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Study closed and subject follow-up completed following analysis of blinded study data.
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The purpose of this study is to determine the safety and minimum effective dose of intraspinal gabapentin when delivered through an implanted drug infusion system.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo (0mg/day) | Placebo Comparator | Intraspinal Placebo delivered continuously for 29 days via an implantable infusion system |
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| Gabapentin Low (1mg/day) | Active Comparator | Intraspinal Gabapentin Low delivered continuously for 22 days via an implantable infusion system followed by 7 days infusion at half dose |
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| Gabapentin Medium (6mg/day) | Active Comparator | Intraspinal Gabapentin Medium delivered continuously for 22 days via an implantable infusion system followed by 7 days infusion at half dose |
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| Gabapentin High (30mg/day) | Active Comparator | Intraspinal Gabapentin High delivered continuously for 22 days via an implantable infusion system followed by 7 days infusion at half dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intraspinal Gabapentin | Drug | Surgical implantation of a drug infusion system with intrathecal (spinal) delivery of active drug (1 of 3 possible dose levels) or placebo (saline) for 22 days followed by 7 days of infusion at half dose level. Subjects may then continue in open-label treatment with study drug. Dosage in open-label may be adjusted to meet subject needs. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in a Pain Rating Scale After 3 Weeks of Blinded Treatment. | Average pain score calculated over last 7 days of baseline minus average pain score calculated over last 7 days of follow-up using the Numeric Pain Rating Scale where 0=no pain, 10=worst possible pain. | Baseline and Post-randomization Day 22 |
| Number of Participants With Treatment-emergent Adverse Events | Evaluation of adverse event profiles between placebo and active treatment groups. | Randomization to Post-randomization Day 29 (includes dose reduction) |
| Measure | Description | Time Frame |
|---|---|---|
| Responder Analysis Between Active Treatment and Placebo Groups. | Responders were subjects that reported at least a 30% decrease in average daily pain scores between baseline and Day 22. | Baseline to Post-randomization Day 22 |
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Inclusion Criteria:
Chronic pain below the neck present for a minimum of one year.
Diagnosis of at least one of the following:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Innovative Spine Care | Little Rock | Arkansas | 72205 | United States | ||
| Napa Pain Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23835590 | Derived | Rauck R, Coffey RJ, Schultz DM, Wallace MS, Webster LR, McCarville SE, Grigsby EJ, Page LM. Intrathecal gabapentin to treat chronic intractable noncancer pain. Anesthesiology. 2013 Sep;119(3):675-86. doi: 10.1097/ALN.0b013e3182a10fbf. |
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During a 2-week screening period subjects were required to meet eligibility criteria including maintaining stable pain medications and demonstrating a numerical pain rating score of 6 or greater averaged over the last 7 days of screening. A total of 170 subjects met eligibility criteria, were implanted with an infusion system and were randomized.
A total of 254 subjects were enrolled into the study between December 2006 and October 2009.
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| ID | Title | Description |
|---|---|---|
| FG000 | 1 Placebo (0mg/Day) | Intraspinal Placebo delivered continuously for 29 days via an implantable infusion system |
| FG001 | 2 Gabapentin Low (1mg/Day) | Intraspinal Gabapentin Low (1mg/day) delivered continuously for 22 days via an implantable infusion system followed by 7 days of infusion at half dose |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Napa |
| California |
| 94558 |
| United States |
| Sarasota Pain Medicine Research | Sarasota | Florida | 34238 | United States |
| WK River Cities Clinical Research Center | Shreveport | Louisiana | 71105 | United States |
| MAPS Applied Research Center | Edina | Minnesota | 55435 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| U B Neurosurgery, Inc. | Buffalo | New York | 14203 | United States |
| The Center for Clinical Research | Winston-Salem | North Carolina | 27103 | United States |
| Pain Research of Oregon, LLC | Eugene | Oregon | 97401 | United States |
| Oregon Health & Science University, Neurosurgery Department | Portland | Oregon | 97201 | United States |
| Lehigh Valley Hospital Center for Pain Management | Allentown | Pennsylvania | 18103 | United States |
| Pinnacle Pain Medicine | Dallas | Texas | 75240 | United States |
| Axis Spine Care/Texas Spine & Joint | Tyler | Texas | 75701 | United States |
| Lifetree Clinical Research | Salt Lake City | Utah | 84106 | United States |
| FG002 | 3 Gabapentin Medium (6mg/Day) | Intraspinal Gabapentin Medium (6mg/day) delivered continuously for 22 days via an implantable infusion system followed by 7 days of infusion at half dose |
| FG003 | 4 Gabapentin High (30mg/Day) | Intraspinal Gabapentin High (30mg/day) delivered continuously for 22 days via an implantable infusion system followed by 7 days of infusion at half dose |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 1 Placebo | Intraspinal Placebo delivered continuously for 29 days via an implantable infusion system |
| BG001 | 2 Gabapentin Low | Intraspinal Gabapentin Low delivered continuously for 22 days via an implantable infusion system followed by 7 days of infusion at half dose |
| BG002 | 3 Gabapentin Medium | Intraspinal Gabapentin Medium delivered continuously for 22 days via an implantable infusion system followed by 7 days of infusion at half dose |
| BG003 | 4 Gabapentin High | Intraspinal Gabapentin High delivered continuously for 22 days via an implantable infusion system followed by 7 days of infusion at half dose |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Changes in a Pain Rating Scale After 3 Weeks of Blinded Treatment. | Average pain score calculated over last 7 days of baseline minus average pain score calculated over last 7 days of follow-up using the Numeric Pain Rating Scale where 0=no pain, 10=worst possible pain. | Primary efficacy analysis was performed on the 167 randomized subjects that completed at least 4 days of the electronic pain diary during the last 7 days prior to the Day 22 or Early Termination Visit as per protocol. No imputation methods were used. | Posted | Mean | Standard Deviation | Scores on a scale | Baseline and Post-randomization Day 22 |
