Neuropathic PainPhase 4NCT01479556
Pregabalin for the Treatment and Prevention of Spinal Cord Injury Neuropathic Pain
A Phase 4 study testing Pregabalin in people with Neuropathic Pain and Spinal Cord Injuries, run by Julian Taylor Green at 1 site in Spain.
Trial summary
This study is a phase IV clinical trial with the objective of evaluating whether pain relief associated with pregabalin for at-level non-evoked and evoked neuropathic pain is more efficient during the early rather than late subacute phase of spinal cord injury. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Neuropathic Pain, Spinal Cord Injuries
- What is being tested?
- Pregabalin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 82 participants
- Where
- 1 siteSpain
- Study dates
- Dec 2011to Oct 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Comprehension of clinical trial and signed informed consent before initiation.
- Male or female adults, age 18 to 70.
- Clinical history of neuropathic pain secondary to SCI
- Patients with an AIS of A, B, C or D according to the American Spinal Cord Injury Association (ASIA) Impairment Scale.
- Persistent neuropathic pain from 1 month up to 6 months after spinal cord injury.
- Non-evoked at-level pain with ≥ 2 intensity measured with the numerical rating scale (0-10).
Show all 9Show fewer
- Non-evoked/evoked at-level pain corresponding to the area of sensory alteration, and within the three dermatomes below the neurological level of the spinal cord injury.
- Formal acceptance of disponibility for all programmed clinical trial visits and other protocol requisites.
- Females of child bearing age must demonstrate a negative pregnancy test (performed on screening and subsequent follow up visits) and use a reliable birth control method including abstinence of sexual activity throughout the duration of the study and for at last 28 days after termination of the clinical trial.
Who cannot join
- Previous or actual use of gabapentin.
- Creatinine clearance level <60 ml/min.
- Neuropathic pain unrelated to spinal cord injury.
- Lactose intolerance, Lapp lactase insufficiency or glucose malabsorption
- Platelet count < 100x103/µl.
- White blood cell count <2.5 x103/µl.
Show all 20Show fewer
- Neutrophil count <1.5 x103/µl.
- Planned surgery during the clinical trial.
- Patients with peripheral neuropathic pain.
- Previous history of malignant melanoma.
- History of malignant tumors, except for in situ uterine cervix carcinoma, in situ basocellular or spinocellular cutaneous carcinomas, superficial bladder tumors (Ta and Tis) with a complete treatment response up to 10 years. Patients with history of lymphoma or breast cancer will be allowed to participate in the trial if a complete treatment response has been observed up to 20 years.
- Chronic or active infection requiring a systemic therapy, chronic kidney infections, chronic lung infections with bronchiectasias, Mycobacterium tuberculosis infection, active Hepatitis B or C. Diagnosis of latent TB confection should be performed according to the local guidelines.
- Severe heart diseases such as unstable angina, cardiopathy during the first 6 months after a myocardial infarction, grade III or IV of the New York Heart Association scale for congestive heart failure.
- Unknown kidney, liver, gastrointestinal, endocrine, lung, hematological, neurological or psychiatric comorbidities.
- Subjects administered with an experimental or non-commercial drug during the 4 weeks prior to the trial.
- Patients participating in other clinical studies.
- Patients that are not competent for completing required tasks (eg. alcohol or drug related problems or psychiatric disorders).
- Subjects unable to be examined with radiological MRI exploration due to contraindications.
- Pregnancy or breastfeeding.
- Any other patient condition that is deemed unsuitable for subject inclusion in the trial according to the research team.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Pregabalin Efficacy for the Treatment and Prevention of At-level Non-evoked and Evoked Spinal Cord Injury Neuropathic Pain
This study is a phase IV clinical trial with the objective of evaluating whether pain relief associated with pregabalin for at-level non-evoked and evoked neuropathic pain is more efficient during the early rather than late subacute phase of spinal cord injury.
