A Proof of Concept Study to Investigate the Effect of a New Treatment in Patient With Chronic Pain

NCT02459197 | Completed Results

• 1 other identifier: T1001-02
• Study Type: interventional
• Target: 114
• Locations: 2 countries
• Sites: 6

Brief Summary

The purpose of this clinical trial conducted in patients suffering from chronic pain is to study the relationship between individual patients' profile and their analgesic response

Conditions

Peripheral Neuropathies; Osteoarthritis

Keywords

Pain

Outcome Measures

Primary Outcomes (1)

• Patient's Change From Baseline of Pain Severity as Measured by the Weekly Means of the Daily Average Pain Scores (APS) During 4 Weeks of Treatment

  11-point Numeric Rating Scale (NRS); the 11 NRS scale ranges from 0 (No pain) to 10 (pain as bad as you can imagine); the baseline APS (weekly mean of the daily average pain score) was computed on the 7 last days before Visit 2 with available APS values; similarly, the end-of-treatment APS (or APS Week 4) was computed on the 7 last days before Visit 4 with available APS values.

  Time zero equals baseline (Day-28 to Day-14) up to Day 36

Secondary Outcomes (4)

• Patient's Change From Baseline of Pain Severity as Measured by the Brief Pain Inventory (BPI)

  Time zero equals baseline (Day-28 to Day-14) up to Day 29

• Patient's Change From Baseline of Investigator and Patient Global Assessment of Changes (IGAC and PGAC)

  Time zero equals baseline (Day-28 to Day-14) up to Day 29

• Patient's Change From Baseline of Heat Pain Threshold From Baseline to End of Treatment

  Time zero equals baseline (Day 1) up to Day 29

• For Osteoarthritic Patients Only: Patient's Change From Baseline of Osteoarthritic Physical Function, Pain and Stiffness as Assessed by Western Ontario and MacMaster (WOMAC) Scales From Baseline to End of Treatment

  Time zero equals baseline (Day-28 to Day-14) up to Day 29

Study Arms (2)

T4P1001

ACTIVE COMPARATOR

Behavioral: Heat Pain Stimuli A; Behavioral: Positive Video; Drug: Administration of T4P1001 capsules

Placebo

SHAM COMPARATOR

Behavioral: Heat Pain Stimuli B; Behavioral: Neutral Video; Drug: Administration of Placebo capsules

Interventions

Heat Pain Stimuli A BEHAVIORAL

T4P1001

Heat Pain Stimuli B BEHAVIORAL

Placebo

Positive Video BEHAVIORAL

T4P1001

Neutral Video BEHAVIORAL

Placebo

Administration of T4P1001 capsules DRUG

This treatment is given as add-on therapy to patient's regular analgesic treatment

T4P1001

Administration of Placebo capsules DRUG

This treatment is given as add-on therapy to patient's regular analgesic treatment

Placebo

Eligibility Criteria

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

You may qualify if:

• Are men or women of at least 18 years of age
• Diagnosed with Peripheral Neuropathic Pain (PNP) or knee or hip pain attributed to Osteoarthritis (OA) since at least 6 months
• Affiliated with national welfare
• Reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures
• Have given written informed consent approved by the relevant Ethics Committee (EC) governing the study sites
• Patients will be required to report pain with a score between 4 and 8 inclusive on the mean Average Pain Score (APS) during the baseline period preceding randomization and to have completed at least 10 days of pain assessments in their diary between Visit 1 and Visit 2. If more than 10 days were completed, the mean APS will be calculated on the last 10 ones.
• Diagnosis criterium for PNP: Patient with chronic PNP supported by a distinct neuroanatomical plausible distribution with sensory signs and symptoms, and consecutive to one of the following causes: a traumatic event, a surgical procedure (excluding limb amputation), radiculopathy, post- herpetic or post- zoster neuralgia, diabetic polyneuropathy or post chemotherapy. Diagnosis will have to be confirmed by the DN4 questionnaire at the screening visit (pain is considered as neuropathic if DN4 score ≥ 4)
• Diagnosis criterium for OA: Patient with a unilateral or bilateral OA of the knee or hip diagnosed according to the American College of Rheumatology (ACR) criteria based on clinical and radiographic evidence (Altman et al. 1986). The clinical diagnosis of OA will be confirmed by the ACR clinical and radiographic criteria for classification of idiopathic OA of the knee or hip based upon the following criteria:
• Knee or hip pain as an average at least half of the time for the last 3 months before screening visit
• At least 1 of the following 3 conditions: Age \> 50 or morning stiffness \< 30 minutes or crepitus
• Kellgren and Lawrence grade \> 1 as assessed if possible by an X-ray of the referred joint to confirm the diagnosis. If considered medically required by the Investigator based on patient needs and as part of regular patient management, a new anterior-posterior view X- ray should be obtained and reviewed by Investigator or his delegates to verify that the patient meets the disease diagnostic criteria

