Small-Fiber NeuropathyNCT00787462
Evaluation of Pregabalin in Idiopathic Small Fiber Neuropathy
A study testing Pregabalin in people with Small-Fiber Neuropathy, run by University of Alberta at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Small-Fiber Neuropathy
- What is being tested?
- Pregabalin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2008to Feb 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Small-Fiber Neuropathy
- Being tested
- Pregabalin, Placebo
- Keywords
- Neuropathic, Neuropathic pain, Nerve pain, Pain, Chronic pain, Pregabalin, Lyrica, Small fiber neuropathy, Neuropathy
- Medical subject headings
- Small Fiber Neuropathy, Neuralgia, Pain, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PregabalinDrug
Also called Lyrica
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.
PlaceboDrug
Also called Visually Identical Placebo
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.
| Study group | Role | What they receive |
|---|---|---|
| Active | Active comparator | 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. Receives: Drug: Pregabalin |
| Placebo | Placebo comparator | 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 21 weeks
Secondary outcomes (1)
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.
Measured: 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2008 (estimated)
- Study startFeb 2008
- Primary completionFeb 2013
- Study completionFeb 2013
Why it stopped: Restrictive inclusion criteria/limited pool of suitable subjects with SFN.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small-Fiber NeuropathyStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- Capital Health, Canada
- Responsible party
- Principal investigator, Zaeem Siddiqi, University of Alberta
- Investigators
- Zaeem A Siddiqi, MD, PhD, Principal investigator, MD, Profesor of Medicine, Neurology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00787462
- Sponsor's protocol ID
- ZAS-2007-HC-01
- Status last verified
- Sep 2010
- First submitted
- 6 Nov 2008
- Last updated
- 28 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Data will not be shared due to insufficient recruitment.
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Pregabalin in Idiopathic Small Fiber Neuropathy
- ClinicalTrials.gov ID
- NCT00787462
- Acronym / sponsor ID
- ZAS-2007-HC-01
- Conditions
- Small-Fiber Neuropathy
- Keywords
- Neuropathic, Neuropathic pain, Nerve pain, Pain, Chronic pain, Pregabalin, Lyrica, Small fiber neuropathy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Restrictive inclusion criteria/limited pool of suitable subjects with SFN.
- Enrolment
- 3 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Collaborators
- Capital Health, Canada
- Study start
- Feb 2008
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 7 Nov 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active | Active comparator | Drug: PregabalinAvailable 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. |
| Placebo | Placebo comparator | Drug: PlaceboAvailable 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PregabalinAlso: LyricaAvailable 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. | Drug | Active |
| PlaceboAlso: Visually Identical PlaceboAvailable 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. | Drug | Placebo |
Primary outcome
Neuropathic pain score
Time frame: 21 weeks
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.
1 secondary outcome
Quality of life measures
Time frame: 21
Results and safety
The study was stopped early (reason given: Restrictive inclusion criteria/limited pool of suitable subjects with SFN.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2017.
- Individual participant dataSharing planned: No. Data will not be shared due to insufficient recruitment.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zaeem A Siddiqi, MD, PhD principal investigator
MD, Profesor of Medicine, Neurology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pregabalin in people with Small-Fiber Neuropathy, run by University of Alberta at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Restrictive inclusion criteria/limited pool of suitable subjects with SFN.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neuropathic pain score (time frame: 21 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2017.