Clinical trial NCT01049217: Pregabalin Versus Placebo In The Treatment Of Neuropathic Pain Associated With HIV Neuropathy
Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Trial Of Pregabalin Versus Placebo In The Treatment Of Neuropathic Pain Associated With HIV Neuropathy (Pregabalin A0081244)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Neuropathy
Keywords: neuropathy
pain
HIV-1
HIV Infections
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-01-14
Enrollment: 377
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy of pregabalin compared to placebo in reducing neuropathic pain associated with HIV neuropathy.

Detailed description: Based on DMC interim efficacy analysis results indicating a low probability for success the study was terminated on April 2, 2012; the termination was unrelated to any safety findings that could impact patient health.

Eligibility criteria: Inclusion Criteria:

* Men and women, ages of 18 or greater
* Documented evidence of HIV-1 infection
* Documented diagnosis of HIV-associated Distal Symmetrical Polyneuropathy (DSP) with subjective sensory symptom of pain
* Pain starts in the feet

Exclusion Criteria:

* Subject has untreated vitamin B12 deficiency (serum B12 level \<200 pg/ml) or if treated B12 deficiency -treatment is less than 6 months of B12 supplementation (injection or intranasal B12) prior to screening
* Diabetes mellitus requiring regular medical treatment (other than diet and exercise) or HbA1C \>6.9
* Subjects with peripheral neuropathic pain that is not associated with HIV infection; including subjects with conditions such as: Post Herpetic Neuralgia (PHN), Diabetic Peripheral Neuropathy (DPN), familial neuropathies; compression related neuropathy, radicular pain, other infection related neuropathies (eg, leprosy); neuropathy related to: metabolic abnormalities; nutritional factors; vascular insults; inflammation; autoimmune disease; and malignancy