You may not qualify if:

• Patient changed his/her " regular analgesic therapy " for PNP or OA in the last 4 weeks prior to Visit 1 or during the study.
• Patient's regular analgesic treatment for PNP or OA consists of more than 2 different treatments, with neurostimulation being considered as an analgesic treatment for PNP.
• Patient reported unvariable APS and WPS scores between Visit 1 and Visit 2 (systematically the same APS score and the same WPS score reported).
• Use or plan to use non-topical corticosteroids during the study.
• Have initiated (or plan to initiate) a program (or modify an existing program in frequency and/or intensity) of physiotherapy or behavioral therapy such as pain self-management, hypnosis, sophrology, meditation program within 2 weeks prior to Visit 1 or during the study.
• Pregnant, breastfeeding, or willing to be pregnant within 3 months.
• Patients with a current or recent history, as determined by the Investigator, of severe, progressive, and/or uncontrolled renal, hepatic, haematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological, or cerebral disease which would interfere with the patient's participation in the study.
• Uncontrolled epilepsy.
• Any current primary psychiatric condition, including depression or personality disorders (such as Axe II of Diagnostic and Statistical Manual of Mental Disorders (DSM-IV); personality disorders and mental retardation).
• Alcohol dependence or regular use of known drugs of abuse (e.g., amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, methadone, opiates, and phencyclidine).
• Any other relevant medical disorder/acute disease state judged by the Investigator as likely to interfere with the trial or represent a risk for the patient.
• Any close relationship with the Investigators or the Sponsor (i.e. belonging to immediate family or subordination link).
• Patient under legal protection, according to the national law.
• Are persons who have previously received T4P1001, have completed or withdrawn from this study or any other study investigating T4P1001.
• Neuropathic pain due to trigeminal neuralgia, central pain or phantom limb pain.

Sponsors & Collaborators

• Tools4Patient: lead
• International Drug Development Institute: collaborator

Study Sites (6)

ATC sa

Liège, 4000, Belgium

Location

CIC Clermont-Ferrand, CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

Location

Eurofins Optimed

Gières, 38610, France

Location

Clinique Breteche

Nantes, 44046, France

Location

Institut Curie

Paris, 75005, France

Location

Centre d'Evaluation et Traitement de la Douleur, CHU Saint-Etienne

Saint-Etienne, 42055, France

Location

MeSH Terms

Conditions

Peripheral Nervous System Diseases; Osteoarthritis; Pain

Condition Hierarchy (Ancestors)

Neuromuscular Diseases; Nervous System Diseases; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Chief Scientific Officer
• Organization: Tools4Patient

alvaro.pereira@tools4patient.com

+32 71 91

Study Officials

• Alvaro Pereira

  Tools4Patient

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2015
• First Posted: June 1, 2015
• Study Start: June 1, 2015
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: August 28, 2019
• Results First Posted: August 1, 2019

Record last verified: 2019-08

Locations

BE (1); FR (5)