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Evaluation of Pregabalin in Idiopathic Small Fiber Neuropathy

Primary Purpose

Small-Fiber Neuropathy

Status
Terminated
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Pregabalin
Placebo
Sponsored by
University of Alberta
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Small-Fiber Neuropathy focused on measuring Neuropathic, Neuropathic pain, Nerve pain, Pain, Chronic pain, Pregabalin, Lyrica, Small fiber neuropathy, Neuropathy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • A diagnosis of idiopathic SFN (based on clinical and electrodiagnostic criteria).
  • Each day for 7 days prior to Visit 2 (Washout) they must complete a modified Quadruple Visual Analogue Scale₁ showing moderate to severe pain (i.e. a daily mean rating score of ≥ 4).
  • As the safety of pregabalin in pregnancy has not been established, females of childbearing potential must have a negative βHCG serum and agree to practice acceptable birth control methods.
  • All subjects must have screening laboratory values that are within normal limits or abnormal values that are deemed not clinically significant by the Principle Investigator.

Exclusion Criteria:

  • Have a psychological or psychiatric condition that may hinder their ability to provide important information
  • History of psychosis, drug or alcohol abuse history within the last year
  • Malignancy within the last 2 years (except skin cancer)
  • Clinically significant conditions (including but not limited to cardiovascular or hepatic diseases), and seizure disorders.
  • Subjects with an abnormal 2-hour glucose tolerance test (i.e., glucose >7.8 mmol/l) will be excluded under "clinically significant conditions" as stated above.
  • May not have participated in a previous trial of pregabalin, have a history of intolerance or hypersensitivity to pregabalin.
  • Patients with renal impairment (CrCl < 60 ml/min) will be excluded.

Sites / Locations

  • University of Alberta Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Active

Placebo

Arm Description

Available as 75 mg capsules. Subjects will begin Phase 1 treatment on either pregabalin (or placebo) 75mg BID (1 capsule BID) for one week then increasing to 150mg BID or placebo (2 capsules BID) for a further 7 weeks. During this period patients will be allowed to taper the drug to 225mg a day (75mg in am, 150mg in pm) or (75mg BID) if they develop significant adverse effects on the higher dose. After 8 weeks Phase 1 treatment subjects will taper study medication to 75mg BID or placebo (1 capsule BID) for 7 days and then continue taking placebo (1 capsule) for 7 additional days prior to the crossover. After the taper and washout, Phase 2 will begin using the alternate treatment and will follow the same dosing regime as Phase 1 for the remaining 10 weeks.

Available as 75 mg capsules. Subjects will begin Phase 1 treatment on either pregabalin (or placebo) 75mg BID (1 capsule BID) for one week then increasing to 150mg BID or placebo (2 capsules BID) for a further 7 weeks. During this period patients will be allowed to taper the drug to 225mg a day (75mg in am, 150mg in pm) or (75mg BID) if they develop significant adverse effects on the higher dose. After 8 weeks Phase 1 treatment subjects will taper study medication to 75mg BID or placebo (1 capsule BID) for 7 days and then continue taking placebo (1 capsule) for 7 additional days prior to the crossover. After the taper and washout, Phase 2 will begin using the alternate treatment and will follow the same dosing regime as Phase 1 for the remaining 10 weeks.

Outcomes

Primary Outcome Measures

Neuropathic pain score
Measured difference in the mean neuropathic pain score recorded in daily pain assessment scores between the pregabalin treatment phase (escalating twice daily dose of 75mg, 150mg) versus placebo treatment phase.

Secondary Outcome Measures

Quality of life measures
Measure differences in the mean scores of other quality of life measures between the pregabalin treatment phase (escalating twice daily dose of 75mg, 150mg) versus placebo treatment phase.

