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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
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The purpose of this study is to assess safety and efficacy of treatment with pregabalin in patients with idiopathic small fiber neuropathy proven by skin biopsy.This is an enriched enrollment randomized withdrawal study that comprises 4 phases: a screening and selection phase, a washout period from previous pain medication for enriched enrollment, an 8 week single blind pregabalin treatment phase; and a 4 week randomized withdrawal phase.
Patients who show any increase in their pain intensity score during the washout phase will be eligible for the single blind pregabalin treatment phase. Patients who respond to pregabalin, with at least 1 point improvement in neuropathic pain from baseline at the end of the single blind pregabalin treatment phase and meeting all other study requirements are considered eligible for participation in the withdrawal phase. These eligible patients are randomly assigned (1:1) to continue pregabalin or to be switched to placebo for a comparison of pregabalin efficacy and safety. Patients who have a worsening of average pain relative to the last week of the single blind pregabalin treatment period by more than one point and average pain level > =4 will be considered to have a loss of therapeutic response (LTR).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pregabalin Treatment phase | Experimental | All patients will be initially treated with pregabalin in a single blind fashion |
|
| Withdrawal phase | Experimental | After finishing the treatment phase, some patients will be randomized to the placebo or continue on pregabalin for the 4 weeks of withdrawal phase. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pregabalin | Drug | Pregabalin will be given to the patients, starting at 75 mg BID and increased weekly to reach 225 mg BID for 8 weeks. During withdrawal phase, dose of pregabalin will be kept the same for patients who are randomized to the pregabalin withdrawal group. |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analogue Score for Pain Intensity. | The primary outcome is change in visual analogue score for pain, with 0 being no pain at all and 10 being the most severe pain and a higher score meaning more pain, after 8 weeks of treatment phase and 4 weeks of randomized withdrawal phase. | Baseline, at 8 weeks after treatment phase and at 12 weeks for subjects completing the withdrawal phase |
| Measure | Description | Time Frame |
|---|---|---|
| Brief Pain Inventory (BPI sf); | Brief pain inventory is a scoring system for average pain intensity on scale of 0-10 with higher number meaning more pain. | Baseline, at 8 weeks after treatment phase and at 12 weeks for subjects completing the withdrawal phase |
| Sleep Quality as Assessed by Daily Sleep Interference Rating Scale (SIRS); |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mohammad Khoshnoodi, MD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Hospital | Baltimore | Maryland | 21287 | United States |
Each subject underwent a washout period to stop the the current pain medications. Subjects who had significant reduction in pain were randomized to either placebo or Lyrica during the double blind withdrawal phase.
11 subjects were recruited in the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Pregabalin Treatment/Pregabalin Withdrawal | Patients in this arm were initially treated with pregabalin in a single blind fashion. After 8 weeks of treatment, they were randomized to continue on pregabalin for 4 weeks in the double blind randomized withdrawal phase as their pain was improved per protocol. |
| FG001 | Pregabalin Treatment/ Placebo Withdrawal | After finishing the pregabalin single-blinded treatment phase for 8 weeks, these patients were randomized to the placebo arm for the withdrawal phase for 4 weeks as their pain was improved during treatment phase. |
| FG002 | Pregabalin Treatment/No Withdrwal | These patients were treated with Pregabalin, but did not qualify for withdrawal phase as their pain did not improve to meet the criteria to enter the withdrawal phase. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Pregabalin Treatment/Pregabalin Withdrawal | All patients will were with pregabalin. after 8 weeks of treatment, they were randomized to continue on pregabalin. |
