Trigeminal NeuralgiaPhase 2NCT04054024
Efficacy and Tolerability of Erenumab in Patients With Trigeminal Neuralgia
A Phase 2 study testing Erenumab in people with Trigeminal Neuralgia, run by Danish Headache Center at 1 site in Denmark.
Trial summary
A placebo-controlled, double-blind, randomized proof-of-concept study to evaluate the efficacy and tolerability of the CGRP receptor antibody erenumab in treating pain experienced by subjects with TN. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Trigeminal Neuralgia
- What is being tested?
- Erenumab
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteDenmark
- Study dates
- 28 Oct 2019to 1 Oct 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 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- A diagnosis of primary TN (idiopathic or classical) according to criteria of The Interna-tional Classification of Headache Disorders 3rd edition (1).
- Age between 18 and 85 years.
- Subjects must have a minimum mean of three TN related pain paroxysms per day with a mean ADP of 4 to 10, inclusive, on the 11-point NRS (0= no pain; 10= maximum pain imaginable) during the 7-day screening phase to enter the baseline phase.
- Subjects must have a minimum mean of three TN related pain paroxysms per day with a mean ADP of 4 to 10, inclusive, on the 11-point NRS (0= no pain; 10= maximum pain imaginable) during the 4-week baseline phase to enter the treatment phase (to be randomized).
- Fertile women must use safe contraceptives and present with a negative u-HCG at visit 1. Safe contraceptives are defined as intra-uterine devices, contraceptive pills or implants and surgical sterilization.
Who cannot join
- Significant cardiovascular and cerebrovascular disease such as ischemic heart disease, previous myocardial infarction or previous stroke or transient ischemic attack, major CVD interventions.
- Language difficulties.
- Poor compliance, i.e. unlikely to be able to complete all protocol required study visits or procedures, and/or to comply with all required study procedures to the best of the sub-ject's and investigator's knowledge.
- Severe psychiatric disease.
- Anamnestic or clinical symptoms of any kind that are deemed relevant for study partici-pation by the physician who examines the patient.
- Taking any TN-medication, where the prescribed daily dose has changed within 2 weeks prior to the baseline period (refer to section 6.4 for the list of these medications).
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- Pregnant or breastfeeding, or is a female expecting to conceive during the study, includ-ing through 4 weeks after treatment.
- Female subject of childbearing potential who is unwilling to use an acceptable method of effective contraception during the study. Acceptable methods of effective birth control include not having intercourse (true abstinence, when this is in line with the preferred and usual lifestyle of the subject), hormonal birth control methods (pills, shots/injections, implants, or patches), intrauterine devices, surgical contraceptive methods (vasectomy with medical assessment of the surgical success of this procedure or bilateral tubal ligation), or two barrier methods (each partner must use one barrier method) with spermicide - males must use a condom with spermicide; females must choose either a diaphragm with spermicide, OR cervical cap with spermicide, OR contraceptive sponge with spermicide. Female subjects not of childbearing potential are defined as any female who: is post-menopausal by history, defined as:
- Age ≥ 55 years with cessation of menses for 12 or more months, OR Age < 55 years but no spontaneous menses for at least 2 years, OR Age < 55 years and spontaneous menses within the past 1 year, but currently amenorrheic (eg, spontaneous or secondary to hysterectomy), AND with postmenopausal gonadotro-pin levels (luteinizing hormone and follicle-stimulating hormone levels > 40 IU/L) or postmenopausal estradiol levels (< 5 ng/dL) or according to the definition of "postmeno-pausal range" for the laboratory involved. OR o Underwent bilateral oophorectomy OR o Underwent hysterectomy OR o Underwent bilateral salpingectomy.
- Known sensitivity to any component of erenumab.
- Member of investigational site staff or relative of the investigator.
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Danish Headache Center, Department of Neurology, Rigshospitalet - Glostrup
Glostrup Municipality, 2600
Stine Maarbjerg, MD, PhD, 004538633525, stine.maarbjerg@regionh.dk
About this study
Official title: A Placebo-Controlled, Double-Blind, Randomized, Proof-of-Concept Study to Evaluate the Efficacy and Tolerability of Erenumab in Patients With Trigeminal Neuralgia
A placebo-controlled, double-blind, randomized proof-of-concept study to evaluate the efficacy and tolerability of the CGRP receptor antibody erenumab in treating pain experienced by subjects with TN.
- Conditions
- Trigeminal Neuralgia
- Being tested
- Erenumab, Placebos
- Medical subject headings
- Trigeminal Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ErenumabDrug
140 mg Erenumab
PlacebosDrug
Saline
| Study group | Role | What they receive |
|---|---|---|
| Active drug | Active comparator | Not described Receives: Drug: Erenumab |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects classified as responders at the end of the evaluation period.
A subject who meets the following criterion will be classified as a responder:
Has a reduction of ≥ 30% in mean average daily pain intensity score (mean ADP) assessed using the 11-point numerical rating scale (NRS) during the evaluation period (week 1-4) compared with baseline (weeks -4 to -1). Patients that are protocol violators, e.g., patients having to increase current medications or undergoes surgery in the evaluation period as well as pa-tients who drop out due to worsening of symptoms or side effects will be recorded as non-responders.
