Small Fiber NeuropathyPhase 2NCT03339336
Efficacy and Safety Study of BIIB074 in Participants With Small Fiber Neuropathy
A Phase 2 study testing BIIB074 in people with Small Fiber Neuropathy and Diabetes Mellitus, run by Biogen at 97 sites in 14 countries.
Trial summary
The primary objective of this study is to evaluate the efficacy of BIIB074 in treating pain experienced by participants with confirmed small fiber neuropathy (SFN) that is idiopathic or associated with diabetes mellitus. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Small Fiber Neuropathy, Diabetes Mellitus
- What is being tested?
- BIIB074
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 265 participants
- Where
- 97 sitesin 14 countries
- Study dates
- 31 May 2018to 12 Apr 2021
- Phase
- Phase 2
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- This study will be conducted in subjects who have had a diagnosis of at least probable SFN, length-dependent distribution, for 6 months and ≤10 years prior to screening, defined as a history of the symptoms and clinical signs based on discussions at the ACTTION CONCEPPT meeting on diagnosis of SFN, Washington, DC March 2018, and confirmed by intraepidermal nerve fiber density (IENFD) values, and weekly mean average daily pain (ADP) score of ≥5 and ≤9 on an 11-point Pain Intensity Numeric Rating Scale (PI-NRS) over the last 7 days of prior to the Screening visit.
- In addition to these criteria, subjects with diabetes will be required to have HbA1c ≤11%, treated with oral hypoglycemics and/or subcutaneous insulin or diet, no evidence of ulcers, advanced retinopathy (defined as greater than State 3 [moderate non-proliferative diabetic retinopathy]) (DCCT/EDIC Research Group 2017), severe nephropathy, or clinically significant obstructive atherosclerotic disease or current class IV heart failure to be eligible for the study.
Who cannot join
- Previous exposure to BIIB074 (formerly known as CNV1014802 or GSK1014802).
- Use of capsaicin patch within 3 months prior to Screening.
- Unable or unwilling to discontinue concomitant medications for SFN pain prior to Day 1.
- Unable or unwilling to comply with the prohibited concomitant medication restrictions, including but not limited to UDP-glucuronosyltransferase (UGT) inducers and inhibitors, monoamine oxidase inhibitors (MAOIs), and Nav blockers.
- Use of over-the-counter medications, vitamin and mineral supplements, herbal remedies (including St. John's wort), dietary supplements, or foods (including grapefruit juice) that affect and UGTs.
- Unable or unwilling to discontinue medications that are P-glycoprotein substrates with a narrow therapeutic index, including but not limited to digoxin.
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- History of hemophilia or Von Willebrand's disease, or use of anticoagulants that may result in bleeding risk during the skin biopsy.
- Any contraindication, as determined by the Investigator, to performing a skin biopsy for intraepidermal nerve fiber analysis.
- NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
97 sites in 14 countries.
97 sites in 14 countries
Germany14 sites
Research Site
Aschaffenburg, Bavaria
Zentrum fur Klinische Forschung
Bad Homburg
Gemeinschaftspraxis für Neurologie
Berlin
Clinical Research
Böblingen, Baden-Wurttemberg
Gemeinschaftspraxis Diabeteszentrum Dortmund Dr.med. Klaus Busch
Dortmund, North Rhine-Westphalia
Research Site
Essen
Diabetologische Schwerpunktpraxis Harburg
Hamburg
Research Site
Künzing, Bavaria
Hausarzt- und Diabetologische Schwerpunktpraxis
Lage, Saxony-Anhalt
Research Site
Mainz
Clinical Research
Münster, Nord Rhein Westfalen
Clinical Research
Westerstede, Lower Saxony
DKD Helios Klinik Wiesbaden
Wiesbaden
Research Site
Würzburg
France12 sites
