An fMRI Study Of Brain Response In Patients With Fibromyalgia

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Pfizer

ClinicalTrials.gov Identifier:

NCT00760474

First received: September 25, 2008

Last updated: June 22, 2012

Last verified: June 2012

History of Changes

Results First Received: March 7, 2012

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Pharmacodynamics Study; Intervention Model: Crossover Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Condition:	Fibromyalgia
Interventions:	Drug: Pregabalin, then placebo Drug: Placebo, then pregabalin

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
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants who met entrance criteria received placebo for 1 week (Day 1 to 8) then were randomized in a 1:1 ratio to blinded treatment sequence.

Reporting Groups

	Description
Pregabalin First, Then Placebo	Pregabalin 75 milligrams (mg) by mouth (PO) twice daily (BID) Period 1/Day 9 to 11; 150 mg BID Day 12 to 16; 200 mg BID Day 17 to 19; 225 mg BID Day 20 to 22 followed by taper Day 23 to 29 and an 8-day placebo washout period. Then, placebo matching study treatment in a similar pattern was administered beginning Period 2/Day 38.
Placebo First, Then Pregabalin	Placebo matching study treatment was administered beginning Period 1/Day9. Then, Pregabalin 75 mg BID Period 2/Day 38 to 40; 150 mg BID Day 41 to 45; 200 mg BID Day 46 to 48; 225 mg BID Day 49 to 51 followed by placebo taper Day 52 to 58.

Participant Flow for 3 periods

Period 1: Period 1 (P1)

	Pregabalin First, Then Placebo	Placebo First, Then Pregabalin
STARTED	13	14
Treated	13 ^[1]	14 ^[1]
Overall Number of Unique Participants	12	13
COMPLETED	12	13
NOT COMPLETED	1	1
Discontinued then re-entered	1	1

[1]	1 participant discontinued in P1; re-entered with new identification number and completed P1, P2.

Period 2: Placebo Washout Period

	Pregabalin First, Then Placebo	Placebo First, Then Pregabalin
STARTED	12	13
COMPLETED	12	12
NOT COMPLETED	0	1
Unspecified	0	1

Period 3: Period 2 (P2)

	Pregabalin First, Then Placebo	Placebo First, Then Pregabalin
STARTED	12	12
COMPLETED	11	11
NOT COMPLETED	1	1
Lost to Follow-up	1	0
Adverse Event	0	1

Baseline Characteristics

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Reporting Groups

	Description
Entire Study Population	Participants who met entrance criteria received placebo for 1 week (Day 1 to 8) then were randomized in a 1:1 ratio to blinded treatment sequence to receive either: Pregabalin, then placebo: Pregabalin 75 mg PO BID Period 1/Day 9 to 11; 150 mg BID Day 12 to 16; 200 mg BID Day 17 to 19; 225 mg BID Day 20 to 22 followed by taper Day 23 to 29 and an 8-day placebo washout period. Then, placebo matching study treatment in a similar pattern was administered beginning Period 2/Day 38 and included dose escalation through Day 51 followed by placebo taper Day 52 to 58. Or placebo, then Pregabalin: Placebo matching study treatment was administered in a similar fashion to Pregabalin treatment beginning Period 1/Day 9 and included dose escalation, taper and an 8-day placebo washout period. Then, Pregabalin 75 mg BID Period 2/Day 38 to 40; 150 mg BID Day 41 to 45; 200 mg BID Day 46 to 48; 225 mg BID Day 49 to 51 followed by placebo taper Day 52 to 58.

Description

Entire Study Population

Participants who met entrance criteria received placebo for 1 week (Day 1 to 8) then were randomized in a 1:1 ratio to blinded treatment sequence to receive either:

Pregabalin, then placebo: Pregabalin 75 mg PO BID Period 1/Day 9 to 11; 150 mg BID Day 12 to 16; 200 mg BID Day 17 to 19; 225 mg BID Day 20 to 22 followed by taper Day 23 to 29 and an 8-day placebo washout period. Then, placebo matching study treatment in a similar pattern was administered beginning Period 2/Day 38 and included dose escalation through Day 51 followed by placebo taper Day 52 to 58.

Or placebo, then Pregabalin: Placebo matching study treatment was administered in a similar fashion to Pregabalin treatment beginning Period 1/Day 9 and included dose escalation, taper and an 8-day placebo washout period. Then, Pregabalin 75 mg BID Period 2/Day 38 to 40; 150 mg BID Day 41 to 45; 200 mg BID Day 46 to 48; 225 mg BID Day 49 to 51 followed by placebo taper Day 52 to 58.

