Chronic Idiopathic Axonal PolyneuropathyPhase 2/3EPHENENCT04647877
Phenytoin Cream for the Treatment of Neuropathic Pain
A Phase 2/3 study testing phenytoin cream in people with Chronic Idiopathic Axonal Polyneuropathy, run by David J. Kopsky at 1 site in Netherlands.
Trial summary
Objectives: The main objective is to evaluate the efficacy and safety of phenytoin cream in patients with neuropathic pain due to chronic idiopathic axonal polyneuropathy (CIAP). Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Idiopathic Axonal Polyneuropathy
- What is being tested?
- phenytoin cream
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 81 participants
- Where
- 1 siteNetherlands
- Study dates
- 17 Sep 2020to 15 Jun 2023
- Phase
- Phase 2/3
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients have been diagnosed with CIAP defined as: presence of symmetrical distal sensory or sensorimotor symptoms such as numbness, pins and needles, tightness, coldness, unsteadiness, muscle cramps, and weakness with onset in the feet, compatible with polyneuropathy; presence of symmetrical distal sensory or sensorimotor signs with evidence of large nerve fiber involvement such as decreased sense of touch, vibration, and proprioception, usually in the presence of decreased pin prick/temperature sense, decreased/absent tendon reflexes, or slight muscle weakness on neurologic examination, compatible with polyneuropathy; an insidious onset and slow or no progression of the polyneuropathy over the course of at least 6 months; no identifiable cause for the polyneuropathy after thorough history-taking, clinical examination, and extensive laboratory testing; no suggestion of a hereditary polyneuropathy based on detailed kinship history (i.e., one or more affected family member), neurologic examination, or confirmation by genetic analysis; and nerve conduction studies excluding a demyelinating polyneuropathy and confirming large nerve fiber involvement if the findings on neurologic examination are equivocal considering the patient's age.
- Presence of chronic localized neuropathic pain due to CIAP
- Neuropathic pain localized in two anatomically symmetrical areas of feet/lower legs
- Duration of neuropathic pain ≥3 months
- Duration of ≥1 hour neuropathic pain per day
- Neuropathic pain characteristics defined by the Douleur Neuropathique 4 questions (DN4) score ≥4
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- Mean pain score during daytime of ≥4 and <10 on the NRS at study entry (baseline)
- Difference of pain intensity between left and right foot and/or lower leg of not more than 1 point on the NRS
- No changes in neuropathic pain medication for at least 1 month
- Absence of any of the exclusion criteria outlined below
Who cannot join
- Painful (poly)neuropathy other than CIAP
- Presence of neuropathic pain due to any other condition than CIAP
- Neuropathic pain (distribution, duration, characteristics, intensity) not fulfilling the inclusion criteria
- Pregnancy or planned pregnancy in the study period (will only be asked)
- Use of oral phenytoin
- Open wounds in the neuropathic pain area
Show all 13Show fewer
- Current use of topical analgesics
- Presence of other pain syndromes such as the widespread pain syndrome or pain in joints
- Presence of serious psychological/psychiatric morbidity
- Addiction to intoxicants
- Hypersensitivity to the study medication (active substance and excipients)
- Insufficient mastery of the Dutch language
- Cognitive impairment and insufficiently capable to understand the purpose of the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Enrichment Randomized Double-blind, Placebo-controlled Cross-over Trial With PHEnytoin Cream in Patients With Painful Chronic Idiopathic Axonal polyNEuropathy
Objectives: The main objective is to evaluate the efficacy and safety of phenytoin cream in patients with neuropathic pain due to chronic idiopathic axonal polyneuropathy (CIAP). The second objective is to determine the predictive value of a double-blind placebo-controlled response test (DOBRET) to identify sustained responders.
Study design: This is a 6-week enrichment randomized double-blind, placebo-controlled cross-over trial evaluating phenytoin cream in 84 participants with painful CIAP, whereafter an open label extension phase is offered with phenytoin 20 percent cream for up to one year.
Read more
At baseline a DOBRET with phenytoin 10 percent and placebo cream will be performed in each study participant to stratify participants according to their response to the DOBRET before entering the double-blind cross-over phase. DOBRET positive participants are those who experience at least two points pain reduction on the 11-point numerical rating scale (NRS) on the phenytoin 10 percent cream applied area within 30 minutes and at least one-point difference in pain reduction on the NRS between phenytoin 10 percent and placebo cream applied area, in favour of the former.