Hôpital Ambroise Paré - Boulogne-Billancourt
Boulogne-Billancourt
Research Site
Brest, Finistere
CHU Clermond Ferrand - Hopital Gabriel Montpied
Clermont-Ferrand, Puy De Dome
Research Site
Corbeil-Essonnes
Hopital Henri Mondor
Créteil
Research Site
Le Creusot
Groupement Hospitalier Sud - Hôpital Bicêtre
Le Kremlin-Bicêtre
Hopital Salengro - CHRU de Lille
Lille, Nord
CHU Nice - Hôpital de l'Archet 1
Nice
Hopital Lariboisiere
Paris
CHU Saint Etienne - Hôpital Nord
Saint Priest En Jarez, Pays de la Loire Region
Research Site
Vénissieux, Rhone
United Kingdom11 sites
Clinical Reseach
Bath
Research Site
Ipswich
Research Site
Liverpool
Guy's Hospital
London
King's College Hospital
London
St Pancras Clinical Research
London
The Royal London Hospital
London
Research Site
Manchester
John Radcliffe Hospital
Oxford
Royal Hallamshire Hospital
Sheffield, South Yorkshire
Research Site
Swansea
Poland8 sites
Research Site
Bydgoszcz
Research Site
Chorzów
PRATIA MCM Kraków
Krakow
Research Site
Lublin
Research Site
Oświęcim
Praktyka Lekarska Ewa Krzyzagorska
Poznan
Research Site
Warsaw
Regionalna Poradnia Diabetologiczna Zytkiewicz-Jaruga,Stasinska
Wroclaw
Spain8 sites
Research Site
A Coruña
Hospital General Universitario de Alicante
Alicante
Hospital Universitari de Bellvitge
Barcelona
Research Site
Barcelona
Hospital Universitario Reina Sofia
Córdoba
Research Site
Madrid
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda
Hospital Universitari i Politecnic La Fe
Valencia
Canada7 sites
Research Site
Greenfield Park, Quebec
Research Site
Kingston
Research Site
Montreal, Quebec
Recherche Médicale St-Jérôme Inc.
Saint-Jérôme, Quebec
Toronto General Hospital
Toronto, Ontario
Vancouver General Hospital
Vancouver, British Columbia
Research Site
Winnipeg
Hungary7 sites
Research Site
Baja
Bekes Megyei Kozponti Korhaz Dr. Rethy Pal Tagkorhaz
Békéscsaba
UNO Medical Trials Kft.
Budapest
Somogy Megyei Kaposi Mor Oktato Korhaz
Kaposvár
Research Site
Nyíregyháza
Research Site
Pécs
Research Site
Szeged
Czechia6 sites
Fakultni Nemocnice Brno
Brno
Fakultni Nemocnice u sv. Anny v Brne
Brno
Research Site
Hradec Králové
Fakultni nemocnice Ostrava
Ostrava-Poruba
Nemocnice Pardubickeho kraje a.s. Pardubicka nemocnice
Pardubice
Fakultni nemocnice v Motole
Prague
Italy6 sites
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili)
Brescia
Research Site
Genova
Research Site
Milan
Azienda Ospedaliero Univeraitaria Pisana
Pisa
Università Campus Bio-Medico di Roma
Roma
Research Site
Telese Terme
Bulgaria4 sites
Research Site
Byala
UMHAT 'Dr Georgi Stranski' EAD
Pleven
Research Site
Plovdiv
Research Site
Sofia
Denmark4 sites
Research Site
Aarhus
Research Site
Copenhagen
Research Site
Herlev
OUH
Odense
Greece4 sites
Research Site
Athens
Research Site
Heraklion
Research Site
Pátrai
AHEPA General Hospital of Thessaloniki
Thessaloniki
Switzerland4 sites
CHUV - Centre Hospitalier Universitaire Vaudois
Lausanne
Ospedale Regionale di Lugano
Lugano
Kantonspital St. Gallen
Sankt Gallen
Research Site
Zurich
Netherlands2 sites
Amsterdam UMC, Locatie AMC
Amsterdam
Maastricht UMC+
Maastricht
About this study
Official title: A Phase 2 Placebo-Controlled, Double-Blind, Enriched Enrollment Randomized Withdrawal Study to Evaluate the Efficacy and Safety of BIIB074 (Vixotrigine) in Treating Pain Experienced by Subjects With Confirmed Small Fiber Neuropathy That is Idiopathic or Associated With Diabetes Mellitus
The primary objective of this study is to evaluate the efficacy of BIIB074 in treating pain experienced by participants with confirmed small fiber neuropathy (SFN) that is idiopathic or associated with diabetes mellitus. A secondary endpoint that relates to the primary objective is the change from Randomization to Week 12 of the double-blind period in mean average daily pain score.
