Peripheral NeuropathiesNCT02459197

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

A study testing Heat Pain Stimuli A, Heat Pain Stimuli B and Positive Video in people with Peripheral Neuropathies and Osteoarthritis, run by Tools4Patient at 6 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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 Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Peripheral Neuropathies, Osteoarthritis
What is being tested?: Heat Pain Stimuli A, Heat Pain Stimuli B and Positive Video
Type of treatment: Pill or oral medicine, Lifestyle or therapy programme
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 114 participants
Where: 6 sitesin 2 countries
Study dates: Jun 2015to Oct 2016
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

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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

Who cannot join

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.

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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.
Patient currently enrolled in a clinical trial involving use of an investigational drug or device, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study, or in an exclusion period according to the national law.
Neuropathic pain due to trigeminal neuralgia, central pain or phantom limb pain.
Have initiated, are planning to initiate an electrical stimulation (or neurostimulation) therapy or modify an existing neurostimulation within 4 weeks prior to Visit 1 or during study period.
Non-ambulatory due to OA.
Use of lower extremity assistive devices other than a cane such as crutches or walker or a knee brace or a "shoe lift" in relation to OA.
Have used in relation to OA systemic corticosteroids 4 weeks prior to Visit 1; Intra-muscular corticosteroid injections or Intra-articular injection of steroids into the referred knee/hip within 3 months before Visit 1, Intra-articular injection of corticosteroids into any other sites than the referred knee/hip within 4 weeks prior to Visit 1(corticosteroids in topical use are allowed).
Have used viscosupplementation or intra articular injection of hyaluronic acid in the referred joint within 3 months prior to Visit 1.

Trial locations and contacts

6 sites in 2 countries.

Country

City, postcode or hospital

6 sites in 2 countries

France5 sites

CIC Clermont-Ferrand, CHU Clermont-Ferrand
Clermont-Ferrand, 63003
Eurofins Optimed
Gières, 38610
Clinique Breteche
Nantes, 44046
Institut Curie
Paris, 75005
Centre d'Evaluation et Traitement de la Douleur, CHU Saint-Etienne
Saint-Etienne, 42055

Other trials in France

Belgium1 site

ATC sa
Liège, 4000

Other trials in Belgium

About this study

Official title: A Proof of Concept Study to Investigate the Effect of T4P1001 Treatment in Patients With Peripheral Neuropathic Pain or Osteoarthritic Pain of Knee or Hip

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
Being tested: Heat Pain Stimuli A, Heat Pain Stimuli B, Positive Video, Neutral Video, Administration of T4P1001 capsules
Keywords: Pain
Medical subject headings: Peripheral Nervous System Diseases, Osteoarthritis, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Heat Pain Stimuli ABehavioural
Heat Pain Stimuli BBehavioural
Positive VideoBehavioural
Neutral VideoBehavioural
Administration of T4P1001 capsulesDrug
This treatment is given as add-on therapy to patient's regular analgesic treatment
Administration of Placebo capsulesDrug
This treatment is given as add-on therapy to patient's regular analgesic treatment

Study groups in NCT02459197
Study group	Role	What they receive
T4P1001	Active comparator	Not described Receives: Behavioral: Heat Pain Stimuli A; Behavioral: Positive Video; Drug: Administration of T4P1001 capsules
Placebo	Sham comparator	Not described Receives: Behavioral: Heat Pain Stimuli B; Behavioral: Neutral Video; Drug: Administration of Placebo capsules

