completion: May 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Neuromuscular Symptoms	36.5; 43.5; 28.5; 32.7	<0.01 sig
PRIMARY Platelet ATP	43.6; 42; 59.2; 51.2	0.15
SECONDARY Household Chores and Neuro Muscular Sumptoms	27.6; 34.9; 16.7; 29.3	<0.01 sig
SECONDARY Cognition	18; 16; 22; 18	0.54
SECONDARY Heart Rate	70.3; 68.2; 68.3; 69.7	0.54
SECONDARY Diastolic Blood Pressure	70.5; 75.0; 69.3; 74.6	<0.01 sig
SECONDARY Systolic Blood Pressure	111.7; 114.6; 109.5; 112.3	0.31
SECONDARY Hemoglobin	140.3; 141.3; 142.2; 141.0	0.48
SECONDARY Hematocrit	0.411; 0.416; 0.416; 0.415	0.84
SECONDARY WBC	5.93; 5.82; 5.88; 6.00	0.63
SECONDARY RBC	4.76; 4.74; 4.82; 4.73	0.05
SECONDARY MCV	86.2; 87.7; 86.4; 87.7	<0.01 sig
SECONDARY MCH	29.5; 29.81; 29.48; 29.86	<0.01 sig
SECONDARY MCHC	342.4; 339.9; 341.2; 340.5	0.48
SECONDARY RDW	13.78; 13.80; 13.77; 13.93	0.06
SECONDARY Platelets	250; 266; 255; 269	0.02 sig
SECONDARY Neutrophils	3.28; 3.35; 3.15; 3.60	0.03 sig
SECONDARY Lymphocyte	2.01; 1.83; 2.04; 1.74	<0.01 sig
SECONDARY Monocyte	0.450; 0.475; 0.473; 0.500	0.47
SECONDARY Eosinophil	0.154; 0.143; 0.181; 0.130	0.11
SECONDARY Basophil	0.0107; 0.0071; 0.0077; 0.0074	0.98
SECONDARY NLR	1.77; 1.90; 1.67; 2.24	0.025 sig
SECONDARY Glucose	5.12; 5.30; 5.25; 5.24	0.06
SECONDARY Urea	5.16; 5.33; 5.05; 5.26	0.51
SECONDARY Creatinine	72.2; 72.9; 72.3; 73.7	0.38
SECONDARY eGFR	90.4; 88.8; 91.2; 85.9	0.01 sig
SECONDARY Sodium	143.39; 143.14; 142.62; 141.89	0.23
SECONDARY Potassium	4.86; 4.84; 4.44; 4.39	0.58
SECONDARY Chloride	106.14; 106.43; 105.08; 105.15	0.87
SECONDARY Bilirubin	11.0; 9.3; 11.2; 9.9	0.36
SECONDARY ALT	27.6; 28.5; 28.2; 28.4	0.95
SECONDARY AST	23.0; 23.1; 24.2; 25.8	0.62
SECONDARY GGT	20.9; 28.6; 24.0; 25.6	0.11
SECONDARY Copper	16.18; 17.62; 16.6; 17.57	0.03 sig

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04737278). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.