Chronic Intractable PainPhase 2NCT00414466

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

A Phase 2 study testing Intraspinal Gabapentin in people with Chronic Intractable Pain, run by MedtronicNeuro at 14 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Chronic Intractable Pain
What is being tested?: Intraspinal Gabapentin
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 254 participants
Where: 14 sitesUnited States
Study dates: Dec 2006to Aug 2010
Phase: Phase 2
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 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Chronic pain below the neck present for a minimum of one year.
Diagnosis of at least one of the following:
back pain with or without leg pain,
post-herpetic neuralgia,
complex regional pain syndrome (CRPS) 1 or 2,
diabetic neuropathy,
or a general neuropathic condition; medically stable and able to undergo surgery for implantation of the drug infusion system.

Who cannot join

None listed.

Trial locations and contacts

14 sites in 1 country.

City, postcode or hospital

14 sites in 1 country

United States14 sites

Lehigh Valley Hospital Center for Pain Management
Allentown, Pennsylvania, 18103
U B Neurosurgery, Inc.
Buffalo, New York, 14203
Pinnacle Pain Medicine
Dallas, Texas, 75240
MAPS Applied Research Center
Edina, Minnesota, 55435
Pain Research of Oregon, LLC
Eugene, Oregon, 97401
Innovative Spine Care
Little Rock, Arkansas, 72205
Napa Pain Institute
Napa, California, 94558
Oregon Health & Science University, Neurosurgery Department
Portland, Oregon, 97201
Mayo Clinic
Rochester, Minnesota, 55905
Lifetree Clinical Research
Salt Lake City, Utah, 84106
Sarasota Pain Medicine Research
Sarasota, Florida, 34238
WK River Cities Clinical Research Center
Shreveport, Louisiana, 71105
Axis Spine Care/Texas Spine & Joint
Tyler, Texas, 75701
The Center for Clinical Research
Winston-Salem, North Carolina, 27103

Other trials in United States

About this study

Official title: A Randomized Double Blind, Placebo-controlled, Dose Response Study of Intraspinal Gabapentin (MDT2004) in Subjects With Chronic, Intractable Pain.

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.

Conditions: Chronic Intractable Pain
Being tested: Intraspinal Gabapentin

What participants receive

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

Intraspinal GabapentinDrug
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.

Study groups in NCT00414466
Study group	Role	What they receive
Placebo (0mg/day)	Placebo comparator	Intraspinal Placebo delivered continuously for 29 days via an implantable infusion system Receives: Drug: Intraspinal Gabapentin
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 Receives: Drug: Intraspinal Gabapentin
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 Receives: Drug: Intraspinal Gabapentin
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 Receives: Drug: Intraspinal Gabapentin

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: Randomization to Post-randomization Day 29 (includes dose reduction)

Secondary outcomes (1)

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.
Measured: Baseline to Post-randomization Day 22

Timeline

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

Dec 2006Aug 2010

First posted21 Dec 2006 (estimated)
Study startDec 2006
Primary completionDec 2009
Study completionAug 2010

Why it stopped: Study closed and subject follow-up completed following analysis of blinded study data.

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Chronic Intractable 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 254 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00414466
Sponsor's protocol ID: 1622
Status last verified: Aug 2013
First submitted: 20 Dec 2006
Last updated: 23 Aug 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

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.
PubMed 23835590

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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All Chronic Intractable Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized Double Blind, Placebo-controlled, Dose Response Study of Intraspinal Gabapentin (MDT2004) in Subjects With Chronic, Intractable Pain.
ClinicalTrials.gov ID: NCT00414466
Acronym / sponsor ID: 1622
Conditions: Chronic Intractable Pain
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Study closed and subject follow-up completed following analysis of blinded study data.
Enrolment: 254 participants (actual)
Lead sponsor: MedtronicNeuroIndustry (pharma, biotech, devices)
Study start: Dec 2006
Primary completion: Dec 2009 (actual)
Study completion: Aug 2010 (actual)
First posted: 21 Dec 2006 (estimated)
Results: Posted 8 Jun 2011

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 study is to determine the safety and minimum effective dose of intraspinal gabapentin when delivered through an implanted drug infusion system.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
Placebo (0mg/day)	Placebo comparator	Drug: Intraspinal GabapentinIntraspinal Placebo delivered continuously for 29 days via an implantable infusion system
Gabapentin Low (1mg/day)	Active comparator	Drug: Intraspinal GabapentinIntraspinal Gabapentin Low delivered continuously for 22 days via an implantable infusion system followed by 7 days infusion at half dose
Gabapentin Medium (6mg/day)	Active comparator	Drug: Intraspinal GabapentinIntraspinal Gabapentin Medium delivered continuously for 22 days via an implantable infusion system followed by 7 days infusion at half dose
Gabapentin High (30mg/day)	Active comparator	Drug: Intraspinal GabapentinIntraspinal Gabapentin High delivered continuously for 22 days via an implantable infusion system followed by 7 days infusion at half dose

