Fenofibrate Treatment in SCI

NCT02455336 | Completed Phase 2 Results FDA Drug

• 1 other identifier: B1925-P
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 2

Brief Summary

Cardiovascular disease-related morbidity in persons with spinal cord injury (SCI) occurs earlier in life, at a greater prevalence than that of the general population, and is the primary cause of death after the first year of injury. During the chronic phase of SCI, a characteristic dyslipidemia emerges, which is characterized by low serum high density lipoprotein cholesterol (HDL-C) concentrations, with values often qualifying to be an independent risk factor for coronary artery disease, and elevations in serum triglycerides (TG). Serum low density lipoprotein cholesterol concentrations in those with SCI are usually similar to those of the general population. The current proposal in persons with SCI aims to determine the safety and efficacy of short-term fenofibrate treatment, an anti-lipid medication whose primary action lowers serum TG and raises serum HDL-C levels.

Conditions

Spinal Cord Injury; Dyslipidemia

Keywords

tetraplegia; paraplegia; hypertriglyceridemia; hyperlipidemia; peroxisome proliferator-activated receptor alpha

Outcome Measures

Primary Outcomes (1)

• Triglyceride Concentration (Percent Change From Baseline)

  To determine the efficacy of fenofibrate monotherapy after 2 months of treatment to improve the lipoprotein profile; a successful response will be defined as a 25% reduction in the serum TG concentration at 2 months.

  two months from initiating drug treatment

Secondary Outcomes (1)

• Triglyceride Concentration (Percent Change From Baseline)

  four months from initiating drug treatment

Other Outcomes (1)

• Adverse Event Profile

  4 months

Study Arms (2)

Fenofibrate

EXPERIMENTAL

Subjects with adverse TG concentrations (i.e., paraplegia: \>/=135 mg/dl; tetraplegia \>/=115 mg/dl) will be randomized to receive once daily fenofibrate therapy (i.e., 145 mg) for 4 months

Drug: Fenofibrate

No Intervention

OTHER

Subjects with adverse TG concentrations (i.e., paraplegia: \>/=135 mg/dl; tetraplegia \>/=115 mg/dl) will be randomized to receive no therapy for 4 months

Other: No intervention

Interventions

Fenofibrate DRUG

Fenofibrate is a peroxisome proliferator-activated receptor alpha agonist that is demonstrated to reduce triglyceride concentrations in the blood.

Fenofibrate

No intervention OTHER

A cohort of participants will be randomized to receive no study drug, but will engage in study encounters.

No Intervention

Eligibility Criteria

• Age: 21 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, age 21 to 69;
• Chronic (e.g., duration of injury at least 6 months), stable SCI (regardless of level of neurological lesion);
• American Spinal Injury Association Impairment Scale (AIS) designation of A, B or C; and
• TG concentration 135 mg/dl (paraplegia) or 115 mg/dl (tetraplegia).

You may not qualify if:

• Acute illness or infection;
• Reduced kidney function (by glomerular filtration rate (GFR \<60 ml/min) or liver function tests (LFTs 2.5 standard deviations above the upper limit of normal);
• Current pharmacological treatment with: HMG-CoA reductase inhibitors (statins), or any other hypolipidemic agent; anti-coagulant therapy; cyclosporine; or any other medications known to effect the TG concentration (i.e., -blockers, thiazides or estrogen);
• Hypersensitivity to fenofibrate;
• Existing diagnosis of atherosclerosis, congestive heart failure, or recent history of myocardial infarction (i.e., 12 months);
• Pregnancy or women who may become pregnant during the course of the study, or those who are nursing;
• Diminished mental capacity; and
• Inability or unwillingness of subject to provide informed consent.

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (2)

Kessler Institute for Rehabilitation

West Orange, New Jersey, 07052, United States

Location

James J. Peters VA Medical Center, Bronx, NY

The Bronx, New York, 10468, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries; Dyslipidemias; Quadriplegia; Paraplegia; Hypertriglyceridemia; Hyperlipidemias

Interventions

Fenofibrate

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fibric Acids; Isobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Phenyl Ethers; Ethers; Benzophenones; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenols; Ketones

Results Point of Contact

• Title: Michael F. La Fountaine, EdD, ATC, FACSM
• Organization: James J. Peters VA Medical Center

michael.lafountaine@va.gov

718-584-9000

Study Officials

• Michael F LaFountaine, EdD

  James J. Peters Veterans Affairs Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2015
• First Posted: May 27, 2015
• Study Start: May 18, 2015
• Primary Completion: August 1, 2018
• Study Completion: August 1, 2018
• Last Updated: June 26, 2019
• Results First Posted: June 26, 2019

Record last verified: 2019-05

Locations

US (2)