Participants will receive three treatments in a double blind fashion and in a randomized order: phenytoin 10 percent, phenytoin 20 percent and placebo cream. The duration of each treatment period is two weeks. Participants will cross-over two times to each of the other treatments. The study does not have wash-out periods between treatments, because the mean duration of analgesic effect after an application is expected to be less than nine hours. A blood sample will be collected at the end of the second week of the first treatment period to test for phenytoin plasma levels.
Study population: The investigators aim to include 84 participants, age 40 years or older, who have been diagnoses with painful CIAP at the University Medical Center Utrecht and fulfil the inclusion criteria and have given written informed consent.
Interventions: Phenytoin cream in concentrations of 10 percent and 20 percent cream compared to placebo cream.
Primary endpoint: Change in pain intensity measured on the NRS between baseline and week 2 for phenytoin 20% cream versus placebo cream.
- Conditions
- Chronic Idiopathic Axonal Polyneuropathy
- Being tested
- phenytoin cream, Placebo cream
- Keywords
- cryptogenic sensory polyneuropathy, CIAP, neuropathic pain
- Medical subject headings
- Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
phenytoin creamDrug
Phenytoin cream to be applied on the neuropathic pain area
Placebo creamOther
Placebo cream to be applied on the neuropathic pain area
| Study group | Role | What they receive |
|---|---|---|
| Phenytoin 10 percent cream | Experimental | Phenytoin 10 percent cream, 2 to 4 times daily application, 2 weeks long Receives: Drug: phenytoin cream |
| Phenytoin 20 percent cream | Experimental | Phenytoin 20 percent cream, 2 to 4 times daily application, 2 weeks long Receives: Drug: phenytoin cream |
| Placebo cream | Placebo comparator | Placebo cream, 2 to 4 times daily application, 2 weeks long Receives: Other: Placebo cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in mean pain intensity measured on the 11-point numerical rating scale (NRS) between baseline and week 2 for phenytoin 20% cream versus placebo cream.
0 = no pain, 10 = worst imaginable pain. The bigger the mean change, the better the outcome
Measured: Mean baseline vs. mean of second week of each intervention
Secondary outcomes (16)
Change in mean pain intensity from baseline 11-point numerical rating scale (NRS) to the mean NRS in the second week in double-blind response test in positive and negative participants and all participants combined
0 = no pain, 10 = worst imaginable pain. The bigger the mean change, the better the outcome
Measured: Mean baseline vs. mean of second week of each intervention
Change of EuroQol (EQ5-5D-5L) from baseline to the end of the second week of each treatment period
EQ5-5D-5L consists of 5 quality of life questions assessed on a 5 point scale: the lower the score, the better quality of life. Furthermore, a visual analogue scale from 0 to 100 is included. The higher the score, the better quality of life.
Measured: Baseline vs. end of second week of each intervention
Change of Neuropathic Pain Symptom Inventory (NPSI) from baseline to the end of the second week of each treatment period
The NPSI consists of 10 neuropathic pain descriptors on the NRS, and 2 items assessing the duration of spontaneous ongoing and paroxysmal pain. The lower the score, the less pain.
Measured: Baseline vs. end of second week of each intervention
Change of subscales of the Brief Pain Inventory (sBPI) from baseline to the end of the second week of each treatment period
The sBPI consists of 7 quality of life questions, assessed on the NRS. The lower the score, the better quality of life.
Measured: Baseline vs. end of second week of each intervention
Change of the 3 worst pain characteristics from baseline to the end of the second week of each treatment period
The 3 worst pain characteristics are scored on the NRS. The lower the score, the less pain.
Measured: Baseline vs. end of second week of each intervention
Change of Patient Global Impression of Change Scale (PGIC) from baseline to the end of the second week of each treatment period
The PGIC is a 7-point satisfaction scale. The lower the score, the better.
Measured: Baseline vs. end of second week of each intervention
30 percent and 50 percent improvement or more on the NRS compared to placebo within one patient
Measured: Baseline vs. end of second week of each intervention
Time of carry-over effects after a treatment period
Measured: First week of each intervention
Onset of analgesic effect after application
The onset of analgesic effect will be noted in minutes.
Measured: At the end of second week of each intervention
Duration of analgesic effect
The duration of analgesic effect will be noted in hours.
Measured: At the end of second week of each intervention
Daily number of cream applications
Measured: At the end of second week of each intervention
Percentage of analgesic effect as rated by the participant
The participant will be asked about the percentage of pain reduction at the end of the second week of each intervention. The higher, the better.
