Peripheral NeuropathiesNCT02301169

A Study to Investigate the Effects of a New Treatment in Patients With Chronic Pain

A study testing Heat pain stimuli A, Video A and Administration of T4P1001 capsules in people with Peripheral Neuropathies, run by Tools4Patient at 1 site in France.

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
What is being tested?: Heat pain stimuli A, Video A and Administration of T4P1001 capsules
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: 42 participants
Where: 1 siteFrance
Study dates: Mar 2014to Nov 2014
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

Men or women of at least 18 years of age
Body weight of more than 40 kg and less than 120 kg with a BMI between 19-31 kg/m2 inclusive
Diagnosed with Peripheral Neuropathic Pain (PNP) since at least 6 months
Being affiliated with the national welfare system
Are 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 site

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PNP disease diagnosis inclusion criteria:
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-zooster neuralgia, diabetic polyneuropathy or post-anticancer chemotherapy. Diagnosis will have to be confirmed by the DN4 questionnaire at the screening visit (pain is considered as neuropathic if DN4 score ≥ 4)
Pain present since at least 6 months
Patients will be required to have a score between 4 and 8 inclusive on the mean Average Pain Score (APS) Numeric Rating Scale (NRS) during the baseline period preceding randomization (data collected in patient diary) and to have completed at least 4 days of pain assessment

Who cannot join

Pregnant, breastfeeding, or willing to be pregnant within 2 months
With a current or recent history, as determined by the Investigator, of severe, progressive, and/or uncontrolled renal, hepatic, hematological, 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 major depression or major 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)
Acute disease state within 7 days before Visit 2

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Any other relevant medical disorder 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
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 national law
Neuropathic pain due to trigeminal neuralgia, central pain, complex regional pain syndrome and phantom limb pain
Plan to have a session of physiotherapy or comportemental therapy such as gestion of pain, hypnosis, sophrology, meditation program during the study
Have initiated or have planned an electrical stimulation (or neurostimulation) therapy within 2 weeks prior to Visit 1 or during the study period up to Visit 5
Patient changed his/her " regular therapy " in the last 4 months

Trial locations and contacts

1 site in 1 country.

France1 site

CIC Clermont-Ferrand, CHU Clermont-Ferrand
Clermont-Ferrand, 63003

Other trials in France

About this study

Official title: A Study to Investigate the Effects of T4P1001 Treatment in Patients With Peripheral Neuropathic Pain

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
Being tested: Heat pain stimuli A, Video A, Administration of T4P1001 capsules, Heat pain stimuli B, Video B
Keywords: Pain
Medical subject headings: Peripheral Nervous System Diseases, Pain

What participants receive

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

Heat pain stimuli ABehavioural
Video ABehavioural
Administration of T4P1001 capsulesDrug
This treatment is given as add on therapy to patients' regular analgesic
Heat pain stimuli BBehavioural
Video BBehavioural
Administration of placebo capsulesDrug
This treatment is given as add on therapy to patients' regular analgesic

Study groups in NCT02301169
Study group	Role	What they receive
T4P1001	Active comparator	Not described Receives: Behavioral: Heat pain stimuli A; Behavioral: Video A; Drug: Administration of T4P1001 capsules
Placebo	Sham comparator	Not described Receives: Behavioral: Heat pain stimuli B; Behavioral: Video B; 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). Scale from 0 to 10, 0 meaning no pain, 10 pain as bad as you can imagine. Lower values represent a better outcome. Unit: arithmetic average of 7 days of a 11-point NRS
Measured: Time zero equals baseline (Day 1) up to Day 42

Secondary outcomes (4)

Patient 's Change From Baseline of Pain Severity as Measured by the Weekly Means of the Daily Worst Pain Scores (WPS)
11-point Numeric Rating Scale (NRS) Scale from 0 to 10, 0 meaning no pain, 10 pain as bad as you can imagine. Lower values represent a better outcome. Unit: arithmetic average of 7 days of a 11-point NRS
Measured: Time zero equals baseline (Day 1) up to Day 42
Patient's Change From Baseline of Investigator Global Assessment of Change (IGAC)
IGAC is an investigator subjective evaluation of patient condition using a NRS from 0 to 10 with 0 meaning best and 10 worst Lower values represent a better outcome.
Measured: Time zero equals baseline (Day 1) up to Day 28
Patient's Change of Pain Intensity After Heat Pain Stimuli From Baseline to End of Treatment Period
11-point Numeric Rating Scale (NRS) from 0 to 10; 0 meaning no pain, 10 pain as bad as you can imagine Lower values represent a better outcome Unit: arithmetic average on 6 reported scores per Visit.
Measured: Time zero equals baseline (Day 1) up to Day 28
Patient 's Change From Baseline of Pain Severity as Measured by the Weekly Means of the Brief Pain Inventory (BPI).
Arithmetic average of 3 questions on an 11-point Numeric Rating Scale (NRS) from 0 to 10, 0 meaning no pain, 10 pain as bad as you can imagine.
Lower values represent a better outcome
Measured: Time zero equals baseline (Day 1) up to Day 28

Timeline

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

Mar 2014Nov 2014

First posted25 Nov 2014 (estimated)
Study startMar 2014
Primary completionNov 2014
Study completionNov 2014