Primary outcomes:
measure: Change From Baseline in Mean Pain Score at Endpoint (up to Week 16)
timeFrame: Baseline, Endpoint (up to Week 16)
Secondary outcomes:
measure: Number of Participants With Categorical Scores on Patient Global Impression of Change (PGIC)
timeFrame: Week 16
measure: Number of Participants With Categorical Scores on Clinician Global Impression of Change (CGIC)
timeFrame: Week 16
measure: Change From Baseline in Numeric Rating Scale (NRS)-Sleep Interference Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16 and Endpoint (up to Week 16)
timeFrame: Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, Endpoint (up to Week 16)
measure: Change From Baseline in Numeric Rating Scale (NRS)-Current Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16 and Endpoint (up to Week 16)
timeFrame: Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, Endpoint (up to Week 16)
measure: Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score at Week 4, 8, 12, 16 and Endpoint (up to Week 16)
timeFrame: Baseline, Week 4, 8, 12, 16, Endpoint (up to Week 16)
measure: Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) Item Scores at Endpoint (up to Week 16)
timeFrame: Baseline, Endpoint (up to Week 16)
measure: Neuropathic Pain Symptom Inventory (NPSI): Change From Baseline in Number of Participants With Duration of Spontaneous Pain and Number of Pain Attacks at Endpoint (up to Week 16)
timeFrame: Baseline, Endpoint (up to Week 16)
measure: Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) Subscales and Total Intensity Score at Endpoint (up to Week 16)
timeFrame: Baseline, Endpoint (up to Week 16)
measure: Total Sleep Time (TST) and Minutes of Interrupted Sleep (MIS)
timeFrame: Baseline (Day -14 to 1), Week 1 through Week 4, Week 12 through Week 16, Endpoint (up to Week 16)
measure: Sleep Fragmentation Index (SFI)
timeFrame: Baseline (Day -14 to 1), Week 1 through Week 4, Week 12 through Week 16, Endpoint (up to Week 16)
measure: Sleep Efficiency
timeFrame: Baseline (Day -14 to 1), Week 1 through Week 4, Week 12 through Week 16, Endpoint (up to Week 16)
measure: Total Activity Counts
timeFrame: Baseline (Day -14 to 1), Week 1 through Week 4, Week 12 through Week 16, Endpoint (up to Week 16)
measure: Percentage Day Time Above Sedentary Level
timeFrame: Baseline (Day -14 to 1), Week 1 through Week 4, Week 12 through Week 16, Endpoint (up to Week 16)
measure: Change From Baseline in Medical Outcomes Study-Sleep Scale (MOS-SS) at Endpoint (up to Week 16)
timeFrame: Baseline, Endpoint (up to Week 16)
measure: Medical Outcomes Study-Sleep Scale (MOS-SS): Number of Participants With Optimal Sleep
timeFrame: Baseline, Endpoint (up to Week 16)
measure: Change From Baseline in Hospital Anxiety and Depression Scales (HADS) at Endpoint (up to Week 16)
timeFrame: Baseline, Endpoint (up to Week 16)
measure: Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Endpoint (up to Week 16)
timeFrame: Baseline, Endpoint (up to Week 16)
measure: Number of Participants Who Were Employed or Unemployed Assessed by Work Productivity and Activity Impairment: Specific Health Problem (WPAI: SHP) Questionnaire
timeFrame: Baseline, Week 16, 17
measure: Absenteeism and Presenteeism Assessed by Work Productivity and Activity Impairment: Specific Health Problem (WPAI: SHP) Questionnaire
timeFrame: Baseline, Week 16, 17
measure: Productivity and Activity Impairment Assessed by Work Productivity and Activity Impairment: Specific Health Problem (WPAI: SHP) Questionnaire
timeFrame: Baseline, Week 16, 17
measure: Diagnostic Neuropathy Assessment
timeFrame: Screening
Other outcomes:
measure: Number of Participants With Treatment-Emergent (TE) Adverse Events (AEs) or Serious Adverse Events (SAEs)
timeFrame: Baseline up to 28 days after last dose
measure: Number of Participants With Abnormal Laboratory Test Findings
timeFrame: Screening up to Week 17
measure: Number of Participants With Positive Serum and Urine Pregnancy
timeFrame: Screening for serum pregnancy test, Week 1 for urine pregnancy test
measure: Number of Participants With Abnormal Physical Examination Findings
timeFrame: Screening, Week 8, 17
measure: Body Weight
timeFrame: Screening, Week 1, 4, 8, 12, 16, 17
measure: Sitting Systolic and Diastolic Blood Pressure
timeFrame: Screening, Week 1, 4, 8, 12, 16, 17
measure: Sitting Heart Rate
timeFrame: Screening, Week 1, 4, 8, 12, 16, 17
measure: Number of Participants With Neurological Examination Findings
timeFrame: Screening
measure: Number of Participants Who Met Mini-International Neuropsychiatric Interview (MINI) Criteria
timeFrame: Screening
measure: Number of Participants With Response to Sheehan-Suicidality Tracking Scale (S-STS) Mapped to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories
timeFrame: Screening, Post-Baseline (Week 4 up to Week 17)
measure: Number of Participants With Response to Patient Health Questionnaire-8 (PHQ-8)
timeFrame: Screening
Locations:
city: Phoenix
country: United States
facility: Southwest Center for HIV/AIDS
state: Arizona
city: Phoenix
country: United States
facility: SW Center for HIV/AIDS
state: Arizona
city: Phoenix
country: United States
facility: Arizona Research Center
state: Arizona
city: Los Angeles
country: United States
facility: AIDS Research Alliance of America
state: California
city: Los Angeles
country: United States
facility: Anthony Mills, MD, Inc.
state: California
city: Los Angeles
country: United States
facility: David Geffen School of Medicine at UCLA c/o NNAB
state: California
city: North Hollywood
country: United States
facility: Providence Clinical Research
state: California
city: Palm Springs
country: United States