Measured: At the end of second week of each intervention.
Local and/or systemic side effects
At each visit and telephone call participants will be asked about possibly occurring side effects.
Measured: During the 6 weeks of double-blind phase and 1 year open phase
Detection of phenytoin in plasma
Two hours after last application phenytoin plasma level will be evaluated
Measured: At the end of second week of first treatment period
Predictive value of DOBRET
Correlation with DOBRET response and mean pain reduction while using phenytoin 10 percent or 20 percent cream. The stronger the correlation, the more predictive the DOBRET is.
Measured: Baseline vs. mean of second week of each intervention
Use of escape pain medication
The daily amount of acetaminophen and/or non-steroid anti-inflammatory drugs
Measured: During the 6 weeks of double-blind phase and 1 year open phase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2020
- Study start17 Sep 2020
- Primary completion15 Jun 2023
- Study completion15 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Chronic Idiopathic Axonal PolyneuropathyStudies of the same condition, open and under way.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- David J. Kopsky
- Sponsor type
- University, hospital or other
- Collaborators
- Princess Beatrix Muscle Foundation, Dr. C.J. Vaillant Fonds
- Responsible party
- Sponsor-investigator, David J. Kopsky, UMC Utrecht
- Investigators
- Alexander FJE Vrancken, MD, PhD, Principal investigator, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04647877
- Sponsor's protocol ID
- UMC-NMZ-EPHENE2020
- Acronym
- EPHENE
- Status last verified
- Jun 2023
- First submitted
- 16 Nov 2020
- Last updated
- 28 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kopsky DJ, Vrancken AFJE, Keppel Hesselink JM, van Eijk RPA, Notermans NC. Usefulness of a Double-Blind Placebo-Controlled Response Test to Demonstrate Rapid Onset Analgesia with Phenytoin 10% Cream in Polyneuropathy. J Pain Res. 2020 May 1;13:877-882. doi: 10.2147/JPR.S243434. eCollection 2020.
PubMed 32431536Kopsky DJ, Keppel Hesselink JM. Single-Blind Placebo-Controlled Response Test with Phenytoin 10% Cream in Neuropathic Pain Patients. Pharmaceuticals (Basel). 2018 Nov 12;11(4):122. doi: 10.3390/ph11040122.
PubMed 30424471Kopsky DJ, Keppel Hesselink JM. Phenytoin Cream for the Treatment for Neuropathic Pain: Case Series. Pharmaceuticals (Basel). 2018 May 28;11(2):53. doi: 10.3390/ph11020053.
PubMed 29843362Kopsky DJ, Keppel Hesselink JM, Russell AL, Vrancken AFJE. No Detectable Phenytoin Plasma Levels After Topical Phenytoin Cream Application in Chronic Pain: Inferences for Mechanisms of Action. J Pain Res. 2022 Feb 9;15:377-383. doi: 10.2147/JPR.S345347. eCollection 2022.
PubMed 35173477Kopsky DJ, van Eijk RPA, Warendorf JK, Keppel Hesselink JM, Notermans NC, Vrancken AFJE. Enriched enrollment randomized double-blind placebo-controlled cross-over trial with phenytoin cream in painful chronic idiopathic axonal polyneuropathy (EPHENE): a study protocol. Trials. 2022 Oct 22;23(1):888. doi: 10.1186/s13063-022-06806-8.
PubMed 36273216
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enrichment Randomized Double-blind, Placebo-controlled Cross-over Trial With PHEnytoin Cream in Patients With Painful Chronic Idiopathic Axonal polyNEuropathy
- ClinicalTrials.gov ID
- NCT04647877
- Acronym / sponsor ID
- EPHENE / UMC-NMZ-EPHENE2020
- Conditions
- Chronic Idiopathic Axonal Polyneuropathy
- Keywords
- cryptogenic sensory polyneuropathy, CIAP, neuropathic pain
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- David J. KopskyUniversity, hospital or other
- Collaborators
- Princess Beatrix Muscle Foundation, Dr. C.J. Vaillant Fonds
- Study start
- 17 Sep 2020 (actual)
- Primary completion
- 15 Jun 2023 (actual)
- Study completion
- 15 Jun 2023 (actual)
- First posted
- 1 Dec 2020 (actual)
- 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.
