Phase 3 N=220 Randomized Double-blind Treatment

A 17-Week Trial To Assess Pregabalin For The Treatment Of Nerve Pain Due To Spinal Cord Injury

Neuralgia · Spinal Cord Injuries

Bottom Line

View on ClinicalTrials.gov: NCT00407745 ↗

Enrolled (actual)

220

Serious AEs

8.7%

Results posted

Dec 2011

Primary outcome: Primary: Duration Adjusted Average Change (DAAC) of Mean Pain Score — -1.66; -1.07 score on scale — p=0.0032

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: placebo (Drug); pregabalin (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Primary completion: Feb 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Duration Adjusted Average Change (DAAC) of Mean Pain Score	-1.66; -1.07	0.0032 sig
SECONDARY Change From Baseline in Weekly Mean Pain Score	6.5; 6.5; -1.9; -1.2	0.0066 sig
SECONDARY Number of Participants With >=30% Reduction in Weekly Mean Pain Score From Baseline	48; 33	0.0390 sig
SECONDARY Number of Participants With Categorical Scores on the Patient Global Impression of Change (PGIC) (Full Scale)	7; 2; 33; 25; 38; 24	0.0006 sig
SECONDARY Change From Baseline in Weekly Mean Sleep Interference Score	4.9; 5.2; -2.0; -1.0	<0.0001 sig
SECONDARY Change From Baseline in Weekly Mean Pain Score by Week	6.44; 6.51; -0.85; -0.38; -1.26; -0.62	0.0295 sig
SECONDARY Number of Participants With >=50% Reduction in Weekly Mean Pain Score From Baseline	31; 16	0.0256 sig
SECONDARY Change From Baseline in Modified Brief Pain Inventory Interference Scale (10-Item) (mBPI-10) Total Score	4.7; 4.9; -1.6; -1.1	0.0438 sig
SECONDARY Change From Baseline in Quantitative Assessment of Neuropathic Pain (QANeP) - Static Mechanical Allodynia	2.9; 2.6; -1.0; -0.3	0.7103
SECONDARY Change From Baseline in Quantitative Assessment of Neuropathic Pain (QANeP) - Dynamic Mechanical Allodynia	2.7; 2.3; -0.6; -0.3	0.5689
SECONDARY Change From Baseline in Quantitative Assessment of Neuropathic Pain (QANeP)- Punctata Hyperalgesia	3.9; 3.4; -1.0; -0.4	0.3362
SECONDARY Change From Baseline in Quantitative Assessment of Neuropathic Pain (QANeP)- Temporal Summation to Tactile Stimuli	4.1; 3.9; -0.5; -0.8	0.2721
SECONDARY Change From Baseline in Quantitative Assessment of Neuropathic Pain (QANeP)- Cold Allodynia	2.5; 2.7; -0.1; 0.4	0.3123
SECONDARY Change From Baseline in Quantitative Assessment of Neuropathic Pain (QANeP)- Cold Hyperalgesia Subscales	2.8; 2.8; -0.1; 0.4	0.4257
SECONDARY Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - 12 Items Total Intensity Score	0.4; 0.4; -0.1; -0.1	0.1377
SECONDARY Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - Burning Spontaneous Pain	0.5; 0.5; -0.1; -0.1	0.3312
SECONDARY Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - Pressing Spontaneous Pain	0.4; 0.4; -0.1; -0.0	0.0440 sig
SECONDARY Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - Paroxysmal Pain	0.4; 0.3; -0.1; -0.1	0.1370
SECONDARY Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - Evoked Pain	0.4; 0.4; -0.1; -0.1	0.8911
SECONDARY Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - Paresthesia/Dysesthesia	0.5; 0.5; -0.1; -0.1	0.3731
SECONDARY Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - Individual Item (1, 2, 3, 5, 6, 8, 9, 10, 11, 12) Score	-1.39; -1.00; -1.04; -0.41; -0.73; -0.20	0.3312
SECONDARY Number of Participants With Improved Duration of Brief Pain Attacks Based on NPSI - Duration (Item 4)	39; 28	0.0536
SECONDARY Number of Participants With Improvement in the Number of Attacks Based on NPSI - Number of Attacks (Item 7)	48; 38	0.3107
SECONDARY Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS)- 9-Item Overall Sleep Problems Index	45.7; 45.9; -10.8; -5.8	0.0262 sig
SECONDARY Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS) - Sleep Disturbance	51.9; 51.2; -17.3; -8.0	0.0041 sig
SECONDARY Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS) - Sleep Adequacy	42.3; 43.8; 11.6; 5.7	0.0998
SECONDARY Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS) - Snoring	31.2; 35.6; 2.2; -4.7	0.1048
SECONDARY Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS) - Awaken Short of Breath or With a Headache	15.0; 12.8; -6.2; -0.2	0.0347 sig
SECONDARY Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS) - Sleep Quantity	5.9; 6.2; 0.6; 0.2	0.0436 sig
SECONDARY Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS) - Somnolence	36.3; 39.7; -0.8; -4.9	0.2761
SECONDARY Number of Participants Having Optimal Sleep Based on Medical Outcomes Study Sleep Scale (MOS-SS)	49; 30	0.0024 sig
SECONDARY Change From Baseline in Hospital and Anxiety Depression Scale (HADS) - Anxiety	6.7; 6.9; -1.4; -0.8	0.1164
SECONDARY Change From Baseline in Hospital and Anxiety Depression Scale (HADS) - Depression	5.2; 6.3; -1.0; -0.5	0.0279 sig

Summary

The purpose of this study is to evaluate if pregabalin relieves nerve pain associated with spinal cord injury compared to placebo (pill that contains no active medicine). This study will also evaluate the safety of pregabalin in this patient population.

Eligibility Criteria

Inclusion Criteria

Subjects with nerve pain after Spinal cord injury (traumatic, diving, ischemic and after removal of benign tumors (except meningioma and fibromas)
Pain has to be chronic(continuous for at least 3 months or intermittent for at least 6 months
Pain score at least 4 in 4 of 7 days prior to receive treatment.

Exclusion Criteria

Pregabalin use in the last 60 days, prior intolerance to pregabalin
Creatinine clearance <60 mL/min.
White blood cell count <2500/mm3; neutrophil count <1500/mm3; platelet count <100 x 103/ mm3.
Abuse of drugs or alcohol
Unstable medial conditions
Clinically significant abnormal electrocardiogram (ECG).
Presence of severe pain associated with conditions other than spinal cord injury that could confound the assessment or self-evaluation of pain due to spinal cord injury.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00407745). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.