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

NCT05561257 | Terminated Phase 2

• 1 other identifier: 218S18VC
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 3

Brief 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

Conditions

Neuropathic Pain

Outcome Measures

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

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

Secondary Outcomes (3)

• Number of standard doses of permitted concomitant analgesic medication

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

• AUC of equianalgesic doses of permitted concomitant analgesic medication

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

• Presence of a Post-herpetic neuralgia

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

Study Arms (4)

Group 1 (control group)

PLACEBO COMPARATOR

300 ml NaCl infusion

Drug: Vitamin C

Group 2 (750 mg Vitamin C)

EXPERIMENTAL

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

Drug: Vitamin C

Group 3 (7.5 g Vitamin C)

EXPERIMENTAL

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

Drug: Vitamin C

Group 4 (15 g Vitamin C)

EXPERIMENTAL

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

Drug: Vitamin C

Interventions

Vitamin C DRUG

Vitamin C

Group 1 (control group); Group 2 (750 mg Vitamin C); Group 3 (7.5 g Vitamin C); Group 4 (15 g Vitamin C)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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®
• 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

Sponsors & Collaborators

• Pascoe Pharmazeutische Praeparate GmbH: lead

Study Sites (3)

dermatologisches zentrum Bonn

Bonn, Hesse, 53111, Germany

Location

Universitätsklinikum Frankfurt am Main

Frankfurt am Main, Hesse, 60590, Germany

Location

Hautklinik der Universitätsmedizin Mainz KöR

Mainz, Hesse, 55101, Germany

Location

MeSH Terms

Conditions

Neuralgia

Interventions

Ascorbic Acid

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates

Study Officials

• Holger Michels

  Pascoe Pharmazeutische Praeparate GmbH

  STUDY DIRECTOR

• Andraes Pinter, Dr.

  Universitätsklinik Frankfurt am Main

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2022
• First Posted: September 30, 2022
• Study Start: July 20, 2020
• Primary Completion: February 28, 2024
• Study Completion: February 28, 2024
• Last Updated: November 7, 2024

Record last verified: 2024-11

Locations

DE (3)