facility: Desert Medical Group, Inc. dba Desert Oasis Healthcare Medical Group
state: California
city: San Diego
country: United States
facility: University of California San Diego
state: California
city: Stanford
country: United States
facility: Stanford University Medical Center
state: California
city: Aventura
country: United States
facility: Neuroscience Consultants, LLC.
state: Florida
city: Aventura
country: United States
facility: South Florida Medical Research
state: Florida
city: Miami Beach
country: United States
facility: Wohlfeiler, Piperato & Associates, LLC
state: Florida
city: Miami
country: United States
facility: The Kinder Medical Group
state: Florida
city: Tampa
country: United States
facility: Meridien Research
state: Florida
city: Atlanta
country: United States
facility: AIDS Research Consortium of Atlanta
state: Georgia
city: Atlanta
country: United States
facility: Midtown Neurology, PC
state: Georgia
city: Decatur
country: United States
facility: Neurology Specialists of Decatur Research Center
state: Georgia
city: Chicago
country: United States
facility: Rehabilitation Institute of Chicago
state: Illinois
city: New York
country: United States
facility: Mount Sinai School of Medicine
state: New York
city: Toledo
country: United States
facility: University of Toledo Medical Center
state: Ohio
city: Toledo
country: United States
facility: University of Toledo
state: Ohio
city: Bellaire
country: United States
facility: University of Texas Physicians
state: Texas
city: Dallas
country: United States
facility: Amelia Court HIV Research Clinic
state: Texas
city: Houston
country: United States
facility: The University of Texas Medical School at Houston
state: Texas
city: Bogota
country: Colombia
facility: Asistencia Cientifica de Alta Complejidad
state: Cundinamarca
city: Bogota
country: Colombia
facility: Centro Instituto de Investigaciones Fundación Universitaria Sanitas
state: Cundinamarca
city: Bogotá
country: Colombia
facility: Riesgo de Fractura S.A
state: Cundinamarca
city: Bucaramanga
country: Colombia
facility: Instituto Colombiano para el Avance de la Medicina- Santander S.A.S. - ICAMEDIC Santander S.A.S
state: Santander
city: Santo Domingo
country: Dominican Republic
facility: Instituto Dominicano de Estudios Virológicos - IDEV
city: Hyderabad
country: India
facility: Mahavir Hospital and Research Centre
state: Andhra Pradesh
city: Hyderabad
country: India
facility: Surakshaka Multispeciality Hospital
state: Andhra Pradesh
city: Ahmedabad
country: India
facility: Infectious Disease Clinic
state: Gujarat
city: Mumbai
country: India
facility: Jaslok Hospital & Research Centre
state: Maharashtra
city: Pune
country: India
facility: Deenanath Mangeshkar Hospital and Research Centre
state: Maharashtra
city: Chennai
country: India
facility: YR Gaitonde Centre for AIDS Research and Education
state: Tamil Nadu
city: Lima
country: Peru
facility: Hospital Nacional Dos de Mayo
city: Lima
country: Peru
facility: Hospital Nacional Guillermo Almenara Irigoyen
city: Bydgoszcz
country: Poland
facility: Katedra Chorob Zakaznych i Hepatologii UMK w Toruniu CM w Bydgoszczy
city: Chorzow
country: Poland
facility: Oddzial Diagnostyki i Terapii AIDS
city: Ponce
country: Puerto Rico
facility: Ponce School of Medicine-CAIMED Center
city: Ponce
country: Puerto Rico
facility: Ponce School of Medicine - Practice Group
city: Rio Piedras
country: Puerto Rico
facility: Puerto Rico Clinical and Translational Research Consortium
city: East London
country: South Africa
facility: Border Diabetic Centre
state: Eastern Cape
city: Port Elizabeth
country: South Africa
facility: MediSynergy
state: Eastern Cape
city: Benoni
country: South Africa
facility: Worthwhile Clinical Trials
state: Gauteng
city: Johannesburg
country: South Africa
facility: Toga Laboratory
state: Gauteng
city: Johannesburg
country: South Africa
facility: Drs Essack and Mitha
state: Gauteng
city: Johannesburg
country: South Africa
facility: University of Witwatersrand-Clinical HIV Research Unit (CHRU)
state: Gauteng
city: Pretoria West
country: South Africa
facility: Pretoria West Hospital
state: Gauteng
city: Pretoria
country: South Africa
facility: Synexus SA Stanza Bopape Clinical Research Centre
state: Gauteng
city: Soweto
country: South Africa
facility: Chris Hani Baragwanath Hospital, The Palliative Care Centre
state: Gauteng
city: Stanger
country: South Africa
facility: Dr J. Reddy's Surgery
state: KwaZulu Natal
city: Cape Town
country: South Africa
facility: University of Cape Town
state: Western Cape
city: Durban
country: South Africa
facility: Synapta Clinical Research Centre
city: Gauteng
country: South Africa
facility: Innovir Institute
city: Middelburg
country: South Africa
facility: Mzansi Ethical Research Centre
city: Paarl
country: South Africa
facility: Be Part Yoluntu Centre
city: Paarl
country: South Africa
facility: Paarl Research Center
city: Pretoria
country: South Africa
facility: Clinical Research Unit, University of Pretoria
city: Tygerberg
country: South Africa
facility: Department of Neurology
city: Bangkok
country: Thailand
facility: South East Asia Research Collaboration with Hawaii
city: Bangkok
country: Thailand
facility: Neurology unit, Department of Medicine,
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Simpson DM, Rice AS, Emir B, Landen J, Semel D, Chew ML, Sporn J. A randomized, double-blind, placebo-controlled trial and open-label extension study to evaluate the efficacy and safety of pregabalin in the treatment of neuropathic pain associated with human immunodeficiency virus neuropathy. Pain. 2014 Oct;155(10):1943-54. doi: 10.1016/j.pain.2014.05.027. Epub 2014 Jun 4.