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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)
BPI is a self-reported scale that measures the severity of pain and the interference of pain on function (Charles S. Cleeland © 2009). In the short form of BPI, there are 4 questions assessing worst pain, least pain, actual pain and average pain in the past 24 hours. The severity scores range from 0 (no pain) to 10 (pain as bad as you can imagine). There are 7 questions assessing the interference of pain in the past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep and enjoyment of life. The interference scores range from 0 (does not interfere) to 10 (completely interferes).
Measured: 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)
IGAC and PGAC are subjective evaluations using a NRS with 0 meaning "best condition" and 10 "worst condition"
Measured: 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
celcius degree, arithmetic average of 6 tests.
Measured: 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
The WOMAC (Bellamy et al., 1988) is a patient-rated instrument that measures OA symptoms.
The questionnaire contains 5 pain questions, 2 stiffness questions, and 17 physical function questions (24 questions total). Each question utilizes a 5-points Numeric Rating Scale (NRS) between 0-4; from 0=none to 4=extreme. Range of possible subscale scores: pain=0-20, stiffness=0-8 and physical function=0-68; higher scores for each subscale indicate worse outcomes.
The WOMAC was completed at each Visit except for Visit 5 by OA patients only.
Measured: Time zero equals baseline (Day-28 to Day-14) up to Day 29

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2015Oct 2016

First posted1 Jun 2015 (estimated)
Study startJun 2015
Primary completionOct 2016
Study completionOct 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Peripheral NeuropathiesStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 114 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02459197
Sponsor's protocol ID: T1001-02
Status last verified: Aug 2019
First submitted: 28 May 2015
Last updated: 28 Aug 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Peripheral Neuropathies trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Proof of Concept Study to Investigate the Effect of T4P1001 Treatment in Patients With Peripheral Neuropathic Pain or Osteoarthritic Pain of Knee or Hip
ClinicalTrials.gov ID: NCT02459197
Acronym / sponsor ID: T1001-02
Conditions: Peripheral Neuropathies, Osteoarthritis
Keywords: Pain
Study type: Interventional
Recruitment status: Completed
Enrolment: 114 participants (actual)
Lead sponsor: Tools4PatientUniversity, hospital or other
Collaborators: International Drug Development Institute
Study start: Jun 2015
Primary completion: Oct 2016 (actual)
Study completion: Oct 2016 (actual)
First posted: 1 Jun 2015 (estimated)
Results: Posted 1 Aug 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
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

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

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

Key exclusion criteria (21 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Heat Pain Stimuli A	Behavioural	T4P1001
Heat Pain Stimuli B	Behavioural	Placebo
Positive Video	Behavioural	T4P1001
Neutral Video	Behavioural	Placebo
Administration of T4P1001 capsulesThis treatment is given as add-on therapy to patient's regular analgesic treatment	Drug	T4P1001
Administration of Placebo capsulesThis treatment is given as add-on therapy to patient's regular analgesic treatment	Drug	Placebo

Primary outcome

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

4 secondary outcomes

Patient's Change From Baseline of Pain Severity as Measured by the Brief Pain Inventory (BPI)
Time frame: 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 frame: 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 frame: 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 frame: Time zero equals baseline (Day-28 to Day-14) up to Day 29

Results and safety

Results posted to the registry on 1 Aug 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
T4P1001	58	58
Placebo	56	55

Primary outcome: 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

Time frame: Time zero equals baseline (Day-28 to Day-14) up to Day 36. Mean (Standard Deviation). Unit: score on a scale

Measure	T4P1001 n = 57	Placebo n = 53
Value	0.54 (1.92)	0.95 (1.86)

Population analysed: 3 patients who completed the study were excluded from the Analysis Population due to protocol violations. Therefore only 110 patients were included in the Analysis Population.

4 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
T4P1001	0 of 58 (0%)	14 of 58 (24.1%)	Not reported
Placebo	1 of 56 (1.8%)	13 of 56 (23.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Peripheral Neuropathies

Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruitingObservational study
Postural Control and Balance Performance in Patients With Carpal Tunnel Syndrome
Carpal Tunnel Syndrome (CTS), Postural Assessment
Active, not recruiting
The AIUR Trial: Surgical Gloves to Prevent Peripheral Neuropathy
Chemotherapy-induced Peripheral Neuropathy
Active, not recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Alvaro Pereira study director

Tools4Patient

6 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Heat Pain Stimuli A, Heat Pain Stimuli B and Positive Video in people with Peripheral Neuropathies and Osteoarthritis, run by Tools4Patient at 6 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in France, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: Time zero equals baseline (Day-28 to Day-14) up to Day 36). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02459197.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2019.