Baseline Measures

	Entire Study Population
Number of Participants [units: participants]	25
Age [units: years] Mean ± Standard Deviation	38.6 ± 12.0
Gender, Customized ^[1] [units: participants]	25

[1]	Female

Outcome Measures

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1. Primary:

Glutamine/Creatine (Gln/Cr) and Glutamate/Creatine (Glu/Cr) Ratios Measured by Proton Magnetic Resonance Spectroscopy (1H-MRS) [ Time Frame: Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51) ]

Show Outcome Measure 1

2. Primary:

Voxel-wise Blood Oxygen Level Dependent (BOLD) Using Functional Magnetic Resonance Imaging (fMRI) of Brain Activation Signals in Response to Blunt Pressure Pain: Percent Change in BOLD Activations Including Outliers [ Time Frame: Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51) ]

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3. Secondary:

Voxel-wise Blood Oxygen Level Dependent (BOLD) Using Functional Magnetic Resonance Imaging (fMRI) of Brain Activation Signals in Response to a Control Visual (Checkerboard) Stimuli [ Time Frame: Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51) ]

Show Outcome Measure 3

4. Secondary:

Resting State Brain Activity (Connectivity Analysis) Assessed by Temporal Correlations in Low Frequency fMRI BOLD Signals Across Pain Processing Regions [ Time Frame: Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51) ]

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5. Secondary:

Gracely Box Scales for Pain Intensity (GBSint) Including Outliers [ Time Frame: Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51) ]

Show Outcome Measure 5

6. Secondary:

Gracely Box Scales for Pain Unpleasantness (GBSunp) Including Outliers [ Time Frame: Baseline/Pre-dose (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51) ]

Show Outcome Measure 6

7. Secondary:

Daily Pain Diary Numeric Rating Scale (NRS) Item From the Modified Brief Pain Inventory (mBPI) for Assessment of Clinical Pain: 7 Day Average Pain Score Including Outliers [ Time Frame: Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51) ]

Show Outcome Measure 7

8. Secondary:

Daily Pain Diary Numeric Rating Scale (NRS) Item From the Modified Brief Pain Inventory (mBPI) for Assessment of Clinical Pain: 3 Day Average Pain Score Including Outliers [ Time Frame: Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51) ]

Show Outcome Measure 8

9. Secondary:

Daily Pain Diary Numeric Rating Scale (NRS) Item From the Modified Brief Pain Inventory (mBPI) for Assessment of Clinical Pain: Individual Daily Pain Score Including Outliers [ Time Frame: Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51) ]

Show Outcome Measure 9

10. Secondary:

Short-Form McGill Pain Questionnaire (SF-MPQ): Affective Total Score Including Outliers [ Time Frame: Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51) ]

Show Outcome Measure 10

11. Secondary:

Short-Form McGill Pain Questionnaire (SF-MPQ): Sensory Total Score Including Outliers [ Time Frame: Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51) ]

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12. Secondary:

Short-Form McGill Pain Questionnaire (SF-MPQ): Overall Score Including Outliers [ Time Frame: Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51) ]

Show Outcome Measure 12

13. Secondary:

Sphygmomanometry Evoked Allodynia in Relation to the Blood Pressure (BP) Value at Which Allodynia Was Evoked [ Time Frame: Day 58 ]

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14. Secondary:

Pain at the Bilateral Epicondyle Tender Points Assessed Using American College of Rheumatology (ACR) Classification Criteria [ Time Frame: Day 58 ]

Show Outcome Measure 14

15. Other Pre-specified:

Hospital Anxiety and Depression Scale (HADS): Anxiety Total Score Including Outliers [ Time Frame: Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51) ]

Show Outcome Measure 15

16. Other Pre-specified:

Hospital Anxiety and Depression Scale (HADS): Depression Total Score Including Outliers [ Time Frame: Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51) ]

Show Outcome Measure 16

17. Other Pre-specified:

Pain Catastrophizing Scale (PCS) Including Outliers [ Time Frame: Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51) ]

Show Outcome Measure 17

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. Restriction Description: Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.

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
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Results Point of Contact:

Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.govCallCenter@pfizer.com

No publications provided

Responsible Party:	Pfizer
ClinicalTrials.gov Identifier:	NCT00760474 History of Changes
Other Study ID Numbers:	A0081211
Study First Received:	September 25, 2008
Results First Received:	March 7, 2012
Last Updated:	June 22, 2012
Health Authority:	United States: Food and Drug Administration

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