Objectives: The main objective is to evaluate the efficacy and safety of phenytoin cream in patients with neuropathic pain due to chronic idiopathic axonal polyneuropathy (CIAP). The second objective is to determine the predictive value of a double-blind placebo-controlled response test (DOBRET) to identify sustained responders.
Study design: This is a 6-week enrichment randomized double-blind, placebo-controlled cross-over trial evaluating phenytoin cream in 84 participants with painful CIAP, whereafter an open label extension phase is offered with phenytoin 20 percent cream for up to one year.
At baseline a DOBRET with phenytoin 10 percent and placebo cream will be performed in each study participant to stratify participants according to their response to the DOBRET before entering the double-blind cross-over phase. DOBRET positive participants are those who experience at least two points pain reduction on the 11-point numerical rating scale (NRS) on the phenytoin 10 percent cream applied area within 30 minutes and at least one-point difference in pain reduction on the NRS between phenytoin 10 percent and placebo cream applied area, in favour of the former.
Participants will receive three treatments in a double blind fashion and in a randomized order: phenytoin 10 percent, phenytoin 20 percent and placebo cream. The duration of each treatment period is two weeks. Participants will cross-over two times to each of the other treatments. The study does not have wash-out periods between treatments, because the mean duration of analgesic effect after an application is expected to be less than nine hours. A blood sample will be collected at the end of the second week of the first treatment period to test for phenytoin plasma levels.
Study population: The investigators aim to include 84 participants, age 40 years or older, who have been diagnoses with painful CIAP at the University Medical Center Utrecht and fulfil the inclusion criteria and have given written informed consent.
Interventions: Phenytoin cream in concentrations of 10 percent and 20 percent cream compared to placebo cream.
Primary endpoint: Change in pain intensity measured on the NRS between baseline and week 2 for phenytoin 20% cream versus placebo cream.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Phenytoin 10 percent cream | Experimental | Drug: phenytoin creamPhenytoin 10 percent cream, 2 to 4 times daily application, 2 weeks long |
| Phenytoin 20 percent cream | Experimental | Drug: phenytoin creamPhenytoin 20 percent cream, 2 to 4 times daily application, 2 weeks long |
| Placebo cream | Placebo comparator | Other: Placebo creamPlacebo cream, 2 to 4 times daily application, 2 weeks long |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients have been diagnosed with CIAP defined as: presence of symmetrical distal sensory or sensorimotor symptoms such as numbness, pins and needles, tightness, coldness, unsteadiness, muscle cramps, and weakness with onset in the feet, compatible with polyneuropathy; presence of symmetrical distal sensory or sensorimotor signs with evidence of large nerve fiber involvement such as decreased sense of touch, vibration, and proprioception, usually in the presence of decreased pin prick/temperature sense, decreased/absent tendon reflexes, or slight muscle weakness on neurologic examination, compatible with polyneuropathy; an insidious onset and slow or no progression of the polyneuropathy over the course of at least 6 months; no identifiable cause for the polyneuropathy after thorough history-taking, clinical examination, and extensive laboratory testing; no suggestion of a hereditary polyneuropathy based on detailed kinship history (i.e., one or more affected family member), neurologic examination, or confirmation by genetic analysis; and nerve conduction studies excluding a demyelinating polyneuropathy and confirming large nerve fiber involvement if the findings on neurologic examination are equivocal considering the patient's age.
- Presence of chronic localized neuropathic pain due to CIAP
- Neuropathic pain localized in two anatomically symmetrical areas of feet/lower legs
- Duration of neuropathic pain ≥3 months
- Duration of ≥1 hour neuropathic pain per day
Key exclusion criteria (13 listed)
- Painful (poly)neuropathy other than CIAP
- Presence of neuropathic pain due to any other condition than CIAP
- Neuropathic pain (distribution, duration, characteristics, intensity) not fulfilling the inclusion criteria
- Pregnancy or planned pregnancy in the study period (will only be asked)
- Use of oral phenytoin
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 |
|---|---|---|
| phenytoin creamPhenytoin cream to be applied on the neuropathic pain area | Drug | Phenytoin 10 percent cream, Phenytoin 20 percent cream |
| Placebo creamPlacebo cream to be applied on the neuropathic pain area | Other | Placebo cream |
Primary outcome
Change in mean pain intensity measured on the 11-point numerical rating scale (NRS) between baseline and week 2 for phenytoin 20% cream versus placebo cream.
