AzTrials
AzTrials

Neuropathic PainPhase 2NCT05561257

Vitamin C as add-on Therapy in Patients With Acute Herpes Zoster

A Phase 2 study testing Vitamin C in people with Neuropathic Pain, run by Pascoe Pharmazeutische Praeparate GmbH at 3 sites in Germany.

Terminated

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

Official record
Search all trials

Trial summary

To compare the efficacy and tolerability of three different doses of Pascorbin® besides standard medication with placebo and the reduction of herpes zoster-associated clinical symptoms as an add-on therapy for patients suffering from acute herpes zoster in primary care Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Neuropathic Pain
What is being tested?
Vitamin C
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
12 participants
Where
3 sitesGermany
Study dates
20 Jul 2020to 28 Feb 2024
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

  • Male and female patients older than 18 years
  • Diagnosis of acute herpes zoster
  • Presence of at least one efflorescence
  • Peak NRS pain score ≥ 5 within the last 24h
  • Based on the appraisal of the investigator: adequate educational as well as intelligence level and communicative capacity in order to comply with the requirements of the trial
  • Written informed consent of the patient
Show all 9Show fewer
  • Negative urine pregnancy test at the baseline visit (prior to the first infusion of study medication) for female patients of childbearing potential.
  • Women of child-bearing potential must apply during the entire duration of the trial a highly effective method of birth control, which is defined as those which result in a low failure rate (i.e., less than 1 % per year) when used constantly and correctly such as implants, injectables, combined oral contraceptive method (oestrogen and progestogen), or some intrauterine devices (IUDs) or sexual abstinence (true abstinence, only if in line with the preferred and usual lifestyle) or vasectomy of partner. Women of non-childbearing potential may be included if surgically sterile (tubal ligation or hysterectomy) or post-menopausal with at least 1 year without spontaneous menses.
  • Patients are suitable for study participation according to their general medical situation

Who cannot join

  • History of oxalate-urolithiasis or nephrolithiasis
  • Current active zoster episode for more than 10 days
  • Known severe renal function impairment consistent with Kidney Disease Improving Global Outcome (KDIGO) Glomerular Filtration Rate (GFR) stages G4 and 5 (< 30 ml/min/1.73m2)
  • Known iron storage disease (e.g., thalassemia, hemochromatosis, sideroblastic anemia)
  • Known erythrocytic glucose-6-phosphate dehydrogenase deficiency (at least class 3 = 10-60% rest activity = moderate deficiency)
  • Prior vaccination with Zostavax®
Show all 40Show fewer
  • Signs or symptoms or diagnosed complications of herpes zoster such as zoster disseminatus, zoster generalisatus, zoster meningitis, zoster encephalitis, zoster myelitis, zoster pneumonitis, acute retinal necrosis (ARN)
  • Contraindication to aciclovir treatment according to the current Summary of Product Characteristics (SmPC).
  • Any disease that may interfere with the assessment of the course of the acute varicella zoster virus reactivation e.g.
  • dermatological diseases such as psoriasis/eczema in the area of affected dermatomes
  • painful local or systemic diseases such as wound infection or inflammation
  • Immunodeficiency diseases, including but not limited to Human Immunodeficiency Virus (HIV)
  • Known active malignancies other than non-melanoma skin cancer (NMSC)
  • Severe uncontrolled diabetes mellitus, implanted insulin pump and severe respiratory obstructive diseases
  • Other severe concomitant diseases with severe impairment of the patient's general condition
  • History of additional herpes zoster in the last 3 months prior to baseline
  • Any of the following medication, that might interact with the study medication or interfere with its effect
  • Intravenous virostatics like aciclovir or brivudin within 4 weeks prior to baseline
  • Oral virostatics like aciclovir or brivudin longer than 48 hours
  • Any supplementary ascorbic acid (vitamin C) within 4 weeks prior to baseline
  • Long-term analgesics (including local and transdermal) for non-Herpes pain (e.g. headache, rheumatism)
  • Intake of any analgesics longer than 3 days for treatment of the current zoster symptoms
  • Anticonvulsive drugs (gabapentin, pregabaline) within 4 weeks prior to baseline
  • Antiepileptic drugs (carbamazepine) within 4 weeks prior to baseline
  • Antidepressant drugs such as tricyclic antidepressants, serotonin-norepinephrine reuptake inhibitors (SSRI/SNRI) within 4 weeks prior to baseline
  • Neuroleptics within 2 days prior to baseline
  • Use of topical analgesics e.g., lidocaine or capsaicin patches on the site of the current herpes zoster efflorescence within 2 days prior to baseline
  • Current therapy with immunosuppressive drugs, including but not limited to:
  • Any systemic chemotherapeutics/cytostatic drugs
  • Corticosteroids (> 5 mg/d prednisolone or equivalent)
  • Methotrexate, ciclosporin, azathioprine
  • Other drugs and interventions that may cause interactions with Vitamin C, including
  • Fluphenazine
  • Cumarine derivates
  • Radiation therapy
  • Nephrotoxic drugs, that may, according to the investigator's discretion, impair renal function
  • Any other non-drug treatment of the acute herpes zoster
  • Known hypersensitivity to the pharmacologic active constituents or any other ingredient of the study medication
  • Participation in another clinical trial within the last 30 days prior to inclusion, simultaneous participation in another clinical trial or previous participation in this trial.
  • Mental or physical disability or imprisonment