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: Double blind
Who is masked: Participant, Investigator
Enrolment: 42 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02301169
Sponsor's protocol ID: T1001-01
Status last verified: Dec 2017
First submitted: 14 Nov 2014
Last updated: 28 Dec 2017
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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The AIUR Trial: Surgical Gloves to Prevent Peripheral Neuropathy
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Neuromuscular Disease, Neuromuscular Diseases (NMD)
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Wearable Insoles for Recurrent Diabetic Ulcer Prevention
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Active, not recruiting
Comparative Effects Of Sensory Reweighting And Proprioceptive Facilitation Training On Balance And Fall Risk In Diabetic Peripheral Neuropathy
Diabetic Peripheral Neuropathy (DPN)
Recruiting
Comparison of Wrist Splint Positions in Carpal Tunnel Syndrome
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All Peripheral Neuropathies trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Study to Investigate the Effects of T4P1001 Treatment in Patients With Peripheral Neuropathic Pain
ClinicalTrials.gov ID: NCT02301169
Acronym / sponsor ID: T1001-01
Conditions: Peripheral Neuropathies
Keywords: Pain
Study type: Interventional
Recruitment status: Completed
Enrolment: 42 participants (actual)
Lead sponsor: Tools4PatientUniversity, hospital or other
Study start: Mar 2014
Primary completion: Nov 2014 (actual)
Study completion: Nov 2014 (actual)
First posted: 25 Nov 2014 (estimated)
Results: Posted 16 May 2016

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: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
T4P1001	Active comparator	Behavioral: Heat pain stimuli A, Behavioral: Video A, Drug: Administration of T4P1001 capsules
Placebo	Sham comparator	Behavioral: Heat pain stimuli B, Behavioral: Video B, 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 (10 listed)

Men or women of at least 18 years of age
Body weight of more than 40 kg and less than 120 kg with a BMI between 19-31 kg/m2 inclusive
Diagnosed with Peripheral Neuropathic Pain (PNP) since at least 6 months
Being affiliated with the national welfare system
Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures

Key exclusion criteria (14 listed)

Pregnant, breastfeeding, or willing to be pregnant within 2 months
With a current or recent history, as determined by the Investigator, of severe, progressive, and/or uncontrolled renal, hepatic, hematological, 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 major depression or major 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)

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
Video A	Behavioural	T4P1001
Administration of T4P1001 capsulesThis treatment is given as add on therapy to patients' regular analgesic	Drug	T4P1001
Heat pain stimuli B	Behavioural	Placebo
Video B	Behavioural	Placebo
Administration of placebo capsulesThis treatment is given as add on therapy to patients' regular analgesic	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 1) up to Day 42
11-point Numeric Rating Scale (NRS). Scale from 0 to 10, 0 meaning no pain, 10 pain as bad as you can imagine. Lower values represent a better outcome. Unit: arithmetic average of 7 days of a 11-point NRS

4 secondary outcomes

Patient 's Change From Baseline of Pain Severity as Measured by the Weekly Means of the Daily Worst Pain Scores (WPS)
Time frame: Time zero equals baseline (Day 1) up to Day 42
Patient's Change From Baseline of Investigator Global Assessment of Change (IGAC)
Time frame: Time zero equals baseline (Day 1) up to Day 28
Patient's Change of Pain Intensity After Heat Pain Stimuli From Baseline to End of Treatment Period
Time frame: Time zero equals baseline (Day 1) up to Day 28
Patient 's Change From Baseline of Pain Severity as Measured by the Weekly Means of the Brief Pain Inventory (BPI).
Time frame: Time zero equals baseline (Day 1) up to Day 28

Results and safety

Results posted to the registry on 16 May 2016, 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	21	20
Placebo	21	21

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 1) up to Day 42. Mean (Standard Deviation). Unit: units on a scale

Measure	T4P1001 n = 20	Placebo n = 21
Value	0.87 (1.49)	0.5 (1.43)

T4P1001 vs Placebo: Mean Difference (Final Values): 0.3748299 (95% CI -0.5479411 to 1.2976010), p = 0.4162, t-test, 2 sided

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 21 (0%)	7 of 21 (33.3%)	Not reported
Placebo	0 of 21 (0%)	6 of 21 (28.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Peripheral Neuropathies

Active, not recruiting
The AIUR Trial: Surgical Gloves to Prevent Peripheral Neuropathy
Chemotherapy-induced Peripheral Neuropathy
Active, not recruitingPhase 3
A Phase 3 Study of NTLA-2001 in ATTRv-PN
Neuromuscular Disease, Neuromuscular Diseases (NMD)
Active, not recruiting
Wearable Insoles for Recurrent Diabetic Ulcer Prevention
Diabetes, Peripheral Neuropathy
Active, not recruiting
Comparative Effects Of Sensory Reweighting And Proprioceptive Facilitation Training On Balance And Fall Risk In Diabetic Peripheral Neuropathy
Diabetic Peripheral Neuropathy (DPN)
Recruiting
Comparison of Wrist Splint Positions in Carpal Tunnel Syndrome
Carpal Tunnel Syndrome (CTS), Peripheral Neuropathies

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

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Heat pain stimuli A, Video A and Administration of T4P1001 capsules in people with Peripheral Neuropathies, run by Tools4Patient at 1 site in France.

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 10 inclusion and 14 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 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. 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 16 May 2016). 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 1) up to Day 42). 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 NCT02301169.

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 Dec 2017; AzTrials last refreshed its copy on 8 Nov 2026.