Efficacy Of Pregabalin In Subjects With Post-Stroke Central Neuropathic Pain - Study Results

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator); Primary Purpose: Treatment
Condition:	Central Neuropathic Pain
Interventions:	Drug: Pregabalin Drug: Placebo

Participant Flow

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
Two-week screening and washout phase prior to randomization.

Reporting Groups

Description

Pregabalin

75 milligram (mg) capsule by mouth (PO) twice a day (BID) for 7 days. Pregabalin was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.

Placebo

75 milligram (mg) capsule PO BID for 7 days. Placebo was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.

Participant Flow for 2 periods

Period 1: Assigned to Treatment

	Pregabalin	Placebo
STARTED	111	109
COMPLETED	110	109
NOT COMPLETED	1	0
Unknown	1	0

Period 2: Pregabalin or Placebo Treatment Period

	Pregabalin	Placebo
STARTED	110	109
COMPLETED	93	90
NOT COMPLETED	17	19
Adverse Event	9	4
Lack of Efficacy	0	1
Lost to Follow-up	0	7
Withdrawal by Subject	6	4
Unknown	2	3

Baseline Characteristics

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Reporting Groups

	Description
Pregabalin	75 milligram (mg) capsule by mouth (PO) twice a day (BID) for 7 days. Pregabalin was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
Placebo	75 milligram (mg) capsule PO BID for 7 days. Placebo was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
Total	Total of all reporting groups

Baseline Measures

	Pregabalin	Placebo	Total
Number of Participants [units: participants]	110	109	219
Age [units: years] Mean ± Standard Deviation	59.4 ± 9.8	57.1 ± 10.2	58.2 ± 10.0
Gender [units: participants]
Female	43	39	82
Male	67	70	137

Outcome Measures

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1. Primary:

Mean Pain Score at Endpoint as Measured by Daily Pain Rating Scale (DPRS) [ Time Frame: Up to Week 12 ]

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2. Secondary:

Pain Score as Measured by DPRS [ Time Frame: Week 1, Week 2, Week 3, Week 6, Week 9, and Week 12 ]

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3. Secondary:

Number of Subjects With at Least a 30% Reduction From Baseline in Mean Pain Score at Endpoint [ Time Frame: Baseline, Week 12 ]

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4. Secondary:

Number of Subjects With at Least a 50% Reduction From Baseline in Mean Pain Score at Endpoint [ Time Frame: Baseline, Week 12 ]

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5. Secondary:

Weekly Mean Sleep Interference Score From Daily Sleep Diary (Daily Sleep Interference Scale [DSIS]) [ Time Frame: Week 1, Week 2, Week 3, Week 6, Week 9, and Week 12 ]

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6. Secondary:

Short Form-McGill Pain Questionnaire (SF-MPQ Visual Analog Scale [VAS]) - Part B Only [ Time Frame: Week 12 ]

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7. Secondary:

Neuropathic Pain Symptom Inventory (NPSI) [ Time Frame: Week 12 ]

Show Outcome Measure 7

8. Secondary:

Medical Outcome Study (MOS) Sleep Scale [ Time Frame: Week 12 ]

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9. Secondary:

Number of Subjects With Yes or No Response for Medical Outcome Study (MOS) Sleep Scale - Optimal Sleep [ Time Frame: Week 12 ]

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10. Secondary:

Hospital Anxiety and Depression Scale (HADS) - ITT Population [ Time Frame: Week 12 ]

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11. Secondary:

Euro Quality of Life (EQ-5D)- Health State Profile Utility Score [ Time Frame: Week 12 ]

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12. Secondary:

EQ-5D - VAS [ Time Frame: Week 12 ]

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13. Secondary:

Patient Global Impression of Change (PGIC) [ Time Frame: Week 12 ]

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14. Secondary:

Clinical Global Impression of Change (CGIC) [ Time Frame: Week 12 ]

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15. Secondary:

Quantitative Assessment of Neuropathic Pain (QANeP) - Sensory Threshold [ Time Frame: Baseline, Week 12 ]

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16. Secondary:

QANeP - Pain Rating Scales [ Time Frame: Baseline, Week 12 ]

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Serious Adverse Events

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Other Adverse Events

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Time Frame	No text entered.
Additional Description	No text entered.

Frequency Threshold

Threshold above which other adverse events are reported	5%

Reporting Groups

Description

Pregabalin

75 milligram (mg) capsule by mouth (PO) twice a day (BID) for 7 days. Pregabalin was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.

Placebo

75 milligram (mg) capsule PO BID for 7 days. Placebo was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.

Other Adverse Events

	Pregabalin	Placebo
Total, other (not including serious) adverse events
# participants affected / at risk	59/110	25/109
Gastrointestinal disorders
Diarrhoea ^{† 1}
# participants affected / at risk	6/110 (5.45%)	2/109 (1.83%)
General disorders
Oedema ^†
# participants affected / at risk	6/110 (5.45%)	0/109 (0.00%)
Oedema peripheral ^†
# participants affected / at risk	10/110 (9.09%)	3/109 (2.75%)
Infections and infestations
Upper respiratory tract infection ^†
# participants affected / at risk	3/110 (2.73%)	6/109 (5.50%)
Investigations
Weight increased ^†
# participants affected / at risk	6/110 (5.45%)	2/109 (1.83%)
Nervous system disorders
Dizziness ^†
# participants affected / at risk	31/110 (28.18%)	8/109 (7.34%)
Headache ^†
# participants affected / at risk	7/110 (6.36%)	8/109 (7.34%)
Somnolence ^†
# participants affected / at risk	24/110 (21.82%)	5/109 (4.59%)

†	Events were collected by systematic assessment
1	Term from vocabulary, MedDRA v 11.1

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 < 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), < 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:	Director, Clinical Trials Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier:	NCT00313820 History of Changes
Other Study ID Numbers:	A0081063
Study First Received:	April 10, 2006
Results First Received:	September 8, 2009
Last Updated:	October 9, 2009
Health Authority:	Australia: National Health and Medical Research Council