Naltrexone and Clonidine Combination (ATNC05) in the Treatment of Chronic Back Pain

NCT01415895 | Completed Phase 2 DMC

• 1 other identifier: AT110491
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

The study includes back pain of the cervical, thoracic, and the lumbar regions.

Conditions

Back Pain; Lower Back Pain; Cervical Pain

Keywords

back pain; cervical pain; neuropathic pain; radicular pain

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in Brief Pain Inventory 24-hour Pain Scores for average pain (Question #5)

  The Brief Pain Inventory is a self-reported medical questionnaire used to measure pain over the past 24-hours - worst pain (Question 3), least pain (Question 4), average pain (Question 5), right now pain (Question 6) and at night pain (Question 7). The score ranges from 0 to 10 (0 - no pain) (10 - intolerable pain).

  baseline to week 3

Secondary Outcomes (18)

• Change from Baseline in Brief Pain Inventory 24-hour assessment of interference in function (Questions 9a - 9i).

  baseline to week 1, week 2 and week 3

• Change From Baseline in Brief Pain Inventory 24-hour subject's Global Impression of Improvement (Question 8)

  baseline to week 1, week 2 and week 3

• Change From Baseline in the subject's Global Assessment of Treatment Satisfaction today

  baseline to week 1, week 2 and week 3

• Change from Baseline in the subject's perception of Ability to Tolerate the study drug and the severity of side effects today.

  baseline to week 1, week 2 and week 3

• Change From Baseline in Oswestry Disability Index and Neck Disability composite scores(ODI), to Week 1, Week 2, and Week 3

  baseline to week 1, week 2 and week 3

Study Arms (2)

ATNC05 - a study drug capsule

EXPERIMENTAL

Naltrexone and Clonidine Combination (ATNC05)

Drug: Naltrexone and Clonidine Combination

placebo

PLACEBO COMPARATOR

Drug: placebo

Interventions

Naltrexone and Clonidine Combination DRUG

subjects will receive 1 study drug capsule by mouth twice daily for 3 weeks, followed by 1 capsule in the morning for 3 days.

Also known as: ATNC05

ATNC05 - a study drug capsule

placebo DRUG

subjects will receive 1 placebo capsule by mouth twice daily for 3 weeks, followed by 1 capsule in the morning for 3 days.

placebo

Eligibility Criteria

• Age: 19 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The subject has chronic back pain for \> 3 months in the lumbar, thoracic or cervical regions.
• The average pain intensity scale during the screening week is 4/10 - 8/10 (On an 11-point Numeric Pain Intensity Scale with 0 = no pain and 10 = worst pain imaginable).
• The subject has not taken Opioid medications 7 days prior to initiation of study drug.
• The subject has a heart rate of 60bpm or above and/or systolic blood pressure 90 or above.
• The subject is willing to refrain from using NSAIDS, Acetaminophen or muscle relaxants, unless for rescue, for the duration of the study The subject is willing to refrain from using Opioid medications and excessive alcohol for the duration of the study.
• The subject is able to read, understand and follow the study instructions, including completion of questionnaires at home.
• The subject must sign an informed consent document indicating willingness to participate.
• If the subject is a female, she must be post-menopausal, not currently pregnant or nursing. A female of child bearing potential should be using a reliable contraception method during the course of the study.

You may not qualify if:

• The subject has a positive urine drug screen. The subject has a history of significant neurological, hepatic, renal, endocrine, cardiovascular, gastrointestinal, pulmonary, or metabolic disease.
• The subject has any significant deviations from normal in physical examination, electrocardiogram (ECG), Echocardiogram or clinical laboratory tests, as evaluated by the investigator.
• The subject has a history of an allergic reaction to the components of the study drug.
• The subject has acute back or cervical pain. The subject has muscular back or cervical pain. The subject has back or cervical pain other than chronic Radicular pain.

Sponsors & Collaborators

• Annette C. Toledano MD: lead

Study Sites (1)

Annette C. Toledano MD

North Miami, Florida, 33181, United States

Location

MeSH Terms

Conditions

Back Pain; Low Back Pain; Neck Pain; Neuralgia

Interventions

Naltrexone

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Naloxone; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Annette C Toledano, MD

  Allodynic Therapeutics, Inc

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor/Investigator

Study Record Dates

• First Submitted: August 11, 2011
• First Posted: August 12, 2011
• Study Start: July 1, 2011
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: April 14, 2021

Record last verified: 2021-04

Locations

US (1)