The secondary objectives of this study are to evaluate the effect on worst pain, neuropathic pain quality, sleep interference due to pain, patient global impression, use of rescue medication, and SFN symptoms in participants treated with BIIB074; to investigate the safety and tolerability of BIIB074 in participants with SFN; and to characterize the pharmacokinetics (PK) of BIIB074 in participants with SFN.
- Conditions
- Small Fiber Neuropathy, Diabetes Mellitus
- Being tested
- BIIB074, Placebo
- Medical subject headings
- Small Fiber Neuropathy, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIIB074Drug
Administered as specified in the treatment arm.
PlaceboDrug
Administered as specified in the treatment arm.
| Study group | Role | What they receive |
|---|---|---|
| BIIB074 350 mg | Experimental | Taper Period (if applicable) from neuropathic pain medication, followed by a washout period, then BIIB074 350 mg tablets orally twice daily (BID) Open-Label Run-In Period, then BIIB074 350 mg tablets orally BID Double-Blind Treatment Period. Receives: Drug: BIIB074 |
| BIIB074 200 mg | Experimental | Taper Period (if applicable) from neuropathic pain medication, followed by a washout period, then BIIB074 350 mg tablets orally twice daily (BID) Open-Label Run-In Period, then BIIB074 200 mg tablets orally BID Double-Blind Treatment Period. Receives: Drug: BIIB074 |
| Placebo | Placebo comparator | Taper Period (if applicable) from neuropathic pain medication, followed by a washout period, then BIIB074 350 mg tablets orally twice daily (BID) Open-Label Run-In Period, then BIIB074 placebo-matching tablets orally BID Double-Blind Treatment Period. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Weekly Mean Average Daily Pain (ADP) Score
Participants will rate their ADP using an 11-point Numerical Rating Scale (NRS) (0=no pain and 10=worst possible pain) and record their score in an electronic diary (eDiary). Weekly mean ADP scores for Baseline (the 5 days prior to the first dose of study treatment in the open-label run-in period) and Week 12 (the 7 days prior to the visit at the end of Week 12) will be derived from the ADP scores and calculated as the mean of the daily scores over the last 7 days.
Measured: Baseline and Week 12 of the Double-Blind Period
Change from Randomization in Weekly Mean ADP Score
Participants will rate their ADP using an 11-point NRS (0=no pain and 10=worst possible pain) and record their score in an eDiary. Weekly mean ADP scores for Randomization (the 7 days prior to the first dose of study treatment in the double-blind period) and Week 12 (the 7 days prior to the visit at the end of Week 12) will be derived from the ADP scores and calculated as the mean of the daily scores over the last 7 days.
Measured: Randomization and Week 12 of the Double-Blind Period
Secondary outcomes (11)
Change from Baseline in Weekly Mean Worst Daily Pain (WDP) Score
Participants will rate their WDP using an 11-point NRS (0=no pain and 10=worst possible pain) and record their score in an eDiary. Weekly mean WDP scores for Baseline (the 5 days prior to the first dose of study treatment in the open-label run-in period) and Week 12 (the 7 days prior to the visit at the end of Week 12) will be derived from the WDP scores and calculated as the mean of the daily scores over the last 7 days.
Measured: Baseline and Week 12 of the Double-Blind Period
Change from Baseline in Weekly Mean Sleep Interference Numerical Rating Scale (S-NRS)
Participants will rate their S-NRS using an 11-point NRS (0=pain does not interfere with sleep and 10= pain completely interferes with sleep) and record their score in an eDiary. Weekly mean S-NRS scores for Baseline (the 5 days prior to the first dose of study treatment in the open-label run-in period) and Week 12 (the 7 days prior to the visit at the end of Week 12) will be derived from the daily S-NRS scores and calculated as the mean of the daily scores over the last 7 days.
Measured: Baseline and Week 12 of the Double-Blind Period
Change from Baseline in Neuropathic Pain Symptom Inventory (NPSI) Total Score and Sum Score
Participant will use the NPSI questionnaire to rate different symptoms of neuropathic pain. The NPSI includes ten items related to different pain descriptors (e.g. burning and pressure) that are rated on an 11-point NRS (0=no symptoms to 10=worst symptoms imaginable). A score in each dimension and also a total score (from 0-100) is generated using data from the questionnaire.
