Pilot Study Of Pregabalin And Prediction Of Treatment Response In Patients With Postherpetic Neuralgia

This study has been terminated.
(See termination reason in detailed description.)
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01603394
First received: April 16, 2012
Last updated: July 7, 2013
Last verified: July 2013
  Purpose

The primary objective is to explore whether sensory symptom cluster analysis is useful for predicting treatment response in Postherpetic Neuralgia.


Condition Intervention Phase
Postherpetic Neuralgia
Drug: pregabalin
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 4 Multicenter, Open-Label, Pilot Study Of Pregabalin And Prediction Of Treatment Response In Patients With Postherpetic Neuralgia

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • The change in the daily pain diary (Numerical Rating Scale, NRS) mean pain score at the end of the study (Week 6) compared with baseline. [ Time Frame: Baseline, Week 6 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of subjects within each phenotype group as determined by sensory symptom clustering using the PainPREDICT, PainDETECT and Neuropathic Pain Symptom Inventory. [ Time Frame: Baseline, Week 6 ] [ Designated as safety issue: No ]
  • Proportions of subjects with >30% and >50% pain reduction based on daily pain diary. [ Time Frame: Baseline, Week 6 ] [ Designated as safety issue: No ]
  • Proportion of phenotypes within the 30% and 50% responder groups. [ Time Frame: Baseline, Week 6 ] [ Designated as safety issue: No ]
  • Pain numeric rating scale (NRS); 1 week recall period. [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Neuropathic Pain Symptom Inventory (NPSI). [ Time Frame: Baseline, Week 6 ] [ Designated as safety issue: No ]
  • Patient Global Impression of Change (PGIC). [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
  • Short Form 12v2 Health Survey (SF 12v2). [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • The change in the daily sleep interference diary (Numerical Rating Scale, NRS) mean pain score at the end of the study (Week 6) compared with baseline. [ Time Frame: Baseline, Week 6 ] [ Designated as safety issue: No ]
  • Patient Health Questionnaire-8 (PHQ 8); Generalized Anxiety Disorder-7 (GAD 7). [ Time Frame: Baseline, Week 6 ] [ Designated as safety issue: No ]
  • Patient Catastrophizing Scale (PCS). [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Brief Pain Inventory (BPI sf). [ Time Frame: Baseline, Week 6 ] [ Designated as safety issue: No ]

Enrollment: 9
Study Start Date: October 2012
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pregabalin (300-600 mg/day; 150 mg/day starting dose) Drug: pregabalin
Pregabalin Capsules (150 mg - 600mg), Dose titration (4 weeks) and fixed dose (2 weeks) for a 6 week treatment period.

Detailed Description:

The study was stopped on 26 April 2013 due to feasibility issues (low enrollment) not safety. The overall risk-benefit of Lyrica has not changed at all due to termination of this trial. Only 9 of the 150 patients were enrolled into the trial, so we are unable to get adequate results from this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects must have pain present for more than 3 months after the healing of the herpes zoster skin rash.
  • At screening (V1) and baseline (V2), subjects must have a score of >=4 on the Numeric Rating Scale for Pain (1 week recall period).
  • At baseline (V2), at least 4 pain diaries must be completed satisfactorily within the last 7 days and the average pain score must be >=4.

Exclusion Criteria:

  • Subjects having other severe pain that may confound assessment or self evaluation of the pain due to PHN.
  • Neurolytic or neurosurgical therapy for Postherpetic Neuralgia
  • Skin conditions in the affected dermatome that could alter sensation.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01603394

Locations
United States, Florida
Pfizer Investigational Site
Leesburg, Florida, United States, 34748
United States, Kentucky
Pfizer Investigational Site
Lexington, Kentucky, United States, 40509
United States, North Carolina
Pfizer Investigational Site
Raleigh, North Carolina, United States, 27612
United States, Pennsylvania
Pfizer Investigational Site
Jekintown, Pennsylvania, United States, 19046
Austria
Pfizer Investigational Site
Senftenberg, A-3541, Austria
Pfizer Investigational Site
Wien, Austria, A-1010
Germany
Pfizer Investigational Site
Schwerin, Germany, 19053
South Africa
Pfizer Investigational Site
Pretoria, Gauteng, South Africa, 0122
Pfizer Investigational Site
Paarl, Western Cape, South Africa, 7626
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01603394     History of Changes
Other Study ID Numbers: A9001464
Study First Received: April 16, 2012
Last Updated: July 7, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Neuralgia
Neuralgia, Postherpetic
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Pregabalin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants

ClinicalTrials.gov processed this record on April 17, 2014