Ignite Creation Date:
2025-12-24 @ 11:29 PM
Ignite Modification Date:
2025-12-25 @ 9:16 PM
Study NCT ID:
NCT01479556
Status:
UNKNOWN
Last Update Posted:
2011-11-24
First Post:
2011-11-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pregabalin for the Treatment and Prevention of Spinal Cord Injury Neuropathic Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009437', 'term': 'Neuralgia'}, {'id': 'D013119', 'term': 'Spinal Cord Injuries'}], 'ancestors': [{'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069583', 'term': 'Pregabalin'}], 'ancestors': [{'id': 'D005680', 'term': 'gamma-Aminobutyric Acid'}, {'id': 'D000613', 'term': 'Aminobutyrates'}, {'id': 'D002087', 'term': 'Butyrates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 82}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2011-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-11', 'completionDateStruct': {'date': '2014-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-11-22', 'studyFirstSubmitDate': '2011-11-17', 'studyFirstSubmitQcDate': '2011-11-22', 'lastUpdatePostDateStruct': {'date': '2011-11-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-11-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Daily at-level non-evoked pain intensity measured with the numerical rating scale (0-10) expressed as the mean 7-day pain intensity'}], 'secondaryOutcomes': [{'measure': 'Weekly below-level non-evoked pain intensity measured with the numerical rating scale (0-10)'}, {'measure': 'Weekly evaluation of at-level neuropathic pain symptoms using the "Neuropathic Pain Symptoms Inventory" (NPSI)'}, {'measure': 'Weekly evaluation of at-level neuropathic pain intensity and interference using the "Brief Pain Inventory" (BPI)'}, {'measure': 'Weekly evaluation of the change in at-level non-evoked neuropathic pain using the "Patient Global Impression Change" (PGIC)'}, {'measure': 'Weekly evaluation of anxiety and depression using the Hospital Anxiety and Depression Scale (HADS)'}, {'measure': 'Weekly evaluation of spasm frequency below the spinal cord injury using the Penn questionnaire'}, {'measure': 'Measurement of the amplitude of cold and heat sensory evoked potentials (Cz-Fz) studied above (C4) and at-level of the SCI'}, {'measure': 'Serum TNF-R1 level'}, {'measure': 'Weekly at-level non-evoked pain intensity measured with the numerical rating scale (0-10) 28 days after the termination of the clinical trial'}, {'measure': 'Number of Paracetamol tablets used as rescue medication during the week'}, {'measure': 'Prevalence and type of adverse events in patients treated with pregabalin'}, {'measure': '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.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Pregabalin', 'Neuropathic pain', 'At-level neuropathic pain', 'Non-evoked neuropathic pain', 'Evoked neuropathic pain', 'Sub-acute spinal cord injury'], 'conditions': ['Neuropathic Pain', 'Spinal Cord Injuries']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Comprehension of clinical trial and signed informed consent before initiation.\n* Male or female adults, age 18 to 70.\n* Clinical history of neuropathic pain secondary to SCI\n* Patients with an AIS of A, B, C or D according to the American Spinal Cord Injury Association (ASIA) Impairment Scale.\n* Persistent neuropathic pain from 1 month up to 6 months after spinal cord injury.\n* Non-evoked at-level pain with ≥ 2 intensity measured with the numerical rating scale (0-10).\n* 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.\n* Formal acceptance of disponibility for all programmed clinical trial visits and other protocol requisites.\n* 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.\n\nExclusion Criteria:\n\n* Previous or actual use of gabapentin.\n* Creatinine clearance level \\<60 ml/min.\n* Neuropathic pain unrelated to spinal cord injury.\n* Lactose intolerance, Lapp lactase insufficiency or glucose malabsorption\n* Platelet count \\< 100x103/µl.\n* White blood cell count \\<2.5 x103/µl.\n* Neutrophil count \\<1.5 x103/µl.\n* Planned surgery during the clinical trial.\n* Patients with peripheral neuropathic pain.\n* Previous history of malignant melanoma.\n* 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.\n* 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.\n* 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.\n* Unknown kidney, liver, gastrointestinal, endocrine, lung, hematological, neurological or psychiatric comorbidities.\n* Subjects administered with an experimental or non-commercial drug during the 4 weeks prior to the trial.\n* Patients participating in other clinical studies.\n* Patients that are not competent for completing required tasks (eg. alcohol or drug related problems or psychiatric disorders).\n* Subjects unable to be examined with radiological MRI exploration due to contraindications.\n* Pregnancy or breastfeeding.\n* Any other patient condition that is deemed unsuitable for subject inclusion in the trial according to the research team.'}, 'identificationModule': {'nctId': 'NCT01479556', 'briefTitle': 'Pregabalin for the Treatment and Prevention of Spinal Cord Injury Neuropathic Pain', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Nacional de Parapléjicos de Toledo'}, 'officialTitle': 'Assessment of Pregabalin Efficacy for the Treatment and Prevention of At-level Non-evoked and Evoked Spinal Cord Injury Neuropathic Pain', 'orgStudyIdInfo': {'id': 'HNP-02-2011'}, 'secondaryIdInfos': [{'id': '2011-000915-14', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '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.', 'interventionNames': ['Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Pregabalin', 'description': '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.', 'interventionNames': ['Drug: Pregabalin']}], 'interventions': [{'name': 'Pregabalin', 'type': 'DRUG', 'otherNames': ['Lyrica'], 'description': 'Pregabalin Alpha2-delta calcium channel blocker. 150mg BID p.o.', 'armGroupLabels': ['Pregabalin']}, {'name': 'Placebo', 'type': 'DRUG', 'description': '150mg BID p.o.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '45071', 'city': 'Toledo', 'state': 'Toledo', 'country': 'Spain', 'facility': 'Hospital Nacional de Parapléjicos de Toledo', 'geoPoint': {'lat': 39.8581, 'lon': -4.02263}}], 'centralContacts': [{'name': 'Julian Taylor Green', 'role': 'CONTACT', 'email': 'jscott@sescam.org', 'phone': '(34) 925 247 700', 'phoneExt': '109'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Julian Taylor Green', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Dr. Julian Taylor Green', 'investigatorFullName': 'Julian Taylor Green', 'investigatorAffiliation': 'Hospital Nacional de Parapléjicos de Toledo'}}}}