Measured: Baseline and Week 12 of Double-Blind Period
Proportion of Participants with at least a 2-point Reduction from Baseline in Weekly Mean ADP
Participants will rate their ADP using an 11-point NRS (0=no pain and 10=worst possible pain) and record their score in an electronic diary (eDiary). Weekly mean ADP scores for Baseline (the 5 days prior to the first dose of study treatment in the open-label run-in period) and Week 12 (the 7 days prior to the visit at the end of Week 12) will be derived from the ADP scores and calculated as the mean of the daily scores over the last 7 days.
Measured: Baseline and Week 12 of the Double-Blind Period
Proportion of Participants with at least a 30% Reduction from Baseline in Weekly Mean ADP
Participants will rate their ADP using an 11-point NRS) (0=no pain and 10=worst possible pain) and record their score in an electronic diary (eDiary). Weekly mean ADP scores for Baseline (the 5 days prior to the first dose of study treatment in the open-label run-in period) and Week 12 (the 7 days prior to the visit at the end of Week 12) will be derived from the ADP scores and calculated as the mean of the daily scores over the last 7 days.
Measured: Baseline and Week 12 of Double-Blind Period
Mean Weekly Amount of Rescue Medication
Use of rescue medication (paracetamol/acetaminophen) will be monitored and dosage will be recorded on a daily basis by the participant using an electronic Diary (eDiary). Mean weekly amount of rescue medication used for neuropathic pain during the double-blind period.
Measured: Weekly from Baseline to Week 12 of the Double-Blind Period
Patient Global Impression of Change (PGIC)
PGIC is a 7-point self-administered scale that depicts changes in a participant's overall status. Participants will rate their change as "1=very much improved," "2=much improved," "3=minimally improved," "4=no change," "5=minimally worse," "6=much worse," or "7=very much worse."
Measured: Week 12 of the Double-Blind Period
Change from Baseline in Brief Pain Inventory-Short Form (BPI-SF) Interference Score
The BPI-SF is a 7-item self-administered questionnaire that measures how much pain has interfered with daily functioning. Participants will rate the level of pain interference on daily functioning on an 11-point NRS where 0=does not interfere and 10=completely interferes.
Measured: Baseline and Week 12 of the Double-Blind Period
Percentage of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) During Double-Blind Period
AEs: any sign, symptom, or diagnosis/disease that is unfavorable or unintended, that is new, or if pre-existing, worsens in participants administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. SAEs: an event that results in death; an event that, in the view of the investigator, places the participant at immediate risk of death (a life-threatening event); an outcome that results in a congenital anomaly/birth defect diagnosed in a child of a participant; an event that requires or prolongs inpatient hospitalization; an event that results in persistent or significant disability/incapacity. Any other medically important event that, in the opinion of the investigator, may jeopardize the participant or may require intervention to prevent one of the other outcomes listed in the definition above.
Measured: Week 5 to Week 17
Area Under the Concentration-time Curve at Steady State
Measured: Week 1, 3, 5, 9, 13 and 17 prior to dosing and 1 to 2 hours after dosing, and at Day 123 (Follow-up clinic visit)
Maximum Observed Concentration (Cmax) at Steady State
Measured: Week 1, 3, 5, 9, 13 and 17 prior to dosing and 1 to 2 hours after dosing, and at Day 123 (Follow-up clinic visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2017
- Study start31 May 2018
- Primary completion12 Apr 2021
- Study completion12 Apr 2021
Why it stopped: Sponsor decision to close study early; not due to safety concerns
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Small Fiber NeuropathyStudies of the same condition, open and under way.
- More trials run by BiogenThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 265 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biogen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Biogen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03339336
- Sponsor's protocol ID
- 802NP206
- Other IDs
- 2017-000991-27, 2017
- Status last verified
- Apr 2021
- First submitted
- 8 Nov 2017
- Last updated
- 5 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Faber CG, Attal N, Lauria G, Dworkin RH, Freeman R, Dawson KT, Finnigan H, Hajihosseini A, Naik H, Serenko M, Morris CJ, Kotecha M. Efficacy and safety of vixotrigine in idiopathic or diabetes-associated painful small fibre neuropathy (CONVEY): a phase 2 placebo-controlled enriched-enrolment randomised withdrawal study. EClinicalMedicine. 2023 Apr 27;59:101971. doi: 10.1016/j.eclinm.2023.101971. eCollection 2023 May.
