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

NCT04737278 | Completed Phase 1 Results DMC

• 1 other identifier: 13MFHM
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Neuralgia; Myalgia

Keywords

Copper; nicotinic acid; energy; strength; fatigue; nerve pain; muscle pain; neuralgia; myalgia

Outcome Measures

Primary Outcomes (2)

• 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.

  baseline and 28 days after enrollment

• Platelet ATP

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

  baseline and 28 days after enrollment

Secondary Outcomes (32)

• Household Chores and Neuro Muscular Sumptoms

  baseline and 28 days after enrollment

• Cognition

  baseline and 28 days after enrollment

• Heart Rate

  baseline and 28 days after enrollment

• Diastolic Blood Pressure

  baseline and 28 days after enrollment

• Systolic Blood Pressure

  baseline and 28 days after enrollment.

Study Arms (2)

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.

Drug: Cunermuspir

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Cunermuspir DRUG

Copper Niacin Chelate, 6.06 mg per capsule Non-medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide

Also known as: cuprous nicotinic acid

Cunermuspir

Placebo OTHER

same non-medical ingredients and encapsulation as Intervention 1

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mitosynergy LLC: lead

Study Sites (1)

KGK Synergize now KGK Science

London, Ontario, N6A 5R8, Canada

Location

MeSH Terms

Conditions

Neuralgia; Myalgia; Fatigue

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases; Musculoskeletal Pain

Results Point of Contact

• Title: Dr Barbara Leinweber, PhD
• Organization: BDL Biochemistry, consultant for Mitosynergy

barb@bdlbiochem.com

(520)334-5444

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: randomized, double--blind, placebo controlled, parallel study

Study Record Dates

• First Submitted: January 25, 2021
• First Posted: February 3, 2021
• Study Start: January 28, 2014
• Primary Completion: May 28, 2014
• Study Completion: September 29, 2014
• Last Updated: April 20, 2021
• Results First Posted: April 20, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: The data will be shared as soon as Mitosynergy meets the regulatory requirements for 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.

Locations

CA (1)