Botulinum Toxin Type A in Treatment of Cranial Allodynia in Patients With Headache

NCT01357798 | Completed Phase 3

• 1 other identifier: LHUFBA001
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is evaluated if the Botulinum Toxin Type A is superior to 0,9% saline in treatment of cranial Allodynia in patients with headache. Hypothesis H(0): Botulinum Toxin Type A is not superior to 0,9% saline in treatment of cranial Allodynia in patients with headache H (1): Botulinum Toxin Type A is superior to 0,9% saline in treatment of cranial Allodynia in patients with headache

Conditions

Headache; Allodynia

Keywords

Headache; Allodynia; Botulinum Toxin Type A

Outcome Measures

Primary Outcomes (1)

• Evaluate the allodynea's improvement following these criteria

  Evaluate the allodynea's improvement following these criteria: Disappearing at least 50% infiltrated painful points.

  six months

Secondary Outcomes (1)

• Evaluate the headache's improvement following these criteria:

  six months

Study Arms (2)

Btx-A: Active Comparator

ACTIVE COMPARATOR

Botulinum Toxin group Will have the syringe with Botulinum toxin type A . During the study the patients will be following in the headache's clinic where the evaluator will graduate the pathologies' evolution.

Drug: Botulinum toxin type A

Placebo Comparator

PLACEBO COMPARATOR

0,9% saline group Will have the syringe with 0,9% saline. During the study the patients will be following in the headache's clinic where the evaluator will graduate the pathologies' evolution .

Drug: 0,9% saline

Interventions

Botulinum toxin type A DRUG

Botulinum Toxin group Will have the syringe with Botulinum toxin type A . During the study the patients will be following in the headache's clinic where the evaluator will graduate the pathologies' evolution.

Btx-A: Active Comparator

0,9% saline DRUG

0,9% saline group Will have the syringe with 0,9% saline. During the study the patients will be following in the headache's clinic where the evaluator will graduate the pathologies' evolution .

Placebo Comparator

Eligibility Criteria

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

You may qualify if:

• Patients diagnosed with tensional headache or migraine as The International Classification of Headache Disorders, 2nd Edition - ICHD II
• Patients from both sexes older than 18 years

You may not qualify if:

• Fill the diagnostics criteria for more than one type of primary headache as ICHD II
• Another neurological disease or systemic illness that causes headache.
• Condition that contraindicate the use of Study's Medication.
• Cognitive impairment
• Use of botulinum toxin within the last six months
• Blood, liver, or kidney disorders and pregnant or lactating women

Sponsors & Collaborators

• Federal University of Bahia: lead

Study Sites (1)

Hospital Universitário Alcides Carneiro

Campina Grande, Paraíba, 58100000, Brazil

Location

MeSH Terms

Conditions

Headache; Hyperalgesia

Interventions

Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Somatosensory Disorders; Sensation Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 19, 2011
• First Posted: May 23, 2011
• Study Start: December 1, 2010
• Primary Completion: April 1, 2011
• Last Updated: May 23, 2011

Record last verified: 2011-05

Locations

BR (1)