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Neuropathic PainPhase 2NCT03777956

The Effect of Lacosamide in Peripheral Neuropathic Pain

A Phase 2 study testing Lacosamide in people with Neuropathic Pain and Neuropathy;Peripheral, run by Danish Pain Research Center at 1 site in Denmark.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The main purpose of this study is to compare the change in pain intensity during treatment with a sodium-channel blocker (lacosamide) in patients with peripheral neuropathic pain with and without the irritable nociceptor phenotype. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Lacosamide
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
63 participants
Where
1 siteDenmark
Study dates
15 Jan 2019to 3 Jun 2022
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

  • Age ≥ 18 years.
  • Probable or definite peripheral neuropathic pain for at least 3 months (Finnerup et al. 2016)
  • Average pain intensity of at least 4 and not above 9 on a 0-10 NRS during the 7-day baseline week (Dworkin et al. 2012).
  • Written informed consent.

Who cannot join

  • Other causes of pain in the same area, or other concomitant pain that cannot be distinguished from the neuropathic pain
  • Patient who cannot cooperate or are unable to complete the project and patients who do not speak Danish.
  • Known and current cardiac conduction disturbance (2⁰ or 3⁰ atrioventricular (AV) block, prolonged QTc interval > 450 ms, heart rate <50 or >110 bpm, a QRS interval >120ms (ECG required)), significant cardiac, renal or liver disease or other severe illness. In patients treated with pregabalin also PQ interval > 0,2s and cardiac disease. Sitting diastolic blood pressure below 50 mmHg or above 105 mmHg.
  • Major depressive episode within 6 months, recurrent depressive disorder or other significant psychiatric disease, alcohol, illicit drug or drug abuse.
  • Pregnancy or lactation
  • Woman of childbearing potential, unless they use and acceptable effective contraception measure as defined in the Clinical Trials Facilitation Group (CTFG) during the study and at least 2 weeks after, or if their male partner is vasectomized and their sole partners. Negative pregnancy test is required.
Show all 14Show fewer
  • Known allergy to lacosamide or excipients.
  • Concomitant pain treatment with tricyclic antidepressants, topical analgesics (lidocaine, capsaicin), lamotrigine, oxcarbazepine, cannabinoids or strong opioids that cannot be discontinued. Other treatment for neuropathic pain are allowed in a stable dose (from 14 days before randomization to completion of the trial), if they cannot be tapered off completely.
  • Concomitant treatment with products known to be associated with PQ (PR) prolongation other than pregabalin.
  • Patients inappropriate for placebo
  • Planned surgery
  • Use of sodium channel blockers within at least five half-lives and investigational drugs within 30 days.
  • Patients on controlled sodium diet, unless the amount of sodium in the capsules is acceptable for their diet.
  • The score "yes" on item 4 or item 5 of the Suicidal Ideation section of the Columbia Suicide Severity Rating Scale (C-SSRS), if the ideation occurred in the past 6 months, or "yes on any item of the Suicidal Behaviour section, except for the "Non-suicidal Self Injurious Behaviour" if this behaviour occurred in the past 2 years.

Trial locations and contacts

1 site in 1 country.

Denmark1 site

  • Danish Pain Research Center, Aarhus University Hospital

    Aarhus, 8200

Other trials in Denmark

About this study

Official title: The Effect of Lacosamide in Peripheral Neuropathic Pain: a Randomized, Double-blind, Placebo Controlled, Phenotype-stratified Study

The main purpose of this study is to compare the change in pain intensity during treatment with a sodium-channel blocker (lacosamide) in patients with peripheral neuropathic pain with and without the irritable nociceptor phenotype.

Read the detailed description

The main purpose of this study is to compare the change in pain intensity during treatment with a sodium-channel blocker (lacosamide) in patients with peripheral neuropathic pain with and without the irritable nociceptor phenotype. As this is a mechanistic study, the main purpose is to compare the change in pain intensity in patients who receive an expected sufficiently effective dose of lacosamide. As supportive evidence for a drug-specific predictive biomarker, the purpose is also to compare the change in pain intensity during lacosamide vs. placebo for the two phenotypes.

We hypothesize that the sodium-channel blocker lacosamide will be more effective in patients with the irritable nociceptor than those without the non-irritable nociceptor phenotype, and that lacosamide is more effective than placebo in patients with the irritable nociceptor phenotype.