Full Information

First Posted
November 6, 2008
Last Updated
August 24, 2017
Sponsor
University of Alberta
Collaborators
Capital Health, Canada
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1. Study Identification

Unique Protocol Identification Number
NCT00787462
Brief Title
Evaluation of Pregabalin in Idiopathic Small Fiber Neuropathy
Official Title
Evaluation of Pregabalin in Idiopathic Small Fiber Neuropathy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2010
Overall Recruitment Status
Terminated
Why Stopped
Restrictive inclusion criteria/limited pool of suitable subjects with SFN.
Study Start Date
February 2008 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
February 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alberta
Collaborators
Capital Health, Canada

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Idiopathic Small Fiber Neuropathy (called SFN for short), is a condition where nerves that sense pain have become damaged, and often painful. SFN pain is common, and it can affect sleep, memory, health and overall quality of life. Pregabalin is a drug commonly used to treat painful conditions, like nerve pain. It has been available to doctors for many years, and many studies have been performed to evaluate its effectiveness. In these studies, pregabalin has been shown to be very effective in the treatment of nerve pain, with fewer side effects than many other medications currently available. The purpose of the study is to determine if pregabalin relieves pain more effectively than a pill containing no medication (called a placebo). The study will also investigate any side effects as well as the effectiveness and safety of the medication.
Detailed Description
Painful small fiber sensory neuropathy (SFN) is relatively common and a disabling medical condition. It is the most common type of painful sensory neuropathy in patients older than 50 years of age. It is defined as a neuropathy that exclusively or predominantly affects the A-δ (small myelinated) and nociceptive C (unmyelinated) nerve fibers and their functions. The neuropathic pain associated with SFN is described by the patients as burning ("feet are on fire"), sharp ("knife-like, jabbing or pins and needles"), shooting, and aching pain in the toes and feet. The feet are described as tingling, numb, or feeling tight, wooden or dead. The pain is disabling and often exacerbated at night interfering and disrupting the sleep pattern. Allodynia and cramps may also occur. Some patients also describe pressure induced pain in their feet with standing and walking. The autonomic nerves may be involved leading to increased or decreased sweating, facial flushing, skin discoloration and erectile dysfunction in up to 40% of males. On examination there is a dramatic mismatch between the symptoms and observable deficits in SFN. Only abnormal findings are the loss of pinprick and temperature sensations in feet that may extend up to the knees. Touch sensation may be diminished but other sensations are usually preserved. By definition, patients with SFN are allowed to have minor involvement of large fibers distally with reduced vibration in toes but the ankle reflexes are usually preserved. This study will be of a crossover design thus minimizing the number of subjects needed. Each patient will act as his/her own control. Previous studies of pregabalin have shown that the desired effect is achieved by eight weeks of treatment. Therefore each patient will start on either placebo or pregabalin. They will be assessed on this treatment arm for eight weeks. There will be a two-week drug tapering and washout period before switching treatments, followed by re-assessment for an additional eight weeks. This design minimizes the amount of time that the patient will be treated with placebo.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Small-Fiber Neuropathy
Keywords
Neuropathic, Neuropathic pain, Nerve pain, Pain, Chronic pain, Pregabalin, Lyrica, Small fiber neuropathy, Neuropathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active
Arm Type
Active Comparator
Arm Description
Available as 75 mg capsules. Subjects will begin Phase 1 treatment on either pregabalin (or placebo) 75mg BID (1 capsule BID) for one week then increasing to 150mg BID or placebo (2 capsules BID) for a further 7 weeks. During this period patients will be allowed to taper the drug to 225mg a day (75mg in am, 150mg in pm) or (75mg BID) if they develop significant adverse effects on the higher dose. After 8 weeks Phase 1 treatment subjects will taper study medication to 75mg BID or placebo (1 capsule BID) for 7 days and then continue taking placebo (1 capsule) for 7 additional days prior to the crossover. After the taper and washout, Phase 2 will begin using the alternate treatment and will follow the same dosing regime as Phase 1 for the remaining 10 weeks.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Available as 75 mg capsules. Subjects will begin Phase 1 treatment on either pregabalin (or placebo) 75mg BID (1 capsule BID) for one week then increasing to 150mg BID or placebo (2 capsules BID) for a further 7 weeks. During this period patients will be allowed to taper the drug to 225mg a day (75mg in am, 150mg in pm) or (75mg BID) if they develop significant adverse effects on the higher dose. After 8 weeks Phase 1 treatment subjects will taper study medication to 75mg BID or placebo (1 capsule BID) for 7 days and then continue taking placebo (1 capsule) for 7 additional days prior to the crossover. After the taper and washout, Phase 2 will begin using the alternate treatment and will follow the same dosing regime as Phase 1 for the remaining 10 weeks.
Intervention Type
Drug
Intervention Name(s)
Pregabalin
Other Intervention Name(s)
Lyrica
Intervention Description
Available as 75 mg capsules. Subjects will begin Phase 1 treatment on either pregabalin (or placebo) 75mg BID (1 capsule BID) for one week then increasing to 150mg BID or placebo (2 capsules BID) for a further 7 weeks. During this period patients will be allowed to taper the drug to 225mg a day (75mg in am, 150mg in pm) or (75mg BID) if they develop significant adverse effects on the higher dose. After 8 weeks Phase 1 treatment subjects will taper study medication to 75mg BID or placebo (1 capsule BID) for 7 days and then continue taking placebo (1 capsule) for 7 additional days prior to the crossover. After the taper and washout, Phase 2 will begin using the alternate treatment and will follow the same dosing regime as Phase 1 for the remaining 10 weeks.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Visually Identical Placebo
Intervention Description
Available as 75 mg capsules. Subjects will begin Phase 1 treatment on either pregabalin (or placebo) 75mg BID (1 capsule BID) for one week then increasing to 150mg BID or placebo (2 capsules BID) for a further 7 weeks. During this period patients will be allowed to taper the drug to 225mg a day (75mg in am, 150mg in pm) or (75mg BID) if they develop significant adverse effects on the higher dose. After 8 weeks Phase 1 treatment subjects will taper study medication to 75mg BID or placebo (1 capsule BID) for 7 days and then continue taking placebo (1 capsule) for 7 additional days prior to the crossover. After the taper and washout, Phase 2 will begin using the alternate treatment and will follow the same dosing regime as Phase 1 for the remaining 10 weeks.
Primary Outcome Measure Information:
Title
Neuropathic pain score
Description
Measured difference in the mean neuropathic pain score recorded in daily pain assessment scores between the pregabalin treatment phase (escalating twice daily dose of 75mg, 150mg) versus placebo treatment phase.
Time Frame
21 weeks
Secondary Outcome Measure Information:
Title
Quality of life measures
Description
Measure differences in the mean scores of other quality of life measures between the pregabalin treatment phase (escalating twice daily dose of 75mg, 150mg) versus placebo treatment phase.
Time Frame
21