PubMed 37152360
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Placebo-Controlled, Double-Blind, Enriched Enrollment Randomized Withdrawal Study to Evaluate the Efficacy and Safety of BIIB074 (Vixotrigine) in Treating Pain Experienced by Subjects With Confirmed Small Fiber Neuropathy That is Idiopathic or Associated With Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT03339336
- Acronym / sponsor ID
- 802NP206
- Conditions
- Small Fiber Neuropathy, Diabetes Mellitus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decision to close study early; not due to safety concerns
- Enrolment
- 265 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- 31 May 2018 (actual)
- Primary completion
- 12 Apr 2021 (actual)
- Study completion
- 12 Apr 2021 (actual)
- First posted
- 13 Nov 2017 (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.
The primary objective of this study is to evaluate the efficacy of BIIB074 in treating pain experienced by participants with confirmed small fiber neuropathy (SFN) that is idiopathic or associated with diabetes mellitus. A secondary endpoint that relates to the primary objective is the change from Randomization to Week 12 of the double-blind period in mean average daily pain score.
The secondary objectives of this study are to evaluate the effect on worst pain, neuropathic pain quality, sleep interference due to pain, patient global impression, use of rescue medication, and SFN symptoms in participants treated with BIIB074; to investigate the safety and tolerability of BIIB074 in participants with SFN; and to characterize the pharmacokinetics (PK) of BIIB074 in participants with SFN.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| BIIB074 350 mg | Experimental | Drug: BIIB074Taper Period (if applicable) from neuropathic pain medication, followed by a washout period, then BIIB074 350 mg tablets orally twice daily (BID) Open-Label Run-In Period, then BIIB074 350 mg tablets orally BID Double-Blind Treatment Period. |
| BIIB074 200 mg | Experimental | Drug: BIIB074Taper Period (if applicable) from neuropathic pain medication, followed by a washout period, then BIIB074 350 mg tablets orally twice daily (BID) Open-Label Run-In Period, then BIIB074 200 mg tablets orally BID Double-Blind Treatment Period. |
| Placebo | Placebo comparator | Drug: PlaceboTaper Period (if applicable) from neuropathic pain medication, followed by a washout period, then BIIB074 350 mg tablets orally twice daily (BID) Open-Label Run-In Period, then BIIB074 placebo-matching tablets orally BID Double-Blind Treatment Period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- This study will be conducted in subjects who have had a diagnosis of at least probable SFN, length-dependent distribution, for 6 months and ≤10 years prior to screening, defined as a history of the symptoms and clinical signs based on discussions at the ACTTION CONCEPPT meeting on diagnosis of SFN, Washington, DC March 2018, and confirmed by intraepidermal nerve fiber density (IENFD) values, and weekly mean average daily pain (ADP) score of ≥5 and ≤9 on an 11-point Pain Intensity Numeric Rating Scale (PI-NRS) over the last 7 days of prior to the Screening visit.
- In addition to these criteria, subjects with diabetes will be required to have HbA1c ≤11%, treated with oral hypoglycemics and/or subcutaneous insulin or diet, no evidence of ulcers, advanced retinopathy (defined as greater than State 3 [moderate non-proliferative diabetic retinopathy]) (DCCT/EDIC Research Group 2017), severe nephropathy, or clinically significant obstructive atherosclerotic disease or current class IV heart failure to be eligible for the study.
Key exclusion criteria (9 listed)
- Previous exposure to BIIB074 (formerly known as CNV1014802 or GSK1014802).
- Use of capsaicin patch within 3 months prior to Screening.
- Unable or unwilling to discontinue concomitant medications for SFN pain prior to Day 1.
- Unable or unwilling to comply with the prohibited concomitant medication restrictions, including but not limited to UDP-glucuronosyltransferase (UGT) inducers and inhibitors, monoamine oxidase inhibitors (MAOIs), and Nav blockers.
- Use of over-the-counter medications, vitamin and mineral supplements, herbal remedies (including St. John's wort), dietary supplements, or foods (including grapefruit juice) that affect and UGTs.