Trial locations and contacts

3 sites in 1 country.

Germany3 sites

  • dermatologisches zentrum Bonn

    Bonn, Hesse, 53111

  • Universitätsklinikum Frankfurt am Main

    Frankfurt am Main, Hesse, 60590

  • Hautklinik der Universitätsmedizin Mainz KöR

    Mainz, Hesse, 55101

Other trials in Germany

About this study

Official title: A Double-blind, Placebo-controlled, 4-arm Pilot Study on the Use of Vitamin C as Add on Therapy in Patients With Acute Herpes Zoster

To compare the efficacy and tolerability of three different doses of Pascorbin® besides standard medication with placebo and the reduction of herpes zoster-associated clinical symptoms as an add-on therapy for patients suffering from acute herpes zoster in primary care

Being tested
Vitamin C
Medical subject headings
Neuralgia

What participants receive

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

Study groups in NCT05561257
Study groupRoleWhat they receive
Group 1 (control group)Placebo comparator300 ml NaCl infusion
Receives: Drug: Vitamin C
Group 2 (750 mg Vitamin C)Experimental295 ml NaCl + 5 ml (750 mg) Vitamin C
Receives: Drug: Vitamin C
Group 3 (7.5 g Vitamin C)Experimental250 ml NaCl + 1 x 50 ml (7.5 g) Vitamin C
Receives: Drug: Vitamin C
Group 4 (15 g Vitamin C)Experimental200 ml NaCl + 2 x 50 ml (2 x 7.5 g) Vitamin C
Receives: Drug: Vitamin C

What is being measured

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

  1. Mean neuropathic pain

    Area under the curve (AUC) of mean neuropathic pain measured by numeric rating scale (NRS) from baseline to V5

    Measured: from Baseline to V5 (day 11-13 after baseline)

Secondary outcomes (3)

  1. Number of standard doses of permitted concomitant analgesic medication

    Number of standard doses of permitted concomitant analgesic medication (step 1 of analgesic potency according to WHO) from baseline to V5

    Step 1 (non-opioids: Paracetamol 500 mg, Ibuprofen 400 mg)

    Measured: from Baseline to V5 (day 11-13 after baseline)

  2. AUC of equianalgesic doses of permitted concomitant analgesic medication

    Area under the curve of equianalgesic doses of permitted concomitant analgesic medication (step 2 of analgesic potency according to WHO) from baseline to V5

    Step 2 (weak opioids: Metamizole 500 mg, Tramadol 50 mg, Tilidine/Naloxone 50 mg/4 mg)

    Measured: from Baseline to V5 (day 11-13 after baseline)

  3. Presence of a Post-herpetic neuralgia

    Proportion of patient who developed a post-herpetic neuralgia at V7

    Measured: at V7 (day 90 (+/- 2 days))

Timeline

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

  1. First posted30 Sep 2022
  2. Study start20 Jul 2020
  3. Primary completion28 Feb 2024
  4. Study completion28 Feb 2024

Why it stopped: the necessary recruitment was no longer ensured and fundamental changes in the medical care of herpes zoster, which prevented the original research objectives and the feasibility of the study in the planned scope from being achieved

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
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05561257
Sponsor's protocol ID
218S18VC
Status last verified
Nov 2024
First submitted
27 Sep 2022
Last updated
7 Nov 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Vitamin C in people with Neuropathic Pain, run by Pascoe Pharmazeutische Praeparate GmbH at 3 sites in Germany.

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 9 inclusion and 40 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 7 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Germany. 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: the necessary recruitment was no longer ensured and fundamental changes in the medical care of herpes zoster, which prevented the original research objectives and the feasibility of the study in the planned scope from being achieved). 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?

Mean neuropathic pain (time frame: from Baseline to V5 (day 11-13 after baseline)). 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 NCT05561257.

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 7 Nov 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in