TO STUDY THE PERIPHERAL EFFECT OF BOTULINUM TOXIN-A (BOTOX-A) ON EXPERIMENTALLY INDUCED CUTANEOUS PAIN IN HEALTHY SUBJECTS

Phase 1

• Conditions: There is no medical condition- the study is done on healthy humans.

• Registration Number: EUCTR2006-001251-35-DK
• Lead Sponsor: Aalborg University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-06-26
• Last Update Posted: 3 April 2017

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Male
• Target Recruitment: 30

Inclusion Criteria

1.Signed and dated Written Informed Consent

2.Male, 18 40 years of age

3.No concomitant medical diseases or clinically significant abnormal findings based on the medical history and baseline physical examination, that could affect the conduct of the study, analysis of the data, or the safety of a subject, as determined by the investigator.

4.In the opinion of the investigator, the subject clearly understands the intent of the study and is willing and able to comply with study instructions, is available for study visits and procedures and is anticipated to complete the entire study

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Any medical condition that may put the subject at increased risk with exposure to Botox, such as myasthenia gravis, Lambert-Eaton syndrome, amyotrophic lateral sclerosis or any other significant disease that might interfere with neuromuscular function, including peripheral neuropathies.

2.Concurrent use or use within 30 days of screening of aminoglycoside antibiotics, curare like agents or other agents that might interfere with neuromuscular function

3.Known allergy or sensitivity to any of the ingredients in the study medication or any clinical supply materials.

4.Current or previous participation in another investigational drug or device study within 30 days prior to screening.

5.Current or previous use of any serotype of botulinum toxin, or anticipated need for treatment with or use of any serotype of botulinum toxin during the study (other than the study medication).

6.Recent history of drug or alcohol abuse.

7.Indications which in the investigator’s opinion, indicates inappropriate/illicit substance abuse, an underlying significant medical condition or which might interfere with the subject’s participation in the study.

8.Infection or dermatological condition at the sites of study medication injection or test site.

9.Family history of hereditary neuropathy.

10.Any disease associated with a peripheral neuropathy (diabetes, etc.)

11.Anticipated need for a medical procedure, surgery or overnight hospitalization during the study

12.Concurrent use of any drug

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified