Study to Assess the Efficacy of Botulinum Toxin B (Myobloc) for the Treatment of Prosthesis-associated Sweating

NCT01671800 | Completed Phase 1

• 1 other identifier: 20548
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to determine if Myobloc significantly decreases prosthesis-associated symptomatic sweating in amputees when compared to a saline solution placebo. The study is randomized, double-blind, placebo-controlled, crossover trial with a total enrollment of 32 amputee subjects.

Conditions

Hyperhidrosis

Keywords

Hyperhidrosis; Botulinum Toxin; Amputation; Phantom limb pain

Outcome Measures

Primary Outcomes (1)

• Amount of sweating

  The amount of sweating will be assessed via gravimetry, which is an accepted method for determining sweating in a particular area. This method involves covering the area of the residual limb in question with filter paper for five minutes. After five minutes, the filter paper is removed and weighed. The weight of the dry filter paper is subtracted to give the approximate weight of the sweat produced. This study will use the total weight of sweat produced as a method of objectively quantifying the amount of sweating in the residual limb. Gravimetry will be used as a measure of change from pre-treatment to post-treatment.

  one month after initial injection

Study Arms (2)

Botulinum Type B (Myobloc)

EXPERIMENTAL

Each vial of active drug will contain 5000 unit/ml of Myobloc, with a total volume of 1 mL. The injections will be spaces 6 cm apart and will cover the entire area to be injected. Each site will receive a volume of 0.08 ml (400 units).

Drug: Botulinum Type B

Saline solution

PLACEBO COMPARATOR

The volume to be injected will be calculated assuming the injectate is an active drug, and will therefore be an equivalent volume as an active drug (i.e. 0.08 mL per injection site with a 6 cm spacing interval)

Drug: Placebo

Interventions

Botulinum Type B DRUG

Also known as: Myobloc

Botulinum Type B (Myobloc)

Placebo DRUG

Saline solution

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female, 18-50 years of age, active duty or retired military
• Limb amputation (single or multiple:for lower extremity amputees, amputation at the ankle or above; for upper extremity amputees, amputation at the wrist or above)
• Clear history of excessive sweating in a residual limb that is interfering with prosthesis fitting and functioning. This will be defined as focal, visible sweating in the region of the residual limb with at least one of the following characteristics: impairs prosthesis fitting, impairs functioning with a limb prosthesis
• Negative urine pregnancy test prior to the administration of study medication (for females)

You may not qualify if:

• Age less than 18 or greater than 50
• Any medical condition that may put the participant at increased risk with exposure to Myobloc, including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis/motor neuron disease, neuropathy, renal stones, or any other disorder that may interfere with neuromuscular function
• Females who are pregnant, breast feeding, or planning a pregnancy during the study, or who think they may be pregnant at the start of the study
• Known allergy or sensitivity to any of the components in the study medication
• Known sensitivity to human albumin or albumin transfusions
• Current or planned use of aminoglycosides
• Systemic medical conditions (such as thyroid disease, hypertension, bleeding disorders, diabetes, cancers, etc.) that are not currently medically managed or controlled
• Current or planned use of a myoelectric prostheses (for upper extremity amputees), as the potential for weakness caused by botulinum toxin could interfere with muscle contraction
• Concurrent participation in another investigational drug or device study, or participation in the 30 days immediately prior to study enrollment
• Any condition or situation, in the investigator's opinion, that may put the participant at significant risk, confound the study results, or interfere significantly with the participant's ability to participate in the study
• Any previous use of Myobloc, Dysport, or BOTOX

Sponsors & Collaborators

• Henry M. Jackson Foundation for the Advancement of Military Medicine: lead
• Walter Reed National Military Medical Center: collaborator

Study Sites (1)

Walter Reed National Military Medical Center

Bethesda, Maryland, 20889, United States

Location

Related Publications (5)

• Kern U, Kohl M, Seifert U, Schlereth T. Botulinum toxin type B in the treatment of residual limb hyperhidrosis for lower limb amputees: a pilot study. Am J Phys Med Rehabil. 2011 Apr;90(4):321-9. doi: 10.1097/PHM.0b013e31820636fd.

  PMID: 21765248 BACKGROUND

• Baumann LS, Halem ML. Botulinum toxin-B and the management of hyperhidrosis. Clin Dermatol. 2004 Jan-Feb;22(1):60-5. doi: 10.1016/j.clindermatol.2003.11.001.

  PMID: 15158547 BACKGROUND

• Hund M, Kinkelin I, Naumann M, Hamm H. Definition of axillary hyperhidrosis by gravimetric assessment. Arch Dermatol. 2002 Apr;138(4):539-41. doi: 10.1001/archderm.138.4.539. No abstract available.

  PMID: 11939828 BACKGROUND

• Flynn TC, Clark RE 2nd. Botulinum toxin type B (MYOBLOC) versus botulinum toxin type A (BOTOX) frontalis study: rate of onset and radius of diffusion. Dermatol Surg. 2003 May;29(5):519-22; discussion 522. doi: 10.1046/j.1524-4725.2003.29124.x.

  PMID: 12752521 BACKGROUND

• Baumann L, Slezinger A, Halem M, Vujevich J, Mallin K, Charles C, Martin LK, Black L, Bryde J. Double-blind, randomized, placebo-controlled pilot study of the safety and efficacy of Myobloc (botulinum toxin type B) for the treatment of palmar hyperhidrosis. Dermatol Surg. 2005 Mar;31(3):263-70. doi: 10.1111/j.1524-4725.2005.31071.

  PMID: 15841624 BACKGROUND

MeSH Terms

Conditions

Hyperhidrosis; Phantom Limb

Interventions

rimabotulinumtoxinB

Condition Hierarchy (Ancestors)

Sweat Gland Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Pain, Postoperative; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain

Study Officials

• Paul F. Pasquina, M.D.

  Walter Reed National Military Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2012
• First Posted: August 24, 2012
• Study Start: September 1, 2008
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: January 10, 2013

Record last verified: 2013-01

Locations

US (1)