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 |
|---|---|---|
| BIIB074Administered as specified in the treatment arm. | Drug | BIIB074 200 mg, BIIB074 350 mg |
| PlaceboAdministered as specified in the treatment arm. | Drug | Placebo |
Primary outcome
Change from Baseline in Weekly Mean Average Daily Pain (ADP) Score
Time frame: Baseline and Week 12 of the Double-Blind Period
Participants will rate their ADP using an 11-point Numerical Rating Scale (NRS) (0=no pain and 10=worst possible pain) and record their score in an electronic diary (eDiary). Weekly mean ADP scores for Baseline (the 5 days prior to the first dose of study treatment in the open-label run-in period) and Week 12 (the 7 days prior to the visit at the end of Week 12) will be derived from the ADP scores and calculated as the mean of the daily scores over the last 7 days.
Change from Randomization in Weekly Mean ADP Score
Time frame: Randomization and Week 12 of the Double-Blind Period
Participants will rate their ADP using an 11-point NRS (0=no pain and 10=worst possible pain) and record their score in an eDiary. Weekly mean ADP scores for Randomization (the 7 days prior to the first dose of study treatment in the double-blind period) and Week 12 (the 7 days prior to the visit at the end of Week 12) will be derived from the ADP scores and calculated as the mean of the daily scores over the last 7 days.
11 secondary outcomes
Change from Baseline in Weekly Mean Worst Daily Pain (WDP) Score
Time frame: Baseline and Week 12 of the Double-Blind Period
Change from Baseline in Weekly Mean Sleep Interference Numerical Rating Scale (S-NRS)
Time frame: Baseline and Week 12 of the Double-Blind Period
Change from Baseline in Neuropathic Pain Symptom Inventory (NPSI) Total Score and Sum Score
Time frame: Baseline and Week 12 of Double-Blind Period
Proportion of Participants with at least a 2-point Reduction from Baseline in Weekly Mean ADP
Time frame: Baseline and Week 12 of the Double-Blind Period
Proportion of Participants with at least a 30% Reduction from Baseline in Weekly Mean ADP
Time frame: Baseline and Week 12 of Double-Blind Period
Mean Weekly Amount of Rescue Medication
Time frame: Weekly from Baseline to Week 12 of the Double-Blind Period
Patient Global Impression of Change (PGIC)
Time frame: Week 12 of the Double-Blind Period
Change from Baseline in Brief Pain Inventory-Short Form (BPI-SF) Interference Score
Time frame: Baseline and Week 12 of the Double-Blind Period
Percentage of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) During Double-Blind Period
Time frame: Week 5 to Week 17
Area Under the Concentration-time Curve at Steady State
Time frame: Week 1, 3, 5, 9, 13 and 17 prior to dosing and 1 to 2 hours after dosing, and at Day 123 (Follow-up clinic visit)
Maximum Observed Concentration (Cmax) at Steady State
Time frame: Week 1, 3, 5, 9, 13 and 17 prior to dosing and 1 to 2 hours after dosing, and at Day 123 (Follow-up clinic visit)
Results and safety
The study was stopped early (reason given: Sponsor decision to close study early; not due to safety concerns). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2021.
- Derived from this study: PubMed 37152360Faber CG, Attal N, Lauria G, Dworkin RH, Freeman R, Dawson KT, Finnigan H, Hajihosseini A, Naik H, Serenko M, Morris CJ, Kotecha M. Efficacy and safety of vixotrigine in idiopathic or diabetes-associated painful small fibre neuropathy (CONVEY): a phase 2 placebo-controlled enriched-enrolment randomised withdrawal study. EClinicalMedicine. 2023 Apr 27;59:101971. doi: 10.1016/j.eclinm.2023.101971. eCollection 2023 May.
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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.
Medical Director study director
Biogen
97 sites in 14 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BIIB074 in people with Small Fiber Neuropathy and Diabetes Mellitus, run by Biogen at 97 sites in 14 countries.
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 2 inclusion and 9 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 5 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 97 sites in Germany, France, United Kingdom, Poland, Spain and 9 more countries. 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 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.
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 was stopped early (reason given: Sponsor decision to close study early; not due to safety concerns). 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?
Change from Baseline in Weekly Mean Average Daily Pain (ADP) Score (time frame: Baseline and Week 12 of the Double-Blind Period). The study lists 2 primary outcomes in all. 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 NCT03339336, which also lists 1 linked publication.
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 5 May 2021.