Being tested
Lacosamide, Placebo
Medical subject headings
Neuralgia, Neuritis, Neuropathy, Painful, Diabetic Neuropathies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LacosamideDrug

    Lacosamide (50 mg) and identical placebo are given as capsules and taken orally twice a day, up to 200 mg b.i.d.

  • PlaceboDrug

    Identical placebo are given as capsules and taken orally twice a day.

Study groups in NCT03777956
Study groupRoleWhat they receive
LacosamideActive comparatorLacosamide (50 mg) are given as capsules and taken orally twice a day, up to 200 mg b.i.d.
Receives: Drug: Lacosamide
PlaceboPlacebo comparatorPlacebo are given as capsules, same as lacosamide, and taken orally twice a day, without active ingredient.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pain intensity

    The difference in the mean value of the patient's daily ratings of average pain intensity in the baseline week and the last week during treatment as experienced during the past 24 hours rated on a 0-10 point numeric rating scale (NRS; 0 = no pain, 10 = worst possible pain).

    The primary objective is to compare the change in pain intensity from baseline to last week of lacosamide treatment in patients with and without the irritable nociceptor phenotype in the PP population.

    The supportive objective is to compare the effect of lacosamide vs. placebo in the two phenotype groups in the PP population. Although we do not expect a phenotype difference in the response to placebo, a comparison of the effect of lacosamide vs. placebo is needed to justify that the phenotype is a predictive biomarker for the effect of lacosamide.

    Measured: 12 weeks

Secondary outcomes (2)

  1. Pain relief

    (complete, good, moderate, mild, none, worse pain) . Measured at last visit/end of treatment period.

    Measured: 12 weeks

  2. Use of escape medicine (paracetamol) during treatment period.

    Number of paracetamol tablets during the 12 weeks treatment period.

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Dec 2018
  2. Study start15 Jan 2019
  3. Primary completion3 Jun 2022
  4. Study completion3 Jun 2022

Why it stopped: COVID 19 and recruitment problems

Resources

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
63 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03777956
Sponsor's protocol ID
LACOSAMIDE-2018
Other IDs
2018-003110-40, 2018
Status last verified
Feb 2023
First submitted
14 Dec 2018
Last updated
16 Feb 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Finnerup NB, Haroutounian S, Kamerman P, Baron R, Bennett DLH, Bouhassira D, Cruccu G, Freeman R, Hansson P, Nurmikko T, Raja SN, Rice ASC, Serra J, Smith BH, Treede RD, Jensen TS. Neuropathic pain: an updated grading system for research and clinical practice. Pain. 2016 Aug;157(8):1599-1606. doi: 10.1097/j.pain.0000000000000492.

    PubMed 27115670

  • Dworkin RH, Turk DC, Peirce-Sandner S, Burke LB, Farrar JT, Gilron I, Jensen MP, Katz NP, Raja SN, Rappaport BA, Rowbotham MC, Backonja MM, Baron R, Bellamy N, Bhagwagar Z, Costello A, Cowan P, Fang WC, Hertz S, Jay GW, Junor R, Kerns RD, Kerwin R, Kopecky EA, Lissin D, Malamut R, Markman JD, McDermott MP, Munera C, Porter L, Rauschkolb C, Rice ASC, Sampaio C, Skljarevski V, Sommerville K, Stacey BR, Steigerwald I, Tobias J, Trentacosti AM, Wasan AD, Wells GA, Williams J, Witter J, Ziegler D. Considerations for improving assay sensitivity in chronic pain clinical trials: IMMPACT recommendations. Pain. 2012 Jun;153(6):1148-1158. doi: 10.1016/j.pain.2012.03.003. Epub 2012 Apr 9.

    PubMed 22494920

  • Carmland ME, Kreutzfeldt M, Holbech JV, Andersen NT, Jensen TS, Bach FW, Sindrup SH, Finnerup NB. Effect of lacosamide in peripheral neuropathic pain: study protocol for a randomized, placebo-controlled, phenotype-stratified trial. Trials. 2019 Oct 11;20(1):588. doi: 10.1186/s13063-019-3695-7.

    PubMed 31604475

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Lacosamide in people with Neuropathic Pain and Neuropathy;Peripheral, run by Danish Pain Research 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 4 inclusion and 14 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 16 Feb 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 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?

The study was stopped early (reason given: COVID 19 and recruitment problems). 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?

Pain intensity (time frame: 12 weeks). 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 NCT03777956, which also lists 3 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 16 Feb 2023.

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