- Conditions
- Neuropathic Pain, Spinal Cord Injuries
- Being tested
- Pregabalin, Placebo
- Keywords
- Pregabalin, Neuropathic pain, At-level neuropathic pain, Non-evoked neuropathic pain, Evoked neuropathic pain, Sub-acute spinal cord injury
- Medical subject headings
- Neuralgia, Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PregabalinDrug
Also called Lyrica
Pregabalin Alpha2-delta calcium channel blocker. 150mg BID p.o.
PlaceboDrug
150mg BID p.o.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Study subjects wil be randomized to the Placebo arm following a stratification procedure based on AIS scale (A-E), neurological level of injury (cervical or thoracic), and presence of at-level neuropathic pain before or after 3 months from the time of spinal cord injury. Receives: Drug: Placebo |
| Pregabalin | Active comparator | Study subjects wil be randomized to the Pregabalin arm following a stratification procedure based on AIS scale (A-E), neurological level of injury (cervical or thoracic), and presence of at-level neuropathic pain before or after 3 months from the time of spinal cord injury. Receives: Drug: Pregabalin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily at-level non-evoked pain intensity measured with the numerical rating scale (0-10) expressed as the mean 7-day pain intensity
Secondary outcomes (12)
Weekly below-level non-evoked pain intensity measured with the numerical rating scale (0-10)
Weekly evaluation of at-level neuropathic pain symptoms using the "Neuropathic Pain Symptoms Inventory" (NPSI)
Weekly evaluation of at-level neuropathic pain intensity and interference using the "Brief Pain Inventory" (BPI)
Weekly evaluation of the change in at-level non-evoked neuropathic pain using the "Patient Global Impression Change" (PGIC)
Weekly evaluation of anxiety and depression using the Hospital Anxiety and Depression Scale (HADS)
Weekly evaluation of spasm frequency below the spinal cord injury using the Penn questionnaire
Measurement of the amplitude of cold and heat sensory evoked potentials (Cz-Fz) studied above (C4) and at-level of the SCI
Serum TNF-R1 level
Weekly at-level non-evoked pain intensity measured with the numerical rating scale (0-10) 28 days after the termination of the clinical trial
Number of Paracetamol tablets used as rescue medication during the week
Prevalence and type of adverse events in patients treated with pregabalin
Unblinding testing: patient and investigator will be asked for the treatment they think to have received. Reasons for their judgement (efficacy and safety) will also be asked.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2011 (estimated)
- Study startDec 2011
- Primary completionMay 2014 (estimated)
- Study completionOct 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuropathic PainStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Julian Taylor Green
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Julian Taylor Green, Hospital Nacional de Parapléjicos de Toledo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01479556
- Sponsor's protocol ID
- HNP-02-2011
- Other IDs
- 2011-000915-14
- Status last verified
- Nov 2011
- First submitted
- 17 Nov 2011
- Last updated
- 24 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Pregabalin Efficacy for the Treatment and Prevention of At-level Non-evoked and Evoked Spinal Cord Injury Neuropathic Pain
- ClinicalTrials.gov ID
- NCT01479556
- Acronym / sponsor ID
- HNP-02-2011
- Conditions
- Neuropathic Pain, Spinal Cord Injuries
- Keywords
- Pregabalin, Neuropathic pain, At-level neuropathic pain, Non-evoked neuropathic pain, Evoked neuropathic pain, Sub-acute spinal cord injury
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- Julian Taylor GreenUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- May 2014 (estimated)
- Study completion
- Oct 2014 (estimated)
- First posted
- 24 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a phase IV clinical trial with the objective of evaluating whether pain relief associated with pregabalin for at-level non-evoked and evoked neuropathic pain is more efficient during the early rather than late subacute phase of spinal cord injury.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboStudy subjects wil be randomized to the Placebo arm following a stratification procedure based on AIS scale (A-E), neurological level of injury (cervical or thoracic), and presence of at-level neuropathic pain before or after 3 months from the time of spinal cord injury. |
| Pregabalin | Active comparator | Drug: PregabalinStudy subjects wil be randomized to the Pregabalin arm following a stratification procedure based on AIS scale (A-E), neurological level of injury (cervical or thoracic), and presence of at-level neuropathic pain before or after 3 months from the time of spinal cord injury. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Comprehension of clinical trial and signed informed consent before initiation.