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| Secondary | Responder Analysis Between Active Treatment and Placebo Groups. | Responders were subjects that reported at least a 30% decrease in average daily pain scores between baseline and Day 22. | All 170 randomized subjects were included as per protocol. Subjects experiencing an intolerable adverse event, discontinuing due to an adverse event or lack of efficacy, or not providing data were considered non-responders. | Posted | Number | Participants | Baseline to Post-randomization Day 22 |
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| Primary | Number of Participants With Treatment-emergent Adverse Events | Evaluation of adverse event profiles between placebo and active treatment groups. | All randomized subjects were included as per protocol. | Posted | Number | Participants | Randomization to Post-randomization Day 29 (includes dose reduction) |
|
Adverse events are reported through 29 days post-randomization, including 22 days of dosing at the randomized dose and 7 days of dose reduction.
All randomized subjects were included in adverse event summaries.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 1 Placebo | Intraspinal Placebo delivered continuously for 29 days via an implantable infusion system | 1 | 44 | 30 | 44 | ||
| EG001 | 2 Gabapentin Low | Intraspinal Gabapentin Low delivered continuously for 22 days via an implantable infusion system followed by 7 days of infusion at half dose | 1 | 42 | 21 | 42 | ||
| EG002 | 3 Gabapentin Medium | Intraspinal Gabapentin Medium delivered continuously for 22 days via an implantable infusion system followed by 7 days of infusion at half dose | 4 | 41 | 27 | 41 | ||
| EG003 | 4 Gabapentin High | Intraspinal Gabapentin High delivered continuously for 22 days via an implantable infusion system followed by 7 days of infusion at half dose | 4 | 43 | 25 | 43 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Catheter site infection | Infections and infestations | MedDRA (8.0) | Non-systematic Assessment |
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| Implant site infection | Infections and infestations | MedDRA (8.0) | Non-systematic Assessment |
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| Osteomyelitis | Infections and infestations | MedDRA (8.0) | Non-systematic Assessment |
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| Bone marrow disorder | Blood and lymphatic system disorders | MedDRA (8.0) | Non-systematic Assessment |
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| Suicidal ideation | Psychiatric disorders | MedDRA (8.0) | Non-systematic Assessment |
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| Neuropathic pain | Nervous system disorders | MedDRA (8.0) | Non-systematic Assessment |
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| Radiculopathy | Nervous system disorders | MedDRA (8.0) | Non-systematic Assessment |
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| Oesophageal spasm | Gastrointestinal disorders | MedDRA (8.0) | Non-systematic Assessment |
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| Pain | General disorders | MedDRA (8.0) | Non-systematic Assessment |
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| Closed head injury | Injury, poisoning and procedural complications | MedDRA (8.0) | Non-systematic Assessment |
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| Overdose | Injury, poisoning and procedural complications | MedDRA (8.0) | Non-systematic Assessment |
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| Therapeutic agent toxicity | Injury, poisoning and procedural complications | MedDRA (8.0) | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Implant site infection | Infections and infestations | MedDRA (8.0) | Non-systematic Assessment |
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| Influenza | Infections and infestations | MedDRA (8.0) | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA (8.0) | Non-systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA (8.0) | Non-systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA (8.0) | Non-systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA (8.0) | Non-systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA (8.0) | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA (8.0) | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (8.0) | Non-systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA (8.0) | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA (8.0) | Non-systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (8.0) | Non-systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (8.0) | Non-systematic Assessment |
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| Fatigue | General disorders | MedDRA (8.0) | Non-systematic Assessment |
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| Oedema Peripheral | General disorders | MedDRA (8.0) | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA (8.0) | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Robert Spencer, Clinical Research Manager | Medtronic Neuromodulation | (763) 514-0253 | robert.j.spencer@medtronic.com |
| Between 18 and 65 years |
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| >=65 years |
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| Male |
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Williams' test for Minimum Effective Dose was used to compare each active group to the placebo.
| Williams test for minimum effective dose |
| 0.874 |
The a priori threshold for statistical significance was 0.05, two-sided. |
| 95 |
| No |
| Superiority or Other |
| Williams' test for Minimum Effective Dose was used to compare each active group to the placebo. | Williams test for minimum effective dose | 0.899 | The a priori threshold for statistical significance was 0.05, two-sided. | 95 | No | Superiority or Other |
Intraspinal Gabapentin High delivered continuously for 22 days via an implantable infusion system followed by 7 days of infusion at half dose
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