Time frame: Mean baseline vs. mean of second week of each intervention
0 = no pain, 10 = worst imaginable pain. The bigger the mean change, the better the outcome
16 secondary outcomes
Change in mean pain intensity from baseline 11-point numerical rating scale (NRS) to the mean NRS in the second week in double-blind response test in positive and negative participants and all participants combined
Time frame: Mean baseline vs. mean of second week of each intervention
Change of EuroQol (EQ5-5D-5L) from baseline to the end of the second week of each treatment period
Time frame: Baseline vs. end of second week of each intervention
Change of Neuropathic Pain Symptom Inventory (NPSI) from baseline to the end of the second week of each treatment period
Time frame: Baseline vs. end of second week of each intervention
Change of subscales of the Brief Pain Inventory (sBPI) from baseline to the end of the second week of each treatment period
Time frame: Baseline vs. end of second week of each intervention
Change of the 3 worst pain characteristics from baseline to the end of the second week of each treatment period
Time frame: Baseline vs. end of second week of each intervention
Change of Patient Global Impression of Change Scale (PGIC) from baseline to the end of the second week of each treatment period
Time frame: Baseline vs. end of second week of each intervention
30 percent and 50 percent improvement or more on the NRS compared to placebo within one patient
Time frame: Baseline vs. end of second week of each intervention
Time of carry-over effects after a treatment period
Time frame: First week of each intervention
Onset of analgesic effect after application
Time frame: At the end of second week of each intervention
Duration of analgesic effect
Time frame: At the end of second week of each intervention
Daily number of cream applications
Time frame: At the end of second week of each intervention
Percentage of analgesic effect as rated by the participant
Time frame: At the end of second week of each intervention.
Local and/or systemic side effects
Time frame: During the 6 weeks of double-blind phase and 1 year open phase
Detection of phenytoin in plasma
Time frame: At the end of second week of first treatment period
Predictive value of DOBRET
Time frame: Baseline vs. mean of second week of each intervention
Use of escape pain medication
Time frame: During the 6 weeks of double-blind phase and 1 year open phase
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2023.
- Background: PubMed 32431536Kopsky DJ, Vrancken AFJE, Keppel Hesselink JM, van Eijk RPA, Notermans NC. Usefulness of a Double-Blind Placebo-Controlled Response Test to Demonstrate Rapid Onset Analgesia with Phenytoin 10% Cream in Polyneuropathy. J Pain Res. 2020 May 1;13:877-882. doi: 10.2147/JPR.S243434. eCollection 2020.
- Background: PubMed 30424471Kopsky DJ, Keppel Hesselink JM. Single-Blind Placebo-Controlled Response Test with Phenytoin 10% Cream in Neuropathic Pain Patients. Pharmaceuticals (Basel). 2018 Nov 12;11(4):122. doi: 10.3390/ph11040122.
- Background: PubMed 29843362Kopsky DJ, Keppel Hesselink JM. Phenytoin Cream for the Treatment for Neuropathic Pain: Case Series. Pharmaceuticals (Basel). 2018 May 28;11(2):53. doi: 10.3390/ph11020053.
- Background: PubMed 35173477Kopsky DJ, Keppel Hesselink JM, Russell AL, Vrancken AFJE. No Detectable Phenytoin Plasma Levels After Topical Phenytoin Cream Application in Chronic Pain: Inferences for Mechanisms of Action. J Pain Res. 2022 Feb 9;15:377-383. doi: 10.2147/JPR.S345347. eCollection 2022.
- Derived from this study: PubMed 36273216Kopsky DJ, van Eijk RPA, Warendorf JK, Keppel Hesselink JM, Notermans NC, Vrancken AFJE. Enriched enrollment randomized double-blind placebo-controlled cross-over trial with phenytoin cream in painful chronic idiopathic axonal polyneuropathy (EPHENE): a study protocol. Trials. 2022 Oct 22;23(1):888. doi: 10.1186/s13063-022-06806-8.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Alexander FJE Vrancken, MD, PhD principal investigator
UMC Utrecht
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing phenytoin cream in people with Chronic Idiopathic Axonal Polyneuropathy, run by David J. Kopsky at 1 site in Netherlands.
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 10 inclusion and 13 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: finished, as of the sponsor's last update on 28 Jun 2023. 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 Netherlands. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in mean pain intensity measured on the 11-point numerical rating scale (NRS) between baseline and week 2 for phenytoin 20% cream versus placebo cream. (time frame: Mean baseline vs. mean of second week of each intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04647877, which also lists 5 linked publications.
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 Jun 2023.