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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00313820
First received: April 10, 2006
Last updated: October 9, 2009
Last verified: October 2009
  Purpose

Efficacy and Safety of flexibly dosed pregabalin compared to placebo among subjects with central post stroke pain (CPSP)


Condition Intervention Phase
Central Neuropathic Pain
Drug: Pregabalin
Drug: Placebo
Phase 4

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
Official Title: A 13-Week, Randomized, Multi-Center, Double-Blind, Placebo-Controlled, Parallel-Group Study To Evaluate The Efficacy, Safety And Tolerability Of Pregabalin (150-600 Mg/Day) Using A Flexible Dosing Schedule In The Treatment Of Subjects With Central Post-Stroke Pain (CPSP)

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Mean Pain Score at Endpoint as Measured by Daily Pain Rating Scale (DPRS) [ Time Frame: Up to Week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pain Score as Measured by DPRS [ Time Frame: Week 1, Week 2, Week 3, Week 6, Week 9, and Week 12 ] [ Designated as safety issue: No ]
  • Number of Subjects With at Least a 30% Reduction From Baseline in Mean Pain Score at Endpoint [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
  • Number of Subjects With at Least a 50% Reduction From Baseline in Mean Pain Score at Endpoint [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Short Form-McGill Pain Questionnaire (SF-MPQ Visual Analog Scale [VAS]) - Part B Only [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Neuropathic Pain Symptom Inventory (NPSI) [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Medical Outcome Study (MOS) Sleep Scale [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Number of Subjects With Yes or No Response for Medical Outcome Study (MOS) Sleep Scale - Optimal Sleep [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Hospital Anxiety and Depression Scale (HADS) - ITT Population [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Euro Quality of Life (EQ-5D)- Health State Profile Utility Score [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • EQ-5D - VAS [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Patient Global Impression of Change (PGIC) [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Clinical Global Impression of Change (CGIC) [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Quantitative Assessment of Neuropathic Pain (QANeP) - Sensory Threshold [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
  • QANeP - Pain Rating Scales [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]

Enrollment: 220
Study Start Date: August 2006
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Pregabalin
The change from in pain scores from baseline to endpoint among stroke subjects receiving pregabalin will be compared to change in pain scores from baseline to endpoint among stroke subjects receiving matched placebo.
Drug: Pregabalin
Eligible subjects with post-stroke central pain will be randomized to receive double blinded treatment using pregabalin or matched placebo. The effects of pregabalin as compared to placebo on pain pain symptoms will be compared over the 13 week clinical trial. At baseline following pain ratings and clinical measures, subjects randomized to pregabalin receive instructions to take 75mg twice a day for 7days. The dosing of pregabalin or matching placebo will be titrated over the first 4 weeks (based on tolerability and pain scores). (Range 150-600mg) After the 4th week, the dose of medication will be maintained until week 12 (when tapering of medication begins) Ratings of Pain severity, review of pain/sleep diaries as well as medication tolerance occur bi-weekly throughout the study. Tapering off med occurs from week 12-13.
Placebo Comparator: Placebo
The change in pain scores from baseline to endpoint will be compared among the two treatment groups- ie subjects receiving 12 weeks of pregabalin treatment vs subjects receiving 12 weeks of placebo treatment.
Drug: Placebo
Eligible subjects with post-stroke central pain will be randomized to receive double blinded treatment using pregabalin or matched placebo. The effects of pregabalin as compared to placebo on pain pain symptoms will be compared over the 13 week clinical trial. At baseline following pain ratings and clinical measures, subjects randomized to pregabalin receive instructions to take 75mg twice a day for 7days. The dosing of pregabalin or matching placebo will be titrated over the first 4 weeks (based on tolerability and pain scores). (Range 150-600mg) After the 4th week, the dose of medication will be maintained until week 12 (when tapering of medication begins) Ratings of Pain severity, review of pain/sleep diaries as well as medication tolerance occur bi-weekly throughout the study. Tapering off med occurs from week 12-13.

  Eligibility

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

Inclusion Criteria:

  • Positive history of clinical stroke at least 4 months prior to randomization CPSP--3 months prior to screening

Exclusion Criteria:

  • History of dementia or any other severe cognitive impairment
  • Diabetic Peripheral Neuropathy (DPN)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00313820

  Show 33 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
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

Keywords provided by Pfizer:
Post-stroke pain, pregabalin

Additional relevant MeSH terms:
Neuralgia
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Pregabalin
Gamma-Aminobutyric Acid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
GABA Agents
Neurotransmitter Agents

ClinicalTrials.gov processed this record on September 18, 2014