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Chronic pain below the neck present for a minimum of one year.
Diagnosis of at least one of the following:

Key exclusion criteria (0 listed)

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
Intraspinal GabapentinSurgical 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.	Drug	Gabapentin High (30mg/day), Gabapentin Low (1mg/day), Gabapentin Medium (6mg/day), Placebo (0mg/day)

Primary outcome

Changes in a Pain Rating Scale After 3 Weeks of Blinded Treatment.
Time frame: 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.
Number of Participants With Treatment-emergent Adverse Events
Time frame: Randomization to Post-randomization Day 29 (includes dose reduction)
Evaluation of adverse event profiles between placebo and active treatment groups.

1 secondary outcome

Responder Analysis Between Active Treatment and Placebo Groups.
Time frame: Baseline to Post-randomization Day 22

Results and safety

Results posted to the registry on 8 Jun 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
1 Placebo (0mg/Day)	44	42
2 Gabapentin Low (1mg/Day)	42	42
3 Gabapentin Medium (6mg/Day)	41	40
4 Gabapentin High (30mg/Day)	43	42

Primary outcome: Changes in a Pain Rating Scale After 3 Weeks of Blinded Treatment.

Time frame: Baseline and Post-randomization Day 22. Mean (Standard Deviation). Unit: Scores on a scale

Measure	1 Placebo n = 43	2 Gabapentin Low n = 42	3 Gabapentin Medium n = 41	4 Gabapentin High n = 41
Value	0.48 (1.52)	0.40 (1.33)	0.10 (0.99)	-0.02 (1.11)

1 Placebo vs 2 Gabapentin Low: p = 0.802, Williams test for minimum effective dose
1 Placebo vs 3 Gabapentin Medium: p = 0.874, Williams test for minimum effective dose
1 Placebo vs 4 Gabapentin High: p = 0.899, Williams test for minimum effective dose

Population analysed: 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.

Primary outcome: Number of Participants With Treatment-emergent Adverse Events

Time frame: Randomization to Post-randomization Day 29 (includes dose reduction). Number. Unit: Participants

Measure	1 Placebo n = 44	2 Gabapentin Low n = 42	3 Gabapentin Medium n = 41	4 Gabapentin High n = 43
Value	40	32	37	36

1 Placebo vs 2 Gabapentin Low: p = 0.083, Fisher Exact
1 Placebo vs 3 Gabapentin Medium: p = 1.000, Fisher Exact
1 Placebo vs 4 Gabapentin High: p = 0.352, Fisher Exact

Population analysed: All randomized subjects were included as per protocol.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse events are reported through 29 days post-randomization, including 22 days of dosing at the randomized dose and 7 days of dose reduction.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
1 Placebo	1 of 44 (2.3%)	30 of 44 (68.2%)	Not reported
2 Gabapentin Low	1 of 42 (2.4%)	21 of 42 (50%)	Not reported
3 Gabapentin Medium	4 of 41 (9.8%)	27 of 41 (65.9%)	Not reported
4 Gabapentin High	4 of 43 (9.3%)	25 of 43 (58.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 23835590Rauck 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.

Related trials for Chronic Intractable Pain

RecruitingObservational study
Post Market Evaluation of Real World Outcomes and Durability to Support Implantable Inceptiv™ Spinal Cord Stimulation Therapy
Chronic Pain, Intractable Pain
Not yet recruiting
Transcutaneous Genital Nerves Stimulation for the Treatment of Refractory Chronic Pelvic and Genital Pain in Women.
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Active, not recruitingObservational study
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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.

The record lists no contact. Use the official record to reach the sponsor.

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Intraspinal Gabapentin in people with Chronic Intractable Pain, run by MedtronicNeuro at 14 sites in United States.

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 7 inclusion and 0 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: stopped early, as of the sponsor's last update on 23 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Jun 2011). 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?

Changes in a Pain Rating Scale After 3 Weeks of Blinded Treatment. (time frame: Baseline and Post-randomization Day 22). The study lists 2 primary outcomes in all. 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 NCT00414466, which also lists 1 linked publication.

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 23 Aug 2013.