MedTrace Logo

Safety and Efficacy Predimenol for Headache

NCT06558006 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-02-07

No results posted yet for this study

Summary

This is a prospective, double-blind, placebo-controlled and randomized study aimed to obtain a description of the efficacy and safety of Predimenol in alleviating headache.

Conditions

Interventions

DRUG

Predimenol tablet

2 tablets of Predimenol (400 mg Predimenol) will be taken with 220 mL of water (one glass of water).

DRUG

Predimenol tablet + Placebo tablet of Predimenol

1 tablet of Predimenol (200 mg Predimenol) + 1 tablet of placebo will be taken with 220 mL of water (one glass of water).

DRUG

Placebo tablet of Predimenol

2 tablets of placebo tablet of Predimenol will be taken with 220 mL of water (one glass of water).

Sponsors & Collaborators

  • Fakultas Kedokteran Universitas Indonesia

    collaborator OTHER

  • Dexa Medica Group

    lead INDUSTRY

Principal Investigators

  • Nalfriadi Nalfriadi, MD,SpPD,PhD · Department Pharmacology & Therapeutics Faculty of Medicine Universitas Indonesia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-19
Primary Completion
2024-10-15
Completion
2024-10-15

Countries

  • Indonesia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06558006 on ClinicalTrials.gov