ClinicalTrials.gg
TerminatedNCT05561257Updated Nov 7, 2024

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

A Phase 2 interventional study of Vitamin C in Neuropathic Pain, sponsored by Pascoe Pharmazeutische Praeparate GmbH. Terminated at 3 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-07.

Sponsored by Pascoe Pharmazeutische Praeparate GmbH · Phase 2, Interventional, and Treatment

Why this study was terminated
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

From the registry’s dates

  • Registered 2 years 2 months after the study started (first participant enrolled Jul 2020, registered Sep 2022).
Phase
Phase 2
Study type
Interventional
Enrollment
12
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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

02

Conditions studied

  • Neuropathic Pain

Browse trials for

03

In context

Neuralgia

1,100 studies on the registry are indexed under Neuralgia; 241 are open to participants now.

This study's enrollment of 12 is below the median of 52 across 831 interventional studies indexed under Neuralgia.

Browse Neuralgia studies →

Lead sponsor

Pascoe Pharmazeutische Praeparate GmbH is the lead sponsor of 15 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Male and female patients older than 18 years
  2. Diagnosis of acute herpes zoster
  3. Presence of at least one efflorescence
  4. Peak NRS pain score ≥ 5 within the last 24h
  5. 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
  6. Written of the patient
  7. Negative urine pregnancy test at the baseline visit (prior to the first infusion of study medication) for female patients of .
  8. Women of child-bearing potential must apply during the entire duration of the trial a highly effective method of , 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 with at least 1 year without spontaneous menses.
  9. Patients are suitable for study participation according to their general medical situation

Exclusion criteria

Exclusion Criteria:

  1. History of oxalate-urolithiasis or nephrolithiasis
  2. Current active zoster episode for more than 10 days
  3. Known severe renal function impairment consistent with Kidney Disease Improving Global Outcome (KDIGO) (GFR) stages G4 and 5 (\< 30 ml/min/1.73m2)
  4. Known iron storage disease (e.g., thalassemia, hemochromatosis, sideroblastic anemia)
  5. Known erythrocytic glucose-6-phosphate dehydrogenase deficiency (at least class 3 = 10-60% rest activity = moderate deficiency)
  6. Prior vaccination with Zostavax®
  7. 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)
  8. to aciclovir treatment according to the current Summary of Product Characteristics (SmPC).
  9. Any disease that may interfere with the assessment of the course of the acute varicella zoster virus reactivation e.g.

    1. dermatological diseases such as psoriasis/eczema in the area of affected dermatomes
    2. painful local or systemic diseases such as wound infection or inflammation
  10. Immunodeficiency diseases, including but not limited to (HIV)
  11. Known active other than non-melanoma skin cancer (NMSC)
  12. Severe uncontrolled diabetes mellitus, implanted insulin pump and severe respiratory obstructive diseases
  13. Other severe concomitant diseases with severe impairment of the patient's general condition
  14. History of additional herpes zoster in the last 3 months prior to baseline
  15. Any of the following medication, that might interact with the study medication or interfere with its effect

    1. Intravenous virostatics like aciclovir or brivudin within 4 weeks prior to baseline
    2. Oral virostatics like aciclovir or brivudin longer than 48 hours
    3. Any supplementary ascorbic acid (vitamin C) within 4 weeks prior to baseline
    4. Long-term analgesics (including local and transdermal) for non-Herpes pain (e.g. headache, rheumatism)
    5. Intake of any analgesics longer than 3 days for treatment of the current zoster symptoms
    6. Anticonvulsive drugs (gabapentin, pregabaline) within 4 weeks prior to baseline
    7. Antiepileptic drugs (carbamazepine) within 4 weeks prior to baseline
    8. Antidepressant drugs such as tricyclic antidepressants, serotonin-norepinephrine reuptake inhibitors (SSRI/SNRI) within 4 weeks prior to baseline
    9. Neuroleptics within 2 days prior to baseline
    10. 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
  16. Current therapy with drugs, including but not limited to:

    1. Any systemic chemotherapeutics/cytostatic drugs
    2. (> 5 mg/d prednisolone or equivalent)
    3. Methotrexate, ciclosporin, azathioprine
  17. Other drugs and interventions that may cause interactions with Vitamin C, including

    1. Fluphenazine
    2. Cumarine derivates
    3. Radiation therapy
  18. Nephrotoxic drugs, that may, according to the investigator's discretion, impair renal function
  19. Any other non-drug treatment of the acute herpes zoster
  20. Known to the pharmacologic active constituents or any other ingredient of the study medication
  21. 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.
  22. Mental or physical disability or imprisonment
Terms in these criteria, in plain language(11)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
12 participants (actual)

Study arms

  • Placebo comparator
    Group 1 (control group)

    300 ml NaCl infusion

    Drug: Vitamin C

  • Experimental
    Group 2 (750 mg Vitamin C)

    295 ml NaCl + 5 ml (750 mg) Vitamin C

    Drug: Vitamin C

  • Experimental
    Group 3 (7.5 g Vitamin C)

    250 ml NaCl + 1 x 50 ml (7.5 g) Vitamin C

    Drug: Vitamin C

  • Experimental
    Group 4 (15 g Vitamin C)

    200 ml NaCl + 2 x 50 ml (2 x 7.5 g) Vitamin C

    Drug: Vitamin C

Interventions

06

What researchers measure

Primary outcomes

  1. Mean neuropathic pain

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

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

Secondary outcomes

  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)

    Time frame: 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)

    Time frame: 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

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

07

Study locations

3 sites
  • dermatologisches zentrum Bonn
    Bonn, Hessen 53111, Germany
  • Universitätsklinikum Frankfurt am Main
    Frankfurt am Main, Hessen 60590, Germany
  • Hautklinik der Universitätsmedizin Mainz KöR
    Mainz, Hessen 55101, Germany
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 7, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05561257
Lead sponsor
Pascoe Pharmazeutische Praeparate GmbH
Responsible party
Sponsor
First posted
Sep 30, 2022
Start date
Jul 20, 2020
Primary completion
Feb 28, 2024
Completion
Feb 28, 2024
Last update
Nov 7, 2024

Study contacts

Holger Michels
study director · Pascoe Pharmazeutische Praeparate GmbH
Andraes Pinter, Dr.
principal investigator · Universitätsklinik Frankfurt am Main

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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