Measured: 4 weeks after randomization
Secondary outcomes (1)
Secondary outcome measures
- proportion of subjects reaching ≥50% reduction in mean ADP (average daily pain) during the evaluation period (week 1-4) compared with baseline (week -4 to -1).
- proportion of subjects reaching ≥75% reduction in mean ADP during the evaluation period (week 1-4) compared with baseline (week -4 to -1).
- subjects with a response in number of paroxysms at evaluation period.
- proportion of subjects with a Patient Global Impression of Change (PGIC) scale response at evaluation period.
Due to word limitations not all secondary outcome measures were explaned in detail and/or registered.
Measured: 4 weeks after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2019
- Study start28 Oct 2019
- Primary completionOct 2021 (estimated)
- Study completion1 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trigeminal NeuralgiaStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Danish Headache Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stine Maarbjerg, MD, Danish Headache Center
- Investigators
- Lars Bendtsen, MD, Dr Med Sci, Principal investigator, Danish Headache Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04054024
- Sponsor's protocol ID
- H-19011013
- Status last verified
- Nov 2019
- First submitted
- 9 Aug 2019
- Last updated
- 20 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Placebo-Controlled, Double-Blind, Randomized, Proof-of-Concept Study to Evaluate the Efficacy and Tolerability of Erenumab in Patients With Trigeminal Neuralgia
- ClinicalTrials.gov ID
- NCT04054024
- Acronym / sponsor ID
- H-19011013
- Conditions
- Trigeminal Neuralgia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Danish Headache CenterUniversity, hospital or other
- Study start
- 28 Oct 2019 (actual)
- Primary completion
- Oct 2021 (estimated)
- Study completion
- 1 Oct 2021 (estimated)
- First posted
- 13 Aug 2019 (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.
A placebo-controlled, double-blind, randomized proof-of-concept study to evaluate the efficacy and tolerability of the CGRP receptor antibody erenumab in treating pain experienced by subjects with TN.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active drug | Active comparator | Drug: Erenumab |
| Placebo | Placebo comparator | Drug: Placebos |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- A diagnosis of primary TN (idiopathic or classical) according to criteria of The Interna-tional Classification of Headache Disorders 3rd edition (1).
- Age between 18 and 85 years.
- Subjects must have a minimum mean of three TN related pain paroxysms per day with a mean ADP of 4 to 10, inclusive, on the 11-point NRS (0= no pain; 10= maximum pain imaginable) during the 7-day screening phase to enter the baseline phase.
- Subjects must have a minimum mean of three TN related pain paroxysms per day with a mean ADP of 4 to 10, inclusive, on the 11-point NRS (0= no pain; 10= maximum pain imaginable) during the 4-week baseline phase to enter the treatment phase (to be randomized).
- Fertile women must use safe contraceptives and present with a negative u-HCG at visit 1. Safe contraceptives are defined as intra-uterine devices, contraceptive pills or implants and surgical sterilization.
Key exclusion criteria (11 listed)
- Significant cardiovascular and cerebrovascular disease such as ischemic heart disease, previous myocardial infarction or previous stroke or transient ischemic attack, major CVD interventions.
- Language difficulties.
- Poor compliance, i.e. unlikely to be able to complete all protocol required study visits or procedures, and/or to comply with all required study procedures to the best of the sub-ject's and investigator's knowledge.
- Severe psychiatric disease.
- Anamnestic or clinical symptoms of any kind that are deemed relevant for study partici-pation by the physician who examines the patient.
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 |
|---|---|---|
| Erenumab140 mg Erenumab | Drug | Active drug |
| PlacebosSaline | Drug | Placebo |
Primary outcome
Proportion of subjects classified as responders at the end of the evaluation period.
Time frame: 4 weeks after randomization
A subject who meets the following criterion will be classified as a responder: Has a reduction of ≥ 30% in mean average daily pain intensity score (mean ADP) assessed using the 11-point numerical rating scale (NRS) during the evaluation period (week 1-4) compared with baseline (weeks -4 to -1). Patients that are protocol violators, e.g., patients having to increase current medications or undergoes surgery in the evaluation period as well as pa-tients who drop out due to worsening of symptoms or side effects will be recorded as non-responders.
1 secondary outcome
Secondary outcome measures
Time frame: 4 weeks after randomization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2019.
- Individual participant dataSharing planned: Undecided
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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.
Lars Bendtsen, MD, Dr Med Sci principal investigator
Danish Headache Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Erenumab in people with Trigeminal Neuralgia, run by Danish Headache Center at 1 site in Denmark.
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 5 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 20 Nov 2019. 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 Denmark. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stine Maarbjerg, MD, PhD (004538633525, stine.maarbjerg@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of subjects classified as responders at the end of the evaluation period. (time frame: 4 weeks after randomization). 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 20 Nov 2019.