- Male or female adults, age 18 to 70.
- Clinical history of neuropathic pain secondary to SCI
- Patients with an AIS of A, B, C or D according to the American Spinal Cord Injury Association (ASIA) Impairment Scale.
- Persistent neuropathic pain from 1 month up to 6 months after spinal cord injury.
Key exclusion criteria (20 listed)
- Previous or actual use of gabapentin.
- Creatinine clearance level <60 ml/min.
- Neuropathic pain unrelated to spinal cord injury.
- Lactose intolerance, Lapp lactase insufficiency or glucose malabsorption
- Platelet count < 100x103/µl.
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 |
|---|---|---|
| PregabalinAlso: LyricaPregabalin Alpha2-delta calcium channel blocker. 150mg BID p.o. | Drug | Pregabalin |
| Placebo150mg BID p.o. | Drug | Placebo |
Primary outcome
Daily at-level non-evoked pain intensity measured with the numerical rating scale (0-10) expressed as the mean 7-day pain intensity
12 secondary outcomes
Weekly below-level non-evoked pain intensity measured with the numerical rating scale (0-10)
Weekly evaluation of at-level neuropathic pain symptoms using the "Neuropathic Pain Symptoms Inventory" (NPSI)
Weekly evaluation of at-level neuropathic pain intensity and interference using the "Brief Pain Inventory" (BPI)
Weekly evaluation of the change in at-level non-evoked neuropathic pain using the "Patient Global Impression Change" (PGIC)
Weekly evaluation of anxiety and depression using the Hospital Anxiety and Depression Scale (HADS)
Weekly evaluation of spasm frequency below the spinal cord injury using the Penn questionnaire
Measurement of the amplitude of cold and heat sensory evoked potentials (Cz-Fz) studied above (C4) and at-level of the SCI
Serum TNF-R1 level
Weekly at-level non-evoked pain intensity measured with the numerical rating scale (0-10) 28 days after the termination of the clinical trial
Number of Paracetamol tablets used as rescue medication during the week
Prevalence and type of adverse events in patients treated with pregabalin
Unblinding testing: patient and investigator will be asked for the treatment they think to have received. Reasons for their judgement (efficacy and safety) will also be asked.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2011.
Related trials for Neuropathic Pain
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Enrolling by invitationPhase 4
Low Dose Naltrexone Therapy for Complex Regional Pain Syndrome
Complex Regional Pain Syndrome, Chronic Pain
RecruitingPhase 2
Effectiveness of Phenotype-based Pain Management Guidelines for Head and Neck Cancer Related Pain: a Pilot Study
Cancer Pain, Orofacial Pain
RecruitingPhase 2
A Master Protocol Study (LY900028) of Multiple Intervention-Specific-Appendices (ISAs) in Participants With Chronic Pain
Osteoarthritis, Knee, Diabetic Neuropathic Pain
RecruitingObservational study
Trigeminal Neuralgia Electrophysiology
Trigeminal Neuralgia
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pregabalin in people with Neuropathic Pain and Spinal Cord Injuries, run by Julian Taylor Green at 1 site in Spain.
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 9 inclusion and 20 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: status not confirmed, as of the sponsor's last update on 24 Nov 2011. 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 Spain. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Julian Taylor Green ((34) 925 247 700 ext. 109, jscott@sescam.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Daily at-level non-evoked pain intensity measured with the numerical rating scale (0-10) expressed as the mean 7-day pain intensity. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Nov 2011.