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

This study has been terminated.

(Study closed and subject follow-up completed following analysis of blinded study data.)

Sponsor:

Information provided by:

MedtronicNeuro

ClinicalTrials.gov Identifier:

NCT00414466

First received: December 20, 2006

Last updated: May 6, 2011

Last verified: May 2011

History of Changes

Results First Received: December 22, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Treatment
Condition:	Chronic Intractable Pain
Intervention:	Drug: Intraspinal MDT2004

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
A total of 254 subjects were enrolled into the study between December 2006 and October 2009.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
During a 2-week screening period subjects were required to meet eligibility criteria including maintaing 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.

Reporting Groups

	Description
1 Placebo	Intraspinal Placebo delivered continuously for 29 days via an implantable infusion system
2 MDT2004 Low	Intraspinal MDT2004 Low delivered continuously for 22 days via an implantable infusion system followed by 7 days of infusion at half dose
3 MDT2004 Medium	Intraspinal MDT2004 Medium delivered continuously for 22 days via an implantable infusion system followed by 7 days of infusion at half dose
4 MDT2004 High	Intraspinal MDT2004 High delivered continuously for 22 days via an implantable infusion system followed by 7 days of infusion at half dose

Participant Flow: Overall Study

	1 Placebo	2 MDT2004 Low	3 MDT2004 Medium	4 MDT2004 High
STARTED	44	42	41	43
COMPLETED	42	42	40	42
NOT COMPLETED	2	0	1	1
Adverse Event	0	0	1	1
Lack of Efficacy	1	0	0	0
Withdrawn by Sponsor	1	0	0	0

Baseline Characteristics

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Reporting Groups

	Description
1 Placebo	Intraspinal Placebo delivered continuously for 29 days via an implantable infusion system
2 MDT2004 Low	Intraspinal MDT2004 Low delivered continuously for 22 days via an implantable infusion system followed by 7 days of infusion at half dose
3 MDT2004 Medium	Intraspinal MDT2004 Medium delivered continuously for 22 days via an implantable infusion system followed by 7 days of infusion at half dose
4 MDT2004 High	Intraspinal MDT2004 High delivered continuously for 22 days via an implantable infusion system followed by 7 days of infusion at half dose
Total	Total of all reporting groups

Baseline Measures

	1 Placebo	2 MDT2004 Low	3 MDT2004 Medium	4 MDT2004 High	Total
Number of Participants [units: participants]	44	42	41	43	170
Age [units: participants]
<=18 years	0	0	0	0	0
Between 18 and 65 years	39	41	40	40	160
>=65 years	5	1	1	3	10
Age [units: years] Mean ± Standard Deviation	51.8 ± 11.2	50.1 ± 9.9	48.1 ± 9.4	48.3 ± 11.1	49.6 ± 10.5
Gender [units: participants]
Female	27	28	20	23	98
Male	17	14	21	20	72
Region of Enrollment [units: participants]
United States	44	42	41	43	170

Outcome Measures

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1. Primary:

Changes in a Pain Rating Scale After 3 Weeks of Blinded Treatment. [ Time Frame: Baseline and Post-randomization Day 22 ]

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2. Primary:

Treatment-emergent Adverse Events [ Time Frame: Randomization to Post-randomization Day 29 (includes dose reduction) ]

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3. Secondary:

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

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact:

Name/Title: Robert Spencer, Clinical Research Manager
Organization: Medtronic Neuromodulation
phone: (763) 505-8690
e-mail: robert.j.spencer@medtronic.com

No publications provided

Responsible Party:	Medtronic Neuromodulation, Medtronic, Inc.
ClinicalTrials.gov Identifier:	NCT00414466 History of Changes
Other Study ID Numbers:	1622
Study First Received:	December 20, 2006
Results First Received:	December 22, 2010
Last Updated:	May 6, 2011
Health Authority:	United States: Food and Drug Administration

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