| BG001 | Pregabalin Treatment/ Placebo Withdrawal |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Visual Analogue Score for Pain Intensity. | The primary outcome is change in visual analogue score for pain, with 0 being no pain at all and 10 being the most severe pain and a higher score meaning more pain, after 8 weeks of treatment phase and 4 weeks of randomized withdrawal phase. | Patient with idiopathic small fiber neuropathy. | Posted | Mean | Standard Deviation | score on visual analogue score | Baseline, at 8 weeks after treatment phase and at 12 weeks for subjects completing the withdrawal phase |
|
3 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pregabalin Treatment/Pregabalin Withdrawal | Patients in this arm were initially treated with pregabalin in a single blind fashion. After 8 weeks of treatment, they were randomized to continue on pregabalin for 4 weeks in the double blind randomized withdrawal phase as their pain was improved per protocol. |
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There were low number of participants due to requirements of the study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Mohammad Khoshnoodi | Johns Hopkins University | 410-955-5406 | mkhoshn1@jhmi.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 20, 2017 | Jul 16, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000069583 | Pregabalin |
| ID | Term |
|---|---|
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
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| Placebo | Drug | Placebo will be given to the patients that are randomized to placebo during withdrawal phase. |
|
a scoring system describing sleep quality between 0-10 with 0 having no problem with sleep and 10 not being to sleep at all. |
| Baseline, at 8 weeks after treatment phase and at 12 weeks for subjects completing the withdrawal phase |
| Patient Global Impression of Change (PGIC); | patient assign a number between 1-7 to the level of improvement, 1 showing substantial improvement and 7 showing no improvement at all. | At 8 weeks after treatment phase and at 12 weeks for subjects completing the withdrawal phase |
After finishing the pregabalin treatment phase for 8 weeks, these patients were randomized to the placebo arm for the withdrawal phase.
| BG002 | Pregabalin Treatment/ No Withdrawal | After finishing the pregabalin treatment phase for 8 weeks, these patients did not qualify to continue to withdrawal phase. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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After finishing the pregabalin treatment phase for 8 weeks, these patients were randomized to the placebo arm for the withdrawal phase. |
| OG002 | Pregabalin Treatment/No Withdrwal | After finishing the 8 weeks pregabalin treatment phase, these patients did not qualify to enter the withdrawal phase. |
|
|
| Secondary | Brief Pain Inventory (BPI sf); | Brief pain inventory is a scoring system for average pain intensity on scale of 0-10 with higher number meaning more pain. | Patients with idiopathic small fiber neuropathy. | Posted | Mean | Standard Deviation | score in brief pain inventory scale | Baseline, at 8 weeks after treatment phase and at 12 weeks for subjects completing the withdrawal phase |
|
|
|
| Secondary | Sleep Quality as Assessed by Daily Sleep Interference Rating Scale (SIRS); | a scoring system describing sleep quality between 0-10 with 0 having no problem with sleep and 10 not being to sleep at all. | Patients with idiopathic small fiber neuropathy | Posted | Mean | Standard Deviation | score on Sleep Interference Rating scale | Baseline, at 8 weeks after treatment phase and at 12 weeks for subjects completing the withdrawal phase |
|
|
|
| Secondary | Patient Global Impression of Change (PGIC); | patient assign a number between 1-7 to the level of improvement, 1 showing substantial improvement and 7 showing no improvement at all. | Patients with idiopathic small fiber neuropathy | Posted | Mean | Standard Deviation | score on PGIC scale | At 8 weeks after treatment phase and at 12 weeks for subjects completing the withdrawal phase |
|
|
|
| 0 |
| 3 |
| 0 |
| 3 |
| 0 |
| 3 |
| EG001 | Pregabalin Treatment/ Placebo Withdrawal | After finishing the pregabalin single-blinded treatment phase for 8 weeks, these patients were randomized to the placebo arm for the withdrawal phase for 4 weeks as their pain was improved during treatment phase | 0 | 3 | 0 | 3 | 0 | 3 |
| EG002 | Pregabalin Treatment/No Withdrawal | These patients were treated with Pregabalin, but did not qualify for withdrawal phase as their pain did not improve to meet the criteria to enter the withdrawal phase. | 0 | 5 | 0 | 5 | 0 | 5 |
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| D002264 |
| Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
|
| After 4 weeks of Withdrawal phase |
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| After 4 weeks of Withdrawal phase |
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