Trial · NCT00414466

A Safety and Effectiveness Study of Intraspinal Gabapentin (MDT2004) for the Treatment of Chronic Pain

NCT00414466, Phase 2, Terminated, MedtronicNeuro; results first posted 2011-06-08

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Safety and Effectiveness Study of Intraspinal Gabapentin (MDT2004) for the Treatment of Chronic Pain. Trials, record NCT00414466. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00414466

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Safety and Effectiveness Study of Intraspinal Gabapentin (MDT2004) for the Treatment of Chronic Pain
NCT number: NCT00414466
Status: Terminated
Phases: Phase 2
Enrollment: 254 participants, actual
Lead sponsor: MedtronicNeuro
Conditions: Chronic Intractable Pain
Interventions: Intraspinal Gabapentin
First posted: 2006-12-21
Last updated: 2013-08-23
Results first posted: 2011-06-08

Source ClinicalTrials.gov

Registered outcomes3

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Changes in a Pain Rating Scale After 3 Weeks of Blinded Treatment.	Baseline and Post-randomization Day 22	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	Number of Participants With Treatment-emergent Adverse Events	Randomization to Post-randomization Day 29 (includes dose reduction)	Evaluation of adverse event profiles between placebo and active treatment groups.
Secondary	Responder Analysis Between Active Treatment and Placebo Groups.	Baseline to Post-randomization Day 22	Responders were subjects that reported at least a 30% decrease in average daily pain scores between baseline and Day 22.

Source ClinicalTrials.gov

Outcomes3

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Changes in a Pain Rating Scale After 3 Weeks of Blinded Treatment.	Baseline and Post-randomization Day 22	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.	Scores on a scale	MEAN
SECONDARY	Responder Analysis Between Active Treatment and Placebo Groups.	Baseline to Post-randomization 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.	Participants	NUMBER
PRIMARY	Number of Participants With Treatment-emergent Adverse Events	Randomization to Post-randomization Day 29 (includes dose reduction)	All randomized subjects were included as per protocol.	Participants	NUMBER

Source ClinicalTrials.gov

Results by group12

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Changes in a Pain Rating Scale After 3 Weeks of Blinded Treatment.	1 Placebo	0.48	Standard Deviation 1.52	Scores on a scale
Changes in a Pain Rating Scale After 3 Weeks of Blinded Treatment.	2 Gabapentin Low	0.40	Standard Deviation 1.33	Scores on a scale
Changes in a Pain Rating Scale After 3 Weeks of Blinded Treatment.	3 Gabapentin Medium	0.10	Standard Deviation 0.99	Scores on a scale
Changes in a Pain Rating Scale After 3 Weeks of Blinded Treatment.	4 Gabapentin High	-0.02	Standard Deviation 1.11	Scores on a scale
Responder Analysis Between Active Treatment and Placebo Groups.	1 Placebo	4		Participants
Responder Analysis Between Active Treatment and Placebo Groups.	2 Gabapentin Low	4		Participants
Responder Analysis Between Active Treatment and Placebo Groups.	3 Gabapentin Medium	1		Participants
Responder Analysis Between Active Treatment and Placebo Groups.	4 Gabapentin High	2		Participants
Number of Participants With Treatment-emergent Adverse Events	1 Placebo	40		Participants
Number of Participants With Treatment-emergent Adverse Events	2 Gabapentin Low	32		Participants

1 to 10 of 12Source ClinicalTrials.gov

See all 12 results by group

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	1 Placebo (0mg/Day)	44
Overall Study	STARTED	2 Gabapentin Low (1mg/Day)	42
Overall Study	STARTED	3 Gabapentin Medium (6mg/Day)	41
Overall Study	STARTED	4 Gabapentin High (30mg/Day)	43
Overall Study	COMPLETED	1 Placebo (0mg/Day)	42
Overall Study	COMPLETED	2 Gabapentin Low (1mg/Day)	42
Overall Study	COMPLETED	3 Gabapentin Medium (6mg/Day)	40
Overall Study	COMPLETED	4 Gabapentin High (30mg/Day)	42
Overall Study	NOT COMPLETED	1 Placebo (0mg/Day)	2
Overall Study	NOT COMPLETED	2 Gabapentin Low (1mg/Day)	0

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events112

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Implant site infection	Infections and infestations	1 Placebo	0	44	0
other	Implant site infection	Infections and infestations	2 Gabapentin Low	0	42	0
other	Implant site infection	Infections and infestations	3 Gabapentin Medium	3	41	4
other	Implant site infection	Infections and infestations	4 Gabapentin High	0	43	0
other	Influenza	Infections and infestations	1 Placebo	2	44	2
other	Influenza	Infections and infestations	2 Gabapentin Low	1	42	1
other	Influenza	Infections and infestations	3 Gabapentin Medium	0	41	0
other	Influenza	Infections and infestations	4 Gabapentin High	4	43	4
other	Nasopharyngitis	Infections and infestations	1 Placebo	3	44	3
other	Nasopharyngitis	Infections and infestations	2 Gabapentin Low	1	42	1

1 to 10 of 112Source ClinicalTrials.gov

See all 112 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	1 Placebo
Total, all-cause mortality	2 Gabapentin Low
Total, all-cause mortality	3 Gabapentin Medium
Total, all-cause mortality	4 Gabapentin High
Total, other adverse events	1 Placebo	30	44
Total, other adverse events	2 Gabapentin Low	21	42
Total, other adverse events	3 Gabapentin Medium	27	41
Total, other adverse events	4 Gabapentin High	25	43
Total, serious adverse events	1 Placebo	1	44
Total, serious adverse events	2 Gabapentin Low	1	42

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
23835590	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00414466

GET https://conductscience.org/api/trials/v1/NCT00414466/events?page=2

API reference For AI assistants