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: A diagnosis of idiopathic SFN (based on clinical and electrodiagnostic criteria). Each day for 7 days prior to Visit 2 (Washout) they must complete a modified Quadruple Visual Analogue Scale₁ showing moderate to severe pain (i.e. a daily mean rating score of ≥ 4). As the safety of pregabalin in pregnancy has not been established, females of childbearing potential must have a negative βHCG serum and agree to practice acceptable birth control methods. All subjects must have screening laboratory values that are within normal limits or abnormal values that are deemed not clinically significant by the Principle Investigator. Exclusion Criteria: Have a psychological or psychiatric condition that may hinder their ability to provide important information History of psychosis, drug or alcohol abuse history within the last year Malignancy within the last 2 years (except skin cancer) Clinically significant conditions (including but not limited to cardiovascular or hepatic diseases), and seizure disorders. Subjects with an abnormal 2-hour glucose tolerance test (i.e., glucose >7.8 mmol/l) will be excluded under "clinically significant conditions" as stated above. May not have participated in a previous trial of pregabalin, have a history of intolerance or hypersensitivity to pregabalin. Patients with renal impairment (CrCl < 60 ml/min) will be excluded.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zaeem A Siddiqi, MD, PhD
Organizational Affiliation
MD, Profesor of Medicine, Neurology
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alberta Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G-2B7
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Data will not be shared due to insufficient recruitment.

Learn more about this trial

Evaluation of Pregabalin in Idiopathic Small Fiber Neuropathy

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