Clinical trial NCT04737278: 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
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Neuralgia
Myalgia
Keywords: Copper
nicotinic acid
energy
strength
fatigue
nerve pain
muscle pain
neuralgia
myalgia
Lead sponsor: Mitosynergy LLC
Sponsor class: INDUSTRY
First posted: 2021-02-03
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized, double--blind, placebo controlled, parallel study
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Neuromuscular Symptoms
timeFrame: baseline and 28 days after enrollment
measure: Platelet ATP
timeFrame: baseline and 28 days after enrollment
Secondary outcomes:
measure: Household Chores and Neuro Muscular Sumptoms
timeFrame: baseline and 28 days after enrollment
measure: Cognition
timeFrame: baseline and 28 days after enrollment
measure: Heart Rate
timeFrame: baseline and 28 days after enrollment
measure: Diastolic Blood Pressure
timeFrame: baseline and 28 days after enrollment
measure: Systolic Blood Pressure
timeFrame: baseline and 28 days after enrollment.
measure: Hemoglobin
timeFrame: baseline and 28 days after enrollment.
measure: Hematocrit
timeFrame: baseline and 28 days after enrollment
measure: WBC
timeFrame: baseline and 28 days after enrollment
measure: RBC
timeFrame: baseline and 28 days after enrollment
measure: MCV
timeFrame: baseline and 28 days after enrollment
measure: MCH
timeFrame: baseline and 28 days after enrollment
measure: MCHC
timeFrame: baseline and 28 days after enrollment
measure: RDW
timeFrame: baseline and 28 days after enrollment
measure: Platelets
timeFrame: baseline and 28 days after enrollment
measure: Neutrophils
timeFrame: baseline and 28 days after enrollment
measure: Lymphocyte
timeFrame: baseline and 28 days after enrollment
measure: Monocyte
timeFrame: baseline and 28 days after enrollment
measure: Eosinophil
timeFrame: baseline and 28 days after enrollment
measure: Basophil
timeFrame: baseline and 28 days after enrollment
measure: NLR
timeFrame: baseline and 28 days after enrollment
measure: Glucose
timeFrame: baseline and 28 days after enrollment
measure: Urea
timeFrame: baseline and 28 days after enrollment
measure: Creatinine
timeFrame: baseline and 28 days after enrollment
measure: eGFR
timeFrame: baseline and 28 days after enrollment
measure: Sodium
timeFrame: baseline and 28 days after enrollment
measure: Potassium
timeFrame: baseline and 28 days after enrollment
measure: Chloride
timeFrame: baseline and 28 days after enrollment
measure: Bilirubin
timeFrame: baseline and 28 days after enrollment
measure: ALT
timeFrame: baseline and 28 days after enrollment
measure: AST
timeFrame: baseline and 28 days after enrollment
measure: GGT
timeFrame: baseline and 28 days after enrollment
measure: Copper
timeFrame: baseline and 28 days after enrollment
Other outcomes:
Locations:
city: London
country: Canada
facility: KGK Synergize now KGK Science
state: Ontario
Study officials:
References: